<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/NCT04502693</url>
  </required_header>
  <id_info>
    <org_study_id>205416</org_study_id>
    <secondary_id>2019-001666-15</secondary_id>
    <nct_id>NCT04502693</nct_id>
  </id_info>
  <brief_title>Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults</brief_title>
  <official_title>A Phase III, Randomized, Controlled, Observer-blind Study to Demonstrate Effectiveness, Immunogenicity and Safety of GSK's Meningococcal Group B and Combined ABCWY Vaccines When Administered to Healthy Adolescents and Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of 2 doses or 3 doses of GSK's&#xD;
      licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's&#xD;
      investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy&#xD;
      adolescents and young adults. The immunogenicity and safety will also be evaluated in the&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As per the feedback from Center for Biologics Evaluation and Research (CBER) the scope of&#xD;
      this post-marketing commitment study has been extended to demonstrate the effectiveness,&#xD;
      immunogenicity and safety of GSK's investigational combined meningococcal ABCWY vaccine along&#xD;
      with the rMenB+OMV NZ vaccine. Note that the rMenB+OMV and MenACWY vaccines provided to&#xD;
      MenB_0_2_6, MenB_0_6 group and MenACWY group respectively at day 211 are only as part of&#xD;
      standard care of treatment and to maintain blinding. These vaccination schedules are not&#xD;
      considered for any endpoint evaluations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Actual">September 13, 2022</completion_date>
  <primary_completion_date type="Actual">September 13, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Observer-blinded study. Recipients &amp; study evaluators will be unaware of vaccine administered.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of samples without bactericidal serum activity against each of the endemic US N. meningitidis serogroup B strains at 1 month after the 3-dose (0,2,6-M), the 2-dose [(0,6-M) and (0,2-M)] vaccination schedule of rMenB+OMV and 1 dose of MenACWY</measure>
    <time_frame>At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group, Day 91 for the MenB_0_2_6 group [2-dose schedule] for rMenB+OMV vaccine and Day 31 for ACWY group for MenACWY vaccine)</time_frame>
    <description>The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 3 and 2 doses in MenB_0_2_6 group and 1 month after the 2 dose schedule in MenB_0_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. The percentage of samples are averaged across all 110 strains.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants whose sera kill ≥70% of the strains tested using enc-hSBA at 1 month after the 3-dose schedule (0,2,6-M) and 2-dose schedule ([0,6-M] and [0,2-M]) of rMenB+OMV vaccine</measure>
    <time_frame>At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group, Day 91 for the MenB_0_2_6 group [2-dose schedule])</time_frame>
    <description>The effectiveness (responder-based) of the rMenB+OMV NZ vaccine is measured in terms of percentage of participants whose sera kill ≥70% of the strains tested using enc-hSBA, being calculated based on Clopper Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric mean titers (GMTs) against serogroups A, C, W and Y for each lot (ABCWY-1 Group, ABCWY-2 Group and ABCWY-3 Group) at 1 month after the last vaccination of MenABCWY</measure>
    <time_frame>At Day 211</time_frame>
    <description>Immune responses of 3 lots of the MenACWY component of the MenABCWY vaccine is measured in terms of hSBA GMTs directed against serogroups A, C, W and Y</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with 4-fold rise in hSBA titers against N. meningitidis serogroups A, C, W and Y at 1 month after last MenABCWY vaccination (pooled lots) and MenACWY vaccination (for the ACWY Group), relative to baseline</measure>
    <time_frame>At 1 month after vaccination schedule (i.e., Day 211 for the ABCWY Group [pooled lots] and Day 31 for the ACWY Group)</time_frame>
    <description>The immunogenicity of the MenABCWY vaccine when compared to MenACWY vaccine, in participants without a previous MenACWY vaccination (unprimed), is measured in terms of percentage of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis 4 serogroups (A, C, W, Y). The calculation is based on Clopper Pearson method. Four-fold rise is defined as: If the pre-vaccination hSBA titer is &lt; 4, then post-vaccination hSBA titer should be ≥ 16 . If the pre-vaccination hSBA titer is ≥ limit of detection (LOD) but &lt; LL of quantification (LLOQ), then post-vaccination hSBA titer should be ≥ 4 times the LLOQ. If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of samples without bactericidal serum activity against each of the endemic U.S N. meningitidis serogroup B strains at 1 month after the last MenABCWY dose (ABCWY group-pooled lots) and MenACWY vaccine (for ACWY group)</measure>
    <time_frame>At 1 month after the vaccination schedule (i.e., at Day 211 for the ABCWY group [pooled lots] and Day 31 for the ACWY group)</time_frame>
    <description>The effectiveness (test-based) of 2 doses of MenABCWY vaccine when compared to 1 dose of MenACWY vaccine, against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. The percentages of samples are averaged across all 110 strains.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of samples with bactericidal serum activity against each of the endemic U.S N. meningitidis serogroup B strains at 1 month after the last MenABCWY dose (pooled lots) and after 3-dose or 2-dose vaccination series of rMenB+OMV</measure>
    <time_frame>At 1 month after the vaccination schedule (i.e., at Day 211 for the ABCWY Group [pooled lots], MenB_0_2_6 Group [3-dose schedule], MenB_0_6 Group and at Day 91 for the MenB_0_2_6 Group [2-dose schedule])</time_frame>
    <description>The effectiveness of the MenABCWY vaccine (0,6-M schedule) when compared to the rMenB+OMV NZ vaccine (0,2,6-M or 0,6-M or 0,2-M) is measured in terms of percentage of samples with bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. The percentages of samples are averaged across all 110 strains.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants whose sera kill ≥70% of the strains tested using enc-hSBA at 1 month after the last vaccination in the ABCWY Group (pooled lots)</measure>
    <time_frame>At Day 211</time_frame>
    <description>The effectiveness (responder-based) of the MenABCWY vaccine is measured in terms of percentage of participants whose sera kill ≥70% of the strains tested using enc-hSBA, being calculated based on Clopper Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with any solicited local adverse events (AEs)</measure>
    <time_frame>During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1, Day 61 and Day 181)</time_frame>
    <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Solicited local adverse events to be assessed include injection site pain, erythema, swelling, induration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with any solicited systemic AEs</measure>
    <time_frame>During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1, Day 61 and Day 181)</time_frame>
    <description>Solicited systemic AEs to be assessed include fever [temperature ≥ 38.0°C], nausea, fatigue, myalgia, arthralgia, headache.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with any unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to withdrawal, AE of special interest (AESIs) and medically attended AEs</measure>
    <time_frame>During the 30 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1, Day 61 and Day 181)</time_frame>
    <description>Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited AE. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterise and understand it. Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs</measure>
    <time_frame>Throughout the study period (Day 1 to Day 361)</time_frame>
    <description>A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with 4-fold rise in hSBA titers against N.meningitidis group B strains at 1 month after last MenABCWY dose(ABCWY group-pooled lots)and 1 month after 3-dose or 2-dose series of rMenB+OMV NZ in MenB groups, relative to baseline</measure>
    <time_frame>At 1 month after the vaccination schedule (i.e., at Day 211 for the ABCWY Group [pooled lots], MenB_0_2_6 Group [3-dose schedule] and MenB_0_6 Group and at Day 91 for the MenB_0_2_6 Group [2-dose schedule])</time_frame>
    <description>The immunogenicity of MenABCWY vaccine at 1 month after the last dose when compared to 1 month after last dose of rMenB+OMV NZ vaccine according to 3 dose (0,2,6-M) or 2 dose (0,6-M and 0,2-M) schedule is measured in terms of percentage of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). The calculation is based on Clopper Pearson method.&#xD;
Four-fold rise per each indicator strain is defined as:- If the pre-vaccination hSBA titer is &lt; 4, then post-vaccination* hSBA titer should be ≥ 16. - If the pre-vaccination hSBA titer is ≥ LOD and &lt; LLOQ, then post-vaccination* hSBA titer should be ≥ 4 times the LLOQ. - If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination* hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer. * post-second vaccination for 0,6 and 0,2 schedule and post-third vaccination for 0,2,6 schedule</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of samples without bactericidal serum activity against each of the endemic U.S N. meningitidis serogroup B strains at 1 month after vaccination schedule in all groups</measure>
    <time_frame>At 1 month after the vaccination schedule (i.e., Day 211 for the MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY group [pooled lots], Day 91 for the MenB_0_2_6 group [2 dose schedule] and Day 31 for the MenACWY group)</time_frame>
    <description>The effectiveness of the 3 dose (0,2,6-M) and 2 dose (0,6-M and 0,2-M) schedule of rMenB+OMV NZ vaccine and 2 doses of MenABCWY vaccine when compared to 1 month after the MenACWY vaccination (Day 31), against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. The percentages of samples are averaged across all 110 strains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants classified by percentage of serogroup B invasive disease strains killed using enc-hSBA in each subject at 1 month after the 3-dose and 2-dose vaccination series of rMenB+OMV NZ and 1 month after last MenABCWY vaccine</measure>
    <time_frame>At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group, ABCWY group (pooled lots), and Day 91 for MenB_0_2_6 group (2 dose schedule)</time_frame>
    <description>The percentage of participants are classified by percentage of N.meningitidis serogroup B invasive strains killed using enc-hSBA and the corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group. The percentage of participants are averaged across 110 strains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with hSBA titers ≥ LLOQ for each and all serogroup B indicator strains at Day 1 and at 1 month after vaccination with rMenB+OMV NZ (0,2,6-months, 0,6-months and 0,2-months) and last MenABCWY (0,6-months)</measure>
    <time_frame>At Day 1 (pre-vaccination) and after 1 month after the vaccination schedule (i.e, Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY group [pooled lots] and Day 91 for MenB_0_2_6 group [2 dose schedule])</time_frame>
    <description>The immune response to rMenB+OMV NZ and MenABCWY vaccine is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains- M14459, 96217, NZ98/254 and M13520.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with 4-fold rise in hSBA titers for each of the serogroup B strains at 1 month after vaccination with rMenB+OMV NZ (0,2,6-months, 0,6-months and 0,2-months) and MenABCWY (0,6-months), relative to baseline</measure>
    <time_frame>At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e, Day 211 for MenB_0_2_6 group [3-dose schedule], MenB_0_6 group, ABCWY group (pooled lots) and Day 91 for MenB_0_2_6 group [2 dose schedule])</time_frame>
    <description>The immune response to 3 dose (0,2,6-M) and 2 dose (0,6-M and 0,2-M) schedule of rMenB+OMV NZ and 2 doses of MenABCWY vaccine is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains- M14459, 96217, NZ98/254 and M13520 compared to baseline (Day 1). Four-fold rise per each indicator strain is defined as: - If the pre-vaccination hSBA titer is &lt; 4, then post-vaccination* hSBA titer should be ≥ 16. - If the pre-vaccination hSBA titer is ≥ LOD and &lt; LLOQ, then post-vaccination* hSBA titer should be ≥ 4 times the LLOQ. - If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination* hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer. * post-2nd vaccination for 0,6 and 0,2 schedule and post-3rd vaccination for 0,2,6 schedule</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hSBA GMTs against each of the N. meningitidis serogroup B strains at baseline and at 1 month after vaccination with rMenB+OMV NZ (0,2,6-months, 0,6-months and 0,2-months) and MenABCWY (0,6-months)</measure>
    <time_frame>At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e, Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY group [pooled lots] and Day 91 for MenB_0_2_6 group [2 dose schedule])</time_frame>
    <description>The immune response to rMenB+OMV NZ and MenABCWY vaccine is evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254), The GMTs (After vaccination/baseline) are calculated, with their associated 2-sided 95% CIs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Ratios (GMRs) for each of the N. meningitidis serogroup B strains at 1 month after vaccination with rMenB+OMV NZ (0,2,6-months, 0,6-months and 0,2-months) and MenABCWY (0,6-months), relative to baseline</measure>
    <time_frame>At 1 month after the vaccination schedule (i.e, Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY group [pooled lots] and Day 91 for MenB_0_2_6 group [2 dose schedule]) versus Day 1</time_frame>
    <description>The immune response to rMenB+OMV NZ and MenABCWY vaccine is evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with hSBA titers ≥ LLOQ for each of the N. meningitidis groups A,C,W,Y at Day 1,1 month after the first and after the last MenABCWY vaccination for ABCWY group (pooled lots) and 1 month after the MenACWY vaccine for ACWY group</measure>
    <time_frame>At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])</time_frame>
    <description>The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y after vaccination compared to baseline (Day 1) and expressed as the percentage of participants with hSBA titers ≥ LLOQ for serogroups A, C, W and Y at baseline and 1 month after vaccination schedule of MenABCWY and MenACWY vaccines.&#xD;
The corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with 4-fold rise in hSBA titers for each of the N. meningitidis serogroups A, C, W and Y at 1 month after the first MenABCWY dose for the ABCWY Group (pooled lots) and 1 month after the MenACWY vaccine for ACWY Group</measure>
    <time_frame>At Day 1 and Day 31</time_frame>
    <description>The immune response to MenABCWY vaccine compared to MenACWY vaccine is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroups A, C, W and Y at Day 31 compared to baseline (Day 1). Four-fold rise is defined as:&#xD;
- If the pre-vaccination hSBA titer is &lt; 4, then post-vaccination hSBA titer should be ≥ 16. - If the pre-vaccination hSBA titer is ≥ LOD but &lt; LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the LLOQ. - If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer. The corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hSBA GMTs against each of the N. meningitidis serogroups A, C, W and Y at Day 1 and 1 month after the first and after the last MenABCWY vaccination for the ABCWY Group (pooled lots) and 1 month after the MenACWY vaccination for ACWY Group</measure>
    <time_frame>At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])</time_frame>
    <description>The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroups A, C, W and Y, the GMTs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMRs for each of the N. meningitidis serogroups A, C, W and Y at 1 month after the first and after the last MenABCWY vaccination for the ABCWY Group (pooled lots) and 1 month after the MenACWY vaccination for ACWY Group</measure>
    <time_frame>At 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose]) versus baseline (Day 1)</time_frame>
    <description>The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y at Day 31 compared to baseline (Day 1). For each N. meningitidis serogroups A, C, W and Y, the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunoglobulin G (IgG) antibodies against N. meningitidis serogroups A, C, W and Y at Day 1 and 1 month after the first and after the last MenABCWY vaccination for ABCWY Group (pooled lots) and 1 month after the MenACWY vaccination for ACWY Group</measure>
    <time_frame>At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])</time_frame>
    <description>The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring the total IgG in terms of enzyme-linked immunosorbent assay (ELISA) geometric mean concentrations (GMCs) after vaccination compared to baseline (Day 1).</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">3657</enrollment>
  <condition>Infections, Meningococcal</condition>
  <arm_group>
    <arm_group_label>MenB_0_2_6 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive rMenB+OMV NZ vaccine as 3 dose schedule at Day 1, 61 and Day 181 or as 2 dose schedule at Day 1 and Day 61 and 1 dose of MenACWY vaccine at Day 211.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MenB_0_6 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive rMenB+OMV NZ vaccine as 2 dose schedule at Day 1, and Day 181, 1 dose of MenACWY vaccine at Day 61 and 1 dose of Placebo at Day 211.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABCWY-1 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABCWY-2 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABCWY-3 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACWY Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants, receive 1 dose of MenACWY vaccine at Day 1, 1 dose of placebo at Day 61 and 2 doses of rMenB+OMV NZ vaccine at Day 181 and Day 211.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>rMenB+OMV NZ vaccine</intervention_name>
    <description>rMenB+OMV NZ vaccine is administered intramuscularly to the non-dominant arm as 3 doses in a 0,2,6-M schedule or as 2 doses in a 0,6-M schedule to participants in the MenB_0_2_6 Group, as 2 doses in a 0,6-M schedule to participants in the MenB_0_6 Group and as 2 doses at Day 181 and Day 211 to participants in the ACWY Group.</description>
    <arm_group_label>ACWY Group</arm_group_label>
    <arm_group_label>MenB_0_2_6 Group</arm_group_label>
    <arm_group_label>MenB_0_6 Group</arm_group_label>
    <other_name>Bexsero</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)</intervention_name>
    <description>MenACWY vaccine is administered intramuscularly to the non-dominant arm as 1 dose at Day 211 to participants in the MenB_0_2_6 Group, as 1 dose at Day 61 to participants in the MenB_0_6 Group and as 1 dose at Day 1 to participants in the ACWY Group.</description>
    <arm_group_label>ACWY Group</arm_group_label>
    <arm_group_label>MenB_0_2_6 Group</arm_group_label>
    <arm_group_label>MenB_0_6 Group</arm_group_label>
    <other_name>Menveo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is administered intramuscularly to the non-dominant arm as 1 dose at Day 211 to participants in the MenB_0_6 Group, 2 doses at Day 61 and Day 211 to participants in the ABCWY groups and as 1 dose at Day 61 to participants in the ACWY Group.</description>
    <arm_group_label>ABCWY-1 Group</arm_group_label>
    <arm_group_label>ABCWY-2 Group</arm_group_label>
    <arm_group_label>ABCWY-3 Group</arm_group_label>
    <arm_group_label>ACWY Group</arm_group_label>
    <arm_group_label>MenB_0_6 Group</arm_group_label>
    <other_name>NaCl, saline solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>MenABCWY-1</intervention_name>
    <description>Lot 1 of the MenABCWY vaccine is administered intramuscularly to the non-dominant arm as 2 doses at Day 1 and Day 181 to participants in the ABCWY-1 Group.</description>
    <arm_group_label>ABCWY-1 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>MenABCWY-2</intervention_name>
    <description>Lot 2 of the MenABCWY vaccine is administered intramuscularly to the non-dominant arm as 2 doses at Day 1 and Day 181 to participants in the ABCWY-2 Group.</description>
    <arm_group_label>ABCWY-2 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>MenABCWY-3</intervention_name>
    <description>Lot 3 of the MenABCWY vaccine is administered intramuscularly to the non-dominant arm as 2 doses at Day 1 and Day 181 to participants in the ABCWY-3 Group.</description>
    <arm_group_label>ABCWY-3 Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects or/and subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who,&#xD;
             in the opinion of the investigator, can and will comply with the requirements of the&#xD;
             protocol.&#xD;
&#xD;
          -  Written or witnessed/thumb printed informed consent obtained from the&#xD;
             subject/parent(s)/LAR(s) of the subject prior to performance of any study specific&#xD;
             procedure.&#xD;
&#xD;
          -  Written informed assent obtained from the subject (if applicable) prior to performing&#xD;
             any study specific procedure.&#xD;
&#xD;
          -  A male or female between, and including, 10 and 25 years of age (i.e. 25 years + 364&#xD;
             days) at the time of the first vaccination.&#xD;
&#xD;
          -  Healthy subjects as established by medical history physical examination and clinical&#xD;
             judgment of the investigator before entering into the study.&#xD;
&#xD;
          -  Subjects who are either unvaccinated with MenACWY vaccine or have received a single&#xD;
             previous dose of MenACWY vaccine can participate in the study, if they have received&#xD;
             it at least 4 years prior to informed consent and assent as applicable (with the&#xD;
             exception of meningococcal C vaccination, if the last dose of MenC was received at ≤24&#xD;
             months of age).&#xD;
&#xD;
          -  Female subjects of non-childbearing potential may be enrolled in the study.&#xD;
             Non-childbearing potential is defined as pre-menarche, current bilateral tubal&#xD;
             ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause*.&#xD;
&#xD;
          -  Female subjects of childbearing potential may be enrolled in the study, if the&#xD;
             subject:&#xD;
&#xD;
               -  has practiced adequate contraception for 30 days prior to vaccination, and&#xD;
&#xD;
               -  has a negative pregnancy test on the day of vaccination, and&#xD;
&#xD;
               -  has agreed to continue adequate contraception until 30 days after completion of&#xD;
                  Visit 6.&#xD;
&#xD;
                    -  A female is considered to be of non-childbearing potential prior to menarche&#xD;
                       and after natural or induced menopause. Natural menopause is recognized to&#xD;
                       have occurred after 12 consecutive months of amenorrhea for which there is&#xD;
                       no other obvious pathological or physiological cause. Induced menopause is&#xD;
                       recognized to have occurred after hysterectomy, after bilateral&#xD;
                       oophorectomy, or iatrogenic ablation of ovarian function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Medical conditions&#xD;
&#xD;
          -  Current or previous, confirmed or suspected disease caused by N. meningitidis.&#xD;
&#xD;
          -  Household contact with and/or intimate exposure to an individual with laboratory&#xD;
             confirmed N. meningitidis infection within 60 days of enrolment.&#xD;
&#xD;
          -  Progressive, unstable or uncontrolled clinical conditions.&#xD;
&#xD;
          -  Clinical conditions representing a contraindication to intramuscular vaccination and&#xD;
             blood draws.&#xD;
&#xD;
          -  Any neuroinflammatory, congenital neurological conditions, encephalopathies, seizures.&#xD;
             History of febrile convulsions should not lead to exclusion.&#xD;
&#xD;
          -  History of any reaction or hypersensitivity likely to be exacerbated by any component&#xD;
             of the vaccine(s)/product(s).&#xD;
&#xD;
               -  Hypersensitivity, including allergy, to any component of vaccines, including&#xD;
                  diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment&#xD;
                  whose use is foreseen in this study.&#xD;
&#xD;
          -  Abnormal function or modification of the immune system resulting from:&#xD;
&#xD;
               -  Autoimmune disorders or immunodeficiency syndromes.&#xD;
&#xD;
               -  Systemic administration of corticosteroids (PO/IV/IM) for more than 14&#xD;
                  consecutive days within 90 days prior to study vaccination until the&#xD;
                  post-vaccination 3 blood sample (Visit 6). This will mean prednisone - ≥20 mg/day&#xD;
                  (for adult subjects) or ≥0.5 mg/kg/day (for paediatric subjects), or equivalent.&#xD;
                  Inhaled and topical steroids are allowed.&#xD;
&#xD;
               -  Administration of antineoplastic and immunomodulating agents or radiotherapy&#xD;
                  within 90 days prior to study vaccination.&#xD;
&#xD;
               -  Administration of long-acting immune-modifying drugs at any time during the study&#xD;
                  period (e.g. infliximab).&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
             medical history and physical examination.&#xD;
&#xD;
        Prior/Concomitant therapy&#xD;
&#xD;
          -  Use of any investigational or non-registered product other than the study&#xD;
             vaccine(s)/product(s) during the period starting 30 days before the first dose of&#xD;
             study vaccine(s)/product(s) (Day -29 to Day 1), or planned use during the study&#xD;
             period.&#xD;
&#xD;
          -  Previous vaccination against any group B meningococcal vaccine at any time prior to&#xD;
             informed consent and assent as applicable.&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products or plasma derivatives&#xD;
             during the period starting 90 days before the first dose of study vaccine/ product or&#xD;
             planned administration during the study period until the post-vaccination 3 blood&#xD;
             sample (Visit 6).&#xD;
&#xD;
          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants&#xD;
             or other immune-modifying drugs during the period starting 90 days prior to the&#xD;
             vaccine/product dose(s) until the post-vaccination 3 blood sample (Visit 6). For&#xD;
             corticosteroids, this will mean prednisone ≥20 mg/day (for adult subjects) or ≥0.5&#xD;
             mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are&#xD;
             allowed.&#xD;
&#xD;
        Prior/Concurrent clinical study experience&#xD;
&#xD;
        • Concurrently participating in another clinical study, at any time during the study&#xD;
        period, in which the subject has been or will be exposed to an investigational or a&#xD;
        non-investigational vaccine/product.&#xD;
&#xD;
        Other exclusions&#xD;
&#xD;
          -  Child in care.&#xD;
&#xD;
          -  Pregnant or lactating female.&#xD;
&#xD;
          -  Female planning to become pregnant or planning to discontinue contraceptive&#xD;
             precautions.&#xD;
&#xD;
          -  History of /current chronic alcohol abuse and/or drug abuse as determined by the&#xD;
             investigator.&#xD;
&#xD;
          -  Any study personnel or immediate dependants, family, or household member.&#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>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85286</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bell Gardens</city>
        <state>California</state>
        <zip>90201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Canoga Park</city>
        <state>California</state>
        <zip>91304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Inglewood</city>
        <state>California</state>
        <zip>90301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Los Gatos</city>
        <state>California</state>
        <zip>95032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cutler Bay</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lake City</city>
        <state>Florida</state>
        <zip>32055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oviedo</city>
        <state>Florida</state>
        <zip>32765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Adairsville</city>
        <state>Georgia</state>
        <zip>30103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buford</city>
        <state>Georgia</state>
        <zip>30519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hinesville</city>
        <state>Georgia</state>
        <zip>31313</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oak Brook</city>
        <state>Illinois</state>
        <zip>60523</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beverly</city>
        <state>Massachusetts</state>
        <zip>01915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Grosse Pointe Woods</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Petal</city>
        <state>Mississippi</state>
        <zip>39465</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45419</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Grants Pass</city>
        <state>Oregon</state>
        <zip>97527</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>West Columbia</city>
        <state>South Carolina</state>
        <zip>29169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Laredo</city>
        <state>Texas</state>
        <zip>78041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kaysville</city>
        <state>Utah</state>
        <zip>84037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Roy</city>
        <state>Utah</state>
        <zip>84067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84095</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Syracuse</city>
        <state>Utah</state>
        <zip>84075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Suffolk</city>
        <state>Virginia</state>
        <zip>23435</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cheney</city>
        <state>Washington</state>
        <zip>99004</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gold Coast</city>
        <state>Queensland</state>
        <zip>4222</zip>
        <country>Australia</country>
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    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taringa</city>
        <state>Queensland</state>
        <zip>4068</zip>
        <country>Australia</country>
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      <name>GSK Investigational Site</name>
      <address>
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        <state>Queensland</state>
        <zip>4121</zip>
        <country>Australia</country>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
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        <state>Victoria</state>
        <zip>3220</zip>
        <country>Australia</country>
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  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3010</zip>
        <country>Australia</country>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
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        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3B 6A8</zip>
        <country>Canada</country>
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    </facility>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5A 4L8</zip>
        <country>Canada</country>
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  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4H4</zip>
        <country>Canada</country>
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    </facility>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3K 6R8</zip>
        <country>Canada</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N5W 6A2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sarnia</city>
        <state>Ontario</state>
        <zip>N7T 4X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M9V 4B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M9W 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pointe-Claire</city>
        <state>Quebec</state>
        <zip>H9R 4S3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Québec City</city>
        <state>Quebec</state>
        <zip>G1E 7G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Québec</city>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ceske Budejovice</city>
        <zip>37008</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 02</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jindrichuv Hradec</city>
        <zip>37701</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kladno</city>
        <zip>272 80</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Melnik</city>
        <zip>27601</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pardubice</city>
        <zip>53003</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pardubice</city>
        <zip>53009</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Praha 6</city>
        <zip>160 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pribram</city>
        <zip>261 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Trutnov</city>
        <zip>541 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tynec nad Sazavou</city>
        <zip>257 41</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>České Budejovice</city>
        <zip>370 06</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tallinn</city>
        <zip>10117</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tallinn</city>
        <zip>10617</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Espoo</city>
        <zip>02230</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Helsinki</city>
        <zip>00100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Helsinki</city>
        <zip>00930</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jarvenpaa</city>
        <zip>04400</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kokkola</city>
        <zip>67100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oulu</city>
        <zip>90220</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pori</city>
        <zip>28100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seinajoki</city>
        <zip>60100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tampere</city>
        <zip>33100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Adana</city>
        <zip>01330</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ankara</city>
        <zip>06590</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eskisehir</city>
        <zip>26040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kayseri</city>
        <zip>38030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Finland</country>
    <country>Turkey</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bexsero</keyword>
  <keyword>Menveo</keyword>
  <keyword>MenABCWY</keyword>
  <keyword>Effectiveness</keyword>
  <keyword>Invasive meningococcal disease</keyword>
  <keyword>Meningitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningococcal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04502693
org study id: 205416
secondary id: 2019-001666-15
nct id: NCT04502693
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to evaluate the effectiveness of 2 doses or 3 doses of GSK's
      licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's
      investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy
      adolescents and young adults. The immunogenicity and safety will also be evaluated in the
      study.
As per the feedback from Center for Biologics Evaluation and Research (CBER) the scope of
      this post-marketing commitment study has been extended to demonstrate the effectiveness,
      immunogenicity and safety of GSK's investigational combined meningococcal ABCWY vaccine along
      with the rMenB+OMV NZ vaccine. Note that the rMenB+OMV and MenACWY vaccines provided to
      MenB_0_2_6, MenB_0_6 group and MenACWY group respectively at day 211 are only as part of
      standard care of treatment and to maintain blinding. These vaccination schedules are not
      considered for any endpoint evaluations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Observer-blinded study. Recipients & study evaluators will be unaware of vaccine administered.
measure: Percentage of samples without bactericidal serum activity against each of the endemic US N. meningitidis serogroup B strains at 1 month after the 3-dose (0,2,6-M), the 2-dose [(0,6-M) and (0,2-M)] vaccination schedule of rMenB+OMV and 1 dose of MenACWY
time frame: At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group, Day 91 for the MenB_0_2_6 group [2-dose schedule] for rMenB+OMV vaccine and Day 31 for ACWY group for MenACWY vaccine)
description: The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 3 and 2 doses in MenB_0_2_6 group and 1 month after the 2 dose schedule in MenB_0_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. The percentage of samples are averaged across all 110 strains.
measure: Percentage of participants whose sera kill ≥70% of the strains tested using enc-hSBA at 1 month after the 3-dose schedule (0,2,6-M) and 2-dose schedule ([0,6-M] and [0,2-M]) of rMenB+OMV vaccine
time frame: At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group, Day 91 for the MenB_0_2_6 group [2-dose schedule])
description: The effectiveness (responder-based) of the rMenB+OMV NZ vaccine is measured in terms of percentage of participants whose sera kill ≥70% of the strains tested using enc-hSBA, being calculated based on Clopper Pearson method.
measure: Geometric mean titers (GMTs) against serogroups A, C, W and Y for each lot (ABCWY-1 Group, ABCWY-2 Group and ABCWY-3 Group) at 1 month after the last vaccination of MenABCWY
time frame: At Day 211
description: Immune responses of 3 lots of the MenACWY component of the MenABCWY vaccine is measured in terms of hSBA GMTs directed against serogroups A, C, W and Y
measure: Percentage of participants with 4-fold rise in hSBA titers against N. meningitidis serogroups A, C, W and Y at 1 month after last MenABCWY vaccination (pooled lots) and MenACWY vaccination (for the ACWY Group), relative to baseline
time frame: At 1 month after vaccination schedule (i.e., Day 211 for the ABCWY Group [pooled lots] and Day 31 for the ACWY Group)
description: The immunogenicity of the MenABCWY vaccine when compared to MenACWY vaccine, in participants without a previous MenACWY vaccination (unprimed), is measured in terms of percentage of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis 4 serogroups (A, C, W, Y). The calculation is based on Clopper Pearson method. Four-fold rise is defined as: If the pre-vaccination hSBA titer is < 4, then post-vaccination hSBA titer should be ≥ 16 . If the pre-vaccination hSBA titer is ≥ limit of detection (LOD) but < LL of quantification (LLOQ), then post-vaccination hSBA titer should be ≥ 4 times the LLOQ. If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer
measure: Percentage of samples without bactericidal serum activity against each of the endemic U.S N. meningitidis serogroup B strains at 1 month after the last MenABCWY dose (ABCWY group-pooled lots) and MenACWY vaccine (for ACWY group)
time frame: At 1 month after the vaccination schedule (i.e., at Day 211 for the ABCWY group [pooled lots] and Day 31 for the ACWY group)
description: The effectiveness (test-based) of 2 doses of MenABCWY vaccine when compared to 1 dose of MenACWY vaccine, against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. The percentages of samples are averaged across all 110 strains.
measure: Percentage of samples with bactericidal serum activity against each of the endemic U.S N. meningitidis serogroup B strains at 1 month after the last MenABCWY dose (pooled lots) and after 3-dose or 2-dose vaccination series of rMenB+OMV
time frame: At 1 month after the vaccination schedule (i.e., at Day 211 for the ABCWY Group [pooled lots], MenB_0_2_6 Group [3-dose schedule], MenB_0_6 Group and at Day 91 for the MenB_0_2_6 Group [2-dose schedule])
description: The effectiveness of the MenABCWY vaccine (0,6-M schedule) when compared to the rMenB+OMV NZ vaccine (0,2,6-M or 0,6-M or 0,2-M) is measured in terms of percentage of samples with bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. The percentages of samples are averaged across all 110 strains.
measure: Percentage of participants whose sera kill ≥70% of the strains tested using enc-hSBA at 1 month after the last vaccination in the ABCWY Group (pooled lots)
time frame: At Day 211
description: The effectiveness (responder-based) of the MenABCWY vaccine is measured in terms of percentage of participants whose sera kill ≥70% of the strains tested using enc-hSBA, being calculated based on Clopper Pearson method.
measure: Percentage of participants with any solicited local adverse events (AEs)
time frame: During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1, Day 61 and Day 181)
description: An adverse event is any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Solicited local adverse events to be assessed include injection site pain, erythema, swelling, induration.
measure: Percentage of participants with any solicited systemic AEs
time frame: During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1, Day 61 and Day 181)
description: Solicited systemic AEs to be assessed include fever [temperature ≥ 38.0°C], nausea, fatigue, myalgia, arthralgia, headache.
measure: Percentage of participants with any unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to withdrawal, AE of special interest (AESIs) and medically attended AEs
time frame: During the 30 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1, Day 61 and Day 181)
description: Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited AE. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterise and understand it. Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
measure: Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs
time frame: Throughout the study period (Day 1 to Day 361)
description: A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
measure: Percentage of participants with 4-fold rise in hSBA titers against N.meningitidis group B strains at 1 month after last MenABCWY dose(ABCWY group-pooled lots)and 1 month after 3-dose or 2-dose series of rMenB+OMV NZ in MenB groups, relative to baseline
time frame: At 1 month after the vaccination schedule (i.e., at Day 211 for the ABCWY Group [pooled lots], MenB_0_2_6 Group [3-dose schedule] and MenB_0_6 Group and at Day 91 for the MenB_0_2_6 Group [2-dose schedule])
description: The immunogenicity of MenABCWY vaccine at 1 month after the last dose when compared to 1 month after last dose of rMenB+OMV NZ vaccine according to 3 dose (0,2,6-M) or 2 dose (0,6-M and 0,2-M) schedule is measured in terms of percentage of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). The calculation is based on Clopper Pearson method.
Four-fold rise per each indicator strain is defined as:- If the pre-vaccination hSBA titer is < 4, then post-vaccination* hSBA titer should be ≥ 16. - If the pre-vaccination hSBA titer is ≥ LOD and < LLOQ, then post-vaccination* hSBA titer should be ≥ 4 times the LLOQ. - If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination* hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer. * post-second vaccination for 0,6 and 0,2 schedule and post-third vaccination for 0,2,6 schedule
measure: Percentage of samples without bactericidal serum activity against each of the endemic U.S N. meningitidis serogroup B strains at 1 month after vaccination schedule in all groups
time frame: At 1 month after the vaccination schedule (i.e., Day 211 for the MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY group [pooled lots], Day 91 for the MenB_0_2_6 group [2 dose schedule] and Day 31 for the MenACWY group)
description: The effectiveness of the 3 dose (0,2,6-M) and 2 dose (0,6-M and 0,2-M) schedule of rMenB+OMV NZ vaccine and 2 doses of MenABCWY vaccine when compared to 1 month after the MenACWY vaccination (Day 31), against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. The percentages of samples are averaged across all 110 strains.
measure: Percentage of participants classified by percentage of serogroup B invasive disease strains killed using enc-hSBA in each subject at 1 month after the 3-dose and 2-dose vaccination series of rMenB+OMV NZ and 1 month after last MenABCWY vaccine
time frame: At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group, ABCWY group (pooled lots), and Day 91 for MenB_0_2_6 group (2 dose schedule)
description: The percentage of participants are classified by percentage of N.meningitidis serogroup B invasive strains killed using enc-hSBA and the corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group. The percentage of participants are averaged across 110 strains.
measure: Percentage of participants with hSBA titers ≥ LLOQ for each and all serogroup B indicator strains at Day 1 and at 1 month after vaccination with rMenB+OMV NZ (0,2,6-months, 0,6-months and 0,2-months) and last MenABCWY (0,6-months)
time frame: At Day 1 (pre-vaccination) and after 1 month after the vaccination schedule (i.e, Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY group [pooled lots] and Day 91 for MenB_0_2_6 group [2 dose schedule])
description: The immune response to rMenB+OMV NZ and MenABCWY vaccine is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains- M14459, 96217, NZ98/254 and M13520.
measure: Percentage of participants with 4-fold rise in hSBA titers for each of the serogroup B strains at 1 month after vaccination with rMenB+OMV NZ (0,2,6-months, 0,6-months and 0,2-months) and MenABCWY (0,6-months), relative to baseline
time frame: At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e, Day 211 for MenB_0_2_6 group [3-dose schedule], MenB_0_6 group, ABCWY group (pooled lots) and Day 91 for MenB_0_2_6 group [2 dose schedule])
description: The immune response to 3 dose (0,2,6-M) and 2 dose (0,6-M and 0,2-M) schedule of rMenB+OMV NZ and 2 doses of MenABCWY vaccine is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains- M14459, 96217, NZ98/254 and M13520 compared to baseline (Day 1). Four-fold rise per each indicator strain is defined as: - If the pre-vaccination hSBA titer is < 4, then post-vaccination* hSBA titer should be ≥ 16. - If the pre-vaccination hSBA titer is ≥ LOD and < LLOQ, then post-vaccination* hSBA titer should be ≥ 4 times the LLOQ. - If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination* hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer. * post-2nd vaccination for 0,6 and 0,2 schedule and post-3rd vaccination for 0,2,6 schedule
measure: hSBA GMTs against each of the N. meningitidis serogroup B strains at baseline and at 1 month after vaccination with rMenB+OMV NZ (0,2,6-months, 0,6-months and 0,2-months) and MenABCWY (0,6-months)
time frame: At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e, Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY group [pooled lots] and Day 91 for MenB_0_2_6 group [2 dose schedule])
description: The immune response to rMenB+OMV NZ and MenABCWY vaccine is evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254), The GMTs (After vaccination/baseline) are calculated, with their associated 2-sided 95% CIs.
measure: Geometric Mean Ratios (GMRs) for each of the N. meningitidis serogroup B strains at 1 month after vaccination with rMenB+OMV NZ (0,2,6-months, 0,6-months and 0,2-months) and MenABCWY (0,6-months), relative to baseline
time frame: At 1 month after the vaccination schedule (i.e, Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY group [pooled lots] and Day 91 for MenB_0_2_6 group [2 dose schedule]) versus Day 1
description: The immune response to rMenB+OMV NZ and MenABCWY vaccine is evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs
measure: Percentage of participants with hSBA titers ≥ LLOQ for each of the N. meningitidis groups A,C,W,Y at Day 1,1 month after the first and after the last MenABCWY vaccination for ABCWY group (pooled lots) and 1 month after the MenACWY vaccine for ACWY group
time frame: At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])
description: The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y after vaccination compared to baseline (Day 1) and expressed as the percentage of participants with hSBA titers ≥ LLOQ for serogroups A, C, W and Y at baseline and 1 month after vaccination schedule of MenABCWY and MenACWY vaccines.
The corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group.
measure: Percentage of participants with 4-fold rise in hSBA titers for each of the N. meningitidis serogroups A, C, W and Y at 1 month after the first MenABCWY dose for the ABCWY Group (pooled lots) and 1 month after the MenACWY vaccine for ACWY Group
time frame: At Day 1 and Day 31
description: The immune response to MenABCWY vaccine compared to MenACWY vaccine is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroups A, C, W and Y at Day 31 compared to baseline (Day 1). Four-fold rise is defined as:
- If the pre-vaccination hSBA titer is < 4, then post-vaccination hSBA titer should be ≥ 16. - If the pre-vaccination hSBA titer is ≥ LOD but < LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the LLOQ. - If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer. The corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group.
measure: hSBA GMTs against each of the N. meningitidis serogroups A, C, W and Y at Day 1 and 1 month after the first and after the last MenABCWY vaccination for the ABCWY Group (pooled lots) and 1 month after the MenACWY vaccination for ACWY Group
time frame: At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])
description: The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroups A, C, W and Y, the GMTs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs.
measure: GMRs for each of the N. meningitidis serogroups A, C, W and Y at 1 month after the first and after the last MenABCWY vaccination for the ABCWY Group (pooled lots) and 1 month after the MenACWY vaccination for ACWY Group
time frame: At 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose]) versus baseline (Day 1)
description: The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y at Day 31 compared to baseline (Day 1). For each N. meningitidis serogroups A, C, W and Y, the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs.
measure: Immunoglobulin G (IgG) antibodies against N. meningitidis serogroups A, C, W and Y at Day 1 and 1 month after the first and after the last MenABCWY vaccination for ABCWY Group (pooled lots) and 1 month after the MenACWY vaccination for ACWY Group
time frame: At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])
description: The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring the total IgG in terms of enzyme-linked immunosorbent assay (ELISA) geometric mean concentrations (GMCs) after vaccination compared to baseline (Day 1).
arm group label: MenB_0_2_6 Group
arm group type: Experimental
description: Participants receive rMenB+OMV NZ vaccine as 3 dose schedule at Day 1, 61 and Day 181 or as 2 dose schedule at Day 1 and Day 61 and 1 dose of MenACWY vaccine at Day 211.
arm group label: MenB_0_6 Group
arm group type: Experimental
description: Participants receive rMenB+OMV NZ vaccine as 2 dose schedule at Day 1, and Day 181, 1 dose of MenACWY vaccine at Day 61 and 1 dose of Placebo at Day 211.
arm group label: ABCWY-1 Group
arm group type: Experimental
description: Participants receive 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
arm group label: ABCWY-2 Group
arm group type: Experimental
description: Participants receive 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
arm group label: ABCWY-3 Group
arm group type: Experimental
description: Participants receive 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
arm group label: ACWY Group
arm group type: Active Comparator
description: Participants, receive 1 dose of MenACWY vaccine at Day 1, 1 dose of placebo at Day 61 and 2 doses of rMenB+OMV NZ vaccine at Day 181 and Day 211.
intervention type: Combination Product
intervention name: rMenB+OMV NZ vaccine
description: rMenB+OMV NZ vaccine is administered intramuscularly to the non-dominant arm as 3 doses in a 0,2,6-M schedule or as 2 doses in a 0,6-M schedule to participants in the MenB_0_2_6 Group, as 2 doses in a 0,6-M schedule to participants in the MenB_0_6 Group and as 2 doses at Day 181 and Day 211 to participants in the ACWY Group.
arm group label: ACWY Group
arm group label: MenB_0_2_6 Group
arm group label: MenB_0_6 Group
other name: Bexsero
intervention type: Biological
intervention name: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
description: MenACWY vaccine is administered intramuscularly to the non-dominant arm as 1 dose at Day 211 to participants in the MenB_0_2_6 Group, as 1 dose at Day 61 to participants in the MenB_0_6 Group and as 1 dose at Day 1 to participants in the ACWY Group.
arm group label: ACWY Group
arm group label: MenB_0_2_6 Group
arm group label: MenB_0_6 Group
other name: Menveo
intervention type: Combination Product
intervention name: Placebo
description: Placebo is administered intramuscularly to the non-dominant arm as 1 dose at Day 211 to participants in the MenB_0_6 Group, 2 doses at Day 61 and Day 211 to participants in the ABCWY groups and as 1 dose at Day 61 to participants in the ACWY Group.
arm group label: ABCWY-1 Group
arm group label: ABCWY-2 Group
arm group label: ABCWY-3 Group
arm group label: ACWY Group
arm group label: MenB_0_6 Group
other name: NaCl, saline solution
intervention type: Combination Product
intervention name: MenABCWY-1
description: Lot 1 of the MenABCWY vaccine is administered intramuscularly to the non-dominant arm as 2 doses at Day 1 and Day 181 to participants in the ABCWY-1 Group.
arm group label: ABCWY-1 Group
intervention type: Combination Product
intervention name: MenABCWY-2
description: Lot 2 of the MenABCWY vaccine is administered intramuscularly to the non-dominant arm as 2 doses at Day 1 and Day 181 to participants in the ABCWY-2 Group.
arm group label: ABCWY-2 Group
intervention type: Combination Product
intervention name: MenABCWY-3
description: Lot 3 of the MenABCWY vaccine is administered intramuscularly to the non-dominant arm as 2 doses at Day 1 and Day 181 to participants in the ABCWY-3 Group.
arm group label: ABCWY-3 Group
criteria: 
gender: All
minimum age: 10 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
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country: Australia
country: Canada
country: Czechia
country: Estonia
country: Finland
country: Turkey
country: United States
responsible party type: Sponsor
mesh term: Meningococcal Infections
mesh term: Vaccines
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.