Meningitis, Meningococcal
Conditions
Keywords
Neisseria meningitidis, Meningococcal disease
Brief summary
The purpose of this study was to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine.
Interventions
COMBINATION_PRODUCTMenABCWY vaccine
2 doses of MenABCWY vaccine administered intramuscularly on Day 1 and Day 181 to participants in ABCWY group.
COMBINATION_PRODUCTPlacebo
1 dose of placebo administered intramuscularly on Day 211 to participants in ABCWY group
BIOLOGICALMenACWY vaccine
1 dose of MenACWY vaccine administered intramuscularly on Day 1 to participants in ACWY group
COMBINATION_PRODUCTMenB vaccine
2 doses of MenB vaccine administered intramuscularly on Day 181 and Day 211 to participants in ACWY group. MenB vaccine is a non-investigational medical product (NIMP) in this study and is administered only in compliance with standard of care.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participants and/or participants' parents/LARs, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits). 2. Written or witnessed/thumb printed informed consent obtained from the participant/participant's parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. 3. Written or witnessed/thumb printed informed assent obtained from participants below the legal age of consent prior to performance of any study specific procedure. 4. Previous vaccination with 1 dose of MenACWY vaccine at an age of 10 years or older, with an interval of at least 4 years between the previous MenACWY vaccine and enrollment (informed consent and assent \[as applicable\]) into this study. 5. A male or female between, and including, 15 and 25 years of age (i.e., 25 years and 364 days) at the time of the first vaccination. 6. Healthy participants as established by medical history, physical examination, and clinical judgment of the investigator before entering into the study. 7. 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. 8. Female participants of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test\* on the day of vaccination, and * has agreed to continue adequate contraception during the entire intervention period and for 30 days after completion of the vaccination series.
Exclusion criteria
1. Current or previous, confirmed or suspected disease caused by N. meningitidis. 2. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrollment. 3. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product. 4. Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment whose use is foreseen in this study. 5. Progressive, unstable or uncontrolled clinical conditions 6. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. 7. 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 (oral/intravenous/intramuscular) for more than 14 consecutive days within 90 days prior to study vaccination until the following post vaccination blood sample. This will mean prednisone ≥20 mg/day (for adult participants and ≥0.5 mg/kg/day with maximum ≥20 mg/day for pediatric 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). 8. 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, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures). History of febrile convulsions should not lead to exclusion. 9. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. 10. Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study vaccine(s)/product during the period beginning 30 days before the first dose of study vaccine(s)/product (Day -29 to Day 1), or planned use during the study period. 11. Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable (according to the participant's age). 12. Previous vaccination with 2 or more doses of MenACWY vaccine. 13. Administration/planned administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before any dose of study vaccine(s)/product until the following post-vaccination blood sample. 14. 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 any vaccine/product dose until the following post-vaccination blood sample. For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants and ≥0.5 mg/kg/day with maximum ≥20 mg/day for pediatric participants. Inhaled and topical steroids are allowed. 15. 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 vaccine/product (drug or medical device). 16. Child in care. 17. Pregnant or lactating female. 18. Female planning to become pregnant or planning to discontinue contraceptive precautions. 19. History of/current chronic alcohol and/or drug abuse. 20. Involvement in the study as a study staff member or being immediate dependents, family, or household member of a study staff member.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group) compared to Day 1 (Baseline) | Four-fold rise is defined as: - a post-vaccination hSBA titer equal to or higher than (\>=) 16 for participants with a pre-vaccination hSBA titer \<4; - a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a pre vaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and - a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ. |
| Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | At 1 month after the first vaccination (i.e., Day 31) compared to Day 1 (Baseline) | Four-fold rise is defined as: - a post-vaccination hSBA titer equal to or higher than (\>=) 16 for participants with a pre-vaccination hSBA titer \<4; - a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a pre vaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and - a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ. |
| Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group | During the 7 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group | Assessed solicited administration site events include injection site pain, erythema, swelling, induration. Any pain = occurrence of the symptom regardless of intensity grade and any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters. |
| Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group | During the 7 days (including day of vaccination) following vaccination at Day 181 for ABCWY group | Assessed solicited administration site events include injection site pain, erythema, swelling, induration. Any pain = occurrence of the symptom regardless of intensity grade and any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters. |
| Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | During the 7 days (including day of vaccination) following vaccination at day 1 for the ABCWY group and ACWY group | Assessed solicited systemic events include fever \[body temperature \>= 38.0°C (celsius) /100.4°F (Fahrenheit)\], nausea, fatigue, myalgia, arthralgia, headache. |
| Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group | During the 7 days (including day of vaccination) following vaccination at day 181 for the ABCWY group | Assessed solicited systemic events include fever \[body temperature \>= 38.0°C/100.4°F\], nausea, fatigue, myalgia, arthralgia, headache. |
| Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs) | During the 30 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group | Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-predefined AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. An MAE is defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. |
| Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs) Following Vaccination at Day 181 for ABCWY Group | During the 30 days (including day of vaccination) following vaccination at day 181 for ABCWY group | Any AE-untoward medical occurrence in a patient/clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-predefined AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. |
| Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs | From Day 1 to Day 361 (throughout the study period) | SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were assessed throughout the study period are reported in this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | At Day 1 (pre-vaccination) and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group) | The immune response to MenABCWY vaccine after the first dose and single dose of MenACWY vaccine was evaluated by measuring the percentage of participants with hSBA titers \>= LLOQ against each of the serogroups A, C, W and Y. |
| GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination | At Day 211 compared to baseline (Day 1) | The immune response to MenABCWY vaccine after second dose was evaluated by measuring the human serum bactericidal activity against each of the N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively) compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint. |
| Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination | 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose]) | The immune response to MenABCWY vaccine after the second dose was evaluated by measuring the percentage of participants with hSBA titers \>= LLOQ against each of the serogroups A, C, W and Y. |
| hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | At Day 1 and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group) | The immune response to MenABCWY after first dose and single dose of MenACWY vaccine was evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y in terms of GMTs. For each serogroup, the GMTs with their associated 2-sided 95% confidence intervals were calculated. |
| hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination | 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose]) | The immune response to MenABCWY after second dose was evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y in terms of GMTs. For each serogroup, the GMTs with their associated 2-sided 95% confidence intervals were calculated. |
| Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | At 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group) compared to baseline (Day 1) | The immune response to MenABCWY vaccine after first and single dose of MenACWY vaccine are evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y, compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint. |
| Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination | At 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose]) compared to baseline (Day 1) | The immune response to MenABCWY vaccine after second dose are evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y, compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint. |
| Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination | At Day 1 and at Day 211 | The immune response to MenABCWY vaccine after second dose was evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). |
| Percentages of Participants With 4-fold Rise in hSBA Titers Against Each N. Meningitidis Serogroup B Indicator Strains at 1 Month After the Second MenABCWY Vaccination | At Day 211 compared to baseline (Day 1) | The immune response to MenABCWY after second dose is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). compared to baseline (day 1) in terms of 4-fold rise in hSBA titers. For each of the serogroup B indicator strains, the 4-fold rise is defined as: a post-vaccination hSBA titer \>=16 for participants with a pre-vaccination hSBA titer \<4; . a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a prevaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and, a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ. |
| GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination | At Day 1 and at Day 211 | The immune response to MenABCWY vaccine after the second dose was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively) in terms of GMTs at baseline (Day 1) and 1 month after second MenABCWY vaccination. |
Countries
Argentina, Australia, Canada, United States
Participant flow
Recruitment details
Out of 1250 participants enrolled,3 participants did not receive vaccination as they did not meet the eligibility criteria, therefore only 1247 participants were included in the Exposed Set and started the study.
Participants by arm
| Arm | Count |
|---|---|
| ABCWY Group Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211. | 626 |
| ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211. | 621 |
| Total | 1,247 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 8 |
| Overall Study | Lost to Follow-up | 44 | 31 |
| Overall Study | MIGRATED / MOVED FROM THE STUDY AREA | 8 | 8 |
| Overall Study | Other | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 5 |
| Overall Study | Withdrawal by Subject | 27 | 25 |
Baseline characteristics
| Characteristic | ABCWY Group | ACWY Group | Total |
|---|---|---|---|
| Age, Continuous | 17.2 YEARS STANDARD_DEVIATION 2.53 | 17.2 YEARS STANDARD_DEVIATION 2.63 | 17.2 YEARS STANDARD_DEVIATION 2.58 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 22 Participants | 33 Participants | 55 Participants |
| Race/Ethnicity, Customized Black or African American | 94 Participants | 86 Participants | 180 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized Other UNSPECIFIED | 33 Participants | 31 Participants | 64 Participants |
| Race/Ethnicity, Customized White | 474 Participants | 464 Participants | 938 Participants |
| Sex: Female, Male Female | 343 Participants | 324 Participants | 667 Participants |
| Sex: Female, Male Male | 283 Participants | 297 Participants | 580 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 626 | 1 / 621 |
| other Total, other adverse events | 583 / 626 | 552 / 621 |
| serious Total, serious adverse events | 18 / 626 | 7 / 621 |
Outcome results
Primary
Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs)
Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-predefined AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. An MAE is defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Time frame: During the 30 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group
Population: Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study intervention and had unsolicited AEs during the specific period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABCWY Group | Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs) | 96 Participants |
| ACWY Group | Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs) | 93 Participants |
Primary
Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs) Following Vaccination at Day 181 for ABCWY Group
Any AE-untoward medical occurrence in a patient/clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-predefined AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Time frame: During the 30 days (including day of vaccination) following vaccination at day 181 for ABCWY group
Population: Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study intervention and had unsolicited AEs during the specific period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABCWY Group | Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs) Following Vaccination at Day 181 for ABCWY Group | 72 Participants |
Primary
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs
SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were assessed throughout the study period are reported in this outcome measure.
Time frame: From Day 1 to Day 361 (throughout the study period)
Population: Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study intervention and had unsolicited AEs during the specific period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABCWY Group | Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs | Medically Attended AEs | 223 Participants |
| ABCWY Group | Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs | AEs leading to withdrawal | 4 Participants |
| ABCWY Group | Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs | SAEs | 18 Participants |
| ABCWY Group | Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs | AESIs | 0 Participants |
| ACWY Group | Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs | SAEs | 7 Participants |
| ACWY Group | Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs | Medically Attended AEs | 206 Participants |
| ACWY Group | Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs | AESIs | 4 Participants |
| ACWY Group | Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs | AEs leading to withdrawal | 6 Participants |
Primary
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group
Assessed solicited administration site events include injection site pain, erythema, swelling, induration. Any pain = occurrence of the symptom regardless of intensity grade and any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters.
Time frame: During the 7 days (including day of vaccination) following vaccination at Day 181 for ABCWY group
Population: Analysis was performed on Solicited Safety Set (SSS), which included participants who received at least 2 dose of the study intervention and had solicited data available during the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABCWY Group | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group | Injection site pain | 377 Participants |
| ABCWY Group | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group | Erythema | 31 Participants |
| ABCWY Group | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group | Swelling | 30 Participants |
| ABCWY Group | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group | Induration | 22 Participants |
Primary
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group
Assessed solicited administration site events include injection site pain, erythema, swelling, induration. Any pain = occurrence of the symptom regardless of intensity grade and any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters.
Time frame: During the 7 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group
Population: Analysis was performed on Solicited Safety Set (SSS),which included participants who received at least 1 dose of the study intervention and had solicited administration data available during the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABCWY Group | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group | Erythema | 29 Participants |
| ABCWY Group | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group | Induration | 24 Participants |
| ABCWY Group | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group | Swelling | 26 Participants |
| ABCWY Group | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group | Injection site pain | 486 Participants |
| ACWY Group | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group | Erythema | 9 Participants |
| ACWY Group | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group | Injection site pain | 191 Participants |
| ACWY Group | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group | Swelling | 13 Participants |
| ACWY Group | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group | Induration | 14 Participants |
Primary
Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group
Assessed solicited systemic events include fever \[body temperature \>= 38.0°C/100.4°F\], nausea, fatigue, myalgia, arthralgia, headache.
Time frame: During the 7 days (including day of vaccination) following vaccination at day 181 for the ABCWY group
Population: Analysis was performed on Solicited Safety Set (SSS),which included participants who received at least 2 dose of the study intervention and had solicited systemic data available during the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABCWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group | Fever | 9 Participants |
| ABCWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group | Nausea | 58 Participants |
| ABCWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group | Fatigue | 167 Participants |
| ABCWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group | Myalgia | 67 Participants |
| ABCWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group | Arthralgia | 30 Participants |
| ABCWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group | Headache | 167 Participants |
Primary
Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group
Assessed solicited systemic events include fever \[body temperature \>= 38.0°C (celsius) /100.4°F (Fahrenheit)\], nausea, fatigue, myalgia, arthralgia, headache.
Time frame: During the 7 days (including day of vaccination) following vaccination at day 1 for the ABCWY group and ACWY group
Population: Analysis was performed on Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study intervention and had solicited systemic data available during the specified period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABCWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | Fever | 12 Participants |
| ABCWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | Nausea | 88 Participants |
| ABCWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | Fatigue | 244 Participants |
| ABCWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | Myalgia | 90 Participants |
| ABCWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | Arthralgia | 45 Participants |
| ABCWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | Headache | 249 Participants |
| ACWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | Arthralgia | 49 Participants |
| ACWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | Fever | 7 Participants |
| ACWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | Myalgia | 66 Participants |
| ACWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | Nausea | 75 Participants |
| ACWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | Headache | 208 Participants |
| ACWY Group | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | Fatigue | 222 Participants |
Primary
Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline
Four-fold rise is defined as: - a post-vaccination hSBA titer equal to or higher than (\>=) 16 for participants with a pre-vaccination hSBA titer \<4; - a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a pre vaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and - a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ.
Time frame: At 1 month after the first vaccination (i.e., Day 31) compared to Day 1 (Baseline)
Population: Analysis was performed on Per Protocol Set (PPS), which included participants who received at least 1 dose of the study intervention to which they were randomized and had post-vaccination data available at the specified timepoint minus participants with protocol deviations that led to exclusion from the PPS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY Group | Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis C | 94.0 Percentage of Participants |
| ABCWY Group | Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis Y | 93.7 Percentage of Participants |
| ABCWY Group | Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis W | 94.3 Percentage of Participants |
| ABCWY Group | Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis A | 92.5 Percentage of Participants |
| ACWY Group | Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis W | 93.9 Percentage of Participants |
| ACWY Group | Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis C | 94.0 Percentage of Participants |
| ACWY Group | Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis A | 95.0 Percentage of Participants |
| ACWY Group | Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis Y | 94.4 Percentage of Participants |
Comparison: To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).0.95% CI: [-5.59, 0.47]
Comparison: To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).0.95% CI: [-2.76, 2.94]
Comparison: To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroupsW at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).0.95% CI: [-2.41, 3.25]
Comparison: To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).0.95% CI: [-3.62, 2.09]
Primary
Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline
Four-fold rise is defined as: - a post-vaccination hSBA titer equal to or higher than (\>=) 16 for participants with a pre-vaccination hSBA titer \<4; - a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a pre vaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and - a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ.
Time frame: At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group) compared to Day 1 (Baseline)
Population: Analysis was performed on Per Protocol Set (PPS), which included participants who received at least 1 dose of the study intervention to which they were randomized and had post-vaccination data available at the specified timepoint minus participants with protocol deviations that led to exclusion from the PPS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY Group | Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis W | 95.6 Percentage of Participants |
| ABCWY Group | Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis A | 95.3 Percentage of Participants |
| ABCWY Group | Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis Y | 95.0 Percentage of Participants |
| ABCWY Group | Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis C | 94.5 Percentage of Participants |
| ACWY Group | Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis Y | 94.4 Percentage of Participants |
| ACWY Group | Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis A | 95.0 Percentage of Participants |
| ACWY Group | Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis W | 93.9 Percentage of Participants |
| ACWY Group | Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | Meningitis C | 94.0 Percentage of Participants |
Comparison: To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).0.95% CI: [-4.38, 3.5]
Comparison: To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).0.95% CI: [-4.14, 3.98]
Comparison: To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups W at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).0.95% CI: [-2.73, 4.89]
Comparison: To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).0.95% CI: [-3.93, 3.91]
Secondary
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination
The immune response to MenABCWY vaccine after second dose are evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y, compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint.
Time frame: At 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose]) compared to baseline (Day 1)
Population: Analysis was performed on the Full Analysis Set (FAS), which included participants who received at least 1 dose of the study intervention and had post-vaccination immunogenicity data for the specified analysis at the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ABCWY Group | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination | Meningitis A, Day 211 | 44.74 Ratio |
| ABCWY Group | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination | Meningitis C, Day 211 | 68.33 Ratio |
| ABCWY Group | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination | Meningitis W, Day 211 | 97.66 Ratio |
| ABCWY Group | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination | Meningitis Y, Day 211 | 82.45 Ratio |
Secondary
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination
The immune response to MenABCWY vaccine after first and single dose of MenACWY vaccine are evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y, compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint.
Time frame: At 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group) compared to baseline (Day 1)
Population: Analysis was performed on the Full Analysis Set (FAS), which included participants who received at least 1 dose of the study intervention and had post-vaccination immunogenicity data for the specified analysis at the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ABCWY Group | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis A, Day 31 | 43.98 Ratio |
| ABCWY Group | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis C, Day 31 | 92.87 Ratio |
| ABCWY Group | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis W, Day 31 | 154.09 Ratio |
| ABCWY Group | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis Y, Day 31 | 124.11 Ratio |
| ACWY Group | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis Y, Day 31 | 134.66 Ratio |
| ACWY Group | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis A, Day 31 | 76.91 Ratio |
| ACWY Group | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis W, Day 31 | 150.83 Ratio |
| ACWY Group | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis C, Day 31 | 86.36 Ratio |
Secondary
GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination
The immune response to MenABCWY vaccine after second dose was evaluated by measuring the human serum bactericidal activity against each of the N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively) compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint.
Time frame: At Day 211 compared to baseline (Day 1)
Population: Analysis was performed on the Full Analysis Set (FAS), which included participants from only ABCWY Group who received at least 1 dose of the MenABCWY vaccine and had post vaccination immunogenicity data for the specified analysis at the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ABCWY Group | GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination | NadA (96217) Ab | 16.67 Ratio |
| ABCWY Group | GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination | NHBA (M13520) Ab | 7.69 Ratio |
| ABCWY Group | GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination | PorAP1.4 (NZ98/254) Ab | 3.65 Ratio |
| ABCWY Group | GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination | fHbp (M14459) Ab | 6.29 Ratio |
Secondary
GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination
The immune response to MenABCWY vaccine after the second dose was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively) in terms of GMTs at baseline (Day 1) and 1 month after second MenABCWY vaccination.
Time frame: At Day 1 and at Day 211
Population: Analysis was performed on the Full Analysis Set (FAS), which included participants from only ABCWY Group who received at least 1 dose of the MenABCWY vaccine and had post vaccination immunogenicity data for the specified analysis at the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ABCWY Group | GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination | fHbp (M14459) Ab, Day 1 | 2.84 Titers |
| ABCWY Group | GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination | fHbp (M14459) Ab, Day 211 | 17.56 Titers |
| ABCWY Group | GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination | NadA (96217) Ab, Day 1 | 8.62 Titers |
| ABCWY Group | GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination | NadA (96217) Ab, Day 211 | 143.61 Titers |
| ABCWY Group | GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination | NHBA (M13520) Ab, Day 1 | 3.28 Titers |
| ABCWY Group | GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination | NHBA (M13520) Ab, Day 211 | 24.82 Titers |
| ABCWY Group | GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination | PorAP1.4 (NZ98/254) Ab, Day 1 | 3.13 Titers |
| ABCWY Group | GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination | PorAP1.4 (NZ98/254) Ab, Day 211 | 11.44 Titers |
Secondary
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination
The immune response to MenABCWY after second dose was evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y in terms of GMTs. For each serogroup, the GMTs with their associated 2-sided 95% confidence intervals were calculated.
Time frame: 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose])
Population: Analysis was performed on the Full Analysis Set (FAS), which included participants who received at least 1 dose of the study intervention and had post-vaccination immunogenicity data for the specified analysis at the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ABCWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination | Meningitis A, Day 211 | 645.24 Titers |
| ABCWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination | Meningitis C, Day 211 | 2350.14 Titers |
| ABCWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination | Meningitis W, Day 211 | 1173.61 Titers |
| ABCWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination | Meningitis Y, Day 211 | 1130.54 Titers |
Secondary
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination
The immune response to MenABCWY after first dose and single dose of MenACWY vaccine was evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y in terms of GMTs. For each serogroup, the GMTs with their associated 2-sided 95% confidence intervals were calculated.
Time frame: At Day 1 and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group)
Population: Analysis was performed on the Full Analysis Set (FAS), which included participants who received at least 1 dose of the study intervention and had post-vaccination immunogenicity data for the specified analysis at the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ABCWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis W, Day 1 | 12.08 Titers |
| ABCWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis A, Day 1 | 15.30 Titers |
| ABCWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis A, Day 31 | 670.78 Titers |
| ABCWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis C, Day 1 | 31.90 Titers |
| ABCWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis C, Day 31 | 2945.68 Titers |
| ABCWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis W, Day 31 | 1899.60 Titers |
| ABCWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis Y, Day 1 | 12.84 Titers |
| ABCWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis Y, Day 31 | 1590.71 Titers |
| ACWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis C, Day 1 | 29.76 Titers |
| ACWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis W, Day 1 | 11.08 Titers |
| ACWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis Y, Day 31 | 1578.42 Titers |
| ACWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis W, Day 31 | 1665.64 Titers |
| ACWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis A, Day 1 | 16.34 Titers |
| ACWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis C, Day 31 | 2552.27 Titers |
| ACWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis A, Day 31 | 1282.56 Titers |
| ACWY Group | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis Y, Day 1 | 11.86 Titers |
Secondary
Percentages of Participants With 4-fold Rise in hSBA Titers Against Each N. Meningitidis Serogroup B Indicator Strains at 1 Month After the Second MenABCWY Vaccination
The immune response to MenABCWY after second dose is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). compared to baseline (day 1) in terms of 4-fold rise in hSBA titers. For each of the serogroup B indicator strains, the 4-fold rise is defined as: a post-vaccination hSBA titer \>=16 for participants with a pre-vaccination hSBA titer \<4; . a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a prevaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and, a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ.
Time frame: At Day 211 compared to baseline (Day 1)
Population: Analysis was performed on the Full Analysis Set (FAS), which included participants from only ABCWY Group who received at least 1 dose of the MenABCWY vaccine and had post vaccination immunogenicity data for the specified analysis at the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY Group | Percentages of Participants With 4-fold Rise in hSBA Titers Against Each N. Meningitidis Serogroup B Indicator Strains at 1 Month After the Second MenABCWY Vaccination | NadA (96217) Ab | 90.1 Percentage of Participants |
| ABCWY Group | Percentages of Participants With 4-fold Rise in hSBA Titers Against Each N. Meningitidis Serogroup B Indicator Strains at 1 Month After the Second MenABCWY Vaccination | NHBA (M13520) Ab | 64.6 Percentage of Participants |
| ABCWY Group | Percentages of Participants With 4-fold Rise in hSBA Titers Against Each N. Meningitidis Serogroup B Indicator Strains at 1 Month After the Second MenABCWY Vaccination | PorAP1.4 (NZ98/254) Ab | 45.7 Percentage of Participants |
| ABCWY Group | Percentages of Participants With 4-fold Rise in hSBA Titers Against Each N. Meningitidis Serogroup B Indicator Strains at 1 Month After the Second MenABCWY Vaccination | fHbp (M14459) Ab | 68.1 Percentage of Participants |
Secondary
Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination
The immune response to MenABCWY vaccine after second dose was evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively).
Time frame: At Day 1 and at Day 211
Population: Analysis was performed on the Full Analysis Set (FAS), which included participants from only ABCWY Group who received at least 1 dose of the MenABCWY vaccine and had post vaccination immunogenicity data for the specified analysis at the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY Group | Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination | NadA (96217) Ab, Day 211 | 95.8 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination | Composite Response, Day 1 | 1.1 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination | Composite Response, Day 211 | 72.0 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination | fHbp (M14459) Ab, Day 1 | 8.7 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination | fHbp (M14459) Ab, Day 211 | 88.5 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination | NadA (96217) Ab, Day 1 | 7.7 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination | NHBA (M13520) Ab, Day 1 | 20.2 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination | NHBA (M13520) Ab, Day 211 | 96.3 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination | PorAP1.4 (NZ98/254) Ab, Day 1 | 2.7 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination | PorAP1.4 (NZ98/254) Ab, Day 211 | 75.6 Percentage of Participants |
Secondary
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination
The immune response to MenABCWY vaccine after the second dose was evaluated by measuring the percentage of participants with hSBA titers \>= LLOQ against each of the serogroups A, C, W and Y.
Time frame: 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose])
Population: Analysis was performed on the Full Analysis Set (FAS), which included participants who received at least 1 dose of the study intervention and had post-vaccination immunogenicity data for the specified analysis at the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination | Meningitis A, Day 211 | 99.5 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination | Meningitis C, Day 211 | 100.0 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination | Meningitis W, Day 211 | 100.0 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination | Meningitis Y, Day 211 | 100.0 Percentage of Participants |
Secondary
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination
The immune response to MenABCWY vaccine after the first dose and single dose of MenACWY vaccine was evaluated by measuring the percentage of participants with hSBA titers \>= LLOQ against each of the serogroups A, C, W and Y.
Time frame: At Day 1 (pre-vaccination) and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group)
Population: Analysis was performed on the Full Analysis Set (FAS), which included participants who received at least 1 dose of the study intervention and had post-vaccination immunogenicity data for the specified analysis at the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis A, Day 1 | 27.7 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis C, Day 1 | 57.7 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis W, Day 31 | 98.4 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis A, Day 31 | 98.3 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis Y, Day 1 | 37.5 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis C, Day 31 | 98.9 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis Y, Day 31 | 97.9 Percentage of Participants |
| ABCWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis W, Day 1 | 36.3 Percentage of Participants |
| ACWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis Y, Day 31 | 97.6 Percentage of Participants |
| ACWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis A, Day 1 | 28.8 Percentage of Participants |
| ACWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis A, Day 31 | 98.1 Percentage of Participants |
| ACWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis C, Day 1 | 56.2 Percentage of Participants |
| ACWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis C, Day 31 | 99.0 Percentage of Participants |
| ACWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis W, Day 1 | 33.4 Percentage of Participants |
| ACWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis W, Day 31 | 96.8 Percentage of Participants |
| ACWY Group | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | Meningitis Y, Day 1 | 34.9 Percentage of Participants |