The purpose of this study was to assess the safety, effectiveness, and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), Phase I part of this study was conducted in healthy adults in a dose-escalating fashion with 2 formulations of the investigational MenABCWY-2Gen vaccine and served as a safety lead-in to the Phase II study. The Phase II part of the study was conducted in 2 parts: The 'formulation and schedule-finding' part followed in healthy adolescents and young adults and was designed to select the vaccine formulation and the schedule to be tested in Phase III. The 'blood sourcing' part was conducted in healthy adults in order to collect sufficient serum samples for the development of assays to be used in the MenABCWY-2Gen vaccine clinical development program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,440
MenABCWY-2Gen low dose vaccine is administered intramuscularly as 2 doses to participants in the ABCWY low dose Group in study Phase I, ABCWY low dose\_06 Group and ABCWY low dose\_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY low dose\_01 Group, ABCWY low doseS\_02 Group and ABCWY low doseS\_06 Group in study Phase II (Sourcing).
MenABCWY-2Gen high dose vaccine is administered intramuscularly 2 doses to participants in the ABCWY high dose Group in study Phase I, ABCWY high dose\_06 Group and ABCWY high dose\_02 Group in study Phase II (Formulation and Schedule-finding) and as 2 doses to participants in the ABCWY high dose\_01 Group, ABCWY high doseS\_02 Group and ABCWY high doseS\_06 Group in study Phase II (Sourcing).
Placebo is administered intramuscularly as 2 doses to participants in the Placebo low dose Group, Placebo high dose Group in study Phase I and as 1 dose to participants in the ABCWY low dose\_06 Group, ABCWY low dose\_02 Group, ABCWY high dose\_06 Group, ABCWY high dose\_02 Group in study Phase II (Formulation and Schedule-finding).
MenB vaccine is administered intramuscularly as 2 doses in a 0,6-months schedule to participants in the Control Group in study Phase II (Formulation and Schedule-finding).
MenACWY vaccine is administered intramuscularly as 1 dose to participants in the Control Group in study Phase II (Formulation and Schedule-finding).
GSK Investigational Site
Colorado Springs, Colorado, United States
GSK Investigational Site
Longmont, Colorado, United States
GSK Investigational Site
Doral, Florida, United States
GSK Investigational Site
Miami Lakes, Florida, United States
GSK Investigational Site
Meridian, Idaho, United States
Number of Participants With Solicited Administration Site Events in Study Phase I (Safety Lead-in)
The solicited administration site events include injection site pain, erythema (redness), swelling and induration. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Solicited Administration Site Events in Study Phase I (Safety Lead-in)
The solicited administration site events include injection site pain, erythema (redness), swelling and induration. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 31
Number of Participants With Solicited Systemic Events in Study Phase I (Safety Lead-in)
The solicited systemic events include fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Solicited Systemic Events in Study Phase I (Safety Lead-in)
The solicited systemic events include fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 31
Number of Participants With Any Unsolicited Adverse Events (AEs), Including All Serious Adverse Events (SAEs), AEs Leading to Withdrawal and AEs of Special Interest (AESIs) in Study Phase I (Safety Lead-in)
Unsolicited AEs includes 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 is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. 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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: During the 30 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Any Unsolicited AEs, Including All SAEs, AEs Leading to Withdrawal and AESIs in Study Phase I (Safety Lead-in)
Unsolicited AEs includes 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 is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. 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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: During the 30 days (including the day of vaccination) following vaccination at Day 31
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase I (Safety Lead-in)
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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: Throughout the Phase 1 study period (Day 1 through Day 211)
Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values, in Study Phase I (Safety Lead-in)
The safety laboratory data included haematological parameters (basophils, eosinophils, Erythrocytes, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Creatinine) Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 8 (7 days after the first vaccination)
Number of Participants With Clinically Significant Haematological and Biochemical Laboratory Values, in Study Phase I (Safety Lead-in)
Clinical laboratory testing included hematological and biochemical laboratory values. Any abnormal laboratory test result (e.g., in hematology or clinical chemistry) that was deemed clinically significant by the investigator's medical and scientific judgment, and not related to an underlying disease, was reported as an unsolicited adverse event (AE) unless it was considered by the investigator to be more severe than expected for the participant's condition. The safety laboratory data included hematological parameters (basophils, eosinophils, erythrocytes, hemoglobin, leukocytes, lymphocytes, monocytes, platelets, and neutrophils) and chemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], and creatinine).
Time frame: At Day 8 (7 days after the first vaccination)
Percentage of Blood Samples With Bactericidal Serum Activity Using Enc-hSBA Against a Panel of 110 Randomly Selected Endemic US N. Meningitidis Serogroup B Invasive Disease Strains at Study Phase II (Formulation and Schedule-finding)
The effectiveness of the MenABCWY-2Gen (low \& high dose) vaccine when administered at 0,2- or 0,6-months schedule compared to MenB vaccine administered at 0,6-months schedule, against a panel of 110 randomly selected endemic N. meningitidis serogroup B strains is measured in terms of percentage of samples with 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.
Time frame: At Day 211 (1 month after the last vaccination)
Number of Participants With a 4-fold Rise in hSBA Titers Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The immune response to the MenABCWY-2Gen (low and high dose) vaccine when administered at 0,2- or 0,6-months schedule compared to MenACWY vaccine (single dose), relative to day 1 in the ABCWY and control groups (0, 6 month schedule) and day 31 in ABCWY (0, 2 month schedule) is measured in terms of number of participants achieving a 4-fold rise in hSBA titers against serogroups A, C, W and Y. 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 pre-vaccination hSBA titer ≥LOD but \<LLOQ, and. -a post-vaccination hSBA titer ≥ 4 times the pre-vaccination hSBA titer for participants with a pre-vaccination hSBA titer ≥LLOQ.
Time frame: At Day 211 for ABCWY groups (1 month after the last MenABCWY-2Gen vaccination) and at Day 31 for Control group (1 month after the last MenACWY vaccination)
Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 121
Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 181
Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 121
Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 181
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)
Unsolicited AEs includes 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 is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. 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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: During the 30 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)
Unsolicited AEs includes 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 is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. 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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: During the 30 days (including the day of vaccination) following vaccination at Day 121
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)
Unsolicited AEs includes 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 is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. 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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: During the 30 days (including the day of vaccination) following vaccination at Day 181
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Formulation and Schedule-Finding)
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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: Throughout the Phase II FSF study period (Day 1 through Day 541)
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 31
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 61
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)
Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 181
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 31
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 61
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)
Assessed solicited systemic events included fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 181
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)
Unsolicited AEs includes 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 is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. 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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: During the 30 days (including the day of vaccination) following vaccination at Day 1
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)
Unsolicited AEs includes 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 is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. 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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: During the 30 days (including the day of vaccination) following vaccination at Day 31
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)
Unsolicited AEs includes 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 is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. 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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: During the 30 days (including the day of vaccination) following vaccination at Day 61
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)
Unsolicited AEs includes 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 is reported as an unsolicited adverse event. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in a subject's offspring. 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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: During the 30 days (including the day of vaccination) following vaccination at Day 181
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)
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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: Throughout the study period (Day 1 through Day 211)
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)
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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: Throughout the study period (Day 1 through Day 241)
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)
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. A participant was considered withdrawn if no study procedures occurred, and no follow-up or further information has been collected from the date of withdrawal or last contact.
Time frame: Throughout the study period (Day 1 through Day 361)
Percentage of Participants Classified by Percentages of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Participant in Study Phase II (Formulation and Schedule-finding)
The percentages of strains killed measured by enc-hSBA against a randomly selected panel of strains and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method is calculated in all groups at 1 month after the last vaccination of MenABCWY-2Gen (low and high dose) vaccine administered at 0,2 and 0,6-months schedule and of the MenB vaccine administered at 0,6-months schedule.
Time frame: At Day 211 (1 month after the last vaccination)
Number of Participants With hSBA Titers ≥ LLOQ for Each and All Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)
The immune response to MenABCWY-2Gen (low and high dose) administered at 0,2 and 0,6-months schedule and MenB vaccine administered at 0,6-months schedule is evaluated by measuring bactericidal activity using a qualified AO hSBA against a standard panel of serogroup B indicator strains.
Time frame: At Day 1 in ABCWY (0,6-months) and Control groups, Day 31 in ABCWY groups (0,2-months) and Day 211 in all study groups
Number of Participants With 4-fold Rise in hSBA Titers Against Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)
The immune response to MenABCWY-2Gen (low and high dose) vaccine when administered at 0,2- or 0,6-months schedule and to MenB vaccine administered at 0,6-months schedule, relative to day 1 in ABCWY (0,6 month schedule) and control groups and day 31 in ABCWY (0,2 month schedule) is measured in terms of number of participants achieving a 4-fold rise in hSBA titers against serogroup B indicator strains. The 4-fold rise is defined as: -a post-vaccination hSBA titer ≥ 16 for participants with a pre-vaccination hSBA titre \< 4, -a post-vaccination hSBA titer ≥ 4 times the LLOQ for participants with a pre-vaccination hSBA titer ≥LOD but \<LLOQ, and. -a post-vaccination hSBA titer ≥ 4 times the pre-vaccination hSBA titer for participants with a pre-vaccination hSBA titer ≥ LLOQ.
Time frame: At Day 211 (1 month after the last vaccination)
hSBA Geometric Mean Titers (GMTs) Against Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)
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GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
Springfield, Missouri, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Charleston, South Carolina, United States
...and 43 more locations
For each B strains, the GMTs are calculated with their associated 2-sided 95% CIs, by exponentiating the corresponding log-transformed means and their 95% CIs.
Time frame: At Day 1 in ABCWY groups (0,6-months) and Control groups, Day 31 in ABCWY groups (0,2-months) and Day 211 in all study groups
hSBA Geometric Mean Ratios (GMRs) Against Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)
For each B strains, the GMRs (post-vaccination/ Baseline) are calculated with their associated 2-sided 95% CIs, by exponentiating the corresponding log-transformed means and their 95% CIs.
Time frame: At Day 211 in all study groups versus Day 1 in ABCWY (0,6-months) and Control groups and Day 31 in ABCWY groups (0,2-months)
Number of Participants With hSBA Titers ≥ LLOQ for Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The number of participants with hSBA titers ≥ LLOQ and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method are calculated. Baseline (pre-vaccination) was evaluated at Day 1 for 0,6 schedules and Control, at Month 1 for 0,2 schedules. Post vaccination was evaluated at Month 7 for all MenABCWY groups, at Month 1 for Control group.
Time frame: Day 1 in ABCWY (0,6 Months) & Control; Day 31 pre-vaccination in ABCWY (0,2 Months); Day 31 post-first MenABCWY-2Gen in ABCWY (0,6 Months); Day 211 post-last MenABCWY-2Gen in all ABCWY; Day 31 post-MenACWY in Control
Number of Participants With a 4-fold Rise in hSBA Titers Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The immune response to the MenABCWY-2Gen (low and high dose) vaccine when administered at 0,6-months schedule, relative to day 1 was measured in terms of percentage of participants achieving a 4-fold rise in hSBA titers against serogroups A, C, W and Y. Serum bactericidal activity against MenACWY were determined by using a validated AO hSBA. The 4-fold rise is defined as: -a post-vaccination hSBA titre ≥ 16 for participants with a pre-vaccination hSBA titre \< 4, -a post-vaccination hSBA titre ≥ 4 times the LLOQ for participants with a pre-vaccination hSBA titre ≥ LOD but \< LLOQ, and. -a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ.
Time frame: At Day 31 (1 month after the first MenABCWY-2Gen vaccination) in ABCWY (0,6-months) groups
hSBA GMTs Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The immune response to the MenABCWY-2Gen (low and high dose) vaccine (0,2- and 0,6-months schedule) and MenACWY vaccine (single dose) was evaluated by hSBA titers which are logarithmically transformed (base10) to fulfil the normal distribution assumption. For each serogroup A, C, W and Y, the GMTs are calculated with their associated 2-sided 95% CIs, by exponentiating the corresponding log-transformed means and their 95% CIs.
Time frame: Day 1 in ABCWY (0,6 Months) & Control; Day 31 pre-vaccination in ABCWY (0,2 Months); Day 31 post-first MenABCWY-2Gen in ABCWY (0,6 Months); Day 211 post-last MenABCWY-2Gen in all ABCWY; Day 31 post-MenACWY in Control
hSBA GMRs Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
For each serogroup A, C, W and Y, the GMRs (post-vaccination/ Day 1 (Month 0)) are calculated with their associated 2-sided 95% CIs, by exponentiating the corresponding log-transformed means and their 95% CIs.
Time frame: At Day 31 [for ABCWY (0,6-months) and Control group compared to Day 1 (Baseline)], at Day 211 [for ABCWY (0,6-months) groups compared to Day 1 (baseline) and for ABCWY (0,2-months) groups compared to Day 31]
Immunoglobulin G (IgG) Antibodies Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)
The immune responses to MenABCWY-2Gen (low and high dose) and MenACWY vaccines are evaluated by measuring the total IgG in terms of electrochemiluminescence-based (ECL) multiplex assay Geometric Mean Concentrations (GMCs).
Time frame: Day 1 in ABCWY (0,6 Months) & Control; Day 31 pre-vaccination in ABCWY (0,2 Months); Day 31 post-first MenABCWY-2Gen in ABCWY (0,6 Months); Day 211 post-last MenABCWY-2Gen in all ABCWY; Day 31 post-MenACWY in Control