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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04886154
Registration number
NCT04886154
Ethics application status
Date submitted
10/05/2021
Date registered
13/05/2021
Date last updated
12/03/2024
Titles & IDs
Public title
A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults
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Scientific title
A Phase I/II, Randomised, Controlled Study to Assess the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Adults (Phase I) and to Healthy Adolescents and Adults (Phase II)
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Secondary ID [1]
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2020-004741-37
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Secondary ID [2]
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212458
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infections, Meningococcal
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Combination Product - MenABCWY-2Gen low dose vaccine
Combination Product - MenABCWY-2Gen high dose vaccine
Combination Product - Placebo
Combination Product - MenB vaccine
Other interventions - MenACWY vaccine
Experimental: ABCWY low dose Group - Participants receive MenABCWY-2Gen low dose vaccine and are followed up until Day 211 in study Phase I.
Placebo Comparator: Placebo low dose Group - Participants receive NaCl as a control for ABCWY low dose group and are followed up until Day 211 in study Phase I.
Experimental: ABCWY high dose Group - Participants receive MenABCWY-2Gen high dose vaccine and are followed up until Day 211 in study Phase I.
Placebo Comparator: Placebo high dose Group - Participants receive NaCl as a control for ABCWY high dose group and are followed up until Day 211 in study Phase I.
Experimental: ABCWY low dose_06 Group - Participants receive MenABCWY-2Gen low dose vaccine in a 0, 6 month schedule and 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).
Experimental: ABCWY low dose_02 Group - Participants receive MenABCWY-2Gen low dose vaccine in a 0, 2 month schedule and 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).
Experimental: ABCWY high dose_06 Group - Participants receive MenABCWY-2Gen high dose vaccine in a 0, 6 month schedule and 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).
Experimental: ABCWY high dose_02 Group - Participants receive MenABCWY-2Gen high dose vaccine in a 0,2 month schedule and 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).
Active Comparator: Control Group - Participants randomized to Control Group receive 2 doses of Bexsero (MenB) vaccine and 1 dose of Menveo (MenACWY), 1 dose of NaCl and are followed up until Day 541 in study Phase II (Formulation and Schedule-finding).
Experimental: ABCWY low dose_01 Group - Participants receive MenABCWY-2Gen low dose vaccine in a 0,1 month schedule and are followed up until Day 211 in study Phase II (Sourcing).
Experimental: ABCWY high dose_01 Group - Participants receive MenABCWY-2Gen high dose vaccine in a 0,1 month schedule and are followed up until Day 211 in study Phase II (Sourcing).
Experimental: ABCWY low doseS_02 Group - Participants receive MenABCWY-2Gen low dose vaccine in a 0, 2 month schedule and are followed up until Day 241 in study Phase II (Sourcing).
Experimental: ABCWY high doseS_02 Group - Participants receive MenABCWY-2Gen high dose vaccine in a 0, 2 month schedule and are followed up until Day 241 in study Phase II (Sourcing).
Experimental: ABCWY low doseS_06 Group - Participants receive MenABCWY-2Gen low dose vaccine in a 0, 6 month schedule and are followed up until Day 361 in study Phase II (Sourcing).
Experimental: ABCWY high doseS_06 Group - Participants receive MenABCWY-2Gen high dose vaccine in a 0, 6 month schedule and are followed up until Day 361 in study Phase II (Sourcing).
Combination Product: MenABCWY-2Gen low dose vaccine
MenABCWY-2Gen low dose vaccine is administered intramuscularly in the deltoid region of the non-dominant arm 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).
Combination Product: MenABCWY-2Gen high dose vaccine
MenABCWY-2Gen high dose vaccine is administered intramuscularly in the deltoid region of the non-dominant arm as 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).
Combination Product: Placebo
Placebo is administered intramuscularly in the deltoid region of the non-dominant arm 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).
Combination Product: MenB vaccine
MenB vaccine is administered intramuscularly in the deltoid region of the non-dominant arm, whenever it's possible, as 2 doses in a 0,6-months schedule to participants in the Control Group in study Phase II (Formulation and Schedule-finding).
Other interventions: MenACWY vaccine
MenACWY vaccine is administered intramuscularly in the deltoid region of the dominant arm as 1 dose to participants in the Control Group in study Phase II (Formulation and Schedule-finding).
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Intervention code [1]
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Combination Product
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentages of participants with solicited administration site events in study Phase I (Safety Lead-in)
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Assessment method [1]
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The solicited administration site events include injection site pain, erythema (redness), swelling and induration. Any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters.
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Timepoint [1]
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During the 7 days (including the day of vaccination) following vaccination at Day 1
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Primary outcome [2]
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Percentages of participants with solicited administration site events in study Phase I (Safety Lead-in)
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Assessment method [2]
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Timepoint [2]
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During the 7 days (including the day of vaccination) following vaccination at Day 31
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Primary outcome [3]
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Percentages of participants with solicited systemic events in study Phase I (Safety Lead-in)
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Assessment method [3]
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The solicited systemic events include fever (temperature = 38.0°C), nausea, fatigue, myalgia, arthralgia and headache.
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Timepoint [3]
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During the 7 days (including the day of vaccination) following vaccination at Day 1
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Primary outcome [4]
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Percentages of participants with solicited systemic events in study Phase I (Safety Lead-in)
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Assessment method [4]
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Timepoint [4]
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During the 7 days (including the day of vaccination) following vaccination at Day 31
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Primary outcome [5]
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Percentages 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)
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Assessment method [5]
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The 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. "Any" occurrence of the event regardless of the intensity grade. 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.
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Timepoint [5]
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During the 30 days (including the day of vaccination) following vaccination at Day 1
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Primary outcome [6]
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Percentages 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)
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Assessment method [6]
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Timepoint [6]
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During the 30 days (including the day of vaccination) following vaccination at Day 31
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Primary outcome [7]
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Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase I (Safety Lead-in)
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Assessment method [7]
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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.
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Timepoint [7]
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Throughout the study period (Day 1 through Day 211)
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Primary outcome [8]
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Percentages of participants with haematological and biochemical laboratory abnormalities, and changes from the baseline values, in study Phase I (Safety Lead-in)
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Assessment method [8]
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Haematology and biochemistry assays for safety assessment are performed in all participants in Phase I, in the investigator's laboratory using standard procedures as per local practice.
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Timepoint [8]
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At Day 8 after the first vaccination
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Primary outcome [9]
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Percentages of samples with bactericidal serum activity against a panel of 110 randomly selected endemic US N. meningitidis serogroup B invasive disease strains in study Phase II (Formulation and Schedule-finding)
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Assessment method [9]
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The effectiveness of the MenABCWY-2Gen (low and 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.
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Timepoint [9]
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At Day 211 (1 month after the last vaccination)
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Primary outcome [10]
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Percentages 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)
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Assessment method [10]
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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 percentage 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.
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Timepoint [10]
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At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY groups and at Day 31 the Control group)
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Primary outcome [11]
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Percentages of participants with solicited administration site events in study Phase II (Formulation and Schedule-finding)
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Assessment method [11]
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The solicited administration site events include injection site pain, erythema (redness), swelling and induration. Any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters.
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Timepoint [11]
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During the 7 days (including the day of vaccination) following vaccination at Day 1
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Primary outcome [12]
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Percentages of participants with solicited administration site events in study Phase II (Formulation and Schedule-finding)
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Assessment method [12]
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Timepoint [12]
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During the 7 days (including the day of vaccination) following vaccination at Day 121
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Primary outcome [13]
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Percentages of participants with solicited administration site events in study Phase II (Formulation and Schedule-finding)
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Assessment method [13]
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Timepoint [13]
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During the 7 days (including the day of vaccination) following vaccination at Day 181
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Primary outcome [14]
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Percentages of participants with solicited systemic events in study Phase II (Formulation and Schedule-finding)
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Assessment method [14]
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The solicited systemic events include fever (temperature = 38.0°C), nausea, fatigue, myalgia, arthralgia and headache.
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Timepoint [14]
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During the 7 days (including the day of vaccination) following vaccination at Day 1
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Primary outcome [15]
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Percentages of participants with solicited systemic events in study Phase II (Formulation and Schedule-finding)
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Assessment method [15]
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Timepoint [15]
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During the 7 days (including the day of vaccination) following vaccination at Day 121
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Primary outcome [16]
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Percentages of participants with solicited systemic events in study Phase II (Formulation and Schedule-finding)
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Assessment method [16]
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0
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Timepoint [16]
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During the 7 days (including the day of vaccination) following vaccination at Day 181
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Primary outcome [17]
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Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Formulation and Schedule-finding)
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Assessment method [17]
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The 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 are reported as an unsolicited adverse event. "Any" occurrence of the event regardless of the intensity grade. 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.
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Timepoint [17]
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During the 30 days (including the day of vaccination) following vaccination at Day 1
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Primary outcome [18]
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Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Formulation and Schedule-finding)
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Assessment method [18]
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0
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Timepoint [18]
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During the 30 days (including the day of vaccination) following vaccination at Day 121
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Primary outcome [19]
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Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Formulation and Schedule-finding)
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Assessment method [19]
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0
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Timepoint [19]
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During the 30 days (including the day of vaccination) following vaccination at Day 181
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Primary outcome [20]
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Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Formulation and Schedule-Finding)
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Assessment method [20]
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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.
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Timepoint [20]
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Throughout the study period (Day 1 through Day 541)
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Primary outcome [21]
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Percentages of participants with solicited administration site events in study Phase II (Sourcing)
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Assessment method [21]
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The solicited administration site events include injection site pain, erythema (redness), swelling and induration. Any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters.
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Timepoint [21]
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During the 7 days (including the day of vaccination) following vaccination at Day 1
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Primary outcome [22]
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Percentages of participants with solicited administration site events in study Phase II (Sourcing)
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Assessment method [22]
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0
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Timepoint [22]
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During the 7 days (including the day of vaccination) following vaccination at Day 31
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Primary outcome [23]
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0
Percentages of participants with solicited administration site events in study Phase II (Sourcing)
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Assessment method [23]
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0
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Timepoint [23]
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0
During the 7 days (including the day of vaccination) following vaccination at Day 61
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Primary outcome [24]
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0
Percentages of participants with solicited administration site events in study Phase II (Sourcing)
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Assessment method [24]
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0
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Timepoint [24]
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During the 7 days (including the day of vaccination) following vaccination at Day 181
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Primary outcome [25]
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0
Percentages of participants with solicited systemic events in study Phase II (Sourcing)
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Assessment method [25]
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The solicited systemic events include fever (temperature = 38.0°C), nausea, fatigue, myalgia, arthralgia and headache.
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Timepoint [25]
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0
During the 7 days (including the day of vaccination) following vaccination at Day 1
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Primary outcome [26]
0
0
Percentages of participants with solicited systemic events in study Phase II (Sourcing)
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Assessment method [26]
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0
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Timepoint [26]
0
0
During the 7 days (including the day of vaccination) following vaccination at Day 31
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Primary outcome [27]
0
0
Percentages of participants with solicited systemic events in study Phase II (Sourcing)
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Assessment method [27]
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0
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Timepoint [27]
0
0
During the 7 days (including the day of vaccination) following vaccination at Day 61
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Primary outcome [28]
0
0
Percentages of participants with solicited systemic events in study Phase II (Sourcing)
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Assessment method [28]
0
0
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Timepoint [28]
0
0
During the 7 days (including the day of vaccination) following vaccination at Day 181
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Primary outcome [29]
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0
Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Sourcing)
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Assessment method [29]
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0
The 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. "Any" occurrence of the event regardless of the intensity grade. 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.
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Timepoint [29]
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0
During the 30 days (including the day of vaccination) following vaccination at Day 1
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Primary outcome [30]
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0
Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Sourcing)
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Assessment method [30]
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0
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Timepoint [30]
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0
During the 30 days (including the day of vaccination) following vaccination at Day 31
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Primary outcome [31]
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0
Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Sourcing)
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Assessment method [31]
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0
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Timepoint [31]
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0
During the 30 days (including the day of vaccination) following vaccination at Day 61
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Primary outcome [32]
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0
Percentages of participants with any unsolicited AEs (including all SAEs, AEs leading to withdrawal, and AESIs) in study Phase II (Sourcing)
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Assessment method [32]
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0
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Timepoint [32]
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0
During the 30 days (including the day of vaccination) following vaccination at Day 181
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Primary outcome [33]
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0
Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Sourcing)
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Assessment method [33]
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0
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.
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Timepoint [33]
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Throughout the study period (Day 1 through Day 211)
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Primary outcome [34]
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0
Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Sourcing)
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Assessment method [34]
0
0
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Timepoint [34]
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Throughout the study period (Day 1 through Day 241)
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Primary outcome [35]
0
0
Percentages of participants with SAEs, AEs leading to withdrawal and AESIs in study Phase II (Sourcing)
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Assessment method [35]
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0
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Timepoint [35]
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Throughout the study period (Day 1 through Day 361)
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Secondary outcome [1]
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Percentages of serogroup B invasive disease strains killed in each participant sample in study Phase II (Formulation and Schedule-finding)
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Assessment method [1]
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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.
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Timepoint [1]
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At Day 211 (1 month after the last vaccination)
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Secondary outcome [2]
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Percentages of participants with hSBA titers =LLOQ for each and all serogroup B indicator strains in study Phase II (Formulation and Schedule-finding)
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Assessment method [2]
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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.
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Timepoint [2]
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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
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Secondary outcome [3]
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Percentages of participants with 4-fold rise in hSBA titers against serogroup B indicator strains in study Phase II (Formulation and Schedule-finding)
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Assessment method [3]
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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 percentage of participants achieving a 4-fold rise in hSBA titers against serogroup B indicator strains. The calculation is based on Clopper Pearson method. 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.
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Timepoint [3]
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At Day 211 (1 month after the last vaccination)
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Secondary outcome [4]
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hSBA Geometric mean titers (GMTs) against serogroup B indicator strains in study Phase II (Formulation and Schedule-finding)
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Assessment method [4]
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The immune response to MenABCWY-2Gen (low and high dose) vaccine administered at 0,2 and 0,6-months schedule and to the MenB vaccine administered at 0,6-months schedule against serogroup B indicator strains is determined using hSBA GMTs.The hSBA titers are logarithmically transformed (base10) to fulfil the normal distribution assumption. 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.
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Timepoint [4]
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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
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Secondary outcome [5]
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hSBA Geometric mean ratios (GMRs) against serogroup B indicator strains in study Phase II (Formulation and Schedule-finding)
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Assessment method [5]
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0
The immune response to the MenABCWY-2Gen (low and high dose) vaccine administered at 0,2 and 0,6-months schedule and to the MenB vaccine administered at 0,6-months schedule against serogroup B indicator strains is determined using hSBA GMRs. The hSBA titers are logarithmically transformed (base10) to fulfil the normal distribution assumption. For each B strains, 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.
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Timepoint [5]
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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)
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Secondary outcome [6]
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Percentages of participants with hSBA titers = LLOQ for serogroups A, C, W and Y in study Phase II (Formulation and Schedule-finding)
Query!
Assessment method [6]
0
0
The immune response to MenABCWY-2Gen (low and high dose) vaccine administered at at 0,2 and 0,6-months schedule and MenACWY vaccine administered at 0,6-months schedule is evaluated against serogroups A, C, W and Y . The percentages of participants with hSBA titers = LLOQ and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method are calculated.
Query!
Timepoint [6]
0
0
At Day 1 in ABCWY (0,6-months) and Control groups, Day 31 in ABCWY groups (0,2- and 0,6-months), Day 211 (1 month after the last vaccination) in all ABCWY groups and Day 31 (1 month after the MenACWY vaccination) in Control group
Query!
Secondary outcome [7]
0
0
Percentages 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)
Query!
Assessment method [7]
0
0
The immune response to the MenABCWY-2Gen (low and high dose) vaccine when administered at 0,6-months schedule, relative to day 1 is 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 will be 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.
Query!
Timepoint [7]
0
0
At Day 31 (1 month after the first MenABCWY-2Gen vaccination)
Query!
Secondary outcome [8]
0
0
hSBA GMTs against serogroups A, C, W and Y
Query!
Assessment method [8]
0
0
The immune response to the MenABCWY-2Gen (low and high dose) vaccine (0,2- and 0,6-months schedule) and MenACWY vaccine (single dose) is 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.
Query!
Timepoint [8]
0
0
At Day 1 in ABCWY groups (0,6-months) and Control group, Day 31 in ABCWY groups (0,2-months and 0,6-moths), Day 211 in all ABCWY groups and Day 31 in the Control group
Query!
Secondary outcome [9]
0
0
hSBA GMRs against serogroups A, C, W and Y
Query!
Assessment method [9]
0
0
The hSBA titers groups will be logarithmically transformed (base10) to fulfil the normal distribution assumption. 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.
Query!
Timepoint [9]
0
0
At Day 31 versus Day 1 in ABCWY (0,6-months) and Control groups, Day 211 versus Day 1 in ABCWY (0,6-months) groups and Day 211 versus Day 31 in ABCWY (0,2-months) groups
Query!
Secondary outcome [10]
0
0
Immunoglobulin G (IgG) antibodies against serogroups A, C, W and Y
Query!
Assessment method [10]
0
0
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)
Query!
Timepoint [10]
0
0
At Day 1 in ABCWY groups (0,6-months) and Control groups, Day 31 in ABCWY groups (0,2-months) and Day 31 in the ABCWY groups (0,6-months) and in Control group, and Day 211 for all ABCWY groups
Query!
Eligibility
Key inclusion criteria
All inclusion criteria are applicable for both study phases, except where specified
otherwise.
- Participants and/or participants' parent(s)/Legally Acceptable Representative(s) (LAR)
who, in the opinion of the investigator, can and will comply with the requirements of
the protocol (e.g. completion of the eDiaries, return for follow-up visits).
- Written or witnessed/thumb printed informed consent obtained from the participant or
/parent(s)/LAR(s) of the participant prior to performance of any study specific
procedure.
- Written informed assent obtained from the participant (if applicable) prior to
performing any study specific procedure.
- Phase I only: A male or female between, and including, 18 and 40 years of age (i.e. 40
years + 364 days) at the time of the first study intervention administration.
- Phase II (Formulation and Schedule-finding) only: 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
study intervention administration.
- Phase II (Sourcing) only: A male or female between, and including, 18 and 50 years of
age (i.e. 50 years + 364 days) at the time of the first study intervention
administration.
- Participants 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).
- Healthy participants as established by medical history and clinical examination before
entering into the study.
- Female participants 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 participants of childbearing potential may be enrolled in the study, if the
participant:
- has practiced adequate contraception for 1 month prior to study intervention
administration, and
- has a negative pregnancy test on the day of study intervention administration,
and
- has agreed to continue adequate contraception during the entire treatment period
and for 1 month after completion of the study intervention administration.
Query!
Minimum age
10
Years
Query!
Query!
Maximum age
50
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
- Are obese at enrolment (e.g. for participants from 20 years of age a body mass index
(BMI) = 30 kg/m2, for participants up to 19 years of age a BMI = 95th percentile for
age and gender or as applicable per country recommendations).
- Any neuroinflammatory (including but not limited to: demyelinating disorders,
encephalitis or myelitis of any origin), congenital neurological conditions,
encephalopathies, seizures (including all subtypes such as: absence seizures,
generalised tonic-clonic seizures, partial complex seizures, partial simple 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 study interventions.
- Hypersensitivity, including allergy, to any component of vaccines, including
diphtheria toxoid (CRM197) 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 (including, but not limited to: blood, endocrine, hepatic,
muscular, nervous system or skin autoimmune disorders; lupus erythematosus and
associated conditions; rheumatoid arthritis and associated conditions;
scleroderma and associated disorders) or immunodeficiency syndromes (including,
but not limited to: acquired immunodeficiency syndromes and primary
immunodeficiency syndromes).
- Systemic administration of corticosteroids (PO/IV/IM) for more than 14
consecutive days within 3 months prior to study vaccination until the last blood
sampling visit for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for
Phase II (Formulation and Schedule-finding). This will mean prednisone equivalent
=20 mg/day for adult participants/ =0.5 mg/kg/day with maximum of 20 mg/day for
paediatric participants. 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 other clinical condition that, in the opinion of the investigator, might pose
additional risk to the participant due to participation in the study.
Prior/Concomitant therapy
- Use of any investigational or non-registered product (drug, vaccine or medical device)
other than the study intervention(s) during the period beginning 30 days before the
first dose of study intervention(s) (Day -29 to Day 1), or their 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 3 months before the administration of the first dose of
study intervention(s) or planned administration until the last blood sampling visit
for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation
and Schedule-finding).
- Chronic administration (defined as more than 14 days in total) of immunosuppressants
or other immune-modifying drugs during the period starting 3 months prior to the first
study intervention dose(s) until the last blood sampling visit for Phase I and Phase
II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation and Schedule-finding).
For corticosteroids, this will mean prednisone equivalent =20 mg/day for adult
participants/ =0.5 mg/kg/day with maximum of 20 mg/day for paediatric participants.
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 participant has been or will be exposed to an investigational or a
non-investigational intervention (drug/invasive medical device).
Other exclusions
- 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 dependents, family, or household member.
- Phase II (Formulation and Schedule-finding): Child in care.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1/Phase 2
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Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
14/06/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/09/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1429
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Darlinghurst
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Fortitude Valley
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Taringa
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Tarragindi
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Recruitment hospital [5]
0
0
GSK Investigational Site - Nedlands
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Spearwood
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
4006 - Fortitude Valley
Query!
Recruitment postcode(s) [3]
0
0
4068 - Taringa
Query!
Recruitment postcode(s) [4]
0
0
4121 - Tarragindi
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Recruitment postcode(s) [5]
0
0
6009 - Nedlands
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Recruitment postcode(s) [6]
0
0
6163 - Spearwood
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Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Idaho
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Illinois
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Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Missouri
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Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Nebraska
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Ohio
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Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
South Carolina
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Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Texas
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Country [11]
0
0
Belgium
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State/province [11]
0
0
Bruxelles
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Country [12]
0
0
Belgium
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State/province [12]
0
0
Edegem
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Gent
Query!
Country [14]
0
0
Belgium
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State/province [14]
0
0
Gozée
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Country [15]
0
0
Brazil
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State/province [15]
0
0
Bahía
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Country [16]
0
0
Brazil
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State/province [16]
0
0
São Paulo
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Country [17]
0
0
Brazil
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State/province [17]
0
0
Rio de Janeiro
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Country [18]
0
0
Finland
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State/province [18]
0
0
Helsinki
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Country [19]
0
0
Finland
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State/province [19]
0
0
Turku
Query!
Country [20]
0
0
Poland
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State/province [20]
0
0
Bydgoszcz
Query!
Country [21]
0
0
Poland
Query!
State/province [21]
0
0
Elblag
Query!
Country [22]
0
0
Poland
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State/province [22]
0
0
Katowice
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Country [23]
0
0
Poland
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State/province [23]
0
0
Krakow
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Country [24]
0
0
Poland
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State/province [24]
0
0
Lubon
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Country [25]
0
0
Poland
Query!
State/province [25]
0
0
Siemianowice Slaskie
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Country [26]
0
0
Poland
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State/province [26]
0
0
Tarnow
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Country [27]
0
0
Poland
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State/province [27]
0
0
Torun
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Country [28]
0
0
Poland
Query!
State/province [28]
0
0
Trzebnica
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Country [29]
0
0
Poland
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State/province [29]
0
0
Warsaw
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Country [30]
0
0
Poland
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State/province [30]
0
0
Warszawa
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Country [31]
0
0
Poland
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State/province [31]
0
0
Wroclaw
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Country [32]
0
0
Sweden
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State/province [32]
0
0
Borås
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Country [33]
0
0
Sweden
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State/province [33]
0
0
Karlskrona
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Country [34]
0
0
Sweden
Query!
State/province [34]
0
0
Stockholm
Query!
Country [35]
0
0
Sweden
Query!
State/province [35]
0
0
Umeå
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Country [36]
0
0
Sweden
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State/province [36]
0
0
Örebro
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Country [37]
0
0
Turkey
Query!
State/province [37]
0
0
Istanbul
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Country [38]
0
0
Turkey
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State/province [38]
0
0
Kocaeli
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is 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 will be conducted in healthy adults in a dose-escalating
fashion with 2 formulations of the investigational MenABCWY-2Gen vaccine and will serve as a
safety lead-in to the Phase II study. The Phase II part of the study will be conducted in 2
parts: The 'formulation and schedule-finding' part will follow in healthy adolescents and
young adults and it is designed to select the vaccine formulation and the schedule to be
tested in Phase III. The 'blood sourcing' part will be 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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04886154
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
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Address
0
0
GlaxoSmithKline
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04886154
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