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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04707391
Other study ID # 213171
Secondary ID 2019-004982-42
Status Completed
Phase Phase 3
First received
Last updated
Start date January 25, 2021
Est. completion date September 29, 2023

Study information

Verified date January 2024
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine


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Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
MenABCWY vaccine
2 doses of MenABCWY vaccine administered intramuscularly on Day 1 and Day 181 to participants in ABCWY group.
Placebo
1 dose of placebo administered intramuscularly on Day 211 to participants in ABCWY group
Biological:
MenACWY vaccine
1 dose of MenACWY vaccine administered intramuscularly on Day 1 to participants in ACWY group
Combination Product:
MenB vaccine
2 doses of MenB vaccine administered intramuscularly on Day 181 and Day 211 to participants in ACWY group. MenB vaccine is a non-investigational medical product (NIMP) in this study and is administered only in compliance with standard of care.

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Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentages of participants with a 4-fold rise in hSBA titers against N. meningitidis serogroups A, C, W, and Y at 1 month after the second MenABCWY vaccine and after the single MenACWY vaccine Immunogenicity of MenABCWY vaccine after its second dose compared to single dose of MenACWY vaccine, relative to baseline (Day 1) is assessed for each serogroups A, C, W and Y
For each serogroup, the 4-fold rise is defined as:
a post-vaccination hSBA titer equal to or higher than (=) 16 for participants with a pre-vaccination hSBA titer <4;
a post-vaccination hSBA titer = 4 times the LLOQ for participants with a pre vaccination hSBA titer = limit of detection (LOD) but < LLOQ; and
a post-vaccination hSBA titer = 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer = LLOQ
At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group)
Primary Percentages of participants with a 4-fold rise in human serum bactericidal assay (hSBA) titers against N. meningitidis serogroups A, C, W, and Y at 1 month after the first MenABCWY vaccine and after the single MenACWY vaccine Immunogenicity of MenABCWY vaccine after first dose compared to single dose of MenACWY vaccine, relative to baseline (Day 1) is measured. For the serogroups A, C, W, Y, evaluation of the 4-fold rise is defined as: a post-vaccination hSBA titer = 16 for participants with a pre-vaccination hSBA titer <4; . a post-vaccination hSBA titer = 4 times the Lower limit of quantitation (LLOQ) for participants with a prevaccination hSBA titer = limit of detection (LOD) but < LLOQ; and, a post-vaccination hSBA titer = 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer = LLOQ. At 1 month after the first vaccination (i.e., Day 31)
Primary Percentages of participants with solicited administration site events Assessed solicited administrative site events include injection site pain, erythema, swelling, induration. Any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters During the 7 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group
Primary Percentages of participants with solicited administration site events Assessed solicited administrative site events include injection site pain, erythema, swelling, induration. Any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters. During the 7 days (including day of vaccination) following vaccination at Day 181 for ABCWY group
Primary Percentages of participants with solicited systemic events Assessed solicited systemic events include fever [body temperature = 38.0°C/100.4°F], nausea, fatigue, myalgia, arthralgia, headache. During the 7 days (including day of vaccination) following vaccination at day 1 for the ABCWY group and ACWY group
Primary Percentages of participants with solicited systemic events Assessed solicited systemic events include fever [body temperature = 38.0°C/100.4°F], nausea, fatigue, myalgia, arthralgia, headache During the 7 days (including day of vaccination) following vaccination at day 181 for the ABCWY group
Primary Percentages of participants with any unsolicited adverse events (AEs) (including all serious adverse events [SAEs], AEs leading to withdrawal, AEs of special interest [AESIs] and medically attended AEs) Any AE-untoward medical occurrence in a patient/clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-predefined 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 characterize and understand it. During the 30 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group
Primary Percentages of participants with any unsolicited adverse events (AEs) (including all serious adverse events [SAEs], AEs leading to withdrawal, AEs of special interest [AESIs] and medically attended AEs) Any unsolicited AEs, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs are evaluated During the 30 days (including day of vaccination) following vaccination at day 181 for ABCWY group
Primary Percentages of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs SAEs, AEs leading to withdrawal, AESIs and medically attended AEs are assessed throughout the study period From Day 1 to Day 361 (throughout the study period)
Secondary Percentages of participants with hSBA titers = Lower Limit of Quantitation (LLOQ) against serogroups A, C, W, and Y at day 1, 1 month after the first and second MenABCWY vaccine and after the single MenACWY vaccine Immune response to MenABCWY vaccine after the first and second dose and single dose of MenACWY vaccine is evaluated by measuring the percentage of participants with hSBA titers = LLOQ against each of the serogroups A, C, W and Y At Day 1 (pre-vaccination) and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group, Day 211 for ABCWY group [second dose])
Secondary hSBA Geometric Mean Titers (GMTs) against serogroups A, C, W, and Y at day 1, 1 month after the first and second MenABCWY vaccine and after the single MenACWY vaccine Immune response to MenABCWY after first and second dose and single dose of MenACWY vaccine is evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y in terms of GMTs. For each serogroup, the GMTs with their 95% confidence intervals are calculated. At Day 1 and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group, Day 211 for ABCWY group [second dose])
Secondary Geometric mean ratios (GMRs) against serogroups A, C, W, and Y at 1 month after the first and second MenABCWY vaccine and after the single MenACWY vaccine Immune response to MenABCWY vaccine after first and second dose and single dose of MenACWY vaccine is evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y, compared to baseline (Day 1) and expressed as GMR (GMT after vaccination over GMT at baseline). At 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group, Day 211 for ABCWY group [second dose]) versus Day 1
Secondary Percentages of participants with hSBA titers = LLOQ for each and all serogroup B indicator strains at day 1 and 1 month after the second dose of MenABCWY vaccine The immune response to MenABCWY vaccine after second dose is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains- M14459, M13520, 96217and NZ98/254 in terms of percentage of participants with hSBA titers = LLOQ At Day 1 and Day 211
Secondary Percentages of participants with 4-fold rise in hSBA titers against each N. meningitidis serogroup B indicator strains at 1 month after the second MenABCWY vaccine The immune response to MenABCWY after second dose is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains M14459, M13520, 96217and NZ98/254 compared to baseline (day 1) in terms of 4-fold rise in hSBA titers. For each of the serogroup B indicator strains, the 4-fold rise is defined as: a post-vaccination hSBA titer =16 for participants with a pre-vaccination hSBA titer <4; . a post-vaccination hSBA titer = 4 times the LLOQ for participants with a prevaccination hSBA titer = limit of detection (LOD) but < LLOQ; and, a post-vaccination hSBA titer = 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer = LLOQ. At Day 211
Secondary GMTs against each serogroup B indicator strains at day 1, 1 month after second MenABCWY vaccine Immune response to MenABCWY vaccine after the second dose is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B indicator strains M14459, M13520, 96217and NZ98/254 in terms of GMTs at baseline (Day 1) and 1 month after second MenABCWY vaccination At Day 1 and Day 211
Secondary GMRs against each serogroup B indicator strains at 1 month after second dose of MenABCWY vaccine Immune response to MenABCWY vaccine after second dose is evaluated by measuring the human serum bactericidal activity against each of the N. meningitidis serogroup B indicator strains- M14459, M13520, 96217and NZ98/254 compared to baseline (Day 1) and expressed as GMR (GMT after vaccination over GMT at baseline). At Day 211 versus Day 1
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