<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/NCT04440163</url>
  </required_header>
  <id_info>
    <org_study_id>C3511001</org_study_id>
    <secondary_id>2019-004313-13</secondary_id>
    <nct_id>NCT04440163</nct_id>
  </id_info>
  <brief_title>MenABCWY Noninferiority Study in Healthy Participants ≥10 to &lt;26 Years of Age</brief_title>
  <official_title>A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO &lt;26 YEARS OF AGE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed&#xD;
      vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of&#xD;
      MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10&#xD;
      to &lt;26 years of age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Actual">July 24, 2022</completion_date>
  <primary_completion_date type="Actual">July 24, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving At Least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2</measure>
    <time_frame>Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 1 and 1 month after Vaccination 1 in Group 2</time_frame>
    <description>4-fold increase was defined as: 1) for participants with baseline hSBA titer below limit of detection (LOD) (or hSBA titer less than [&lt;] 1:4), 4-fold rise was defined as hSBA titer greater than or equal to (&gt;=) 1:16; 2) baseline hSBA titer &gt;=LOD and &lt; lower limit of quantitation (LLOQ) (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer &gt;=4 times LLOQ; 3) baseline hSBA titer &gt;=LLOQ, 4-fold rise was defined as hSBA titer &gt;=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. Analysis was performed on post-vaccination (PV) 1 evaluable immunogenicity population (EIP) for Group 2 and PV2 evaluable immunogenicity population for Group 1. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4</measure>
    <time_frame>Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 3 and 1 month after Vaccination 1 in Group 4</time_frame>
    <description>4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer &lt;1:4), 4-fold rise was defined as hSBA titer &gt;=1:16; 2) baseline hSBA titer &gt;=LOD (i.e., hSBA titer of &gt;=1:4) and &lt; LLOQ (i.e., hSBA titer of 1:8), 4-fold rise was defined as hSBA titer &gt;=4times LLOQ; 3) baseline hSBA titer &gt;=LLOQ, 4-fold rise was defined as hSBA titer &gt;=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving hSBA Titer Greater Than or Equal to (&gt;=) LLOQ for All Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined</measure>
    <time_frame>1 month after Vaccination 2</time_frame>
    <description>Percentage of participants achieving hSBA titer &gt;= LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all MenB test strains (A22, A56, B24 and B44) combined were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving At Least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined</measure>
    <time_frame>Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2</time_frame>
    <description>Percentage of participants achieving at least a 4-fold rise in hSBA titer for each primary MenB test strains (A22, A56, B24 and B44) were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 7 days after Vaccination 1</time_frame>
    <description>Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: &gt;2.0 to 5.0 cm, moderate: &gt;5.0 to 10.0 cm and severe: &gt;10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 7 days after Vaccination 2</time_frame>
    <description>Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: &gt;2.0 to 5.0 cm, moderate: &gt;5.0 to 10.0 cm and severe: &gt;10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 7 days after Vaccination 1</time_frame>
    <description>Systemic events were recorded by participants in e-diary. Fever was defined as temperature &gt;=38.0 degrees (deg) Celsius (C) and was categorized as 38.0 to 38.4 deg C, &gt;38.4 to 38.9 deg C, &gt;38.9 to 40.0 deg C and &gt;40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: &gt;2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 7 days after Vaccination 2</time_frame>
    <description>Systemic events were recorded by participants in e-diary. Fever was defined as temperature &gt;=38.0 deg C and was categorized as 38.0 to 38.4 deg C, &gt;38.4 to 38.9 deg C, &gt;38.9 to 40.0 deg C and &gt;40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: &gt;2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 7 days after Vaccination 1</time_frame>
    <description>The use of antipyretic medication was recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 7 days after Vaccination 2</time_frame>
    <description>The use of antipyretic medication recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 days after Vaccination 1</time_frame>
    <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 days after Vaccination 2</time_frame>
    <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 days after any vaccination</time_frame>
    <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 days after Vaccination 1</time_frame>
    <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 days after Vaccination 2</time_frame>
    <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 days after any vaccination</time_frame>
    <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)</time_frame>
    <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)</time_frame>
    <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)</time_frame>
    <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 days after Vaccination 1</time_frame>
    <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 days after Vaccination 2</time_frame>
    <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 days after any vaccination</time_frame>
    <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)</time_frame>
    <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)</time_frame>
    <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)</time_frame>
    <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 days after Vaccination 1</time_frame>
    <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 days after Vaccination 2</time_frame>
    <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 Days after any vaccination</time_frame>
    <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)</time_frame>
    <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)</time_frame>
    <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)</time_frame>
    <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 minutes after Vaccination 1</time_frame>
    <description>Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>Within 30 minutes after Vaccination 2</time_frame>
    <description>Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Missed Days of School or Work Due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</measure>
    <time_frame>From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Percentage of participants who missed days of school or work due to AEs during vaccination phase were reported in this outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 1 Compared to Group 2</measure>
    <time_frame>Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1</time_frame>
    <description>4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer &lt;1:4), 4-fold rise was defined as hSBA titer &gt;=1:16; 2) baseline hSBA titer &gt;=LOD (i.e., hSBA titer of &gt;=1:4) and &lt; LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer &gt;=4times LLOQ; 3) baseline hSBA titer &gt;=LLOQ, 4-fold rise was defined as hSBA titer &gt;=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 3 Compared to Group 4</measure>
    <time_frame>Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1</time_frame>
    <description>4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer &lt;1:4), 4-fold rise was defined as hSBA titer &gt;=1:16; 2) baseline hSBA titer &gt;=LOD (i.e., hSBA titer of &gt;=1:4) and &lt; LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer &gt;=4 times LLOQ; 3) baseline hSBA titer &gt; =LLOQ, 4-fold rise was defined as hSBA titer &gt;=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">2431</enrollment>
  <condition>Meningococcal Vaccine</condition>
  <arm_group>
    <arm_group_label>1-Immuno Subset (ACWY Naive,MenABCWY/Saline)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACWY Naive subjects, MenABCWY/Saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACWY Naive subjects, Trumenba/MenACWY-CRM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACWY Experienced subjects, MenABCWY/Saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACWY Experienced subjects, Trumenba/MenACWY-CRM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5-Safety Subset (ACWY Naive,MenABCWY/Saline)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACWY Naive subjects, MenABCWY/Saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACWY Naive subjects, Trumenba/MenACWY-CRM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>7-Safety Subset (ACWY Experienced,MenABCWY/Saline)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACWY Experienced subjects, MenABCWY/Saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACWY Experienced subjects, Trumenba/MenACWY-CRM</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MenABCWY</intervention_name>
    <description>N meningitidis groups A, B, C, W, and Y vaccine</description>
    <arm_group_label>1-Immuno Subset (ACWY Naive,MenABCWY/Saline)</arm_group_label>
    <arm_group_label>3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)</arm_group_label>
    <arm_group_label>5-Safety Subset (ACWY Naive,MenABCWY/Saline)</arm_group_label>
    <arm_group_label>7-Safety Subset (ACWY Experienced,MenABCWY/Saline)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Placebo</description>
    <arm_group_label>1-Immuno Subset (ACWY Naive,MenABCWY/Saline)</arm_group_label>
    <arm_group_label>3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)</arm_group_label>
    <arm_group_label>5-Safety Subset (ACWY Naive,MenABCWY/Saline)</arm_group_label>
    <arm_group_label>7-Safety Subset (ACWY Experienced,MenABCWY/Saline)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Trumenba</intervention_name>
    <description>Bivalent recombinant lipoprotein 2086 vaccine</description>
    <arm_group_label>2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)</arm_group_label>
    <arm_group_label>4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)</arm_group_label>
    <arm_group_label>6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)</arm_group_label>
    <arm_group_label>8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MenACWY-CRM</intervention_name>
    <description>Meningococcal group A, C, W-135, and Y conjugate vaccine</description>
    <arm_group_label>2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)</arm_group_label>
    <arm_group_label>4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)</arm_group_label>
    <arm_group_label>6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)</arm_group_label>
    <arm_group_label>8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subject aged &gt;=10 and &lt;26 years at the time of randomization.&#xD;
&#xD;
          -  Healthy subject as determined by medical history, physical examination, and judgment&#xD;
             of the investigator.&#xD;
&#xD;
          -  Negative urine pregnancy test for all female subjects.&#xD;
&#xD;
          -  ACWY-naïve participants: Participants who have never received a prior dose of a&#xD;
             meningococcal vaccine containing ACWY serogroups.&#xD;
&#xD;
          -  ACWY-experienced participants: Participants who have received not more than 1 prior&#xD;
             dose, no sooner than 4 years prior to the date of randomization of Menactra or Menveo.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous vaccination with any meningococcal group B vaccine, any purely polysaccharide&#xD;
             (nonconjugate) meningococcal vaccine, or monovalent/bivalent meningococcal vaccine.-&#xD;
             Subjects receiving any allergen immunotherapy with a non-licensed product or receiving&#xD;
             allergen immunotherapy with a licensed product and are not on stable maintenance&#xD;
             doses.&#xD;
&#xD;
          -  A known or suspected defect of the immune system that would prevent an immune response&#xD;
             to the vaccine, such as subjects with congenital or acquired defects in B cell&#xD;
             function, those receiving chronic systemic (oral, intravenous, or intramuscular)&#xD;
             corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the&#xD;
             United States with terminal complement deficiency are excluded from participation in&#xD;
             this study.&#xD;
&#xD;
          -  Significant neurological disorder or history of seizure (excluding simple febrile&#xD;
             seizure).&#xD;
&#xD;
          -  Current chronic use of systemic antibiotics.&#xD;
&#xD;
          -  Participation in other studies involving investigational drug(s) or investigational&#xD;
             vaccine(s) within 28 days prior to study entry and/or during study participation.&#xD;
&#xD;
          -  Any neuroinflammatory or autoimmune condition, including, but not limited to,&#xD;
             transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.&#xD;
&#xD;
          -  History of microbiologically proven disease caused by N meningitidis or Neisseria&#xD;
             gonorrhoeae.&#xD;
&#xD;
          -  Receipt of any blood products, including immunoglobulin, within 6 months before the&#xD;
             first study vaccination.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alabama Clinical Therapeutics, LLC, Birmington Pediatric Assocaites</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Research Associates, Inc.</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fiel Family and Sports Medicine, PC/CCT Research</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velocity Clinical Research (Banning)</name>
      <address>
        <city>Banning</city>
        <state>California</state>
        <zip>92220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Madera Family Medical Group</name>
      <address>
        <city>Madera</city>
        <state>California</state>
        <zip>93637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Trials, LLC</name>
      <address>
        <city>Paramount</city>
        <state>California</state>
        <zip>90723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Trials</name>
      <address>
        <city>Paramount</city>
        <state>California</state>
        <zip>90723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optumcare Colorado Springs, LLC</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ALL Medical Research, LLC</name>
      <address>
        <city>Cooper City</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for MultiSpecialty Research, LLC - Miami</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Awareness, Inc.</name>
      <address>
        <city>Jupiter</city>
        <state>Florida</state>
        <zip>33458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altus Research</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crystal Biomedical Research, LLC</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Marcus Research Clinic, Inc.</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acevedo Clinical Research Associates</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthy Life Research, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bio-Medical Research, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33184</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complete Health Research</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oviedo Medical Research, LLC</name>
      <address>
        <city>Oviedo</city>
        <state>Florida</state>
        <zip>32765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PAS Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekton Research, Inc.</name>
      <address>
        <city>Chamblee</city>
        <state>Georgia</state>
        <zip>30341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velocity Clinical Research - Boise</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saltzer Health</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MOC Research</name>
      <address>
        <city>Mishawaka</city>
        <state>Indiana</state>
        <zip>46544</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The South Bend Clinic Center for Research</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Iowa Clinic</name>
      <address>
        <city>Ankeny</city>
        <state>Iowa</state>
        <zip>50023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Iowa Clinic</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Multispecialty Research, LLC</name>
      <address>
        <city>El Dorado</city>
        <state>Kansas</state>
        <zip>67042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Multispecialty Research, LLC</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael W. Simon, MD, PSC</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorn to Oak Pediatrics - ACC Pediatric Research</name>
      <address>
        <city>Haughton</city>
        <state>Louisiana</state>
        <zip>71037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sundance Clinical Research, LLC</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skyline Medical Center, PC/CCT Research</name>
      <address>
        <city>Elkhorn</city>
        <state>Nebraska</state>
        <zip>68022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality Clinical Research</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Salisbury, LLC</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington, LLC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accellacare - Winston-Salem</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Winston-Salem, LLC</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velocity Clinical Research - Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Clinical Research</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Associates of Fairfield, Inc.</name>
      <address>
        <city>Fairfield</city>
        <state>Ohio</state>
        <zip>45014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Senders Pediatrics</name>
      <address>
        <city>South Euclid</city>
        <state>Ohio</state>
        <zip>44121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Institute of Norman</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekton Research</name>
      <address>
        <city>Yukon</city>
        <state>Oklahoma</state>
        <zip>73099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liberty Family Practice</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accellacare US Inc.</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Internal Medicine and Pediatric Associates of Bristol, PC</name>
      <address>
        <city>Bristol</city>
        <state>Tennessee</state>
        <zip>37620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holston Medical Group</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Medicine Associates of Texas</name>
      <address>
        <city>Carrollton</city>
        <state>Texas</state>
        <zip>75010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AIM Trials, LLC</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Texas Family Medicine</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekton Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olympus Family Medicine/CCT Research</name>
      <address>
        <city>Holladay</city>
        <state>Utah</state>
        <zip>84117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Care</name>
      <address>
        <city>Provo</city>
        <state>Utah</state>
        <zip>84604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research, Inc. / Foothill Family Clinic</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research, Inc. / Foothill Family Clinic South</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research, Inc. / Jordan River Family Medicine</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SANARE s.r.o</name>
      <address>
        <city>Ceske Budejovice</city>
        <zip>37006</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Hradec Kralove</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>50005</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Jindrichuv Hradec</city>
        <zip>377 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MUDr. Katerina Stichhauerova s.r.o.</name>
      <address>
        <city>Pardubice</city>
        <zip>530 03</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicentrum 6 s.r.o.</name>
      <address>
        <city>Praha 6</city>
        <zip>160 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praktik Pb s.r.o.</name>
      <address>
        <city>Pribram</city>
        <zip>26101</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus Universitetshospital</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DRC Gyógyszervizsgáló Központ Kft.</name>
      <address>
        <city>Balatonfüred</city>
        <zip>8230</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia</name>
      <address>
        <city>Debrecen</city>
        <zip>4031</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coronella Orvosi Centrum / Trial Pharma Kft.</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRU Hungary Kft.</name>
      <address>
        <city>Miskolc</city>
        <zip>3529</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fejér Megyei Szent György Egyetemi Oktató Kórház</name>
      <address>
        <city>Székesfehérvár</city>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Badan Klinicznych JCI</name>
      <address>
        <city>Krakow</city>
        <zip>30-348</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Przylądek Zdrowia</name>
      <address>
        <city>Krakow</city>
        <zip>30-644</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niepubliczny Zaklad Opieki Zdrowotnej &quot;Salmed&quot;</name>
      <address>
        <city>Leczna</city>
        <zip>21-010</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niepubliczny Zaklad Lecznictwa Ambulatoryjnego MICHALKOWICE</name>
      <address>
        <city>Siemianowice Slaskie</city>
        <zip>41-103</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy</name>
      <address>
        <city>Trzebnica</city>
        <zip>55-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=C3511001</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <results_first_submitted>March 22, 2023</results_first_submitted>
  <results_first_submitted_qc>March 22, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 18, 2023</results_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 13, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT04440163/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 13, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT04440163/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 2431 participants were enrolled and randomized in the study of which 18 participants did not receive any vaccination. Out of 2431 participants, 2413 participants received at least 1 dose of vaccination.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)</title>
          <description>On Day 1 (Visit 1), Neisseria meningitidis group A, C, W, and Y (ACWY) naive participants received a single dose of 0.5 milliliter (mL) Neisseria meningitidis serogroup A, B, C, W, Y (MenABCWY) intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="P2">
          <title>ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria conjugate vaccine (MenACWY-CRM) intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3,participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="P3">
          <title>ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="P4">
          <title>ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="P5">
          <title>ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2). and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="P6">
          <title>ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="P7">
          <title>ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="P8">
          <title>ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Vaccination Phase (Approx. 7 Months)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="552"/>
                <participants group_id="P2" count="276"/>
                <participants group_id="P3" count="528"/>
                <participants group_id="P4" count="261">One participant initially randomized to group 3 was included in group 4 as participant received the wrong vaccination (Trumenba + saline).</participants>
                <participants group_id="P5" count="544"/>
                <participants group_id="P6" count="57"/>
                <participants group_id="P7" count="154"/>
                <participants group_id="P8" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 1</title>
              <participants_list>
                <participants group_id="P1" count="547"/>
                <participants group_id="P2" count="274"/>
                <participants group_id="P3" count="526"/>
                <participants group_id="P4" count="261"/>
                <participants group_id="P5" count="537"/>
                <participants group_id="P6" count="56"/>
                <participants group_id="P7" count="153"/>
                <participants group_id="P8" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 2</title>
              <participants_list>
                <participants group_id="P1" count="500"/>
                <participants group_id="P2" count="254"/>
                <participants group_id="P3" count="453"/>
                <participants group_id="P4" count="218"/>
                <participants group_id="P5" count="481"/>
                <participants group_id="P6" count="46"/>
                <participants group_id="P7" count="123"/>
                <participants group_id="P8" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="490"/>
                <participants group_id="P2" count="248"/>
                <participants group_id="P3" count="440"/>
                <participants group_id="P4" count="209"/>
                <participants group_id="P5" count="476"/>
                <participants group_id="P6" count="45"/>
                <participants group_id="P7" count="122"/>
                <participants group_id="P8" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="88"/>
                <participants group_id="P4" count="52"/>
                <participants group_id="P5" count="68"/>
                <participants group_id="P6" count="12"/>
                <participants group_id="P7" count="32"/>
                <participants group_id="P8" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="42"/>
                <participants group_id="P4" count="22"/>
                <participants group_id="P5" count="30"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="18"/>
                <participants group_id="P8" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Medication error without associated adverse event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer met eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="18"/>
                <participants group_id="P4" count="14"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by parent/guardian</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="16"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawn before vaccination</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-up Phase (Approx. 5 Months)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="490"/>
                <participants group_id="P2" count="248"/>
                <participants group_id="P3" count="440"/>
                <participants group_id="P4" count="209"/>
                <participants group_id="P5" count="476"/>
                <participants group_id="P6" count="45"/>
                <participants group_id="P7" count="122"/>
                <participants group_id="P8" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="487"/>
                <participants group_id="P2" count="243"/>
                <participants group_id="P3" count="440"/>
                <participants group_id="P4" count="208"/>
                <participants group_id="P5" count="475"/>
                <participants group_id="P6" count="45"/>
                <participants group_id="P7" count="120"/>
                <participants group_id="P8" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. One participant initially randomized to group 3 was excluded from safety population set as the participant received the wrong vaccination (Trumenba + saline).</population>
      <group_list>
        <group group_id="B1">
          <title>ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="B2">
          <title>ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="B3">
          <title>ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="B4">
          <title>ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. . Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="B5">
          <title>ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="B6">
          <title>ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="B7">
          <title>ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="B8">
          <title>ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="B9">
          <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="547"/>
            <count group_id="B2" value="274"/>
            <count group_id="B3" value="526"/>
            <count group_id="B4" value="260"/>
            <count group_id="B5" value="537"/>
            <count group_id="B6" value="56"/>
            <count group_id="B7" value="153"/>
            <count group_id="B8" value="59"/>
            <count group_id="B9" value="2412"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.7" spread="5.49"/>
                    <measurement group_id="B2" value="16.7" spread="5.39"/>
                    <measurement group_id="B3" value="17.3" spread="3.17"/>
                    <measurement group_id="B4" value="17.4" spread="3.28"/>
                    <measurement group_id="B5" value="13.5" spread="4.05"/>
                    <measurement group_id="B6" value="13.5" spread="4.50"/>
                    <measurement group_id="B7" value="17.1" spread="3.04"/>
                    <measurement group_id="B8" value="16.0" spread="2.75"/>
                    <measurement group_id="B9" value="16.1" spread="4.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="289"/>
                    <measurement group_id="B2" value="140"/>
                    <measurement group_id="B3" value="279"/>
                    <measurement group_id="B4" value="131"/>
                    <measurement group_id="B5" value="253"/>
                    <measurement group_id="B6" value="20"/>
                    <measurement group_id="B7" value="96"/>
                    <measurement group_id="B8" value="28"/>
                    <measurement group_id="B9" value="1236"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="258"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="247"/>
                    <measurement group_id="B4" value="129"/>
                    <measurement group_id="B5" value="284"/>
                    <measurement group_id="B6" value="36"/>
                    <measurement group_id="B7" value="57"/>
                    <measurement group_id="B8" value="31"/>
                    <measurement group_id="B9" value="1176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="156"/>
                    <measurement group_id="B4" value="86"/>
                    <measurement group_id="B5" value="131"/>
                    <measurement group_id="B6" value="15"/>
                    <measurement group_id="B7" value="58"/>
                    <measurement group_id="B8" value="29"/>
                    <measurement group_id="B9" value="621"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="450"/>
                    <measurement group_id="B2" value="217"/>
                    <measurement group_id="B3" value="366"/>
                    <measurement group_id="B4" value="173"/>
                    <measurement group_id="B5" value="405"/>
                    <measurement group_id="B6" value="41"/>
                    <measurement group_id="B7" value="93"/>
                    <measurement group_id="B8" value="30"/>
                    <measurement group_id="B9" value="1775"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="74"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="57"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="27"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="467"/>
                    <measurement group_id="B2" value="239"/>
                    <measurement group_id="B3" value="370"/>
                    <measurement group_id="B4" value="195"/>
                    <measurement group_id="B5" value="419"/>
                    <measurement group_id="B6" value="46"/>
                    <measurement group_id="B7" value="103"/>
                    <measurement group_id="B8" value="42"/>
                    <measurement group_id="B9" value="1881"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="48"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="42"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="18"/>
                    <measurement group_id="B8" value="10"/>
                    <measurement group_id="B9" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving At Least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2</title>
        <description>4-fold increase was defined as: 1) for participants with baseline hSBA titer below limit of detection (LOD) (or hSBA titer less than [&lt;] 1:4), 4-fold rise was defined as hSBA titer greater than or equal to (&gt;=) 1:16; 2) baseline hSBA titer &gt;=LOD and &lt; lower limit of quantitation (LLOQ) (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer &gt;=4 times LLOQ; 3) baseline hSBA titer &gt;=LLOQ, 4-fold rise was defined as hSBA titer &gt;=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. Analysis was performed on post-vaccination (PV) 1 evaluable immunogenicity population (EIP) for Group 2 and PV2 evaluable immunogenicity population for Group 1. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.</description>
        <time_frame>Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 1 and 1 month after Vaccination 1 in Group 2</time_frame>
        <population>PV1 EIP and PV2 EIP: randomized to study group of interest; eligible at visit (V) 2 and 4 respectively; received vaccine at V1 or V1 and V3, respectively; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY or MenACWY/MenB assay result; no prohibited vaccine/treatment, no protocol deviations through V2 and V4, respectively. N=participants evaluable for outcome measure; n=participants evaluable for rows.</population>
        <group_list>
          <group group_id="O1">
            <title>ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)</title>
            <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)</title>
            <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving At Least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2</title>
          <description>4-fold increase was defined as: 1) for participants with baseline hSBA titer below limit of detection (LOD) (or hSBA titer less than [&lt;] 1:4), 4-fold rise was defined as hSBA titer greater than or equal to (&gt;=) 1:16; 2) baseline hSBA titer &gt;=LOD and &lt; lower limit of quantitation (LLOQ) (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer &gt;=4 times LLOQ; 3) baseline hSBA titer &gt;=LLOQ, 4-fold rise was defined as hSBA titer &gt;=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. Analysis was performed on post-vaccination (PV) 1 evaluable immunogenicity population (EIP) for Group 2 and PV2 evaluable immunogenicity population for Group 1. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.</description>
          <population>PV1 EIP and PV2 EIP: randomized to study group of interest; eligible at visit (V) 2 and 4 respectively; received vaccine at V1 or V1 and V3, respectively; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY or MenACWY/MenB assay result; no prohibited vaccine/treatment, no protocol deviations through V2 and V4, respectively. N=participants evaluable for outcome measure; n=participants evaluable for rows.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="451"/>
                <count group_id="O2" value="254"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="447"/>
                    <count group_id="O2" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.8" lower_limit="95.9" upper_limit="98.9"/>
                    <measurement group_id="O2" value="95.3" lower_limit="91.9" upper_limit="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="451"/>
                    <count group_id="O2" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.3" lower_limit="90.6" upper_limit="95.5"/>
                    <measurement group_id="O2" value="52.4" lower_limit="46.0" upper_limit="58.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="244"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="95.3" upper_limit="98.6"/>
                    <measurement group_id="O2" value="73.0" lower_limit="66.9" upper_limit="78.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="446"/>
                    <count group_id="O2" value="248"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.4" lower_limit="91.8" upper_limit="96.3"/>
                    <measurement group_id="O2" value="70.6" lower_limit="64.5" upper_limit="76.2"/>
                  </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>
            <groups_desc>MenA</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was greater than (&gt;) minus (-)10 percent (%), the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>2.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>6.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MenC</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>41.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>34.4</ci_lower_limit>
            <ci_upper_limit>47.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MenW</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>24.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>18.8</ci_lower_limit>
            <ci_upper_limit>30.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MenY</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>23.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>18.0</ci_lower_limit>
            <ci_upper_limit>30.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4</title>
        <description>4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer &lt;1:4), 4-fold rise was defined as hSBA titer &gt;=1:16; 2) baseline hSBA titer &gt;=LOD (i.e., hSBA titer of &gt;=1:4) and &lt; LLOQ (i.e., hSBA titer of 1:8), 4-fold rise was defined as hSBA titer &gt;=4times LLOQ; 3) baseline hSBA titer &gt;=LLOQ, 4-fold rise was defined as hSBA titer &gt;=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.</description>
        <time_frame>Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 3 and 1 month after Vaccination 1 in Group 4</time_frame>
        <population>PV1 and PV2 EIP for Group 4 and Group 3, respectively: randomized to study group of interest; eligible at V2 and V4, respectively; received vaccine at V1 or V1 and V3, respectively; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY or MenACWY/MenB assay result, no prohibited vaccines/treatment, no protocol deviations through V2 and V4 respectively. N=participants evaluable for outcome measure; n=participants evaluable for rows.</population>
        <group_list>
          <group group_id="O1">
            <title>ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)</title>
            <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)</title>
            <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. . Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4</title>
          <description>4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer &lt;1:4), 4-fold rise was defined as hSBA titer &gt;=1:16; 2) baseline hSBA titer &gt;=LOD (i.e., hSBA titer of &gt;=1:4) and &lt; LLOQ (i.e., hSBA titer of 1:8), 4-fold rise was defined as hSBA titer &gt;=4times LLOQ; 3) baseline hSBA titer &gt;=LLOQ, 4-fold rise was defined as hSBA titer &gt;=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.</description>
          <population>PV1 and PV2 EIP for Group 4 and Group 3, respectively: randomized to study group of interest; eligible at V2 and V4, respectively; received vaccine at V1 or V1 and V3, respectively; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY or MenACWY/MenB assay result, no prohibited vaccines/treatment, no protocol deviations through V2 and V4 respectively. N=participants evaluable for outcome measure; n=participants evaluable for rows.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="387"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="385"/>
                    <count group_id="O2" value="227"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.8" lower_limit="90.9" upper_limit="96.0"/>
                    <measurement group_id="O2" value="96.9" lower_limit="93.7" upper_limit="98.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="386"/>
                    <count group_id="O2" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.8" lower_limit="90.9" upper_limit="96.0"/>
                    <measurement group_id="O2" value="94.7" lower_limit="90.9" upper_limit="97.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="386"/>
                    <count group_id="O2" value="222"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.1" lower_limit="94.8" upper_limit="98.5"/>
                    <measurement group_id="O2" value="96.4" lower_limit="93.0" upper_limit="98.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="387"/>
                    <count group_id="O2" value="223"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.0" lower_limit="90.0" upper_limit="95.4"/>
                    <measurement group_id="O2" value="93.7" lower_limit="89.7" upper_limit="96.5"/>
                  </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>
            <groups_desc>MenA</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>-3.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.5</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MenC</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.6</ci_lower_limit>
            <ci_upper_limit>3.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MenW</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.2</ci_lower_limit>
            <ci_upper_limit>4.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MenY</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>-0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.6</ci_lower_limit>
            <ci_upper_limit>3.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving hSBA Titer Greater Than or Equal to (&gt;=) LLOQ for All Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined</title>
        <description>Percentage of participants achieving hSBA titer &gt;= LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all MenB test strains (A22, A56, B24 and B44) combined were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.</description>
        <time_frame>1 month after Vaccination 2</time_frame>
        <population>PV2 EIP: participants randomized to study group of interest; eligible at V4; received vaccine at V1 and V3; blood drawn for assay testing at specified time points; had at least 1 valid, determinate MenACWY or MenB assay result at V4; received no prohibited vaccines; no protocol deviations through V4. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set)</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving hSBA Titer Greater Than or Equal to (&gt;=) LLOQ for All Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined</title>
          <description>Percentage of participants achieving hSBA titer &gt;= LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all MenB test strains (A22, A56, B24 and B44) combined were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.</description>
          <population>PV2 EIP: participants randomized to study group of interest; eligible at V4; received vaccine at V1 and V3; blood drawn for assay testing at specified time points; had at least 1 valid, determinate MenACWY or MenB assay result at V4; received no prohibited vaccines; no protocol deviations through V4. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="755"/>
                <count group_id="O2" value="383"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.3" lower_limit="75.2" upper_limit="81.2"/>
                    <measurement group_id="O2" value="68.7" lower_limit="63.8" upper_limit="73.3"/>
                  </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>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>9.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.2</ci_lower_limit>
            <ci_upper_limit>15.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving At Least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined</title>
        <description>Percentage of participants achieving at least a 4-fold rise in hSBA titer for each primary MenB test strains (A22, A56, B24 and B44) were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.</description>
        <time_frame>Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2</time_frame>
        <population>PV2 EIP: participants randomized to study group of interest; eligible at V4; received vaccine at V1 and V3; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY or MenB assay result at V4; no prohibited vaccines; no protocol deviations through V4. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified rows.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set)</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving At Least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined</title>
          <description>Percentage of participants achieving at least a 4-fold rise in hSBA titer for each primary MenB test strains (A22, A56, B24 and B44) were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.</description>
          <population>PV2 EIP: participants randomized to study group of interest; eligible at V4; received vaccine at V1 and V3; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY or MenB assay result at V4; no prohibited vaccines; no protocol deviations through V4. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified rows.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="845"/>
                <count group_id="O2" value="419"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="778"/>
                    <count group_id="O2" value="396"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.0" lower_limit="80.2" upper_limit="85.6"/>
                    <measurement group_id="O2" value="79.0" lower_limit="74.7" upper_limit="82.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="807"/>
                    <count group_id="O2" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.9" lower_limit="94.3" upper_limit="97.2"/>
                    <measurement group_id="O2" value="94.5" lower_limit="91.8" upper_limit="96.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="833"/>
                    <count group_id="O2" value="418"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.1" lower_limit="64.8" upper_limit="71.2"/>
                    <measurement group_id="O2" value="57.2" lower_limit="52.3" upper_limit="62.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="845"/>
                    <count group_id="O2" value="419"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.5" lower_limit="84.0" upper_limit="88.7"/>
                    <measurement group_id="O2" value="79.2" lower_limit="75.0" upper_limit="83.0"/>
                  </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>
            <groups_desc>A22</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>4.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>8.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A56</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>4.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>B24</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>10.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.2</ci_lower_limit>
            <ci_upper_limit>16.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>B44</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage</param_type>
            <param_value>7.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.9</ci_lower_limit>
            <ci_upper_limit>11.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: &gt;2.0 to 5.0 cm, moderate: &gt;5.0 to 10.0 cm and severe: &gt;10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 7 days after Vaccination 1</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; (N) signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: &gt;2.0 to 5.0 cm, moderate: &gt;5.0 to 10.0 cm and severe: &gt;10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; (N) signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1722"/>
                <count group_id="O2" value="630"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Redness: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" lower_limit="7.5" upper_limit="10.3"/>
                    <measurement group_id="O2" value="7.3" lower_limit="5.4" upper_limit="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" lower_limit="12.8" upper_limit="16.2"/>
                    <measurement group_id="O2" value="10.0" lower_limit="7.8" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1.8" upper_limit="3.3"/>
                    <measurement group_id="O2" value="2.2" lower_limit="1.2" upper_limit="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" lower_limit="9.0" upper_limit="12.0"/>
                    <measurement group_id="O2" value="8.3" lower_limit="6.2" upper_limit="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3" lower_limit="11.7" upper_limit="15.0"/>
                    <measurement group_id="O2" value="12.4" lower_limit="9.9" upper_limit="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0.7" upper_limit="1.8"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.3" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at injection site: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.3" lower_limit="30.1" upper_limit="34.6"/>
                    <measurement group_id="O2" value="31.1" lower_limit="27.5" upper_limit="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at injection site: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.5" lower_limit="47.1" upper_limit="51.9"/>
                    <measurement group_id="O2" value="47.6" lower_limit="43.7" upper_limit="51.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at injection site: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="6.3" upper_limit="8.8"/>
                    <measurement group_id="O2" value="6.3" lower_limit="4.6" upper_limit="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: &gt;2.0 to 5.0 cm, moderate: &gt;5.0 to 10.0 cm and severe: &gt;10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 7 days after Vaccination 2</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: &gt;2.0 to 5.0 cm, moderate: &gt;5.0 to 10.0 cm and severe: &gt;10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1456"/>
                <count group_id="O2" value="529"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Redness: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="6.4" upper_limit="9.2"/>
                    <measurement group_id="O2" value="6.6" lower_limit="4.7" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" lower_limit="10.9" upper_limit="14.4"/>
                    <measurement group_id="O2" value="7.2" lower_limit="5.1" upper_limit="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2.1" upper_limit="4.0"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.3" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" lower_limit="8.9" upper_limit="12.1"/>
                    <measurement group_id="O2" value="6.4" lower_limit="4.5" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" lower_limit="11.1" upper_limit="14.6"/>
                    <measurement group_id="O2" value="8.1" lower_limit="5.9" upper_limit="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.5" upper_limit="1.6"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at injection site: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.1" lower_limit="26.7" upper_limit="31.5"/>
                    <measurement group_id="O2" value="33.1" lower_limit="29.1" upper_limit="37.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at injection site: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.8" lower_limit="46.2" upper_limit="51.4"/>
                    <measurement group_id="O2" value="40.3" lower_limit="36.1" upper_limit="44.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at injection site: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" lower_limit="5.3" upper_limit="7.9"/>
                    <measurement group_id="O2" value="5.3" lower_limit="3.5" upper_limit="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>Systemic events were recorded by participants in e-diary. Fever was defined as temperature &gt;=38.0 degrees (deg) Celsius (C) and was categorized as 38.0 to 38.4 deg C, &gt;38.4 to 38.9 deg C, &gt;38.9 to 40.0 deg C and &gt;40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: &gt;2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 7 days after Vaccination 1</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>Systemic events were recorded by participants in e-diary. Fever was defined as temperature &gt;=38.0 degrees (deg) Celsius (C) and was categorized as 38.0 to 38.4 deg C, &gt;38.4 to 38.9 deg C, &gt;38.9 to 40.0 deg C and &gt;40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: &gt;2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1739"/>
                <count group_id="O2" value="638"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fever: 38.0 deg C to 38.4 deg C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" lower_limit="2.8" upper_limit="4.7"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.1" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: &gt;38.4 deg C to 38.9 deg C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.0" upper_limit="2.3"/>
                    <measurement group_id="O2" value="2.8" lower_limit="1.7" upper_limit="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: &gt;38.9 deg C to 40.0 deg C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.3" upper_limit="1.1"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.3" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: &gt;40.0 deg C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.5" lower_limit="21.5" upper_limit="25.5"/>
                    <measurement group_id="O2" value="25.7" lower_limit="22.4" upper_limit="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5" lower_limit="23.4" upper_limit="27.6"/>
                    <measurement group_id="O2" value="25.7" lower_limit="22.4" upper_limit="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" lower_limit="2.4" upper_limit="4.1"/>
                    <measurement group_id="O2" value="3.3" lower_limit="2.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6" lower_limit="23.6" upper_limit="27.8"/>
                    <measurement group_id="O2" value="24.5" lower_limit="21.2" upper_limit="28.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="17.4" upper_limit="21.1"/>
                    <measurement group_id="O2" value="20.4" lower_limit="17.3" upper_limit="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="1.3" upper_limit="2.7"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.1" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" lower_limit="11.1" upper_limit="14.2"/>
                    <measurement group_id="O2" value="10.2" lower_limit="8.0" upper_limit="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="5.5" upper_limit="7.9"/>
                    <measurement group_id="O2" value="7.8" lower_limit="5.9" upper_limit="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="0.4" upper_limit="1.3"/>
                    <measurement group_id="O2" value="1.6" lower_limit="0.8" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1.8" upper_limit="3.4"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.1" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.3" upper_limit="1.1"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.3" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" lower_limit="7.5" upper_limit="10.2"/>
                    <measurement group_id="O2" value="11.9" lower_limit="9.5" upper_limit="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.4" upper_limit="2.7"/>
                    <measurement group_id="O2" value="1.6" lower_limit="0.8" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.1" upper_limit="0.7"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle Pain: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6" lower_limit="12.0" upper_limit="15.3"/>
                    <measurement group_id="O2" value="13.5" lower_limit="10.9" upper_limit="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle Pain: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" lower_limit="9.1" upper_limit="12.1"/>
                    <measurement group_id="O2" value="11.9" lower_limit="9.5" upper_limit="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle Pain: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.1" upper_limit="2.3"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.1" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint Pain: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" lower_limit="9.3" upper_limit="12.2"/>
                    <measurement group_id="O2" value="12.9" lower_limit="10.4" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint Pain: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" lower_limit="7.3" upper_limit="10.0"/>
                    <measurement group_id="O2" value="8.6" lower_limit="6.6" upper_limit="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint Pain: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.6" upper_limit="1.6"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.4" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>Systemic events were recorded by participants in e-diary. Fever was defined as temperature &gt;=38.0 deg C and was categorized as 38.0 to 38.4 deg C, &gt;38.4 to 38.9 deg C, &gt;38.9 to 40.0 deg C and &gt;40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: &gt;2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 7 days after Vaccination 2</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>Systemic events were recorded by participants in e-diary. Fever was defined as temperature &gt;=38.0 deg C and was categorized as 38.0 to 38.4 deg C, &gt;38.4 to 38.9 deg C, &gt;38.9 to 40.0 deg C and &gt;40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: &gt;2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1459"/>
                <count group_id="O2" value="532"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fever: 38.0 deg C to 38.4 deg C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="1.2" upper_limit="2.6"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.0" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: &gt;38.4 deg C to 38.9 deg C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.1" upper_limit="0.7"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.3" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: &gt;38.9 deg C to 40.0 deg C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.0" upper_limit="0.6"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: &gt;40.0 deg C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" lower_limit="20.7" upper_limit="25.1"/>
                    <measurement group_id="O2" value="22.0" lower_limit="18.5" upper_limit="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.8" lower_limit="19.7" upper_limit="24.0"/>
                    <measurement group_id="O2" value="19.9" lower_limit="16.6" upper_limit="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="2.1" upper_limit="3.9"/>
                    <measurement group_id="O2" value="1.7" lower_limit="0.8" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3" lower_limit="19.2" upper_limit="23.5"/>
                    <measurement group_id="O2" value="21.1" lower_limit="17.7" upper_limit="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" lower_limit="14.9" upper_limit="18.8"/>
                    <measurement group_id="O2" value="16.2" lower_limit="13.1" upper_limit="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="1.1" upper_limit="2.5"/>
                    <measurement group_id="O2" value="0.6" lower_limit="0.1" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9" lower_limit="8.5" upper_limit="11.6"/>
                    <measurement group_id="O2" value="8.8" lower_limit="6.6" upper_limit="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4.9" upper_limit="7.4"/>
                    <measurement group_id="O2" value="5.8" lower_limit="4.0" upper_limit="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.2" upper_limit="0.9"/>
                    <measurement group_id="O2" value="1.5" lower_limit="0.7" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.8" upper_limit="2.1"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.2" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.0" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="5.6" upper_limit="8.3"/>
                    <measurement group_id="O2" value="6.0" lower_limit="4.2" upper_limit="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.8" upper_limit="2.1"/>
                    <measurement group_id="O2" value="2.4" lower_limit="1.3" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle Pain: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="8.5" upper_limit="11.7"/>
                    <measurement group_id="O2" value="10.0" lower_limit="7.6" upper_limit="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle Pain: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" lower_limit="10.3" upper_limit="13.7"/>
                    <measurement group_id="O2" value="11.5" lower_limit="8.9" upper_limit="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle Pain: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="0.4" upper_limit="1.4"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.2" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint Pain: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6" lower_limit="8.1" upper_limit="11.2"/>
                    <measurement group_id="O2" value="7.9" lower_limit="5.7" upper_limit="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint Pain: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="6.9" upper_limit="9.8"/>
                    <measurement group_id="O2" value="6.8" lower_limit="4.8" upper_limit="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint Pain: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.2" upper_limit="0.9"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.3" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>The use of antipyretic medication was recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 7 days after Vaccination 1</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>The use of antipyretic medication was recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1739"/>
                <count group_id="O2" value="638"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5" lower_limit="27.4" upper_limit="31.7"/>
                    <measurement group_id="O2" value="28.1" lower_limit="24.6" upper_limit="31.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>The use of antipyretic medication recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 7 days after Vaccination 2</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>The use of antipyretic medication recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1459"/>
                <count group_id="O2" value="532"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.1" lower_limit="22.9" upper_limit="27.4"/>
                    <measurement group_id="O2" value="20.5" lower_limit="17.1" upper_limit="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.</description>
        <time_frame>Within 30 days after Vaccination 1</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" lower_limit="4.7" upper_limit="7.0"/>
                    <measurement group_id="O2" value="6.5" lower_limit="4.7" upper_limit="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.</description>
        <time_frame>Within 30 days after Vaccination 2</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1558"/>
                <count group_id="O2" value="562"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" lower_limit="4.3" upper_limit="6.6"/>
                    <measurement group_id="O2" value="3.7" lower_limit="2.3" upper_limit="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.</description>
        <time_frame>Within 30 days after any vaccination</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" lower_limit="8.4" upper_limit="11.2"/>
                    <measurement group_id="O2" value="9.1" lower_limit="7.0" upper_limit="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.</description>
        <time_frame>From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" lower_limit="19.0" upper_limit="22.8"/>
                    <measurement group_id="O2" value="20.3" lower_limit="17.3" upper_limit="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 30 days after Vaccination 1</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" lower_limit="0.0" upper_limit="0.3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 30 days after Vaccination 2</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1558"/>
                <count group_id="O2" value="562"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="0.0" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 30 days after any vaccination</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.0" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.2" upper_limit="0.8"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1390"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.1" upper_limit="0.7"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.2" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.3" upper_limit="1.1"/>
                    <measurement group_id="O2" value="0.6" lower_limit="0.2" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 30 days after Vaccination 1</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="2.8" upper_limit="4.5"/>
                    <measurement group_id="O2" value="4.3" lower_limit="2.9" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 30 days after Vaccination 2</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1558"/>
                <count group_id="O2" value="562"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="2.7" upper_limit="4.6"/>
                    <measurement group_id="O2" value="2.8" lower_limit="1.6" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 30 days after any vaccination</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="5.2" upper_limit="7.5"/>
                    <measurement group_id="O2" value="6.3" lower_limit="4.6" upper_limit="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" lower_limit="13.3" upper_limit="16.7"/>
                    <measurement group_id="O2" value="14.3" lower_limit="11.7" upper_limit="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1390"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" lower_limit="7.8" upper_limit="10.9"/>
                    <measurement group_id="O2" value="7.5" lower_limit="5.3" upper_limit="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.3" lower_limit="17.5" upper_limit="21.2"/>
                    <measurement group_id="O2" value="18.3" lower_limit="15.4" upper_limit="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 30 days after Vaccination 1</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.1" upper_limit="0.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 30 days after Vaccination 2</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1558"/>
                <count group_id="O2" value="562"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" lower_limit="0.0" upper_limit="0.4"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 30 Days after any vaccination</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.1" upper_limit="0.7"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.7" upper_limit="1.7"/>
                    <measurement group_id="O2" value="0.3" lower_limit="0.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1390"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.1" upper_limit="0.8"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.9" upper_limit="2.1"/>
                    <measurement group_id="O2" value="0.3" lower_limit="0.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 30 minutes after Vaccination 1</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Lower and upper limit of 95% CI could not be estimated, due to insufficient participants with event.</measurement>
                    <measurement group_id="O2" value="0" lower_limit="NA" upper_limit="NA">Lower and upper limit of 95% CI could not be estimated, due to insufficient participants with event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
        <time_frame>Within 30 minutes after Vaccination 2</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1558"/>
                <count group_id="O2" value="562"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">Lower and upper limit of 95% CI could not be estimated, due to insufficient participants with event.</measurement>
                    <measurement group_id="O2" value="0" lower_limit="NA" upper_limit="NA">Lower and upper limit of 95% CI could not be estimated, due to insufficient participants with event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Missed Days of School or Work Due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
        <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Percentage of participants who missed days of school or work due to AEs during vaccination phase were reported in this outcome measure.</description>
        <time_frame>From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Groups 1+3+5+7 Combined MenABCWY + Saline</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM</title>
            <description>On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Missed Days of School or Work Due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)</title>
          <description>An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Percentage of participants who missed days of school or work due to AEs during vaccination phase were reported in this outcome measure.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="649"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 1 Compared to Group 2</title>
        <description>4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer &lt;1:4), 4-fold rise was defined as hSBA titer &gt;=1:16; 2) baseline hSBA titer &gt;=LOD (i.e., hSBA titer of &gt;=1:4) and &lt; LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer &gt;=4times LLOQ; 3) baseline hSBA titer &gt;=LLOQ, 4-fold rise was defined as hSBA titer &gt;=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.</description>
        <time_frame>Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1</time_frame>
        <population>PV1 EIP: participants randomized to study group of interest; eligible at V2; received vaccine at V1; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY assay result at V2; no prohibited vaccines; no protocol deviations through V2. Here &quot;Overall Number of Participants Analyzed&quot; = participants evaluable for outcome measure and &quot;Number Analyzed&quot; = number of participants evaluable for specified rows.</population>
        <group_list>
          <group group_id="O1">
            <title>ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)</title>
            <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)</title>
            <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 1 Compared to Group 2</title>
          <description>4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer &lt;1:4), 4-fold rise was defined as hSBA titer &gt;=1:16; 2) baseline hSBA titer &gt;=LOD (i.e., hSBA titer of &gt;=1:4) and &lt; LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer &gt;=4times LLOQ; 3) baseline hSBA titer &gt;=LLOQ, 4-fold rise was defined as hSBA titer &gt;=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.</description>
          <population>PV1 EIP: participants randomized to study group of interest; eligible at V2; received vaccine at V1; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY assay result at V2; no prohibited vaccines; no protocol deviations through V2. Here &quot;Overall Number of Participants Analyzed&quot; = participants evaluable for outcome measure and &quot;Number Analyzed&quot; = number of participants evaluable for specified rows.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="501"/>
                <count group_id="O2" value="254"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="499"/>
                    <count group_id="O2" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0" lower_limit="95.1" upper_limit="98.3"/>
                    <measurement group_id="O2" value="95.3" lower_limit="91.9" upper_limit="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="501"/>
                    <count group_id="O2" value="252"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.9" lower_limit="58.5" upper_limit="67.1"/>
                    <measurement group_id="O2" value="52.4" lower_limit="46.0" upper_limit="58.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="492"/>
                    <count group_id="O2" value="244"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.3" lower_limit="75.4" upper_limit="82.8"/>
                    <measurement group_id="O2" value="73.0" lower_limit="66.9" upper_limit="78.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="248"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.0" lower_limit="78.3" upper_limit="85.3"/>
                    <measurement group_id="O2" value="70.6" lower_limit="64.5" upper_limit="76.2"/>
                  </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>
            <groups_desc>MenA</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>5.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MenC</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>10.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.0</ci_lower_limit>
            <ci_upper_limit>17.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MenW</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>6.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>13.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MenY</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>11.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.0</ci_lower_limit>
            <ci_upper_limit>18.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 3 Compared to Group 4</title>
        <description>4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer &lt;1:4), 4-fold rise was defined as hSBA titer &gt;=1:16; 2) baseline hSBA titer &gt;=LOD (i.e., hSBA titer of &gt;=1:4) and &lt; LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer &gt;=4 times LLOQ; 3) baseline hSBA titer &gt; =LLOQ, 4-fold rise was defined as hSBA titer &gt;=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.</description>
        <time_frame>Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1</time_frame>
        <population>PV1 EIP: participants randomised to study group of interest; eligible at V 2; received vaccine at V1; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY assay result at V2; no prohibited vaccines and no protocol deviations through V2. Here &quot;Overall Number of Participants Analyzed&quot; = participants evaluable for outcome measure and &quot;Number Analyzed&quot; = number of participants evaluable for specified rows.</population>
        <group_list>
          <group group_id="O1">
            <title>ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)</title>
            <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
          <group group_id="O2">
            <title>ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)</title>
            <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. . Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 3 Compared to Group 4</title>
          <description>4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer &lt;1:4), 4-fold rise was defined as hSBA titer &gt;=1:16; 2) baseline hSBA titer &gt;=LOD (i.e., hSBA titer of &gt;=1:4) and &lt; LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer &gt;=4 times LLOQ; 3) baseline hSBA titer &gt; =LLOQ, 4-fold rise was defined as hSBA titer &gt;=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.</description>
          <population>PV1 EIP: participants randomised to study group of interest; eligible at V 2; received vaccine at V1; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY assay result at V2; no prohibited vaccines and no protocol deviations through V2. Here &quot;Overall Number of Participants Analyzed&quot; = participants evaluable for outcome measure and &quot;Number Analyzed&quot; = number of participants evaluable for specified rows.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="442"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="227"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.8" lower_limit="92.2" upper_limit="96.7"/>
                    <measurement group_id="O2" value="96.9" lower_limit="93.7" upper_limit="98.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="439"/>
                    <count group_id="O2" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.4" lower_limit="90.7" upper_limit="95.5"/>
                    <measurement group_id="O2" value="94.7" lower_limit="90.9" upper_limit="97.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="428"/>
                    <count group_id="O2" value="222"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.4" lower_limit="95.4" upper_limit="98.7"/>
                    <measurement group_id="O2" value="96.4" lower_limit="93.0" upper_limit="98.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="442"/>
                    <count group_id="O2" value="223"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.3" lower_limit="91.8" upper_limit="96.3"/>
                    <measurement group_id="O2" value="93.7" lower_limit="89.7" upper_limit="96.5"/>
                  </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>
            <groups_desc>MenA</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>-2.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.2</ci_lower_limit>
            <ci_upper_limit>1.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MenC</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>-1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.9</ci_lower_limit>
            <ci_upper_limit>2.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MenW</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>4.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MenY</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was &gt; -10%, the non-inferiority was concluded.</non_inferiority_desc>
            <param_type>Difference in percentage of participants</param_type>
            <param_value>0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.0</ci_lower_limit>
            <ci_upper_limit>5.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Local reactions and systemic events recorded using systematic assessment within 7 days after Vaccination 1 and 2; SAEs and all-cause mortality recorded using non-systematic assessment from Day 1 up to 6 months after vaccination 2 (approximately 12 months) and other AEs recorded using non-systematic assessment from Day 1 up to 1 month after vaccination 2 (approximately 7 months)</time_frame>
      <desc>Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.</desc>
      <group_list>
        <group group_id="E1">
          <title>ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="E2">
          <title>ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="E3">
          <title>ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="E4">
          <title>ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. . Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="E5">
          <title>ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="E6">
          <title>ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="E7">
          <title>ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
        <group group_id="E8">
          <title>ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)</title>
          <description>On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 25.0</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="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Postural orthostatic tachycardia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Spinal cord injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Food intolerance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Status migrainosus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Depression suicidal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Disruptive mood dysregulation disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 25.0</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="533" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="262" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="504" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="244" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="512" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="53" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="148" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="58" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Diarrhoea (DIARRHEA)</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="116" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="54" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="72" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="23" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Vomiting (VOMITING)</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="21" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills (CHILLS)</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="155" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="78" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="151" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="59" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="130" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="43" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="19" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Fatigue (FATIGUE)</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="364" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="183" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="337" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="160" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="317" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="30" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="99" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="43" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Injection site pain (PAIN AT INJECTION SITE)</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="522" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="247" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="486" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="228" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="493" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="51" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="144" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="57" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pyrexia (FEVER)</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="42" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Swelling (SWELLING)</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="186" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="71" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="158" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="57" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="200" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="49" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="19" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="36" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lice infestation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>SARS-CoV-2 test positive</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Arthralgia (JOINT PAIN)</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="156" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="75" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="156" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="83" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="144" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="48" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="19" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Myalgia (MUSCLE PAIN)</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="198" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="97" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="207" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="97" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="167" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="57" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="22" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Headache (HEADACHE)</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="330" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="152" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="312" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="161" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="282" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="24" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="86" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="37" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Amenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Heavy menstrual bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Painful respiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Alopecia areata</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Erythema (REDNESS)</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="183" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="75" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="162" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="58" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="190" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="15" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="39" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="16" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Keratosis pilaris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="260"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="537"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="59"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04440163
org study id: C3511001
secondary id: 2019-004313-13
nct id: NCT04440163
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed
      vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of
      MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10
      to <26 years of age.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Achieving At Least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2
time frame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 1 and 1 month after Vaccination 1 in Group 2
description: 4-fold increase was defined as: 1) for participants with baseline hSBA titer below limit of detection (LOD) (or hSBA titer less than [<] 1:4), 4-fold rise was defined as hSBA titer greater than or equal to (>=) 1:16; 2) baseline hSBA titer >=LOD and < lower limit of quantitation (LLOQ) (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4 times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. Analysis was performed on post-vaccination (PV) 1 evaluable immunogenicity population (EIP) for Group 2 and PV2 evaluable immunogenicity population for Group 1. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.
measure: Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4
time frame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 3 and 1 month after Vaccination 1 in Group 4
description: 4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e., hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.
measure: Percentage of Participants Achieving hSBA Titer Greater Than or Equal to (>=) LLOQ for All Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
time frame: 1 month after Vaccination 2
description: Percentage of participants achieving hSBA titer >= LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all MenB test strains (A22, A56, B24 and B44) combined were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
measure: Percentage of Participants Achieving At Least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
time frame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2
description: Percentage of participants achieving at least a 4-fold rise in hSBA titer for each primary MenB test strains (A22, A56, B24 and B44) were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 7 days after Vaccination 1
description: Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 7 days after Vaccination 2
description: Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 7 days after Vaccination 1
description: Systemic events were recorded by participants in e-diary. Fever was defined as temperature >=38.0 degrees (deg) Celsius (C) and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 7 days after Vaccination 2
description: Systemic events were recorded by participants in e-diary. Fever was defined as temperature >=38.0 deg C and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 7 days after Vaccination 1
description: The use of antipyretic medication was recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 7 days after Vaccination 2
description: The use of antipyretic medication recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 days after Vaccination 1
description: An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
measure: Percentage of Participants With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 days after Vaccination 2
description: An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
measure: Percentage of Participants With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 days after any vaccination
description: An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
measure: Percentage of Participants With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
description: An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
measure: Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 days after Vaccination 1
description: An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 days after Vaccination 2
description: An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 days after any vaccination
description: An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
description: An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
description: An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
description: An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 days after Vaccination 1
description: MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 days after Vaccination 2
description: MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 days after any vaccination
description: MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
description: MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
description: MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
description: MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 days after Vaccination 1
description: An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 days after Vaccination 2
description: An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 Days after any vaccination
description: An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
description: An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
description: An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
description: An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 minutes after Vaccination 1
description: Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: Within 30 minutes after Vaccination 2
description: Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.
measure: Percentage of Participants Who Missed Days of School or Work Due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
time frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
description: An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Percentage of participants who missed days of school or work due to AEs during vaccination phase were reported in this outcome measure.
measure: Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 1 Compared to Group 2
time frame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
description: 4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.
measure: Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 3 Compared to Group 4
time frame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
description: 4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4 times LLOQ; 3) baseline hSBA titer > =LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.
arm group label: 1-Immuno Subset (ACWY Naive,MenABCWY/Saline)
arm group type: Experimental
description: ACWY Naive subjects, MenABCWY/Saline
arm group label: 2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)
arm group type: Experimental
description: ACWY Naive subjects, Trumenba/MenACWY-CRM
arm group label: 3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)
arm group type: Experimental
description: ACWY Experienced subjects, MenABCWY/Saline
arm group label: 4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)
arm group type: Experimental
description: ACWY Experienced subjects, Trumenba/MenACWY-CRM
arm group label: 5-Safety Subset (ACWY Naive,MenABCWY/Saline)
arm group type: Experimental
description: ACWY Naive subjects, MenABCWY/Saline
arm group label: 6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)
arm group type: Experimental
description: ACWY Naive subjects, Trumenba/MenACWY-CRM
arm group label: 7-Safety Subset (ACWY Experienced,MenABCWY/Saline)
arm group type: Experimental
description: ACWY Experienced subjects, MenABCWY/Saline
arm group label: 8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)
arm group type: Experimental
description: ACWY Experienced subjects, Trumenba/MenACWY-CRM
intervention type: Biological
intervention name: MenABCWY
description: N meningitidis groups A, B, C, W, and Y vaccine
arm group label: 1-Immuno Subset (ACWY Naive,MenABCWY/Saline)
arm group label: 3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)
arm group label: 5-Safety Subset (ACWY Naive,MenABCWY/Saline)
arm group label: 7-Safety Subset (ACWY Experienced,MenABCWY/Saline)
intervention type: Biological
intervention name: Saline
description: Placebo
arm group label: 1-Immuno Subset (ACWY Naive,MenABCWY/Saline)
arm group label: 3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)
arm group label: 5-Safety Subset (ACWY Naive,MenABCWY/Saline)
arm group label: 7-Safety Subset (ACWY Experienced,MenABCWY/Saline)
intervention type: Biological
intervention name: Trumenba
description: Bivalent recombinant lipoprotein 2086 vaccine
arm group label: 2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)
arm group label: 4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)
arm group label: 6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)
arm group label: 8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)
intervention type: Biological
intervention name: MenACWY-CRM
description: Meningococcal group A, C, W-135, and Y conjugate vaccine
arm group label: 2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)
arm group label: 4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)
arm group label: 6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)
arm group label: 8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)
criteria: 
gender: All
minimum age: 10 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Czechia
country: Denmark
country: Hungary
country: Poland
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=C3511001
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 