A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults

Phase 1

Completed

Conditions: Infections, Meningococcal

Interventions: Combination Product: MenABCWY-2Gen low dose vaccine
Combination Product: Placebo
Combination Product: MenABCWY-2Gen high dose vaccine
Combination Product: MenB vaccine
Biological: MenACWY vaccine

Registration Number: NCT04886154

Lead Sponsor: GlaxoSmithKline

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1440

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.

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABCWY low dose Group	MenABCWY-2Gen low dose vaccine	Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
Placebo low dose Group	Placebo	Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY low-dose group.
ABCWY high dose Group	MenABCWY-2Gen high dose vaccine	Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In).
Placebo high dose Group	Placebo	Participants received two doses of a placebo on Day 1 and Day 31, following a 0, 1-month schedule during Study Phase I (Safety Lead-In), as the control group for the ABCWY high-dose group.
ABCWY low dose_06 Group	MenABCWY-2Gen low dose vaccine	Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
ABCWY low dose_06 Group	Placebo	Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
ABCWY low dose_02 Group	MenABCWY-2Gen low dose vaccine	Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
ABCWY low dose_02 Group	Placebo	Participants received two doses of the MenABCWY-2Gen low-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
ABCWY high dose_06 Group	MenABCWY-2Gen high dose vaccine	Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
ABCWY high dose_06 Group	Placebo	Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 1 and Day 181, following a 0, 6-month schedule, along with one dose of a placebo on Day 121 during Phase II (Formulation and Schedule-Finding).
ABCWY high dose_02 Group	MenABCWY-2Gen high dose vaccine	Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
ABCWY high dose_02 Group	Placebo	Participants received two doses of the MenABCWY-2Gen high-dose vaccine on Day 121 and Day 181, following a 0, 2-month schedule, along with one dose of a placebo on Day 1 during Phase II (Formulation and Schedule-Finding).
Control Group	MenB vaccine	Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
Control Group	MenACWY vaccine	Participants randomized to the control group received two doses of the Bexsero (MenB) vaccine on Day 1 and Day 181, following a 0, 6-month schedule, and one dose of Menveo (MenACWY) on Day 1 during Study Phase II (Formulation and Schedule-Finding).
ABCWY low dose_01 Group	MenABCWY-2Gen low dose vaccine	Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
ABCWY high dose_01 Group	MenABCWY-2Gen high dose vaccine	Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and Day 31, following a 0, 1-month schedule during study Phase II (Sourcing).
ABCWY low doseS_02 Group	MenABCWY-2Gen low dose vaccine	Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
ABCWY high doseS_02 Group	MenABCWY-2Gen high dose vaccine	Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 61 following a 0, 2-month schedule during study Phase II (Sourcing).
ABCWY low doseS_06 Group	MenABCWY-2Gen low dose vaccine	Participants received two doses of MenABCWY-2Gen low dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).
ABCWY high doseS_06 Group	MenABCWY-2Gen high dose vaccine	Participants received two doses of MenABCWY-2Gen high dose vaccine on Day 1 and day 181 following a 0, 6-month schedule during study Phase II (Sourcing).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Solicited Administration Site Events in Study Phase I (Safety Lead-in)	During the 7 days (including the day of vaccination) following vaccination at Day 31	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.
Number of Participants With Solicited Systemic Events in Study Phase I (Safety Lead-in)	During the 7 days (including the day of vaccination) following vaccination at Day 31	The solicited systemic events include fever (temperature ≥ 38.0°C), nausea, fatigue, myalgia, arthralgia and headache.
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)	During the 30 days (including the day of vaccination) following vaccination at Day 1	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.
Number of Participants With Any Unsolicited AEs, Including All SAEs, AEs Leading to Withdrawal and AESIs in Study Phase I (Safety Lead-in)	During the 30 days (including the day of vaccination) following vaccination at Day 31	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.
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase I (Safety Lead-in)	Throughout the Phase 1 study period (Day 1 through Day 211)	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.
Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values, in Study Phase I (Safety Lead-in)	At Day 8 (7 days after the first vaccination)	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.
Number of Participants With Clinically Significant Haematological and Biochemical Laboratory Values, in Study Phase I (Safety Lead-in)	At Day 8 (7 days after the first vaccination)	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).
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)	At Day 211 (1 month after the last vaccination)	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.
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)	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)	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.
Number of Participants With Solicited Administration Site Events in Study Phase II (Formulation and Schedule-finding)	During the 7 days (including the day of vaccination) following vaccination at Day 181	Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Number of Participants With Solicited Systemic Events in Study Phase II (Formulation and Schedule-finding)	During the 7 days (including the day of vaccination) following vaccination at Day 181	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.
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Formulation and Schedule-finding)	During the 30 days (including the day of vaccination) following vaccination at Day 181	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.
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Formulation and Schedule-Finding)	Throughout the Phase II FSF study period (Day 1 through Day 541)	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.
Number of Participants With Solicited Administration Site Events in Study Phase II (Sourcing)	During the 7 days (including the day of vaccination) following vaccination at Day 181	Assessed solicited administration site events included injection site pain, erythema (redness), swelling and induration. Any = occurrence of the event regardless of intensity grade.
Number of Participants With Solicited Systemic Events in Study Phase II (Sourcing)	During the 7 days (including the day of vaccination) following vaccination at Day 181	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.
Number of Participants With Any Unsolicited AEs (Including All SAEs, AEs Leading to Withdrawal, and AESIs) in Study Phase II (Sourcing)	During the 30 days (including the day of vaccination) following vaccination at Day 181	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.
Number of Participants With SAEs, AEs Leading to Withdrawal and AESIs in Study Phase II (Sourcing)	Throughout the study period (Day 1 through Day 361)	A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. 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.

Secondary Outcome Measures

Name	Time	Method
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)	At Day 211 (1 month after the last vaccination)	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.
Number of Participants With hSBA Titers ≥ LLOQ for Each and All Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)	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	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.
Number of Participants With 4-fold Rise in hSBA Titers Against Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)	At Day 211 (1 month after the last vaccination)	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.
hSBA Geometric Mean Titers (GMTs) Against Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)	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	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.
Number of Participants With hSBA Titers ≥ LLOQ for Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)	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	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.
hSBA Geometric Mean Ratios (GMRs) Against Serogroup B Indicator Strains in Study Phase II (Formulation and Schedule-finding)	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)	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.
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)	At Day 31 (1 month after the first MenABCWY-2Gen vaccination) in ABCWY (0,6-months) groups	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.
hSBA GMTs Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)	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	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.
hSBA GMRs Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)	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]	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.
Immunoglobulin G (IgG) Antibodies Against Serogroups A, C, W and Y in Study Phase II (Formulation and Schedule-finding)	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	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).