<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/NCT02968849</url>
  </required_header>
  <id_info>
    <org_study_id>HVTN 702</org_study_id>
    <nct_id>NCT02968849</nct_id>
  </id_info>
  <brief_title>Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa</brief_title>
  <acronym>HVTN702</acronym>
  <official_title>A Pivotal Phase 2b/3 Multisite, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59 in Preventing HIV-1 Infection in Adults in South Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the preventive vaccine efficacy, safety, and tolerability of&#xD;
      ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults&#xD;
      over 24 months and potentially up to 36 months from enrollment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the preventive vaccine efficacy, safety, and tolerability of the&#xD;
      ALVAC-HIV vaccine + Bivalent Subtype C gp120 protein adjuvanted with MF59 in HIV-seronegative&#xD;
      South African adults over 24 months from enrollment.&#xD;
&#xD;
      Participants will be randomized to receive ALVAC-HIV (vCP2438), or placebo, by intramuscular&#xD;
      injection at weeks 0 and 4; they will receive ALVAC-HIV (vCP2438) + Bivalent Subtype C&#xD;
      gp120/MF59, or placebo, by IM injection at weeks 12, 24, and 52.&#xD;
&#xD;
      In addition to the vaccination visits, participants will attend study visits at weeks 26, 39,&#xD;
      54, 65, 78, 91, 104, 117, 130, 142, and 156. All study visits, including vaccination visits,&#xD;
      will include HIV risk reduction counseling, a physical exam, and an interview/questionnaire.&#xD;
      and pregnancy testing for participants capable of becoming pregnant. Select study visits will&#xD;
      include a medical history review, physical exam, blood collection, urine collection, HIV&#xD;
      testing, and pregnancy testing for participants capable of becoming pregnant.&#xD;
&#xD;
      As of February 3, 2020, vaccinations for this study were suspended. Participants have been&#xD;
      asked to continue attending follow-up visits for 12 months after the last vaccination they&#xD;
      received. Participants who become HIV infected will be followed for 6 months after diagnosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2016</start_date>
  <completion_date type="Actual">November 16, 2021</completion_date>
  <primary_completion_date type="Actual">November 16, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment</measure>
    <time_frame>Measured through 24 months after first vaccination</time_frame>
    <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness</measure>
    <time_frame>Measured through 3 full days following each vaccination</time_frame>
    <description>Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration</measure>
    <time_frame>Measured through 3 full days following each vaccination</time_frame>
    <description>Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms</measure>
    <time_frame>Measured through 3 full days following each vaccination</time_frame>
    <description>Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product</measure>
    <time_frame>Measured through 30 days after each vaccination</time_frame>
    <description>For participants reporting multiple AEs over the time frame, the maximum relationship is counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Reporting Adverse Events (AEs), by Severity Grade</measure>
    <time_frame>Measured through 30 days after each vaccination</time_frame>
    <description>For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Reporting Serious Adverse Events (SAEs)</measure>
    <time_frame>Measured through 12 months after last vaccination</time_frame>
    <description>Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Reporting Adverse Events of Special Interest (AESIs)</measure>
    <time_frame>Measured through 12 months after last vaccination</time_frame>
    <description>Adverse events of special interest (AESI) were described in Appendix J of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Reporting New Chronic Medical Conditions</measure>
    <time_frame>Measured through 12 months after last vaccination</time_frame>
    <description>A new chronic medical condition is defined as a new onset or exacerbation of medical condition requiring 2 or more visits to a medical provider during a period of at least 30 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Early Study Termination Associated With an AE or Reactogenicity</measure>
    <time_frame>Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)</time_frame>
    <description>From the termination form, early study termination associated with an AE or reactogenicity reasons are tabulated by treatment group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity</measure>
    <time_frame>Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)</time_frame>
    <description>From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up</measure>
    <time_frame>Measured through 36 months after first vaccination</time_frame>
    <description>Per the 23 January 2020 DSMB finding that monitoring boundaries for non-efficacy have been met, Primary outcome 1 has been superseded by this primary outcome. Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 36 Months Post Enrollment</measure>
    <time_frame>Measured through 36 months after first vaccination</time_frame>
    <description>This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment</measure>
    <time_frame>Measured after Month 6.5 through 24 months after first vaccination</time_frame>
    <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5</measure>
    <time_frame>Measured at Month 6.5</time_frame>
    <description>PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5</measure>
    <time_frame>Measured at Month 6.5</time_frame>
    <description>PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5</measure>
    <time_frame>Measured at Month 6.5</time_frame>
    <description>PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5</measure>
    <time_frame>Measured at Month 6.5</time_frame>
    <description>PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5</measure>
    <time_frame>Measured at Month 6.5</time_frame>
    <description>Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution.The readout is background-subtracted mean fluorescent intensity(MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1,and net MFI &gt; 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5</measure>
    <time_frame>Measured at Month 6.5</time_frame>
    <description>Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:40 dilution.The readout is background-subtracted mean fluorescent intensity(MFI), with background adjustment for an antigen-specific plate level control.For each sample, response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline M</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5</measure>
    <time_frame>Measured at Month 6.5</time_frame>
    <description>Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:10 dilution.The readout is background-subtracted mean fluorescent intensity (MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5</measure>
    <time_frame>Measured at Month 6.5</time_frame>
    <description>Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 and 1:100 dilutions. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5</measure>
    <time_frame>Measured at Month 6.5</time_frame>
    <description>Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5</measure>
    <time_frame>Measured at Month 6.5</time_frame>
    <description>Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants</measure>
    <time_frame>Measured through 24 months after first vaccination</time_frame>
    <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Male Participants</measure>
    <time_frame>Measured through 24 months after first vaccination</time_frame>
    <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Aged 25 or Younger</measure>
    <time_frame>Measured through 24 months after first vaccination</time_frame>
    <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Older Than 25</measure>
    <time_frame>Measured through 24 months after first vaccination</time_frame>
    <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through Month 24 by Genotypic Characteristics of Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis, Such As Signature Site Mutations</measure>
    <time_frame>Measured through 24 months after first vaccination</time_frame>
    <description>Analysis will only be performed if significant positive evidence of vaccine efficacy from enrollment through 24 months is seen. However, monitoring boundaries for non-efficacy have been met per the 23 January 2020 DSMB finding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis</measure>
    <time_frame>Measured at the earliest post-infection time-point</time_frame>
    <description>The sieve analysis will be conducted using updates of the methods that were used for the Step (Rolland et al., 2011) and RV144 HIV vaccine efficacy trials.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5404</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>ALVAC-HIV + subtype C gp120/MF59</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2700 participants will receive an IM injection of ALVAC-HIV (vCP2438) at months 0 and 1, and an IM injection of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, and 12.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2700 participants will receive Sodium Chloride for injection, 0.9% at months 0, 1, 3, 6, and 12.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALVAC-HIV (vCP2438)</intervention_name>
    <description>Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a dose &gt; 10^6 cell culture infectious dose 50% (CCIDv50) and &lt; 1 × 10^8 CCIDv50 (nominal dose of 10^7 CCIDv50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%) delivered IM</description>
    <arm_group_label>ALVAC-HIV + subtype C gp120/MF59</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Bivalent Subtype C gp120/MF59</intervention_name>
    <description>Subtype C TV1.C gp120 Env and 1086.C gp120 Env proteins, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion) and delivered IM</description>
    <arm_group_label>ALVAC-HIV + subtype C gp120/MF59</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sodium Chloride for injection, 0.9% delivered IM</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Age of 18 to 35 years&#xD;
&#xD;
          -  Sexually active, defined as having had sexual intercourse at least twice in the past&#xD;
             30 days prior to screening, and is considered by the site staff to be at risk for HIV&#xD;
             infection.&#xD;
&#xD;
          -  Access to a participating HVTN CRS and willingness to be followed for the planned&#xD;
             duration of the study&#xD;
&#xD;
          -  Ability and willingness to provide informed consent&#xD;
&#xD;
          -  Assessment of understanding: volunteer demonstrates understanding of this study prior&#xD;
             to first vaccination with verbal demonstration of understanding of all questions.&#xD;
&#xD;
          -  Agrees not to enroll in another study of an investigational research agent until the&#xD;
             participant is unblinded or their study participation ends, whichever occurs last&#xD;
&#xD;
          -  Good general health as shown by medical history, physical exam, and screening&#xD;
             laboratory tests&#xD;
&#xD;
          -  Willingness to receive HIV test results&#xD;
&#xD;
          -  Willingness to discuss HIV infection risks and willing to receive HIV risk reduction&#xD;
             counseling.&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) &lt; 2.5 times the institutional upper limit of normal&#xD;
&#xD;
          -  Negative HIV-1 and -2 blood test within 30 days prior to enrollment: Sites may use&#xD;
             locally available assays that have been approved by HVTN Laboratory Operations.&#xD;
&#xD;
          -  Volunteers who were born female: negative serum or urine beta human chorionic&#xD;
             gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of&#xD;
             initial vaccination. Persons who are NOT of reproductive potential due to having&#xD;
             undergone total hysterectomy or bilateral oophorectomy (verified by medical records),&#xD;
             are not required to undergo pregnancy testing.&#xD;
&#xD;
          -  Reproductive status: A volunteer who was born female must:&#xD;
&#xD;
               -  Agree to consistently use effective contraception (Appendix B and Appendix C) for&#xD;
                  sexual activity that could lead to pregnancy from at least 21 days prior to&#xD;
                  enrollment through 3 months after the last vaccination. Effective contraception&#xD;
                  is defined as using 2 methods of birth control. These include 1 of the following&#xD;
                  methods:&#xD;
&#xD;
                    -  Condoms (male or female)&#xD;
&#xD;
                    -  Diaphragm or cervical cap&#xD;
&#xD;
        PLUS 1 of the following methods:&#xD;
&#xD;
          -  Intrauterine device (IUD),&#xD;
&#xD;
          -  Hormonal contraception (in accordance with applicable national contraception&#xD;
             guidelines), or&#xD;
&#xD;
          -  Successful vasectomy in the male partner (considered successful if a volunteer reports&#xD;
             that a male partner has [1] documentation of azoospermia by microscopy, or [2] a&#xD;
             vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity&#xD;
             postvasectomy), or&#xD;
&#xD;
          -  Any other contraceptive method approved by the protocol safety review team;&#xD;
&#xD;
               -  Or not be of reproductive potential, such as having been diagnosed with premature&#xD;
                  menopause (with no menses for 1 year) or having undergone hysterectomy, bilateral&#xD;
                  oophorectomy, or tubal ligation.&#xD;
&#xD;
                    -  Volunteers who were born female must also agree not to seek pregnancy&#xD;
                       through alternative methods, such as artificial insemination or in vitro&#xD;
                       fertilization until 3 months after the last vaccination&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Blood products received within 90 days before first vaccination&#xD;
&#xD;
          -  Investigational research agents received within 30 days before first vaccination&#xD;
&#xD;
          -  Intent to participate in another study of an investigational research agent or any&#xD;
             other study that requires non-HVTN HIV antibody testing during the planned duration of&#xD;
             the study&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received&#xD;
             control/placebo in an HIV vaccine trial, the HVTN 702 PSRT will determine eligibility&#xD;
             on a case-by-case basis.&#xD;
&#xD;
          -  Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine&#xD;
             trial. Exceptions may be made for vaccines that have subsequently undergone licensure.&#xD;
             For volunteers who have received control/placebo in an experimental vaccine trial, the&#xD;
             protocol safety review team will determine eligibility on a case-by-case basis. For&#xD;
             volunteers who have received an experimental vaccine(s) greater than 5 years ago,&#xD;
             eligibility for enrollment will be determined by the protocol safety review team on a&#xD;
             case-by-case basis.&#xD;
&#xD;
          -  Live attenuated vaccines other than influenza vaccine received within 30 days before&#xD;
             first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and&#xD;
             rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)&#xD;
&#xD;
          -  Influenza vaccine or any vaccines that are not live attenuated vaccines and were&#xD;
             received within 14 days prior to first vaccination (eg, tetanus, pneumococcal,&#xD;
             Hepatitis A or B)&#xD;
&#xD;
          -  Immunosuppressive medications received within 168 days before first vaccination. (Not&#xD;
             exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical&#xD;
             corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of&#xD;
             oral/parenteral corticosteroids at doses &lt; 2 mg/kg/day and length of therapy &lt; 11 days&#xD;
             with completion at least 30 days prior to enrollment.)&#xD;
&#xD;
          -  Serious adverse reactions to vaccines or to vaccine components such as eggs, egg&#xD;
             products, or neomycin including history of anaphylaxis and related symptoms such as&#xD;
             hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from&#xD;
             participation: a volunteer who had a non-anaphylactic adverse reaction to pertussis&#xD;
             vaccine as a child.)&#xD;
&#xD;
          -  Immunoglobulin received within 60 days before first vaccination&#xD;
&#xD;
          -  Immunodeficiency&#xD;
&#xD;
          -  Clinically significant medical condition, physical examination findings, clinically&#xD;
             significant abnormal laboratory results, or past medical history with clinically&#xD;
             significant implications for current health. A clinically significant condition or&#xD;
             process includes but is not limited to:&#xD;
&#xD;
               -  A process that would affect the immune response,&#xD;
&#xD;
               -  A process that would require medication that affects the immune response,&#xD;
&#xD;
               -  Any contraindication to repeated injections or blood draws,&#xD;
&#xD;
               -  A condition that requires active medical intervention or monitoring to avert&#xD;
                  grave danger to the volunteer's health or well-being during the study period,&#xD;
&#xD;
               -  A condition or process for which signs or symptoms could be confused with&#xD;
                  reactions to vaccine, or&#xD;
&#xD;
               -  Any condition specifically listed among the exclusion criteria below.&#xD;
&#xD;
          -  Any medical, psychiatric, occupational, or other condition that, in the judgment of&#xD;
             the investigator, would interfere with, or serve as a contraindication to, protocol&#xD;
             adherence, assessment of safety or reactogenicity, or a volunteer's ability to give&#xD;
             informed consent&#xD;
&#xD;
          -  Psychiatric condition that precludes compliance with the protocol. Specifically&#xD;
             excluded are persons with psychoses within the past 3 years, ongoing risk for suicide,&#xD;
             or history of suicide attempt or gesture within the past 3 years.&#xD;
&#xD;
          -  Active tuberculosis (TB) disease&#xD;
&#xD;
          -  Uncontrolled hypertension: systolic blood pressure (SBP) ≥ 160 mm Hg or diastolic&#xD;
             blood pressure (DBP) ≥ 100 mm Hg&#xD;
&#xD;
          -  Bleeding disorder (diagnosed by a doctor) contraindicating IM injection and/or blood&#xD;
             draws, based on investigator's judgment&#xD;
&#xD;
          -  Malignancy (Not excluded from participation: Volunteer who has had malignancy excised&#xD;
             surgically and who, in the investigator's estimation, has a reasonable assurance of&#xD;
             sustained cure or who is unlikely to experience recurrence of malignancy during the&#xD;
             period of the study)&#xD;
&#xD;
          -  History of hereditary angioedema, acquired angioedema, or idiopathic angioedema&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glenda Gray, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Perinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Walter Sisulu University HIV Vaccine Research Unit CRS</name>
      <address>
        <city>Mthatha</city>
        <state>Eastern Cape</state>
        <zip>5099</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliptown Soweto CRS</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>1409</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurum Tembisa CRS</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>1632</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soweto HVTN CRS</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>1862</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MeCRU CRS</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0204</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Setshaba Research Centre CRS</name>
      <address>
        <city>Soshanguve</city>
        <state>Gauteng</state>
        <zip>0152</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>eThekwini CRS</name>
      <address>
        <city>Durban</city>
        <state>Kwa Zulu Natal</state>
        <zip>4013</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isipingo CRS</name>
      <address>
        <city>Isipingo</city>
        <state>Kwa Zulu Natal</state>
        <zip>4110</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qhakaza Mbokodo Research Clinic CRS</name>
      <address>
        <city>Ladysmith</city>
        <state>Kwa Zulu Natal</state>
        <zip>3370</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Verulam CRS</name>
      <address>
        <city>Verulam</city>
        <state>Kwa Zulu Natal</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurum Institute Klerksdorp CRS</name>
      <address>
        <city>Klerksdorp</city>
        <state>North West Province</state>
        <zip>2571</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rustenburg CRS</name>
      <address>
        <city>Rustenburg</city>
        <state>North West Province</state>
        <zip>0300</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emavundleni CRS</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7750</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khayelitsha CRS</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7784</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <reference>
    <citation>Gray GE, Bekker LG, Laher F, Malahleha M, Allen M, Moodie Z, Grunenberg N, Huang Y, Grove D, Prigmore B, Kee JJ, Benkeser D, Hural J, Innes C, Lazarus E, Meintjes G, Naicker N, Kalonji D, Nchabeleng M, Sebe M, Singh N, Kotze P, Kassim S, Dubula T, Naicker V, Brumskine W, Ncayiya CN, Ward AM, Garrett N, Kistnasami G, Gaffoor Z, Selepe P, Makhoba PB, Mathebula MP, Mda P, Adonis T, Mapetla KS, Modibedi B, Philip T, Kobane G, Bentley C, Ramirez S, Takuva S, Jones M, Sikhosana M, Atujuna M, Andrasik M, Hejazi NS, Puren A, Wiesner L, Phogat S, Diaz Granados C, Koutsoukos M, Van Der Meeren O, Barnett SW, Kanesa-Thasan N, Kublin JG, McElrath MJ, Gilbert PB, Janes H, Corey L; HVTN 702 Study Team. Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120-MF59 in Adults. N Engl J Med. 2021 Mar 25;384(12):1089-1100. doi: 10.1056/NEJMoa2031499.</citation>
    <PMID>33761206</PMID>
  </reference>
  <reference>
    <citation>Moodie Z, Dintwe O, Sawant S, Grove D, Huang Y, Janes H, Heptinstall J, Omar FL, Cohen K, De Rosa SC, Zhang L, Yates NL, Sarzotti-Kelsoe M, Seaton KE, Laher F, Bekker LG, Malahleha M, Innes C, Kassim S, Naicker N, Govender V, Sebe M, Singh N, Kotze P, Lazarus E, Nchabeleng M, Ward AM, Brumskine W, Dubula T, Randhawa AK, Grunenberg N, Hural J, Kee JJ, Benkeser D, Jin Y, Carpp LN, Allen M, D'Souza P, Tartaglia J, DiazGranados CA, Koutsoukos M, Gilbert PB, Kublin JG, Corey L, Andersen-Nissen E, Gray GE, Tomaras GD, McElrath MJ. Analysis of the HIV Vaccine Trials Network 702 Phase 2b-3 HIV-1 Vaccine Trial in South Africa Assessing RV144 Antibody and T-Cell Correlates of HIV-1 Acquisition Risk. J Infect Dis. 2022 Aug 24;226(2):246-257. doi: 10.1093/infdis/jiac260.</citation>
    <PMID>35758878</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>November 16, 2022</results_first_submitted>
  <results_first_submitted_qc>January 13, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2023</results_first_posted>
  <last_update_submitted>April 14, 2023</last_update_submitted>
  <last_update_submitted_qc>April 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT02968849/Prot_ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT02968849/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Vaccine</title>
          <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2704"/>
                <participants group_id="P2" count="2700"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Modified Intent-to-Treat (MITT) Cohort</title>
              <participants_list>
                <participants group_id="P1" count="2695"/>
                <participants group_id="P2" count="2689"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>MITT Infected Cohort</title>
              <participants_list>
                <participants group_id="P1" count="151"/>
                <participants group_id="P2" count="143"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Week 26 At-Risk Cohort</title>
              <participants_list>
                <participants group_id="P1" count="2430"/>
                <participants group_id="P2" count="2393"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Immunogenicity Cohort</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2557"/>
                <participants group_id="P2" count="2557"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="143"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Unable to Adhere to Visit Schedule</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Cohort</population>
      <group_list>
        <group group_id="B1">
          <title>Vaccine</title>
          <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2704"/>
            <count group_id="B2" value="2700"/>
            <count group_id="B3" value="5404"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2704"/>
                    <count group_id="B2" value="2700"/>
                    <count group_id="B3" value="5404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24" lower_limit="18" upper_limit="35"/>
                    <measurement group_id="B2" value="23" lower_limit="18" upper_limit="35"/>
                    <measurement group_id="B3" value="24" lower_limit="18" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2704"/>
                    <count group_id="B2" value="2700"/>
                    <count group_id="B3" value="5404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26" lower_limit="18" upper_limit="35"/>
                    <measurement group_id="B2" value="26" lower_limit="18" upper_limit="35"/>
                    <measurement group_id="B3" value="26" lower_limit="18" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <population>Age categories are summarized separately within females and males.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1893"/>
                    <count group_id="B2" value="1893"/>
                    <count group_id="B3" value="3786"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>18 - 20 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="349"/>
                    <measurement group_id="B2" value="392"/>
                    <measurement group_id="B3" value="741"/>
                  </measurement_list>
                </category>
                <category>
                  <title>21 - 25 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="917"/>
                    <measurement group_id="B2" value="877"/>
                    <measurement group_id="B3" value="1794"/>
                  </measurement_list>
                </category>
                <category>
                  <title>26 - 30 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="465"/>
                    <measurement group_id="B2" value="461"/>
                    <measurement group_id="B3" value="926"/>
                  </measurement_list>
                </category>
                <category>
                  <title>31 - 35 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="162"/>
                    <measurement group_id="B2" value="163"/>
                    <measurement group_id="B3" value="325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="811"/>
                    <count group_id="B2" value="807"/>
                    <count group_id="B3" value="1618"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>18 - 20 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="212"/>
                  </measurement_list>
                </category>
                <category>
                  <title>21 - 25 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="271"/>
                    <measurement group_id="B2" value="276"/>
                    <measurement group_id="B3" value="547"/>
                  </measurement_list>
                </category>
                <category>
                  <title>26 - 30 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="244"/>
                    <measurement group_id="B2" value="254"/>
                    <measurement group_id="B3" value="498"/>
                  </measurement_list>
                </category>
                <category>
                  <title>31 - 35 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="182"/>
                    <measurement group_id="B2" value="179"/>
                    <measurement group_id="B3" value="361"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2704"/>
                    <count group_id="B2" value="2700"/>
                    <count group_id="B3" value="5404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1893"/>
                    <measurement group_id="B2" value="1893"/>
                    <measurement group_id="B3" value="3786"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="811"/>
                    <measurement group_id="B2" value="807"/>
                    <measurement group_id="B3" value="1618"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2704"/>
                    <count group_id="B2" value="2700"/>
                    <count group_id="B3" value="5404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2704"/>
                    <measurement group_id="B2" value="2700"/>
                    <measurement group_id="B3" value="5404"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2704"/>
                    <count group_id="B2" value="2700"/>
                    <count group_id="B3" value="5404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2672"/>
                    <measurement group_id="B2" value="2676"/>
                    <measurement group_id="B3" value="5348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Colored/Mixed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2704"/>
                    <count group_id="B2" value="2700"/>
                    <count group_id="B3" value="5404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2704"/>
                    <count group_id="B2" value="2700"/>
                    <count group_id="B3" value="5404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2704"/>
                    <count group_id="B2" value="2700"/>
                    <count group_id="B3" value="5404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2704"/>
                    <count group_id="B2" value="2700"/>
                    <count group_id="B3" value="5404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2704"/>
                    <count group_id="B2" value="2700"/>
                    <count group_id="B3" value="5404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Not Reported</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2704"/>
                    <count group_id="B2" value="2700"/>
                    <count group_id="B3" value="5404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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>South Africa</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2704"/>
                    <count group_id="B2" value="2700"/>
                    <count group_id="B3" value="5404"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2704"/>
                    <measurement group_id="B2" value="2700"/>
                    <measurement group_id="B3" value="5404"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment</title>
        <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.</description>
        <time_frame>Measured through 24 months after first vaccination</time_frame>
        <population>MITT cohort</population>
        <group_list>
          <group group_id="O1">
            <title>ALVAC-HIV + Subtype C gp120/MF59</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment</title>
          <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.</description>
          <population>MITT cohort</population>
          <units>events per 100 person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2695"/>
                <count group_id="O2" value="2689"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cox PH method</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.034"/>
                    <measurement group_id="O2" value="0.033"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CIR method</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.034"/>
                    <measurement group_id="O2" value="0.033"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.84</p_value>
            <method>Log Rank</method>
            <method_desc>The hazard ratio was tested using a sex-stratified log rank test.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
            <estimate_desc>The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.83</p_value>
            <method>Wald</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.31</ci_upper_limit>
            <estimate_desc>The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness</title>
        <description>Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.</description>
        <time_frame>Measured through 3 full days following each vaccination</time_frame>
        <population>Safety cohort</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness</title>
          <description>Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.</description>
          <population>Safety cohort</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="2704"/>
                <count group_id="O2" value="2700"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2161"/>
                    <measurement group_id="O2" value="2539"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="480"/>
                    <measurement group_id="O2" value="149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Potentially Life-threatening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tenderness</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2368"/>
                    <measurement group_id="O2" value="2600"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="297"/>
                    <measurement group_id="O2" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Potentially Life-threatening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain and/or Tenderness</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2082"/>
                    <measurement group_id="O2" value="2493"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="552"/>
                    <measurement group_id="O2" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Potentially Life-threatening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration</title>
        <description>Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.</description>
        <time_frame>Measured through 3 full days following each vaccination</time_frame>
        <population>Safety cohort</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration</title>
          <description>Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.</description>
          <population>Safety cohort</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="2704"/>
                <count group_id="O2" value="2700"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erythema/Redness</title>
              <category_list>
                <category>
                  <title>None / Not Gradable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2494"/>
                    <measurement group_id="O2" value="2683"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gr 1: 2.5 - &lt;5cm / 6.25 - &lt;25cm^2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gr 2: 5 - &lt;10cm / 25 - &lt;100cm^2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gr 3: &gt;=10cm / &gt;=100cm^2 / Complications</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gr 4: Complications</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration/Swelling</title>
              <category_list>
                <category>
                  <title>None / Not Gradable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2380"/>
                    <measurement group_id="O2" value="2675"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gr 1: 2.5 - &lt;5cm / 6.25 - &lt;25cm^2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gr 2: 5 - &lt;10cm / 25 - &lt;100cm^2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="133"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gr 3: &gt;=10cm / &gt;=100cm^2 / Complications</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gr 4: Complications</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema and/or Induration</title>
              <category_list>
                <category>
                  <title>None / Not Gradable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2314"/>
                    <measurement group_id="O2" value="2662"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gr 1: 2.5 - &lt;5cm / 6.25 - &lt;25cm^2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="196"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gr 2: 5 - &lt;10cm / 25 - &lt;100cm^2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="156"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gr 3: &gt;=10cm / &gt;=100cm^2 / Complications</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gr 4: Complications</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms</title>
        <description>Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.</description>
        <time_frame>Measured through 3 full days following each vaccination</time_frame>
        <population>Safety cohort</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms</title>
          <description>Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.</description>
          <population>Safety cohort</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="2704"/>
                <count group_id="O2" value="2700"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Arthralgia</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2622"/>
                    <measurement group_id="O2" value="2649"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Potentially Life-threatening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2614"/>
                    <measurement group_id="O2" value="2641"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Potentially Life-threatening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2267"/>
                    <measurement group_id="O2" value="2276"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="317"/>
                    <measurement group_id="O2" value="311"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Potentially Life-threatening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise and/or fatigue</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2461"/>
                    <measurement group_id="O2" value="2497"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="221"/>
                    <measurement group_id="O2" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Potentially Life-threatening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2604"/>
                    <measurement group_id="O2" value="2644"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Potentially Life-threatening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2585"/>
                    <measurement group_id="O2" value="2583"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Potentially Life-threatening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2625"/>
                    <measurement group_id="O2" value="2629"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Potentially Life-threatening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max. Systemic Symptoms (excl. Temp.)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2004"/>
                    <measurement group_id="O2" value="2095"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="545"/>
                    <measurement group_id="O2" value="459"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="151"/>
                    <measurement group_id="O2" value="143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Potentially Life-threatening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2409"/>
                    <measurement group_id="O2" value="2406"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="176"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Potentially Life-threatening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product</title>
        <description>For participants reporting multiple AEs over the time frame, the maximum relationship is counted.</description>
        <time_frame>Measured through 30 days after each vaccination</time_frame>
        <population>Safety cohort</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product</title>
          <description>For participants reporting multiple AEs over the time frame, the maximum relationship is counted.</description>
          <population>Safety cohort</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="2704"/>
                <count group_id="O2" value="2700"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1689"/>
                    <measurement group_id="O2" value="1722"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No AE Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="977"/>
                    <measurement group_id="O2" value="966"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Adverse Events (AEs), by Severity Grade</title>
        <description>For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.</description>
        <time_frame>Measured through 30 days after each vaccination</time_frame>
        <population>Safety cohort</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Adverse Events (AEs), by Severity Grade</title>
          <description>For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.</description>
          <population>Safety cohort</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="2704"/>
                <count group_id="O2" value="2700"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161"/>
                    <measurement group_id="O2" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1443"/>
                    <measurement group_id="O2" value="1472"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potentially life-threatening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No AE Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="977"/>
                    <measurement group_id="O2" value="966"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Serious Adverse Events (SAEs)</title>
        <description>Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).</description>
        <time_frame>Measured through 12 months after last vaccination</time_frame>
        <population>Safety cohort</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Serious Adverse Events (SAEs)</title>
          <description>Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).</description>
          <population>Safety cohort</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="2704"/>
                <count group_id="O2" value="2700"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1624"/>
                    <measurement group_id="O2" value="1639"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No AE Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="977"/>
                    <measurement group_id="O2" value="966"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Adverse Events of Special Interest (AESIs)</title>
        <description>Adverse events of special interest (AESI) were described in Appendix J of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.</description>
        <time_frame>Measured through 12 months after last vaccination</time_frame>
        <population>Safety cohort</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Adverse Events of Special Interest (AESIs)</title>
          <description>Adverse events of special interest (AESI) were described in Appendix J of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.</description>
          <population>Safety cohort</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="2704"/>
                <count group_id="O2" value="2700"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1693"/>
                    <measurement group_id="O2" value="1700"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No AE Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1007"/>
                    <measurement group_id="O2" value="998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting New Chronic Medical Conditions</title>
        <description>A new chronic medical condition is defined as a new onset or exacerbation of medical condition requiring 2 or more visits to a medical provider during a period of at least 30 days.</description>
        <time_frame>Measured through 12 months after last vaccination</time_frame>
        <population>Safety cohort</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting New Chronic Medical Conditions</title>
          <description>A new chronic medical condition is defined as a new onset or exacerbation of medical condition requiring 2 or more visits to a medical provider during a period of at least 30 days.</description>
          <population>Safety cohort</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="2704"/>
                <count group_id="O2" value="2700"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1673"/>
                    <measurement group_id="O2" value="1680"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No AE Reported</title>
                  <measurement_list>
                    <measurement group_id="O1" value="977"/>
                    <measurement group_id="O2" value="966"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Early Study Termination Associated With an AE or Reactogenicity</title>
        <description>From the termination form, early study termination associated with an AE or reactogenicity reasons are tabulated by treatment group.</description>
        <time_frame>Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)</time_frame>
        <population>Safety cohort</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Early Study Termination Associated With an AE or Reactogenicity</title>
          <description>From the termination form, early study termination associated with an AE or reactogenicity reasons are tabulated by treatment group.</description>
          <population>Safety cohort</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="2704"/>
                <count group_id="O2" value="2700"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Termination associated with adverse event or reactogenicity</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other reason</title>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                    <measurement group_id="O2" value="129"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No discontinuation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2555"/>
                    <measurement group_id="O2" value="2557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity</title>
        <description>From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment group.</description>
        <time_frame>Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)</time_frame>
        <population>Safety cohort</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity</title>
          <description>From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment group.</description>
          <population>Safety cohort</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="2704"/>
                <count group_id="O2" value="2700"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Clinical event other than reactogenicity, HIV, infection or death</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reactogenicity symptom</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other reason</title>
                  <measurement_list>
                    <measurement group_id="O1" value="539"/>
                    <measurement group_id="O2" value="598"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No discontinuation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2153"/>
                    <measurement group_id="O2" value="2095"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up</title>
        <description>Per the 23 January 2020 DSMB finding that monitoring boundaries for non-efficacy have been met, Primary outcome 1 has been superseded by this primary outcome. Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.</description>
        <time_frame>Measured through 36 months after first vaccination</time_frame>
        <population>MITT cohort</population>
        <group_list>
          <group group_id="O1">
            <title>ALVAC-HIV + Subtype C gp120/MF59</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up</title>
          <description>Per the 23 January 2020 DSMB finding that monitoring boundaries for non-efficacy have been met, Primary outcome 1 has been superseded by this primary outcome. Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.</description>
          <population>MITT cohort</population>
          <units>events per 100 person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2695"/>
                <count group_id="O2" value="2689"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cox PH method</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.032"/>
                    <measurement group_id="O2" value="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CIR method</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.038"/>
                    <measurement group_id="O2" value="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.66</p_value>
            <method>Log Rank</method>
            <method_desc>The hazard ratio was tested using a sex-stratified log rank test.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
            <estimate_desc>The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.98</p_value>
            <method>Wald</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.23</ci_upper_limit>
            <estimate_desc>The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 36 Months Post Enrollment</title>
        <description>This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness.</description>
        <time_frame>Measured through 36 months after first vaccination</time_frame>
        <population>This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness.</population>
        <group_list>
          <group group_id="O1">
            <title>ALVAC-HIV + Subtype C gp120/MF59</title>
            <description>ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, 12, and 18 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5 mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, 12, and 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, 12, and 18 AND Placebo for Bivalent Subtype C gp120/MF59 (Sodium Chloride for Injection, 0.9%) administered as 0.5 mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, 12, and 18</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 36 Months Post Enrollment</title>
          <description>This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness.</description>
          <population>This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment</title>
        <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.</description>
        <time_frame>Measured after Month 6.5 through 24 months after first vaccination</time_frame>
        <population>Week 26 at-risk cohort</population>
        <group_list>
          <group group_id="O1">
            <title>ALVAC-HIV + Subtype C gp120/MF59</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment</title>
          <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.</description>
          <population>Week 26 at-risk cohort</population>
          <units>events per 100 person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2430"/>
                <count group_id="O2" value="2393"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cox PH method</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03"/>
                    <measurement group_id="O2" value="0.026"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CIR method</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03"/>
                    <measurement group_id="O2" value="0.026"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.39</p_value>
            <method>Log Rank</method>
            <method_desc>The hazard ratio was tested using a sex-stratified log rank test.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>1.58</ci_upper_limit>
            <estimate_desc>The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.50</p_value>
            <method>Wald</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.54</ci_upper_limit>
            <estimate_desc>The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5</title>
        <description>PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.</description>
        <time_frame>Measured at Month 6.5</time_frame>
        <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5</title>
          <description>PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.</description>
          <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</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="119"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD4+ : 1086 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : ANY ENV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : ANY HIV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : LAI Gag</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : TV1 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : ZM96 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : 1086 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : ANY ENV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : ANY HIV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : LAI Gag</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : TV1 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : ZM96 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5</title>
        <description>PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.</description>
        <time_frame>Measured at Month 6.5</time_frame>
        <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5</title>
          <description>PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.</description>
          <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</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="119"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD4+ : 1086 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : ANY ENV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : ANY HIV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : LAI Gag</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : TV1 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : ZM96 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : 1086 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : ANY ENV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : ANY HIV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : LAI Gag</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : TV1 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : ZM96 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5</title>
        <description>PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.</description>
        <time_frame>Measured at Month 6.5</time_frame>
        <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5</title>
          <description>PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.</description>
          <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
          <units>% T-Cells</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD4+ : 1086 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : ANY ENV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : ANY HIV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : LAI Gag</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : TV1 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : ZM96 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : 1086 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : ANY ENV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : ANY HIV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : LAI Gag</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : TV1 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : ZM96 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5</title>
        <description>PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.</description>
        <time_frame>Measured at Month 6.5</time_frame>
        <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5</title>
          <description>PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.</description>
          <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
          <units>% T-Cells</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD4+ : 1086 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.1" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : ANY ENV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.1" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : ANY HIV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.2" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : LAI Gag</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : TV1 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.1" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4+ : ZM96 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.1" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : 1086 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : ANY ENV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : ANY HIV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : LAI Gag</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : TV1 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8+ : ZM96 gp120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5</title>
        <description>Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution.The readout is background-subtracted mean fluorescent intensity(MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1,and net MFI &gt; 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.</description>
        <time_frame>Measured at Month 6.5</time_frame>
        <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5</title>
          <description>Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution.The readout is background-subtracted mean fluorescent intensity(MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1,and net MFI &gt; 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.</description>
          <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</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="120"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HVTN 505 Env Breadth Panel : VRC A_avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel : VRC B gp140</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel : VRC C_avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : 00MSA 4076 gp140</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : A244 gp 120 gDneg/293F/mon</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : B.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : C.con.env03 140 CF_avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : Con 6 gp120/B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : Con S gp140 CFI</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : G.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : HV 13700 AE.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : HV 14000 (DRCBL) gp140</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG : 92TH023 gp120 gDneg 293F mon</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG : A1.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG : AE.A244 V1V2 Tags/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG : C.1086C_V1_V2 Tags</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG : gp70-92TH023 V1V2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG : gp70_B.CaseA_V1_V2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG3 : gp70_B.CaseA2 V1/V2/169K</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA : Bio-1086C C1_HS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA : Bio-92TH023 C1_HS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA : Bio-96ZM651 C1_HS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA : Bio-TV1 C1_HS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env : 1086C_D7gp120.avi/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env : 96ZM651.D11gp120.avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env : TV1c8_D11gp120.avi/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2 : gp70-96ZM651.02 V1v2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2 : gp70-TV1.GSKvacV1V2/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2 : gp70_C.1086C V1/V2/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>gp41</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5</title>
        <description>Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:40 dilution.The readout is background-subtracted mean fluorescent intensity(MFI), with background adjustment for an antigen-specific plate level control.For each sample, response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline M</description>
        <time_frame>Measured at Month 6.5</time_frame>
        <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5</title>
          <description>Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:40 dilution.The readout is background-subtracted mean fluorescent intensity(MFI), with background adjustment for an antigen-specific plate level control.For each sample, response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline M</description>
          <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</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="120"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HVTN 505 Env Breadth Panel : A1.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel : B.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel : C.con.env03 140 CF_avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel : Con 6 gp120/B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel : Con S gp140 CFI</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel : VRC A_avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel : VRC B gp140</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel : VRC C_avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG3 : C.1086C_V1_V2 Tags</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG3 : gp70_B.CaseA2 V1/V2/169K</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG3 : gp70_B.CaseA_V1_V2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>V1V2 Subtype AW : AE.A244 V1V2 Tags/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env : 1086C_D7gp120.avi/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env : 96ZM651.D11gp120.avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env : TV1c8_D11gp120.avi/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2 : gp70-96ZM651.02 V1v2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2 : gp70-TV1.GSKvacV1V2/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2 : gp70_C.1086C V1/V2/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5</title>
        <description>Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:10 dilution.The readout is background-subtracted mean fluorescent intensity (MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.</description>
        <time_frame>Measured at Month 6.5</time_frame>
        <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5</title>
          <description>Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:10 dilution.The readout is background-subtracted mean fluorescent intensity (MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.</description>
          <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</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="120"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bio-1086C C1_HS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bio-96ZM651 C1_HS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bio-TV1 C1_HS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : 00MSA 4076 gp140</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : 92TH023 gp120 gDneg 293F mon</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : A1.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : A244 gp 120 gDneg/293F/mon</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : B.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : C.con.env03 140 CF_avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : Con 6 gp120/B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : Con S gp140 CFI</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : G.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : HV 13700 AE.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score : HV 14000 (DRCBL) gp140</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA : Bio-92TH023 C1_HS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env : 1086C_D7gp120.avi/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env : 96ZM651.D11gp120.avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env : TV1c8_D11gp120.avi/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>gp41</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>gp70-96ZM651.02 V1v2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>gp70-TV1.GSKvacV1V2/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>gp70_C.1086C V1/V2/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5</title>
        <description>Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 and 1:100 dilutions. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).</description>
        <time_frame>Measured at Month 6.5</time_frame>
        <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5</title>
          <description>Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 and 1:100 dilutions. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).</description>
          <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
          <units>net mean fluorescent intensity (net MFI)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HVTN 505 Env Breadth Panel: VRC A_avi, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20132" lower_limit="8982.8" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel: VRC A_avi, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10290" lower_limit="4369.2" upper_limit="20537.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel: VRC B gp140, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7503.5" lower_limit="4020.5" upper_limit="13312.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel: VRC B gp140, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3708.5" lower_limit="1640.5" upper_limit="7191.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel: VRC C_avi, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12765" lower_limit="7504.8" upper_limit="20089.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel: VRC C_avi, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6247.2" lower_limit="3347.5" upper_limit="11681.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: 00MSA 4076 gp140, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17184" lower_limit="9261.5" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: 00MSA 4076 gp140, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8842.2" lower_limit="4311.8" upper_limit="16801.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: A244 gp 120 gDneg/293F/mon, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18126.8" lower_limit="11247.2" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: A244 gp 120 gDneg/293F/mon, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8697.2" lower_limit="5161.8" upper_limit="16319.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: B.con.env03 140 CF, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22000" lower_limit="19561" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: B.con.env03 140 CF, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21073.2" lower_limit="10314.8" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: C.con.env03 140 CF_avi, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19326.2" lower_limit="11303.5" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: C.con.env03 140 CF_avi, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11210.5" lower_limit="5829.5" upper_limit="17740"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: Con 6 gp120/B, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15732" lower_limit="9491.3" upper_limit="20903.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: Con 6 gp120/B, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7617.4" lower_limit="4618.9" upper_limit="11111.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: Con S gp140 CFI, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22000" lower_limit="22000" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: Con S gp140 CFI, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22000" lower_limit="20274.6" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: G.con.env03 140 CF, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22000" lower_limit="22000" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: G.con.env03 140 CF, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22000" lower_limit="14411.5" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: HV 13700 AE.con.env03 140 CF, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15539.5" lower_limit="8042" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: HV 13700 AE.con.env03 140 CF, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6859" lower_limit="3508.2" upper_limit="14297.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: HV 14000 (DRCBL) gp140, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10932" lower_limit="6895.2" upper_limit="19457.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: HV 14000 (DRCBL) gp140, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5141.5" lower_limit="2910.8" upper_limit="9346.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG3: gp70_B.CaseA2 V1/V2/169K, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1133.8" lower_limit="416.2" upper_limit="4078.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG3: gp70_B.CaseA2 V1/V2/169K, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="527.5" lower_limit="202.1" upper_limit="1440.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG: 92TH023 gp120 gDneg 293F mon, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15096.5" lower_limit="9387.8" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG: 92TH023 gp120 gDneg 293F mon, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7544.2" lower_limit="4182.8" upper_limit="13109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG: A1.con.env03 140 CF, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19319.5" lower_limit="12159.5" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG: A1.con.env03 140 CF, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12505.2" lower_limit="6220.2" upper_limit="19676.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG: AE.A244 V1V2 Tags/293F, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2659.8" lower_limit="1054.1" upper_limit="7085.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG: AE.A244 V1V2 Tags/293F, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1014.8" lower_limit="430.4" upper_limit="2907.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG: C.1086C_V1_V2 Tags, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1273" lower_limit="525.2" upper_limit="3343.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG: C.1086C_V1_V2 Tags, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="566.5" lower_limit="266.3" upper_limit="1335.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG: gp70-92TH023 V1V2, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20359.2" lower_limit="7733.3" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG: gp70-92TH023 V1V2, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7925.4" lower_limit="2726.2" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG: gp70_B.CaseA_V1_V2, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="974.4" lower_limit="360.8" upper_limit="3270.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG: gp70_B.CaseA_V1_V2, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="452.8" lower_limit="173.9" upper_limit="1350.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA: Bio-1086C C1_HS, dilution 1: 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="657" lower_limit="324.1" upper_limit="1034.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA: Bio-92TH023 C1_HS, dilution 1: 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3345.5" lower_limit="1613.6" upper_limit="6390.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA: Bio-96ZM651 C1_HS, dilution 1: 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6250.6" lower_limit="3556.6" upper_limit="11699.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA: Bio-TV1 C1_HS, dilution 1: 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="318" lower_limit="232.2" upper_limit="556.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env: 1086C_D7gp120.avi/293F, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22000" lower_limit="22000" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env: 1086C_D7gp120.avi/293F, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22000" lower_limit="22000" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env: 96ZM651.D11gp120.avi, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22000" lower_limit="22000" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env: 96ZM651.D11gp120.avi, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19310.5" lower_limit="12406.2" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env: TV1c8_D11gp120.avi/293F, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22000" lower_limit="22000" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env: TV1c8_D11gp120.avi/293F, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22000" lower_limit="22000" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2: gp70-96ZM651.02 V1v2, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1319.8" lower_limit="620" upper_limit="4714.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2: gp70-96ZM651.02 V1v2, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="538.5" lower_limit="283.8" upper_limit="1248.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2: gp70-TV1.GSKvacV1V2/293F, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1452.8" lower_limit="530.2" upper_limit="5018.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2: gp70-TV1.GSKvacV1V2/293F, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="640.2" lower_limit="259.5" upper_limit="1809.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2: gp70_C.1086C V1/V2/293F, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4573.2" lower_limit="1793.4" upper_limit="14216.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2: gp70_C.1086C V1/V2/293F, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2029.2" lower_limit="688.2" upper_limit="6273.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>gp41, dilution 1: 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2125" lower_limit="2125" upper_limit="2125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>gp41, dilution 1:100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="780.8" lower_limit="780.8" upper_limit="780.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5</title>
        <description>Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).</description>
        <time_frame>Measured at Month 6.5</time_frame>
        <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5</title>
          <description>Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).</description>
          <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
          <units>net mean fluorescent intensity (net MFI)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HVTN 505 Env Breadth Panel: A1.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="277.1" lower_limit="171.1" upper_limit="702.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel: B.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="369.5" lower_limit="217.2" upper_limit="974.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel: C.con.env03 140 CF_avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="302.2" lower_limit="154.2" upper_limit="601.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel: Con 6 gp120/B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="318.5" lower_limit="181.5" upper_limit="775.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel: Con S gp140 CFI</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="843" lower_limit="471.9" upper_limit="2435"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel: VRC A_avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="337.8" lower_limit="160.2" upper_limit="844.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel: VRC B gp140</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="208.2" lower_limit="140.9" upper_limit="432.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HVTN 505 Env Breadth Panel: VRC C_avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="262.9" lower_limit="135.2" upper_limit="540.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG3: C.1086C_V1_V2 Tags</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="277.5" lower_limit="131.2" upper_limit="601.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG3: gp70_B.CaseA2 V1/V2/169K</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="963.5" lower_limit="213.8" upper_limit="3295.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgG3: gp70_B.CaseA_V1_V2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1598.9" lower_limit="316.9" upper_limit="3041.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>V1V2 Subtype AW: AE.A244 V1V2 Tags/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="350.8" lower_limit="237" upper_limit="868.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env: 1086C_D7gp120.avi/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4534.8" lower_limit="2132.6" upper_limit="11252.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env: 96ZM651.D11gp120.avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="700.5" lower_limit="333.9" upper_limit="1815.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env: TV1c8_D11gp120.avi/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2059.5" lower_limit="896.6" upper_limit="5165.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2: gp70-96ZM651.02 V1v2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1398.2" lower_limit="370.2" upper_limit="3796.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2: gp70-TV1.GSKvacV1V2/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="511.4" lower_limit="222.6" upper_limit="1469.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Strain Matched V1V2: gp70_C.1086C V1/V2/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="572.6" lower_limit="379.7" upper_limit="1367.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5</title>
        <description>Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).</description>
        <time_frame>Measured at Month 6.5</time_frame>
        <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Vaccine</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5</title>
          <description>Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI &gt; 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen &gt; 5,000 MFI or baseline net MFI &gt; 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).</description>
          <population>Immunogenicity cohort. &quot;Overall Number of Participants Analyzed&quot; represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. &quot;Number Analyzed&quot; represents those participants with available data after filtering for assay-specific quality control criteria.</population>
          <units>net mean fluorescent intensity (net MFI)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: 00MSA 4076 gp140</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1521.5" lower_limit="657.8" upper_limit="3967.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: 92TH023 gp120 gDneg 293F mon</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1024.8" lower_limit="666.6" upper_limit="1453.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: A1.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2511.9" lower_limit="949.1" upper_limit="5347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: A244 gp 120 gDneg/293F/mon</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="801.2" lower_limit="506.3" upper_limit="1325.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: B.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3140.2" lower_limit="1685" upper_limit="6907.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: C.con.env03 140 CF_avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2149.8" lower_limit="1102.6" upper_limit="4907"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: Con 6 gp120/B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2877.9" lower_limit="1620.6" upper_limit="5074.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: Con S gp140 CFI</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5239.2" lower_limit="2974.8" upper_limit="11492.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: G.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2845" lower_limit="1261" upper_limit="6844.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: HV 13700 AE.con.env03 140 CF</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="791" lower_limit="483.8" upper_limit="1970.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RV144 CoR IgA Primary gp120 Score: HV 14000 (DRCBL) gp140</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1291.5" lower_limit="588.2" upper_limit="3242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env: 1086C_D7gp120.avi/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22000" lower_limit="21620.4" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env: 96ZM651.D11gp120.avi</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6673.8" lower_limit="4418.9" upper_limit="10935.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaccine Matched Env: TV1c8_D11gp120.avi/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6205" lower_limit="3399" upper_limit="9946.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>gp70-96ZM651.02 V1v2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22000" lower_limit="22000" upper_limit="22000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>gp70-TV1.GSKvacV1V2/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1059.5" lower_limit="731.9" upper_limit="3515.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>gp70_C.1086C V1/V2/293F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5786.5" lower_limit="5169" upper_limit="8446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants</title>
        <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.</description>
        <time_frame>Measured through 24 months after first vaccination</time_frame>
        <population>Females in MITT cohort</population>
        <group_list>
          <group group_id="O1">
            <title>ALVAC-HIV + Subtype C gp120/MF59</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants</title>
          <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.</description>
          <population>Females in MITT cohort</population>
          <units>events per 100 person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1887"/>
                <count group_id="O2" value="1886"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.043"/>
                    <measurement group_id="O2" value="0.042"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.82</p_value>
            <method>Log Rank</method>
            <method_desc>The hazard ratio was tested using a sex-stratified log rank test.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
            <estimate_desc>The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Male Participants</title>
        <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.</description>
        <time_frame>Measured through 24 months after first vaccination</time_frame>
        <population>Males in MITT cohort</population>
        <group_list>
          <group group_id="O1">
            <title>ALVAC-HIV + Subtype C gp120/MF59</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Male Participants</title>
          <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.</description>
          <population>Males in MITT cohort</population>
          <units>events per 100 person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="803"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.013"/>
                    <measurement group_id="O2" value="0.013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.98</p_value>
            <method>Log Rank</method>
            <method_desc>The hazard ratio was tested using a sex-stratified log rank test.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>1.98</ci_upper_limit>
            <estimate_desc>The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Aged 25 or Younger</title>
        <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.</description>
        <time_frame>Measured through 24 months after first vaccination</time_frame>
        <population>Females in MITT cohort aged 25 or younger</population>
        <group_list>
          <group group_id="O1">
            <title>ALVAC-HIV + Subtype C gp120/MF59</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Aged 25 or Younger</title>
          <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.</description>
          <population>Females in MITT cohort aged 25 or younger</population>
          <units>events per 100 person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1264"/>
                <count group_id="O2" value="1267"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.047"/>
                    <measurement group_id="O2" value="0.044"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.60</p_value>
            <method>Log Rank</method>
            <method_desc>The hazard ratio was tested using a sex-stratified log rank test.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
            <estimate_desc>The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Older Than 25</title>
        <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.</description>
        <time_frame>Measured through 24 months after first vaccination</time_frame>
        <population>Females in MITT cohort older than 25</population>
        <group_list>
          <group group_id="O1">
            <title>ALVAC-HIV + Subtype C gp120/MF59</title>
            <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Older Than 25</title>
          <description>Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.</description>
          <population>Females in MITT cohort older than 25</population>
          <units>events per 100 person-years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="623"/>
                <count group_id="O2" value="619"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.035"/>
                    <measurement group_id="O2" value="0.039"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.71</p_value>
            <method>Log Rank</method>
            <method_desc>The hazard ratio was tested using a sex-stratified log rank test.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
            <estimate_desc>The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through Month 24 by Genotypic Characteristics of Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis, Such As Signature Site Mutations</title>
        <description>Analysis will only be performed if significant positive evidence of vaccine efficacy from enrollment through 24 months is seen. However, monitoring boundaries for non-efficacy have been met per the 23 January 2020 DSMB finding.</description>
        <time_frame>Measured through 24 months after first vaccination</time_frame>
        <population>Analysis will only be performed if significant positive evidence of vaccine efficacy from enrollment through 24 months is seen. However, monitoring boundaries for non-efficacy have been met per the 23 January 2020 DSMB finding.</population>
        <group_list>
          <group group_id="O1">
            <title>ALVAC-HIV + Subtype C gp120/MF59</title>
            <description>ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, 12, and 18 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5 mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, 12, and 18</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo for ALVAC-HIV (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, 12, and 18 AND Placebo for Bivalent Subtype C gp120/MF59 (Sodium Chloride for Injection, 0.9%) administered as 0.5 mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, 12, and 18</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through Month 24 by Genotypic Characteristics of Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis, Such As Signature Site Mutations</title>
          <description>Analysis will only be performed if significant positive evidence of vaccine efficacy from enrollment through 24 months is seen. However, monitoring boundaries for non-efficacy have been met per the 23 January 2020 DSMB finding.</description>
          <population>Analysis will only be performed if significant positive evidence of vaccine efficacy from enrollment through 24 months is seen. However, monitoring boundaries for non-efficacy have been met per the 23 January 2020 DSMB finding.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis</title>
        <description>The sieve analysis will be conducted using updates of the methods that were used for the Step (Rolland et al., 2011) and RV144 HIV vaccine efficacy trials.</description>
        <time_frame>Measured at the earliest post-infection time-point</time_frame>
        <posting_date>09/2023</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious adverse events, adverse events of special interest, adverse events of STIs, new chronic medical conditions, and adverse events leading to early participant withdrawal or early discontinuation of study product(s) administration were collected through 12 months after the last vaccination received. All other adverse events were collected through 30 days after each vaccination.</time_frame>
      <desc>Adverse events of special interest (AESI) were described in Appendix J of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.</desc>
      <group_list>
        <group group_id="E1">
          <title>Vaccine</title>
          <description>ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MEDRA 24.1</default_vocab>
        <default_assessment>Non-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="8" subjects_at_risk="2704"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="103" subjects_at_risk="2704"/>
                <counts group_id="E2" subjects_affected="95" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Anaemia of pregnancy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tympanic membrane perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Alcoholic pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Obstructive pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pancreatic pseudocyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Electrocution</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="2704"/>
                <counts group_id="E2" events="20" subjects_affected="17" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Acute hepatitis B</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Appendiceal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Central nervous system infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genital abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Meningitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Meningitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Meningitis tuberculous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pelvic inflammatory disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="44" subjects_affected="42" subjects_at_risk="2704"/>
                <counts group_id="E2" events="40" subjects_affected="38" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abdominal injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Back injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Burns second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Chemical poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Chest injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Eye injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Face injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gun shot wound</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Limb traumatic amputation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Peripancreatic fluid collection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Skull fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Snake bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Stab wound</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2704"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tendon injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Traumatic haemothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Mixed connective tissue disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Systemic lupus erythematosus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Anogenital warts</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Status epilepticus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="2704"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abortion incomplete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Breech presentation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ectopic pregnancy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gestational hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pre-eclampsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Premature baby</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Premature delivery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Premature labour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Premature separation of placenta</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Stillbirth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2704"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Acute psychosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Acute stress disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Intentional self-injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Schizoaffective disorder bipolar type</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Stress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Substance-induced psychotic disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dysfunctional uterine bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Female reproductive tract disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Testicular torsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hypertensive urgency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MEDRA 24.1</default_vocab>
        <default_assessment>Non-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="1707" subjects_at_risk="2704"/>
                <counts group_id="E2" subjects_affected="1704" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="2704"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Basedow's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="18" subjects_affected="17" subjects_at_risk="2704"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Atopic keratoconjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Chalazion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2704"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Periorbital pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Periorbital swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Photokeratitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Swelling of eyelid</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="165" subjects_affected="151" subjects_at_risk="2704"/>
                <counts group_id="E2" events="178" subjects_affected="162" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="2704"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="2704"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Anal pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Angular cheilitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Breath odour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2704"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="29" subjects_affected="29" subjects_at_risk="2704"/>
                <counts group_id="E2" events="44" subjects_affected="41" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2704"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="2704"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2704"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Lip swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Mouth cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2704"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Proctitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rectal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tooth impacted</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="2704"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2704"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="233" subjects_affected="206" subjects_at_risk="2704"/>
                <counts group_id="E2" events="218" subjects_affected="198" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2704"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hangover</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="181" subjects_affected="166" subjects_at_risk="2704"/>
                <counts group_id="E2" events="188" subjects_affected="171" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Injection site dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Injection site discolouration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" events="23" subjects_affected="21" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Injection site ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vessel puncture site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Anti-neutrophil cytoplasmic antibody positive vasculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="2247" subjects_affected="1243" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2290" subjects_affected="1295" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abdominal wall abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abdominal wall infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abscess jaw</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="2704"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" events="37" subjects_affected="36" subjects_at_risk="2704"/>
                <counts group_id="E2" events="37" subjects_affected="34" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Acute hepatitis B</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Bacterial urethritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Bacterial vaginosis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2704"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Bartholin's abscess</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Body tinea</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="2704"/>
                <counts group_id="E2" events="24" subjects_affected="23" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cestode infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Chest wall abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Chlamydial infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Chronic hepatitis B</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2704"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Conjunctivitis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Conjunctivitis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dysentery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ecthyma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Endometritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Extrapulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="2704"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="2704"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gastritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="50" subjects_affected="46" subjects_at_risk="2704"/>
                <counts group_id="E2" events="57" subjects_affected="53" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="2704"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genital abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genital herpes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genital herpes simplex</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genital infection fungal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genital ulcer syndrome</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2704"/>
                <counts group_id="E2" events="23" subjects_affected="20" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genitourinary chlamydia infection</sub_title>
                <counts group_id="E1" events="908" subjects_affected="661" subjects_at_risk="2704"/>
                <counts group_id="E2" events="917" subjects_affected="689" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genitourinary tract gonococcal infection</sub_title>
                <counts group_id="E1" events="332" subjects_affected="286" subjects_at_risk="2704"/>
                <counts group_id="E2" events="319" subjects_affected="272" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genitourinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gonococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Groin abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Implant site abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Implant site infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Infected bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Injection site cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Joint abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Latent syphilis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Lice infestation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="27" subjects_affected="27" subjects_at_risk="2704"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Lymphogranuloma venereum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Male genital tract tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Nasal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="2704"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Omphalitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Onychomycosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Oral pustule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Orchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Otitis media bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Otitis media chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pelvic abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pelvic inflammatory disease</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="2704"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="2704"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Proctitis chlamydial</sub_title>
                <counts group_id="E1" events="32" subjects_affected="27" subjects_at_risk="2704"/>
                <counts group_id="E2" events="18" subjects_affected="13" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Proctitis gonococcal</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="2704"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pustule</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2704"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="2704"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Schistosomiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Secondary syphilis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Sexually transmitted disease</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Skin bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="26" subjects_affected="24" subjects_at_risk="2704"/>
                <counts group_id="E2" events="27" subjects_affected="26" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Syphilis</sub_title>
                <counts group_id="E1" events="46" subjects_affected="41" subjects_at_risk="2704"/>
                <counts group_id="E2" events="38" subjects_affected="34" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Syphilis genital</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tinea capitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tinea cruris</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tinea faciei</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tinea infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tinea versicolour</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="2704"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="33" subjects_affected="31" subjects_at_risk="2704"/>
                <counts group_id="E2" events="35" subjects_affected="34" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tonsillitis bacterial</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="142" subjects_affected="131" subjects_at_risk="2704"/>
                <counts group_id="E2" events="127" subjects_affected="119" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" events="28" subjects_affected="25" subjects_at_risk="2704"/>
                <counts group_id="E2" events="35" subjects_affected="31" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="50" subjects_affected="47" subjects_at_risk="2704"/>
                <counts group_id="E2" events="53" subjects_affected="50" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Urogenital trichomoniasis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vaginitis chlamydial</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Varicella zoster virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vestibulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Viral rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Viral sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Viral tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="2704"/>
                <counts group_id="E2" events="23" subjects_affected="22" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vulval abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="37" subjects_affected="33" subjects_at_risk="2704"/>
                <counts group_id="E2" events="39" subjects_affected="38" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vulvovaginitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vulvovaginitis chlamydial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vulvovaginitis gonococcal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vulvovaginitis trichomonal</sub_title>
                <counts group_id="E1" events="179" subjects_affected="150" subjects_at_risk="2704"/>
                <counts group_id="E2" events="210" subjects_affected="165" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Wound sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="124" subjects_affected="118" subjects_at_risk="2704"/>
                <counts group_id="E2" events="84" subjects_affected="80" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2704"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Burns first degree</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Chest injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Epicondylitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Eye contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Face injury</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>First degree chemical burn of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Foreign body in ear</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genital contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Gun shot wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Herbal toxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Human bite</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ligament injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="2704"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Lip injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Neck injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Nerve injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Penis injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Periorbital haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Post procedural contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Procedural dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Procedural vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2704"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="2704"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Stab wound</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="108" subjects_affected="92" subjects_at_risk="2704"/>
                <counts group_id="E2" events="111" subjects_affected="95" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="59" subjects_affected="47" subjects_at_risk="2704"/>
                <counts group_id="E2" events="63" subjects_affected="53" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Creatinine renal clearance decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="42" subjects_affected="38" subjects_at_risk="2704"/>
                <counts group_id="E2" events="44" subjects_affected="38" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="2704"/>
                <counts group_id="E2" events="20" subjects_affected="20" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Abnormal loss of weight</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2704"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="2704"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Polydipsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vitamin B12 deficiency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="95" subjects_affected="90" subjects_at_risk="2704"/>
                <counts group_id="E2" events="106" subjects_affected="98" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="2704"/>
                <counts group_id="E2" events="20" subjects_affected="20" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Axillary mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="26" subjects_affected="26" subjects_at_risk="2704"/>
                <counts group_id="E2" events="33" subjects_affected="29" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Fracture pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Joint range of motion decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Neck mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="2704"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Polyarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Soft tissue mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Soft tissue swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tenosynovitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="2704"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Anogenital warts</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Fibroadenoma of breast</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Neoplasm skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Penile wart</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vulvovaginal warts</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="178" subjects_affected="165" subjects_at_risk="2704"/>
                <counts group_id="E2" events="166" subjects_affected="151" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cluster headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="2704"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="121" subjects_affected="117" subjects_at_risk="2704"/>
                <counts group_id="E2" events="114" subjects_affected="107" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Migraine with aura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Motor dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Nystagmus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Radial nerve palsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Sensory loss</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="2704"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Device expulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="2704"/>
                <counts group_id="E2" events="22" subjects_affected="20" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Acute stress disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Generalised anxiety disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Intentional self-injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Libido decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Loss of libido</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Post-traumatic stress disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Premature ejaculation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Substance-induced mood disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Substance-induced psychotic disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="21" subjects_affected="20" subjects_at_risk="2704"/>
                <counts group_id="E2" events="23" subjects_affected="23" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Ketonuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Lower urinary tract symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="2704"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Urethral discharge</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Urethral syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="190" subjects_affected="167" subjects_at_risk="2704"/>
                <counts group_id="E2" events="193" subjects_affected="176" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Amenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Balanoposthitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Bartholin's cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Breast haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Breast inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Breast tenderness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cervical cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cervical dysplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Coital bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dysfunctional uterine bleeding</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dyspareunia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Galactorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genital pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genital rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Genital ulceration</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2704"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Nipple pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Penile blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Penile discharge</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Penile pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Polycystic ovaries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pruritus genital</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Sexual dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" events="154" subjects_affected="134" subjects_at_risk="2704"/>
                <counts group_id="E2" events="142" subjects_affected="132" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vulval ulceration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vulvovaginal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pruritus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="55" subjects_affected="53" subjects_at_risk="2704"/>
                <counts group_id="E2" events="42" subjects_affected="40" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Allergic sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="2704"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="2704"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="2704"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Tonsillar hypertrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="147" subjects_affected="136" subjects_at_risk="2704"/>
                <counts group_id="E2" events="146" subjects_affected="134" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="2704"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="2704"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="2704"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2704"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hidradenitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Lipohypertrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Penile ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pityriasis rosea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="22" subjects_affected="20" subjects_at_risk="2704"/>
                <counts group_id="E2" events="23" subjects_affected="22" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Pseudofolliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="2704"/>
                <counts group_id="E2" events="24" subjects_affected="24" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="2704"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="2704"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Rash vesicular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Skin depigmentation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2704"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Solar dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Urticaria papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Physical assault</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Victim of sexual abuse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Any Event in SOC</sub_title>
                <counts group_id="E1" events="29" subjects_affected="24" subjects_at_risk="2704"/>
                <counts group_id="E2" events="23" subjects_affected="21" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="26" subjects_affected="21" subjects_at_risk="2704"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2704"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2704"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2700"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2704"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2700"/>
              </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>Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations</name_or_title>
      <organization>Fred Hutchinson Cancer Center</organization>
      <phone>206-667-5812</phone>
      <email>hvtn.covpn.sdmc@hvtn.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/NCT02968849
org study id: HVTN 702
nct id: NCT02968849
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is us export: Yes
This study will evaluate the preventive vaccine efficacy, safety, and tolerability of
      ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults
      over 24 months and potentially up to 36 months from enrollment.
This study will evaluate the preventive vaccine efficacy, safety, and tolerability of the
      ALVAC-HIV vaccine + Bivalent Subtype C gp120 protein adjuvanted with MF59 in HIV-seronegative
      South African adults over 24 months from enrollment.

      Participants will be randomized to receive ALVAC-HIV (vCP2438), or placebo, by intramuscular
      injection at weeks 0 and 4; they will receive ALVAC-HIV (vCP2438) + Bivalent Subtype C
      gp120/MF59, or placebo, by IM injection at weeks 12, 24, and 52.

      In addition to the vaccination visits, participants will attend study visits at weeks 26, 39,
      54, 65, 78, 91, 104, 117, 130, 142, and 156. All study visits, including vaccination visits,
      will include HIV risk reduction counseling, a physical exam, and an interview/questionnaire.
      and pregnancy testing for participants capable of becoming pregnant. Select study visits will
      include a medical history review, physical exam, blood collection, urine collection, HIV
      testing, and pregnancy testing for participants capable of becoming pregnant.

      As of February 3, 2020, vaccinations for this study were suspended. Participants have been
      asked to continue attending follow-up visits for 12 months after the last vaccination they
      received. Participants who become HIV infected will be followed for 6 months after diagnosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment
time frame: Measured through 24 months after first vaccination
description: Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.
measure: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
time frame: Measured through 3 full days following each vaccination
description: Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.
measure: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
time frame: Measured through 3 full days following each vaccination
description: Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.
measure: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
time frame: Measured through 3 full days following each vaccination
description: Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented.
measure: Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
time frame: Measured through 30 days after each vaccination
description: For participants reporting multiple AEs over the time frame, the maximum relationship is counted.
measure: Number of Participants Reporting Adverse Events (AEs), by Severity Grade
time frame: Measured through 30 days after each vaccination
description: For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
measure: Number of Participants Reporting Serious Adverse Events (SAEs)
time frame: Measured through 12 months after last vaccination
description: Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).
measure: Number of Participants Reporting Adverse Events of Special Interest (AESIs)
time frame: Measured through 12 months after last vaccination
description: Adverse events of special interest (AESI) were described in Appendix J of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
measure: Number of Participants Reporting New Chronic Medical Conditions
time frame: Measured through 12 months after last vaccination
description: A new chronic medical condition is defined as a new onset or exacerbation of medical condition requiring 2 or more visits to a medical provider during a period of at least 30 days.
measure: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
time frame: Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)
description: From the termination form, early study termination associated with an AE or reactogenicity reasons are tabulated by treatment group.
measure: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
time frame: Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)
description: From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment group.
measure: Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up
time frame: Measured through 36 months after first vaccination
description: Per the 23 January 2020 DSMB finding that monitoring boundaries for non-efficacy have been met, Primary outcome 1 has been superseded by this primary outcome. Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.
measure: Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 36 Months Post Enrollment
time frame: Measured through 36 months after first vaccination
description: This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness.
measure: Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment
time frame: Measured after Month 6.5 through 24 months after first vaccination
description: Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.
measure: Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5
time frame: Measured at Month 6.5
description: PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.
measure: Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5
time frame: Measured at Month 6.5
description: PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.
measure: Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5
time frame: Measured at Month 6.5
description: PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.
measure: Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5
time frame: Measured at Month 6.5
description: PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.
measure: Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5
time frame: Measured at Month 6.5
description: Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution.The readout is background-subtracted mean fluorescent intensity(MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1,and net MFI > 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen > 5,000 MFI or baseline net MFI > 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
measure: Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5
time frame: Measured at Month 6.5
description: Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:40 dilution.The readout is background-subtracted mean fluorescent intensity(MFI), with background adjustment for an antigen-specific plate level control.For each sample, response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen > 5,000 MFI or baseline net MFI > 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline M
measure: Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5
time frame: Measured at Month 6.5
description: Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:10 dilution.The readout is background-subtracted mean fluorescent intensity (MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen > 5,000 MFI or baseline net MFI > 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
measure: Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5
time frame: Measured at Month 6.5
description: Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 and 1:100 dilutions. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI or baseline net MFI > 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).
measure: Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5
time frame: Measured at Month 6.5
description: Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI or baseline net MFI > 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).
measure: Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5
time frame: Measured at Month 6.5
description: Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI or baseline net MFI > 6,500. Summary was calculated among positive responders only. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).
measure: Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants
time frame: Measured through 24 months after first vaccination
description: Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.
measure: Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Male Participants
time frame: Measured through 24 months after first vaccination
description: Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.
measure: Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Aged 25 or Younger
time frame: Measured through 24 months after first vaccination
description: Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.
measure: Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Older Than 25
time frame: Measured through 24 months after first vaccination
description: Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.
measure: Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through Month 24 by Genotypic Characteristics of Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis, Such As Signature Site Mutations
time frame: Measured through 24 months after first vaccination
description: Analysis will only be performed if significant positive evidence of vaccine efficacy from enrollment through 24 months is seen. However, monitoring boundaries for non-efficacy have been met per the 23 January 2020 DSMB finding.
measure: Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis
time frame: Measured at the earliest post-infection time-point
description: The sieve analysis will be conducted using updates of the methods that were used for the Step (Rolland et al., 2011) and RV144 HIV vaccine efficacy trials.
arm group label: ALVAC-HIV + subtype C gp120/MF59
arm group type: Active Comparator
description: 2700 participants will receive an IM injection of ALVAC-HIV (vCP2438) at months 0 and 1, and an IM injection of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, and 12.
arm group label: Placebo
arm group type: Placebo Comparator
description: 2700 participants will receive Sodium Chloride for injection, 0.9% at months 0, 1, 3, 6, and 12.
intervention type: Biological
intervention name: ALVAC-HIV (vCP2438)
description: Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a dose > 10^6 cell culture infectious dose 50% (CCIDv50) and < 1 × 10^8 CCIDv50 (nominal dose of 10^7 CCIDv50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%) delivered IM
arm group label: ALVAC-HIV + subtype C gp120/MF59
intervention type: Biological
intervention name: Bivalent Subtype C gp120/MF59
description: Subtype C TV1.C gp120 Env and 1086.C gp120 Env proteins, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion) and delivered IM
arm group label: ALVAC-HIV + subtype C gp120/MF59
intervention type: Biological
intervention name: Placebo
description: Sodium Chloride for injection, 0.9% delivered IM
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Glenda Gray, MD
role: Study Chair
affiliation: Perinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Hospital
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country: South Africa
citation: Gray GE, Bekker LG, Laher F, Malahleha M, Allen M, Moodie Z, Grunenberg N, Huang Y, Grove D, Prigmore B, Kee JJ, Benkeser D, Hural J, Innes C, Lazarus E, Meintjes G, Naicker N, Kalonji D, Nchabeleng M, Sebe M, Singh N, Kotze P, Kassim S, Dubula T, Naicker V, Brumskine W, Ncayiya CN, Ward AM, Garrett N, Kistnasami G, Gaffoor Z, Selepe P, Makhoba PB, Mathebula MP, Mda P, Adonis T, Mapetla KS, Modibedi B, Philip T, Kobane G, Bentley C, Ramirez S, Takuva S, Jones M, Sikhosana M, Atujuna M, Andrasik M, Hejazi NS, Puren A, Wiesner L, Phogat S, Diaz Granados C, Koutsoukos M, Van Der Meeren O, Barnett SW, Kanesa-Thasan N, Kublin JG, McElrath MJ, Gilbert PB, Janes H, Corey L; HVTN 702 Study Team. Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120-MF59 in Adults. N Engl J Med. 2021 Mar 25;384(12):1089-1100. doi: 10.1056/NEJMoa2031499.
PMID: 33761206
citation: Moodie Z, Dintwe O, Sawant S, Grove D, Huang Y, Janes H, Heptinstall J, Omar FL, Cohen K, De Rosa SC, Zhang L, Yates NL, Sarzotti-Kelsoe M, Seaton KE, Laher F, Bekker LG, Malahleha M, Innes C, Kassim S, Naicker N, Govender V, Sebe M, Singh N, Kotze P, Lazarus E, Nchabeleng M, Ward AM, Brumskine W, Dubula T, Randhawa AK, Grunenberg N, Hural J, Kee JJ, Benkeser D, Jin Y, Carpp LN, Allen M, D'Souza P, Tartaglia J, DiazGranados CA, Koutsoukos M, Gilbert PB, Kublin JG, Corey L, Andersen-Nissen E, Gray GE, Tomaras GD, McElrath MJ. Analysis of the HIV Vaccine Trials Network 702 Phase 2b-3 HIV-1 Vaccine Trial in South Africa Assessing RV144 Antibody and T-Cell Correlates of HIV-1 Acquisition Risk. J Infect Dis. 2022 Aug 24;226(2):246-257. doi: 10.1093/infdis/jiac260.
PMID: 35758878
responsible party type: Sponsor
mesh term: Infections
sharing ipd: No
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