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Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04502693
Collaborator
(none)
3,651
Enrollment
112
Locations
6
Arms
24.7
Anticipated Duration (Months)
32.6
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: rMenB+OMV NZ vaccine
  • Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
  • Combination Product: Placebo
  • Combination Product: MenABCWY-1
  • Combination Product: MenABCWY-2
  • Combination Product: MenABCWY-3
 Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3651 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Observer-blinded study. Recipients & study evaluators will be unaware of vaccine administered.
Primary Purpose:
Prevention
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
Actual Study Start Date :
Aug 14, 2020
Anticipated Primary Completion Date :
Sep 6, 2022
Anticipated Study Completion Date :
Sep 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: MenB_0_2_6 Group

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.

Combination Product: rMenB+OMV NZ vaccine
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.
Other Names:
  • Bexsero

    • Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
    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.
    Other Names:
  • Menveo

    		•
    Experimental: MenB_0_6 Group

    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.

    Combination Product: rMenB+OMV NZ vaccine
    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.
    Other Names:
  • Bexsero

    • Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
    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.
    Other Names:
  • Menveo

    • Combination Product: Placebo
    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.
    Other Names:
  • NaCl, saline solution

    		•
    Experimental: ABCWY-1 Group

    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.

    Combination Product: Placebo
    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.
    Other Names:
  • NaCl, saline solution

    • Combination Product: MenABCWY-1
    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.
    Experimental: ABCWY-2 Group

    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.

    Combination Product: Placebo
    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.
    Other Names:
  • NaCl, saline solution

    • Combination Product: MenABCWY-2
    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.
    Experimental: ABCWY-3 Group

    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.

    Combination Product: Placebo
    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.
    Other Names:
  • NaCl, saline solution

    • Combination Product: MenABCWY-3
    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.
    Active Comparator: ACWY Group

    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.

    Combination Product: rMenB+OMV NZ vaccine
    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.
    Other Names:
  • Bexsero

    • Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
    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.
    Other Names:
  • Menveo

    • Combination Product: Placebo
    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.
    Other Names:
  • NaCl, saline solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [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)]

      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.

    2. 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 [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])]

      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.

    3. 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 [At Day 211]

      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

    4. 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 [At 1 month after vaccination schedule (i.e., Day 211 for the ABCWY Group [pooled lots] and Day 31 for the ACWY Group)]

      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

    5. 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) [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)]

      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.

    6. 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 [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])]

      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.

    7. 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) [At Day 211]

      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.

    8. Percentage of participants with any solicited local adverse events (AEs) [During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1, Day 61 and Day 181)]

      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.

    9. Percentage of participants with any solicited systemic AEs [During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1, Day 61 and Day 181)]

      Solicited systemic AEs to be assessed include fever [temperature ≥ 38.0°C], nausea, fatigue, myalgia, arthralgia, headache.

    10. Percentage of participants with any unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to withdrawal, AE of special interest (AESIs) and medically attended AEs [During the 30 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1, Day 61 and Day 181)]

      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.

    11. Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs [Throughout the study period (Day 1 to Day 361)]

      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.

    Secondary Outcome Measures

    1. 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 [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])]

      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

    2. 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 [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)]

      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.

    3. 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 [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)]

      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.

    4. 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) [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])]

      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.

    5. 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 [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])]

      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

    6. 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) [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])]

      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.

    7. 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 [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]

      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

    8. 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 [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])]

      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.

    9. 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 [At Day 1 and Day 31]

      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.

    10. 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 [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])]

      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.

    11. 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 [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)]

      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.

    12. 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 [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])]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Subjects or/and subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

    • Written or witnessed/thumb printed informed consent obtained from the subject/parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.

    • Written informed assent obtained from the subject (if applicable) prior to performing any study specific procedure.

    • A male or female between, and including, 10 and 25 years of age (i.e. 25 years + 364 days) at the time of the first vaccination.

    • Healthy subjects as established by medical history physical examination and clinical judgment of the investigator before entering into the study.

    • Subjects who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine can participate in the study, if they have received it at least 4 years prior to informed consent and assent as applicable (with the exception of meningococcal C vaccination, if the last dose of MenC was received at ≤24 months of age).

    • Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause*.

    • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and

    • has a negative pregnancy test on the day of vaccination, and

    • has agreed to continue adequate contraception until 30 days after completion of Visit 6.

    • A female is considered to be of non-childbearing potential prior to menarche and after natural or induced menopause. Natural menopause is recognized to have occurred after 12 consecutive months of amenorrhea for which there is no other obvious pathological or physiological cause. Induced menopause is recognized to have occurred after hysterectomy, after bilateral oophorectomy, or iatrogenic ablation of ovarian function.

    Exclusion Criteria:

    Medical conditions

    • Current or previous, confirmed or suspected disease caused by N. meningitidis.

    • Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrolment.

    • Progressive, unstable or uncontrolled clinical conditions.

    • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.

    • Any neuroinflammatory, congenital neurological conditions, encephalopathies, seizures. History of febrile convulsions should not lead to exclusion.

    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).

    • Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment whose use is foreseen in this study.

    • Abnormal function or modification of the immune system resulting from:

    • Autoimmune disorders or immunodeficiency syndromes.

    • Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination until the post-vaccination 3 blood sample (Visit 6). This will mean prednisone - ≥20 mg/day (for adult subjects) or ≥0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed.

    • Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.

    • Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).

    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

    Prior/Concomitant therapy

    • Use of any investigational or non-registered product other than the study vaccine(s)/product(s) during the period starting 30 days before the first dose of study vaccine(s)/product(s) (Day -29 to Day 1), or planned use during the study period.

    • Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable.

    • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine/ product or planned administration during the study period until the post-vaccination 3 blood sample (Visit 6).

    • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the vaccine/product dose(s) until the post-vaccination 3 blood sample (Visit 6). For corticosteroids, this will mean prednisone ≥20 mg/day (for adult subjects) or ≥0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed.

    Prior/Concurrent clinical study experience

    • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

    Other exclusions

    • Child in care.

    • Pregnant or lactating female.

    • Female planning to become pregnant or planning to discontinue contraceptive precautions.

    • History of /current chronic alcohol abuse and/or drug abuse as determined by the investigator.

    • Any study personnel or immediate dependants, family, or household member.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Chandler Arizona United States 85286
    2 GSK Investigational Site Glendale Arizona United States 85308
    3 GSK Investigational Site Jonesboro Arkansas United States 72401
    4 GSK Investigational Site Bell Gardens California United States 90201
    5 GSK Investigational Site Canoga Park California United States 91304
    6 GSK Investigational Site Garden Grove California United States 92840
    7 GSK Investigational Site Inglewood California United States 90301
    8 GSK Investigational Site Los Gatos California United States 95032
    9 GSK Investigational Site Cutler Bay Florida United States 33157
    10 GSK Investigational Site Lake City Florida United States 32055
    11 GSK Investigational Site Miami Florida United States 33126
    12 GSK Investigational Site Miami Florida United States 33144
    13 GSK Investigational Site Miami Florida United States 33165
    14 GSK Investigational Site Miami Florida United States 33174
    15 GSK Investigational Site Miami Florida United States 33186
    16 GSK Investigational Site Orlando Florida United States 32801
    17 GSK Investigational Site Orlando Florida United States 32806
    18 GSK Investigational Site Orlando Florida United States 32808
    19 GSK Investigational Site Oviedo Florida United States 32765
    20 GSK Investigational Site West Palm Beach Florida United States 33409
    21 GSK Investigational Site Adairsville Georgia United States 30103
    22 GSK Investigational Site Buford Georgia United States 30519
    23 GSK Investigational Site Columbus Georgia United States 31904
    24 GSK Investigational Site Hinesville Georgia United States 31313
    25 GSK Investigational Site Nampa Idaho United States 83686
    26 GSK Investigational Site Oak Brook Illinois United States 60523
    27 GSK Investigational Site Wichita Kansas United States 67205
    28 GSK Investigational Site Wichita Kansas United States 67207
    29 GSK Investigational Site Bardstown Kentucky United States 40004
    30 GSK Investigational Site Louisville Kentucky United States 40243
    31 GSK Investigational Site Metairie Louisiana United States 70006
    32 GSK Investigational Site Fall River Massachusetts United States 02721
    33 GSK Investigational Site Methuen Massachusetts United States 01844
    34 GSK Investigational Site Grosse Pointe Woods Michigan United States 48236
    35 GSK Investigational Site Minneapolis Minnesota United States 55402
    36 GSK Investigational Site Petal Mississippi United States 39465
    37 GSK Investigational Site Missoula Montana United States 59804
    38 GSK Investigational Site Missoula Montana United States 59808
    39 GSK Investigational Site Bronx New York United States 10455
    40 GSK Investigational Site Dayton Ohio United States 45406
    41 GSK Investigational Site Dayton Ohio United States 45419
    42 GSK Investigational Site Grants Pass Oregon United States 97527
    43 GSK Investigational Site Greenville South Carolina United States 29607
    44 GSK Investigational Site North Charleston South Carolina United States 29405
    45 GSK Investigational Site West Columbia South Carolina United States 29169
    46 GSK Investigational Site Laredo Texas United States 78041
    47 GSK Investigational Site Plano Texas United States 75024
    48 GSK Investigational Site San Antonio Texas United States 78229
    49 GSK Investigational Site Kaysville Utah United States 84037
    50 GSK Investigational Site Layton Utah United States 84041
    51 GSK Investigational Site Murray Utah United States 84107
    52 GSK Investigational Site Orem Utah United States 84057
    53 GSK Investigational Site Roy Utah United States 84067
    54 GSK Investigational Site Salt Lake City Utah United States 84109
    55 GSK Investigational Site Salt Lake City Utah United States 84121
    56 GSK Investigational Site South Jordan Utah United States 84095
    57 GSK Investigational Site Syracuse Utah United States 84075
    58 GSK Investigational Site Falls Church Virginia United States 22044
    59 GSK Investigational Site Newport News Virginia United States 23606
    60 GSK Investigational Site Richmond Virginia United States 23294
    61 GSK Investigational Site Suffolk Virginia United States 23435
    62 GSK Investigational Site Cheney Washington United States 99004
    63 GSK Investigational Site Spokane Washington United States 99202
    64 GSK Investigational Site Marshfield Wisconsin United States 54449
    65 GSK Investigational Site Sydney New South Wales Australia 2010
    66 GSK Investigational Site Gold Coast Queensland Australia 4222
    67 GSK Investigational Site Taringa Queensland Australia 4068
    68 GSK Investigational Site Tarragindi Queensland Australia 4121
    69 GSK Investigational Site Geelong Victoria Australia 3220
    70 GSK Investigational Site Melbourne Victoria Australia 3010
    71 GSK Investigational Site Nedlands Western Australia Australia 6009
    72 GSK Investigational Site Calgary Alberta Canada T3B 6A8
    73 GSK Investigational Site Edmonton Alberta Canada T5A 4L8
    74 GSK Investigational Site Vancouver British Columbia Canada V5Z 4H4
    75 GSK Investigational Site Halifax Nova Scotia Canada B3K 6R8
    76 GSK Investigational Site London Ontario Canada N5W 6A2
    77 GSK Investigational Site Sarnia Ontario Canada N7T 4X3
    78 GSK Investigational Site Toronto Ontario Canada M9V 4B4
    79 GSK Investigational Site Toronto Ontario Canada M9W 4L6
    80 GSK Investigational Site Montreal Quebec Canada H3T 1C5
    81 GSK Investigational Site Pointe-Claire Quebec Canada H9R 4S3
    82 GSK Investigational Site Québec City Quebec Canada G1E 7G9
    83 GSK Investigational Site Québec Canada G1V 4G2
    84 GSK Investigational Site Ceske Budejovice Czechia 37008
    85 GSK Investigational Site Hradec Kralove Czechia 50002
    86 GSK Investigational Site Jindrichuv Hradec Czechia 37701
    87 GSK Investigational Site Kladno Czechia 272 80
    88 GSK Investigational Site Melnik Czechia 27601
    89 GSK Investigational Site Pardubice Czechia 53003
    90 GSK Investigational Site Pardubice Czechia 53009
    91 GSK Investigational Site Praha 6 Czechia 160 00
    92 GSK Investigational Site Pribram Czechia 261 01
    93 GSK Investigational Site Trutnov Czechia 541 01
    94 GSK Investigational Site Tynec nad Sazavou Czechia 257 41
    95 GSK Investigational Site České Budejovice Czechia 370 06
    96 GSK Investigational Site Tallinn Estonia 10117
    97 GSK Investigational Site Tallinn Estonia 10617
    98 GSK Investigational Site Espoo Finland 02230
    99 GSK Investigational Site Helsinki Finland 00100
    100 GSK Investigational Site Helsinki Finland 00930
    101 GSK Investigational Site Jarvenpaa Finland 04400
    102 GSK Investigational Site Kokkola Finland 67100
    103 GSK Investigational Site Oulu Finland 90220
    104 GSK Investigational Site Pori Finland 28100
    105 GSK Investigational Site Seinajoki Finland 60100
    106 GSK Investigational Site Tampere Finland 33100
    107 GSK Investigational Site Turku Finland 20520
    108 GSK Investigational Site Adana Turkey 01330
    109 GSK Investigational Site Ankara Turkey 06590
    110 GSK Investigational Site Eskisehir Turkey 26040
    111 GSK Investigational Site Izmir Turkey 35340
    112 GSK Investigational Site Kayseri Turkey 38030

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT04502693
    Other Study ID Numbers:
    • 205416
    • 2019-001666-15
    First Posted:
    Aug 6, 2020
    Last Update Posted:
    Jul 11, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by GlaxoSmithKline
    Bexsero
    Menveo
    MenABCWY
    Effectiveness
    Invasive meningococcal disease
    Meningitis
    Additional relevant MeSH terms:
    Meningococcal Infections
    Vaccines

    Study Results

    No Results Posted as of Jul 11, 2022