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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04502693




Registration number
NCT04502693
Ethics application status
Date submitted
4/08/2020
Date registered
6/08/2020
Date last updated
23/04/2021

Titles & IDs
Public title
Study to Assess Effectiveness of GlaxoSmithKline's (GSK's) Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults.
Scientific title
Effectiveness of GlaxoSmithKline Biologicals S.A.'s Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults.
Secondary ID [1] 0 0
2019-001666-15
Secondary ID [2] 0 0
205416
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infections, Meningococcal 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - rMenB+OMV NZ vaccine
Other interventions - Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
Treatment: Drugs - Placebo
Other interventions - MenABCWY-1
Other interventions - MenABCWY-2
Other interventions - MenABCWY-3

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.

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.

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.

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.

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.

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.


Other interventions: 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 interventions: 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.

Treatment: Drugs: 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 interventions: 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.

Other interventions: 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.

Other interventions: 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.

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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 - 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.
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
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 - 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.
Timepoint [2] 0 0
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])
Primary outcome [3] 0 0
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 - 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
Timepoint [3] 0 0
At Day 211
Primary outcome [4] 0 0
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 - 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
Timepoint [4] 0 0
At 1 month after vaccination schedule (i.e., Day 211 for the ABCWY Group [pooled lots] and Day 31 for the ACWY Group)
Primary outcome [5] 0 0
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) - 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.
Timepoint [5] 0 0
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)
Primary outcome [6] 0 0
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 - 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.
Timepoint [6] 0 0
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])
Primary outcome [7] 0 0
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) - 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.
Timepoint [7] 0 0
At Day 211
Primary outcome [8] 0 0
Percentage of participants with any solicited local adverse events (AEs) - 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.
Timepoint [8] 0 0
During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1, Day 61 and Day 181)
Primary outcome [9] 0 0
Percentage of participants with any solicited systemic AEs - Solicited systemic AEs to be assessed include fever [temperature = 38.0°C], nausea, fatigue, myalgia, arthralgia, headache.
Timepoint [9] 0 0
During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1, Day 61 and Day 181)
Primary outcome [10] 0 0
Percentage of participants with any unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to withdrawal, AE of special interest (AESIs) and medically attended AEs - 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.
Timepoint [10] 0 0
During the 30 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1, Day 61 and Day 181)
Primary outcome [11] 0 0
Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs - 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.
Timepoint [11] 0 0
Throughout the study period (Day 1 to Day 361)
Secondary outcome [1] 0 0
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 - 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, M07-0241084 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
Timepoint [1] 0 0
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])
Secondary outcome [2] 0 0
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 - 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.
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
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 - 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.
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
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) - 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 M07-0241084.
Timepoint [4] 0 0
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])
Secondary outcome [5] 0 0
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 - 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 M07-0241084 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
Timepoint [5] 0 0
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])
Secondary outcome [6] 0 0
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) - 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, M07-0241084, 96217 and NZ98/254), The GMTs (After vaccination/baseline) are calculated, with their associated 2-sided 95% CIs.
Timepoint [6] 0 0
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])
Secondary outcome [7] 0 0
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 - 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, M07-0241084, 96217 and NZ98/254), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
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 - 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.
Timepoint [8] 0 0
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])
Secondary outcome [9] 0 0
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 - 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.
Timepoint [9] 0 0
At Day 1 and Day 31
Secondary outcome [10] 0 0
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 - 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.
Timepoint [10] 0 0
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])
Secondary outcome [11] 0 0
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 - 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.
Timepoint [11] 0 0
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)
Secondary outcome [12] 0 0
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 - 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).
Timepoint [12] 0 0
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])

Eligibility
Key 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.
Minimum age
10 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Gold Coast
Recruitment hospital [3] 0 0
GSK Investigational Site - Taringa
Recruitment hospital [4] 0 0
GSK Investigational Site - Tarragindi
Recruitment hospital [5] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [6] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [7] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4222 - Gold Coast
Recruitment postcode(s) [3] 0 0
4068 - Taringa
Recruitment postcode(s) [4] 0 0
4121 - Tarragindi
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
3010 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Montana
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
British Columbia
Country [27] 0 0
Canada
State/province [27] 0 0
Nova Scotia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Canada
State/province [30] 0 0
Québec
Country [31] 0 0
Czechia
State/province [31] 0 0
Ceske Budejovice
Country [32] 0 0
Czechia
State/province [32] 0 0
Hradec Kralove
Country [33] 0 0
Czechia
State/province [33] 0 0
Jindrichuv Hradec
Country [34] 0 0
Czechia
State/province [34] 0 0
Kladno
Country [35] 0 0
Czechia
State/province [35] 0 0
Melnik
Country [36] 0 0
Czechia
State/province [36] 0 0
Pardubice
Country [37] 0 0
Czechia
State/province [37] 0 0
Praha 6
Country [38] 0 0
Czechia
State/province [38] 0 0
Pribram
Country [39] 0 0
Czechia
State/province [39] 0 0
Trutnov
Country [40] 0 0
Czechia
State/province [40] 0 0
Tynec nad Sazavou
Country [41] 0 0
Czechia
State/province [41] 0 0
Ceské Budejovice
Country [42] 0 0
Estonia
State/province [42] 0 0
Tallinn
Country [43] 0 0
Finland
State/province [43] 0 0
Espoo
Country [44] 0 0
Finland
State/province [44] 0 0
Helsinki
Country [45] 0 0
Finland
State/province [45] 0 0
Jarvenpaa
Country [46] 0 0
Finland
State/province [46] 0 0
Kokkola
Country [47] 0 0
Finland
State/province [47] 0 0
Oulu
Country [48] 0 0
Finland
State/province [48] 0 0
Pori
Country [49] 0 0
Finland
State/province [49] 0 0
Seinajoki
Country [50] 0 0
Finland
State/province [50] 0 0
Tampere
Country [51] 0 0
Finland
State/province [51] 0 0
Turku
Country [52] 0 0
Turkey
State/province [52] 0 0
Adana
Country [53] 0 0
Turkey
State/province [53] 0 0
Ankara
Country [54] 0 0
Turkey
State/province [54] 0 0
Eskisehir
Country [55] 0 0
Turkey
State/province [55] 0 0
Izmir
Country [56] 0 0
Turkey
State/province [56] 0 0
Kayseri

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04502693
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04502693