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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04502693
Recruitment Status : Completed
First Posted : August 6, 2020
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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
Infections, Meningococcal 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
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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3657 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 : August 14, 2020
Actual Primary Completion Date : September 13, 2022
Actual Study Completion Date : September 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: NaCl, saline solution


Outcome Measures
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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 [ 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) ]
    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 [ 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]) ]
    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 [ Time Frame: 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 [ 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) ]
    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) [ 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) ]
    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 [ 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]) ]
    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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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]) ]

    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 [ 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) ]
    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 [ 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) ]
    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) [ 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]) ]
    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 [ 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]) ]
    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) [ 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]) ]
    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 [ 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 ]
    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 [ 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]) ]

    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 [ Time Frame: 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 [ 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]) ]
    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 [ 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) ]
    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 [ 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]) ]
    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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502693


Locations
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Sponsors and Collaborators
GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04502693    
Other Study ID Numbers: 205416
2019-001666-15 ( EudraCT Number )
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.

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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:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs