A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules

A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO <15 YEARS OF AGE

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04440176

Enrollment

309

Registered

2020-06-19

Start date

2020-06-17

Completion date

2024-01-05

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Vaccine

Keywords

pentavalent meningococcal vaccine

Brief summary

This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.

Interventions

BIOLOGICALMenABCWY

Neisseria meningitidis group A, B, C, W, and Y vaccine

BIOLOGICALSaline

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

11 Years to 14 Years

Healthy volunteers

Yes

Inclusion criteria

* Male or female participants 11 through \<15 years of age at the time of randomization. * Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization. * Available for the entire study period and can be reached by telephone. * Healthy participant as determined by medical history, physical examination, and judgement of the investigator. * Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants.

Exclusion criteria

* A previous anaphylactic reaction to any vaccine or vaccine-related component. * Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. * A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. * History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae. * Significant neurological disorder or history of seizure (excluding simple febrile seizure). * Any neuroinflammatory or autoimmune condition, including, but no limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. * Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. * Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination. * Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date of enrollment (first vaccination).

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Who Missed School or Work Because of AEs Within 1 Month After Vaccination 3: 0 and 36 Month Schedule	Within 1 month after vaccination 3 (Second dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 36 Month Schedule	30 minutes after vaccination 2 (Saline)	Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 3: 0 and 36 Month Schedule	30 minutes after vaccination 3 (Second dose of MenABCWY)	Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 12 Month Schedule	Within 6 months after vaccination 1 (First dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 36 Month Schedule	Within 6 months after vaccination 1 (First dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 12 Month Schedule	Within 6 months after vaccination 2 (Second dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 36 Month Schedule	Within 6 months after vaccination 2 (Saline)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MenB) Test Strains at Baseline: 0 and 12 Month Schedule	Baseline (before vaccination 1)	Percentage of participants achieving hSBA titer \>=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at baseline were reported in this outcome measure. Here, 'Post Vaccination 2 Evaluable Population'=PV2 EP and Number analyzed = number of participants evaluable at specific rows.
Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 2: 0 and 12 Month Schedule	1 month after vaccination 2 (second dose of MenABCWY)	Percentage of participants achieving hSBA titer \>=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at 1 month after vaccination 2 in participants who received MenABCWY at Month 0 and Month 12 were reported in this outcome measure. Number analyzed = number of participants evaluable at specific rows.
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at Baseline: 0 and 36 Month Schedule	Baseline (before vaccination 1)	Percentage of participants achieving hSBA titer \>=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at baseline were reported in this outcome measure. Number of Participants Analyzed= number of participants evaluable for this outcome measure and Number analyzed = number of participants evaluable at specific rows.
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 3: 0 and 36 Month Schedule	1 Month After Vaccination 3 (second dose of MenABCWY)	Percentage of participants achieving hSBA titer \>=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at 1 month after vaccination 3 (second dose of MenABCWY) in participants who received MenABCWY at Month 0 and Month 36. Number of Participants Analyzed= number of participants evaluable for this outcome measure and Number analyzed = number of participants evaluable at specific rows.
Percentage of Participants Reporting Adverse Events (AEs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule	Within 30 days after vaccination 1 (first dose of MenABCWY)	An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule	Within 30 days after vaccination 2 (second dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule	Within 30 days after vaccination 1 (first dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule	Within 30 days after vaccination 2 (saline)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule	Within 30 days after vaccination 3 (second dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Newly Diagnosed Chronic Medical Condition (NDCMCs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule	Within 30 days after vaccination 1 (First dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a non-serious AE (other than serious AE) that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule	Within 30 days after vaccination 2 (Second dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule	Within 30 days after vaccination 1 (First dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule	Within 30 days after vaccination 2 (Saline)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule	Within 30 days after vaccination 3 (Second dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule	Within 30 Days after any MenABCWY vaccination	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule	Within 30 days after any MenABCWY vaccination	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule	Within 30 days after any MenABCWY vaccination	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule	Within 30 days after any MenABCWY vaccination	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule	From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule	Vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule	From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule	From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule	From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule	From vaccination 2 through 1 month after vaccination 2 (Saline)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule	From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule	From vaccination 2 through 1 month after vaccination 2 (Saline)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting AEs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule	From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule	From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule	From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule	From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule	From 1 month after vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule	From 1 month after vaccination 2 through 6 months after vaccination 2 (Saline)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule	From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule	From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule	From vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule	From vaccination 2 through 6 months after vaccination 2 (Saline)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 12 Month Schedule	30 minutes after vaccination 1 (First dose of MenABCWY)	Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 12 Month Schedule	30 minutes after vaccination 2 (Second dose of MenABCWY)	Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 36 Month Schedule	30 minutes after vaccination 1 (First dose of MenABCWY)	Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.

Secondary

Measure	Time frame	Description
Percentage of Participants With hSBA Titer >= LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After the Second Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 2 Evaluable Population	Baseline (before vaccination 1) and 1 month after the second dose of MenABCWY	Percentage of participants achieving hSBA titer \>=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the MenACWY test strains at baseline and one month after second dose of MenABCWY in participants who received the first and second dose of MenABCWY were reported in this outcome measure. Number analyzed = number of participants evaluable at specific rows.
Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After First Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 1 Evaluable Population	Baseline (before vaccination 1) and 1 month after first dose of MenABCWY	Percentage of participants achieving hSBA titer \>=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the MenACWY test strains at baseline and one month after first dose of MenABCWY in participants who received who received the first dose of MenABCWY were reported in this outcome measure. Number analyzed = number of participants evaluable at specific rows.
Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After Second Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 2 Evaluable Population	Baseline (before vaccination 1) and 1 month after second dose of MenABCWY	Percentage of participants achieving hSBA titer \>=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the meningococcal group A, C, W, and Y (MenACWY) test strains at baseline and one month after second dose of MenABCWY in participants who received the first and second dose of MenABCWY were reported in this outcome measure. Number of Participants Analyzed= number of participants evaluable for this outcome measure and Number analyzed = number of participants evaluable at specific rows.
Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule	At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY)	Percentage of participants achieving hSBA titer \>=LLOQ for each of the 4 primary MenB test strains (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) at 12 and 24 months after the second dose of MenABCWY were reported in this outcome measure. Number of Participants Analyzed= number of participants evaluable for this outcome measure and Number analyzed = number of participants evaluable at specific rows.
Percentage of Participants With hSBA Titer >=LLOQ for Each ACWY Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule	At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY)	Percentage of participants achieving hSBA titer \>=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the ACWY test (MenA, MenC, MenW, MenY) at 12 and 24 months after the second dose of MenABCWY2 were reported in this outcome measure. Number of Participants Analyzed= number of participants evaluable for this outcome measure and Number analyzed = number of participants evaluable at specific rows.
Percentage of Participants With hSBA Titer >= LLOQ for Each of the Meningococcal Group A, C, W, and Y (MenACWY) Test Strains at Baseline and 1 Month After the First Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 1 Evaluable Population	Baseline (before vaccination 1) and 1 month after the first dose of MenABCWY	Percentage of participants achieving hSBA titer \>=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the MenACWY test strains at baseline and one month after first dose of MenABCWY in participants who received the first dose of MenABCWY were reported in this outcome measure. Number analyzed = number of participants evaluable at specific rows.

Countries

United States

Participant flow

Recruitment details

A total of 309 participants were enrolled and randomized to receive study vaccination in this study out of which, 300 participants were vaccinated.

Pre-assignment details

Participants aged greater than or equal to (\>=) 11 years to less than (\<) 15 years were randomized to receive Neisseria meningitidis Group A, B, C, W, and Y (MenABCWY) vaccine either at 0-and 12-Month schedule (Group 1) or at 0- and 36-Month schedule (Group 2).

Participants by arm

Arm	Count
Group 1 (MenABCWY 0- and 12-Month Schedule) Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2).	146
Group 2 (MenABCWY 0- and 36-Month Schedule) Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2).	148
Total	294

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	2	6
Overall Study	Lost to Follow-up	22	23
Overall Study	Medication error without associated adverse event	0	1
Overall Study	No longer met eligibility criteria	7	1
Overall Study	Other	1	2
Overall Study	Protocol deviation	6	8
Overall Study	Randomized but not vaccinated	6	3
Overall Study	Withdrawal by parent/guardian	4	5
Overall Study	Withdrawal by Subject	5	3

Baseline characteristics

Characteristic	Group 2 (MenABCWY 0- and 36-Month Schedule)	Total	Group 1 (MenABCWY 0- and 12-Month Schedule)
Age, Continuous	11.5 Years STANDARD_DEVIATION 0.65	11.5 Years STANDARD_DEVIATION 0.65	11.5 Years STANDARD_DEVIATION 0.65
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants	54 Participants	22 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	116 Participants	239 Participants	123 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	4 Participants	3 Participants
Race (NIH/OMB) Black or African American	14 Participants	24 Participants	10 Participants
Race (NIH/OMB) More than one race	5 Participants	10 Participants	5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) White	126 Participants	251 Participants	125 Participants
Sex: Female, Male Female	66 Participants	131 Participants	65 Participants
Sex: Female, Male Male	82 Participants	163 Participants	81 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 146	0 / 148
other Total, other adverse events	64 / 146	64 / 148
serious Total, serious adverse events	2 / 146	2 / 148

Outcome results

Primary

Percentage of Participants Reporting Adverse Events (AEs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.

Time frame: Within 30 days after vaccination 1 (first dose of MenABCWY)

Population: Vaccination 1 safety population included participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2.

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting Adverse Events (AEs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule	28.8 Percentage of participants

Primary

Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule

Time frame: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)

Population: Vaccination 1 safety population included all participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2.

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule	30.8 Percentage of participants

Primary

Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule

Time frame: Vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule	29.1 Percentage of participants

Primary

Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule

Time frame: From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)

Population: Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available.

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule	15.7 Percentage of participants

Primary

Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule

Time frame: From vaccination 2 through 1 month after vaccination 2 (Saline)

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule	16.2 Percentage of participants

Primary

Percentage of Participants Reporting AEs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule

Time frame: From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)

Population: Vaccination 3 safety population included participants who received the third dose of study intervention at Visit 9 (MenABCWY for Group 2) and for whom safety information from Visit 9 through Visit 10 was available.

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting AEs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule	19.4 Percentage of participants

Primary

Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule

Time frame: Within 30 Days after any MenABCWY vaccination

Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule	34.9 Percentage of participants

Primary

Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule

Time frame: Within 30 days after any MenABCWY vaccination

Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule	32.4 Percentage of participants

Primary

Percentage of Participants Reporting AEs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule

Time frame: Within 30 days after vaccination 1 (first dose of MenABCWY)

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting AEs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule	27.7 Percentage of participants

Primary

Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule

Time frame: Within 30 days after vaccination 2 (second dose of MenABCWY)

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule	15.7 Percentage of participants

Primary

Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule

Time frame: Within 30 days after vaccination 2 (saline)

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule	13.8 Percentage of participants

Primary

Percentage of Participants Reporting AEs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule

Time frame: Within 30 days after vaccination 3 (second dose of MenABCWY)

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting AEs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule	19.4 Percentage of participants

Primary

Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 12 Month Schedule

Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.

Time frame: 30 minutes after vaccination 1 (First dose of MenABCWY)

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 12 Month Schedule	0.7 Percentage of participants

Primary

Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 36 Month Schedule

Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.

Time frame: 30 minutes after vaccination 1 (First dose of MenABCWY)

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 36 Month Schedule	0.7 Percentage of participants

Primary

Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 12 Month Schedule

Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.

Time frame: 30 minutes after vaccination 2 (Second dose of MenABCWY)

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 12 Month Schedule	0.0 Percentage of participants

Primary

Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 36 Month Schedule

Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.

Time frame: 30 minutes after vaccination 2 (Saline)

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 36 Month Schedule	1.5 Percentage of participants

Primary

Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 3: 0 and 36 Month Schedule

Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.

Time frame: 30 minutes after vaccination 3 (Second dose of MenABCWY)

Arm	Measure	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 3: 0 and 36 Month Schedule	2.9 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule

An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Time frame: From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)

Population: Follow-up safety population 1 included participants who received the first dose of study intervention and for whom safety information from Visit 2 up to Visit 4 in Groups 1 and 2 was available.

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule	SAEs	0.7 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule	MAEs	16.6 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule	NDCMCs	0.7 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule

Time frame: From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule	MAEs	14.2 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule	NDCMCs	0.7 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule

Time frame: From 1 month after vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)

Population: Follow-up safety population 2 included participants who received the second dose of study intervention (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 5 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule	SAEs	0.8 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule	MAEs	8.5 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule	NDCMCs	0.0 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule

Time frame: From 1 month after vaccination 2 through 6 months after vaccination 2 (Saline)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule	SAEs	1.6 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule	MAEs	9.4 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule	NDCMCs	3.1 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule

Time frame: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule	MAEs	8.2 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule	NDCMCs	0.7 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule

Time frame: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule	MAEs	8.8 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule	NDCMCs	0.0 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule

Time frame: From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule	SAEs	0.7 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule	MAEs	23.3 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule	NDCMCs	1.4 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule

Time frame: From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule	MAEs	19.6 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule	NDCMCs	0.7 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule

Time frame: From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule	MAEs	5.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule	NDCMCs	0.0 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule

Time frame: From vaccination 2 through 1 month after vaccination 2 (Saline)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule	MAEs	6.9 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule	NDCMCs	1.5 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule

Time frame: From vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule	SAEs	0.8 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule	MAEs	13.2 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule	NDCMCs	0.0 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule

Time frame: From vaccination 2 through 6 months after vaccination 2 (Saline)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule	SAEs	1.5 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule	MAEs	14.6 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule	NDCMCs	4.6 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule

Time frame: From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule	MAEs	3.9 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule	NDCMCs	0.0 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule

Time frame: Within 30 days after any MenABCWY vaccination

Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule	MAEs	10.3 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule	NDCMCs	0.7 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule

Time frame: Within 30 days after any MenABCWY vaccination

Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule	MAEs	8.8 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule	NDCMCs	0.0 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule

Time frame: Within 30 days after vaccination 1 (First dose of MenABCWY)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule	MAEs	7.4 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule	NDCMCs	0.0 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule

Time frame: Within 30 days after vaccination 2 (Second dose of MenABCWY)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule	MAEs	5.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule	NDCMCs	0.0 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule

Time frame: Within 30 days after vaccination 2 (Saline)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule	MAEs	6.9 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule	NDCMCs	0.8 Percentage of participants

Primary

Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule

Time frame: Within 30 days after vaccination 3 (Second dose of MenABCWY)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule	MAEs	1.9 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule	NDCMCs	0.0 Percentage of participants

Primary

Percentage of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Newly Diagnosed Chronic Medical Condition (NDCMCs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule

An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a non-serious AE (other than serious AE) that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Time frame: Within 30 days after vaccination 1 (First dose of MenABCWY)

Arm	Measure	Group	Value (NUMBER)
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Newly Diagnosed Chronic Medical Condition (NDCMCs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule	SAEs	0.0 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Newly Diagnosed Chronic Medical Condition (NDCMCs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule	MAEs	6.2 Percentage of participants
Group 1 (MenABCWY 0- and 12-Month Schedule)	Percentage of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Newly Diagnosed Chronic Medical Condition (NDCMCs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule	NDCMCs	0.7 Percentage of participants

Primary