Trial Outcomes & Findings for Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4) (NCT NCT04084769)

Results Overview

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by Serum Bactericidal Assay Using Human Complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

570 participants

Primary outcome timeframe

Day 30 (post-vaccination) in study MET59

Results posted on

2025-09-15

Participant Flow

Study participants were enrolled from 03-September-2019 to 07-March-2020 at 30 active sites in the United States and Puerto Rico.

A total of 570 participants who received meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine or Menveo (meningococcal Group B) vaccine either in Study MET50 (NCT02199691), or Study MET43 (NCT02842853), or outside of Sanofi Pasteur trials were enrolled in the present study (MET59).

Participant milestones

Participant milestones
Measure	Group 1: MenACYW Conjugate Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Overall Study STARTED	191	190	95	94
Overall Study Safety Analysis Set (SAfAS)	186	184	93	92
Overall Study Full Analysis Set	191	190	95	94
Overall Study Per-Protocol Analysis Set 1 (PPAS1)	46	45	0	0
Overall Study Per-Protocol Analysis Set 2 (PPAS2)	174	176	90	89
Overall Study COMPLETED	187	186	95	92
Overall Study NOT COMPLETED	4	4	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: MenACYW Conjugate Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Overall Study Protocol Violation	1	3	1
Overall Study Withdrawal by Subject	0	1	0
Overall Study Withdrawal by parent/guardian	1	0	1
Overall Study Lost to Follow-up	2	0	0

Baseline Characteristics

Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: MenACYW Conjugate Vaccine n=191 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=190 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine n=95 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine n=94 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).	Total n=570 Participants Total of all reporting groups
Age, Continuous	15.4 years STANDARD_DEVIATION 1.59 • n=5 Participants	15.8 years STANDARD_DEVIATION 1.37 • n=7 Participants	15.1 years STANDARD_DEVIATION 1.12 • n=5 Participants	15.3 years STANDARD_DEVIATION 1.34 • n=4 Participants	15.4 years STANDARD_DEVIATION 1.43 • n=21 Participants
Sex: Female, Male Female	99 Participants n=5 Participants	85 Participants n=7 Participants	41 Participants n=5 Participants	45 Participants n=4 Participants	270 Participants n=21 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	105 Participants n=7 Participants	54 Participants n=5 Participants	49 Participants n=4 Participants	300 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	16 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	49 Participants n=21 Participants
Race (NIH/OMB) White	163 Participants n=5 Participants	165 Participants n=7 Participants	83 Participants n=5 Participants	86 Participants n=4 Participants	497 Participants n=21 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	19 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 30 (post-vaccination) in study MET59

Population: Analysis was performed on Per-Protocol Analysis Set 2 (PPAS2) population that included participants who received 1 dose of study vaccine in MET59 and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or rSBA assessed at Day 30 after vaccination. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by Serum Bactericidal Assay Using Human Complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=174 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 Serogroup C	97.1 percentage of participants Interval 93.4 to 99.1	—	—	—
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 Serogroup Y	98.9 percentage of participants Interval 95.9 to 99.9	—	—	—
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 Serogroup W	97.7 percentage of participants Interval 94.2 to 99.4	—	—	—
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 Serogroup A	94.8 percentage of participants Interval 90.4 to 97.6	—	—	—

PRIMARY outcome

Timeframe: Day 30 (post-vaccination) in study MET59

Population: Analysis was performed on PPAS2 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=176 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2 Serogroup C	98.9 percentage of participants Interval 96.0 to 99.9	—	—	—
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2 Serogroup Y	100 percentage of participants Interval 97.9 to 100.0	—	—	—
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2 Serogroup A	93.2 percentage of participants Interval 88.4 to 96.4	—	—	—
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2 Serogroup W	98.9 percentage of participants Interval 96.0 to 99.9	—	—	—

SECONDARY outcome

Timeframe: Day 6 (post-vaccination) in study MET59

Population: Analysis was performed on Per-Protocol Analysis Set 1 (PPAS1) population that included participants who received 1 dose of study vaccine in MET59 and had valid serology result with no relevant protocol deviations; defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 06 after vaccination in Groups 1 and 2. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=46 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=45 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup A	82.6 percentage of participants Interval 68.6 to 92.2	77.8 percentage of participants Interval 62.9 to 88.8	—	—
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup C	89.1 percentage of participants Interval 76.4 to 96.4	93.3 percentage of participants Interval 81.7 to 98.6	—	—
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup Y	95.7 percentage of participants Interval 85.2 to 99.5	91.1 percentage of participants Interval 78.8 to 97.5	—	—
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup W	97.8 percentage of participants Interval 88.5 to 99.9	88.9 percentage of participants Interval 75.9 to 96.3	—	—

SECONDARY outcome

Timeframe: Day 6 (post-vaccination) in study MET59

Population: Analysis was performed on PPAS1 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=46 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=45 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup C	100 percentage of participants Interval 92.3 to 100.0	97.8 percentage of participants Interval 88.2 to 99.9	—	—
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup Y	97.8 percentage of participants Interval 88.5 to 99.9	100 percentage of participants Interval 92.1 to 100.0	—	—
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup W	100 percentage of participants Interval 92.3 to 100.0	100 percentage of participants Interval 92.1 to 100.0	—	—
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup A	91.3 percentage of participants Interval 79.2 to 97.6	95.6 percentage of participants Interval 84.9 to 99.5	—	—

SECONDARY outcome

Timeframe: Day 6 (post-vaccination) in study MET59

Population: Analysis was performed on PPAS1 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=46 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=45 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup A	289 titers Interval 133.0 to 625.0	161 titers Interval 93.0 to 280.0	—	—
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup C	3799 titers Interval 2504.0 to 5763.0	919 titers Interval 500.0 to 1690.0	—	—
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup Y	1658 titers Interval 973.0 to 2826.0	800 titers Interval 467.0 to 1371.0	—	—
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup W	1928 titers Interval 1187.0 to 3131.0	708 titers Interval 463.0 to 1082.0	—	—

SECONDARY outcome

Timeframe: Day 30 (post-vaccination) in study MET59

Population: Analysis was performed on PPAS2 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=174 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=176 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup C	97.1 percentage of participants Interval 93.4 to 99.1	98.9 percentage of participants Interval 96.0 to 99.9	—	—
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup Y	98.9 percentage of participants Interval 95.9 to 99.9	100 percentage of participants Interval 97.9 to 100.0	—	—
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup W	97.7 percentage of participants Interval 94.2 to 99.4	98.9 percentage of participants Interval 96.0 to 99.9	—	—
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup A	94.8 percentage of participants Interval 90.4 to 97.6	93.2 percentage of participants Interval 88.4 to 96.4	—	—

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59

Population: Analysis was performed on PPAS2 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.

Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. Seroprotection were defined as hSBA titer \>=1:8.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=174 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=176 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup A: Day 0	71.3 percentage of participants Interval 63.9 to 77.9	71.0 percentage of participants Interval 63.7 to 77.6	—	—
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup A: Day 30	99.4 percentage of participants Interval 96.8 to 100.0	99.4 percentage of participants Interval 96.9 to 100.0	—	—
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup C: Day 0	87.9 percentage of participants Interval 82.1 to 92.4	50.6 percentage of participants Interval 42.9 to 58.2	—	—
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup C: Day 30	100 percentage of participants Interval 97.9 to 100.0	100 percentage of participants Interval 97.9 to 100.0	—	—
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup Y: Day 30	100 percentage of participants Interval 97.9 to 100.0	100 percentage of participants Interval 97.9 to 100.0	—	—
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup W: Day 0	86.2 percentage of participants Interval 80.2 to 91.0	77.8 percentage of participants Interval 71.0 to 83.7	—	—
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup Y: Day 0	79.9 percentage of participants Interval 73.2 to 85.6	52.8 percentage of participants Interval 45.2 to 60.4	—	—
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup W: Day 30	100 percentage of participants Interval 97.9 to 100.0	100 percentage of participants Interval 97.9 to 100.0	—	—

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59

Population: Analysis was performed on PPAS2 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=174 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=176 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup W: Day 30	2290 titers Interval 1934.0 to 2711.0	2574 titers Interval 2178.0 to 3041.0	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup C: Day 30	3708 titers Interval 3146.0 to 4369.0	2533 titers Interval 2076.0 to 3091.0	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup Y: Day 0	20.5 titers Interval 16.6 to 25.2	8.35 titers Interval 6.7 to 10.4	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup Y: Day 30	2308 titers Interval 1925.0 to 2767.0	3036 titers Interval 2547.0 to 3620.0	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup W: Day 0	27.0 titers Interval 22.0 to 33.1	14.8 titers Interval 12.2 to 18.1	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup A: Day 0	11.7 titers Interval 9.89 to 13.8	11.5 titers Interval 9.72 to 13.7	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup A: Day 30	502 titers Interval 388.0 to 649.0	399 titers Interval 318.0 to 502.0	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 Serogroup C: Day 0	36.6 titers Interval 28.8 to 46.7	10.2 titers Interval 8.03 to 13.0	—	—

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) in study MET59

Population: Analysis was performed on full analysis set which included all participants who had a valid pre-vaccination serology result. Here, 'Number analyzed' = participants with available data for each specified category.

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=191 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=190 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine n=95 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine n=94 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 Serogroup A	72.3 percentage of participants Interval 65.3 to 78.5	71.1 percentage of participants Interval 64.0 to 77.4	73.7 percentage of participants Interval 63.6 to 82.2	73.1 percentage of participants Interval 62.9 to 81.8
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 Serogroup C	86.9 percentage of participants Interval 81.3 to 91.3	52.6 percentage of participants Interval 45.3 to 59.9	86.3 percentage of participants Interval 77.7 to 92.5	85.1 percentage of participants Interval 76.3 to 91.6
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 Serogroup Y	79.1 percentage of participants Interval 72.6 to 84.6	55.3 percentage of participants Interval 47.9 to 62.5	88.3 percentage of participants Interval 80.0 to 94.0	80.9 percentage of participants Interval 71.4 to 88.2
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 Serogroup W	86.9 percentage of participants Interval 81.3 to 91.3	77.9 percentage of participants Interval 71.3 to 83.6	90.5 percentage of participants Interval 82.8 to 95.6	91.4 percentage of participants Interval 83.8 to 96.2

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) in study MET59

Population: Analysis was performed on full analysis set which included all participants who had a valid pre-vaccination serology result. Here, 'number analyzed' = participants with available data for each specified category.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=191 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=190 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine n=95 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine n=94 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 Serogroup A	12.3 titers Interval 10.5 to 14.5	12.2 titers Interval 10.2 to 14.6	12.8 titers Interval 10.0 to 16.3	12.7 titers Interval 9.7 to 16.6
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 Serogroup C	34.5 titers Interval 27.4 to 43.6	11.9 titers Interval 9.17 to 15.3	38.4 titers Interval 27.3 to 54.0	43.3 titers Interval 29.8 to 63.0
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 Serogroup Y	19.8 titers Interval 16.2 to 24.2	9.19 titers Interval 7.39 to 11.4	26.0 titers Interval 19.6 to 34.5	22.0 titers Interval 16.1 to 30.0
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 Serogroup W	27.4 titers Interval 22.4 to 33.4	15.1 titers Interval 12.5 to 18.3	28.1 titers Interval 21.8 to 36.2	32.7 titers Interval 24.5 to 43.7

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Day 30 (post-vaccination) in study MET50 or MET43

Population: Analysis was performed on full analysis set which included all participants who had a valid pre-vaccination serology result. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for pooled population of groups 1, 3 and 4 as pre-specified in the protocol.

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=376 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=134 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 Serogroup Y: Day 0 of MET50 or MET43	4.5 percentage of participants Interval 2.7 to 7.1	3.7 percentage of participants Interval 1.2 to 8.5	—	—
Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 Serogroup Y: Day 30 of MET50 or MET43	97.9 percentage of participants Interval 95.9 to 99.1	88.7 percentage of participants Interval 82.1 to 93.5	—	—
Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 Serogroup A: Day 0 of MET50 or MET43	54.5 percentage of participants Interval 49.3 to 59.6	35.8 percentage of participants Interval 27.7 to 44.6	—	—
Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 Serogroup A: Day 30 of MET50 or MET43	94.7 percentage of participants Interval 91.9 to 96.7	81.2 percentage of participants Interval 73.5 to 87.5	—	—
Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 Serogroup C: Day 0 of MET50 or MET43	18.6 percentage of participants Interval 14.8 to 22.9	12.7 percentage of participants Interval 7.6 to 19.5	—	—
Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 Serogroup C: Day 30 of MET50 or MET43	98.1 percentage of participants Interval 96.2 to 99.2	74.2 percentage of participants Interval 65.9 to 81.5	—	—
Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 Serogroup W: Day 0 of MET50 or MET43	39.9 percentage of participants Interval 34.9 to 45.0	40.3 percentage of participants Interval 31.9 to 49.1	—	—
Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 Serogroup W: Day 30 of MET50 or MET43	100 percentage of participants Interval 99.0 to 100.0	93.2 percentage of participants Interval 87.5 to 96.9	—	—

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET50 or MET43; Day 0 (pre-vaccination) in study MET59

Population: Analysis was performed on full analysis set which included all participants who had a valid pre-vaccination serology result. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for pooled population of groups 1, 3 and 4 as pre-specified in the protocol.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=380 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=140 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 Serogroup A: Day 0 of MET50 or MET43	7.28 titers Interval 6.53 to 8.11	5.72 titers Interval 4.75 to 6.87	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 Serogroup A: Day 30 of MET50 or MET43	45.2 titers Interval 39.9 to 51.1	32.8 titers Interval 25.0 to 43.1	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 Serogroup W: Day 0 of MET50 or MET43	5.34 titers Interval 4.76 to 6.0	5.54 titers Interval 4.57 to 6.72	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 Serogroup W: Day 30 of MET50 or MET43	82.7 titers Interval 73.6 to 92.9	45.1 titers Interval 34.3 to 59.4	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 Serogroup W: Day 0 of MET59	28.8 titers Interval 25.1 to 33.0	14.9 titers Interval 11.9 to 18.6	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 Serogroup A: Day 0 of MET59	12.5 titers Interval 11.1 to 14.1	11.6 titers Interval 9.41 to 14.3	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 Serogroup C: Day 0 of MET50 or MET43	3.48 titers Interval 3.22 to 3.76	2.98 titers Interval 2.69 to 3.3	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 Serogroup C: Day 30 of MET50 or MET43	417 titers Interval 348.0 to 500.0	49.7 titers Interval 32.4 to 76.4	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 Serogroup C: Day 0 of MET59	37.5 titers Interval 31.6 to 44.5	11.0 titers Interval 8.09 to 14.9	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 Serogroup Y: Day 0 of MET50 or MET43	2.36 titers Interval 2.22 to 2.5	2.30 titers Interval 2.13 to 2.48	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 Serogroup Y: Day 30 of MET50 or MET43	91.0 titers Interval 78.6 to 105.0	36.1 titers Interval 27.2 to 47.8	—	—
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 Serogroup Y: Day 0 of MET59	21.8 titers Interval 18.8 to 25.1	8.49 titers Interval 6.5 to 11.1	—	—

SECONDARY outcome

Timeframe: Day 30 (post-vaccination) in study MET59

Population: Analysis was performed on PPAS2 population. Here, 'number analyzed' = participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for individual groups 1, 3 and 4 and for pooled population of groups 3 and 4 only, and not for group 2 as pre-specified in the protocol.

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=174 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=90 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine n=89 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine n=179 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup C	97.1 percentage of participants Interval 93.4 to 99.1	97.8 percentage of participants Interval 92.2 to 99.7	96.6 percentage of participants Interval 90.4 to 99.3	97.2 percentage of participants Interval 93.6 to 99.1
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup Y	98.9 percentage of participants Interval 95.9 to 99.9	98.9 percentage of participants Interval 93.9 to 100.0	97.8 percentage of participants Interval 92.1 to 99.7	98.3 percentage of participants Interval 95.2 to 99.7
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup W	97.7 percentage of participants Interval 94.2 to 99.4	98.9 percentage of participants Interval 94.0 to 100.0	96.6 percentage of participants Interval 90.4 to 99.3	97.8 percentage of participants Interval 94.3 to 99.4
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup A	94.8 percentage of participants Interval 90.4 to 97.6	93.3 percentage of participants Interval 86.1 to 97.5	95.5 percentage of participants Interval 88.8 to 98.7	94.4 percentage of participants Interval 89.9 to 97.3

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59

Population: Analysis was performed on PPAS2 population. Here, 'number analyzed'=participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for individual groups 1, 3 and 4 and for pooled population of groups 3 and 4 only, and not for group 2 as pre-specified in the protocol.

Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=174 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=90 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine n=89 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine n=179 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup A: Day 0	71.3 percentage of participants Interval 63.9 to 77.9	73.3 percentage of participants Interval 63.0 to 82.1	71.6 percentage of participants Interval 61.0 to 80.7	72.5 percentage of participants Interval 65.3 to 78.9
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup A: Day 30	99.4 percentage of participants Interval 96.8 to 100.0	98.9 percentage of participants Interval 94.0 to 100.0	100 percentage of participants Interval 95.9 to 100.0	99.4 percentage of participants Interval 96.9 to 100.0
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup W: Day 0	86.2 percentage of participants Interval 80.2 to 91.0	91.1 percentage of participants Interval 83.2 to 96.1	90.9 percentage of participants Interval 82.9 to 96.0	91.0 percentage of participants Interval 85.8 to 94.8
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup W: Day 30	100 percentage of participants Interval 97.9 to 100.0	100 percentage of participants Interval 96.0 to 100.0	100 percentage of participants Interval 95.9 to 100.0	100 percentage of participants Interval 98.0 to 100.0
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup C: Day 0	87.9 percentage of participants Interval 82.1 to 92.4	86.7 percentage of participants Interval 77.9 to 92.9	86.5 percentage of participants Interval 77.6 to 92.8	86.6 percentage of participants Interval 80.7 to 91.2
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup C: Day 30	100 percentage of participants Interval 97.9 to 100.0	100 percentage of participants Interval 96.0 to 100.0	100 percentage of participants Interval 95.9 to 100.0	100 percentage of participants Interval 97.9 to 100.0
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup Y: Day 0	79.9 percentage of participants Interval 73.2 to 85.6	89.9 percentage of participants Interval 81.7 to 95.3	80.9 percentage of participants Interval 71.2 to 88.5	85.4 percentage of participants Interval 79.3 to 90.2
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup Y: Day 30	100 percentage of participants Interval 97.9 to 100.0	100 percentage of participants Interval 96.0 to 100.0	100 percentage of participants Interval 95.9 to 100.0	100 percentage of participants Interval 98.0 to 100.0

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59

Population: Analysis was performed on PPAS2 population. Here, 'number analyzed'=participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for individual groups 1, 3 and 4 and for pooled population of groups 3 and 4 only, and not for group 2 as pre-specified in the protocol.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=174 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=90 Participants Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine n=89 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine n=179 Participants Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup A: Day 0	11.7 titers Interval 9.89 to 13.8	12.5 titers Interval 9.78 to 16.0	12.3 titers Interval 9.37 to 16.2	12.4 titers Interval 10.4 to 14.9
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup Y: Day 30	2308 titers Interval 1925.0 to 2767.0	2600 titers Interval 2042.0 to 3311.0	2469 titers Interval 1881.0 to 3241.0	2534 titers Interval 2117.0 to 3034.0
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup W: Day 30	2290 titers Interval 1934.0 to 2711.0	2702 titers Interval 2134.0 to 3422.0	2064 titers Interval 1601.0 to 2662.0	2363 titers Interval 1988.0 to 2810.0
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup A: Day 30	502 titers Interval 388.0 to 649.0	593 titers Interval 426.0 to 825.0	667 titers Interval 477.0 to 933.0	629 titers Interval 498.0 to 794.0
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup C: Day 0	36.6 titers Interval 28.8 to 46.7	37.6 titers Interval 26.6 to 53.3	42.4 titers Interval 29.4 to 61.0	39.9 titers Interval 31.1 to 51.2
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup C: Day 30	3708 titers Interval 3146.0 to 4369.0	4741 titers Interval 3882.0 to 5791.0	3472 titers Interval 2667.0 to 4518.0	4064 titers Interval 3446.0 to 4793.0
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup Y: Day 0	20.5 titers Interval 16.6 to 25.2	25.5 titers Interval 19.4 to 33.6	21.0 titers Interval 15.4 to 28.7	23.2 titers Interval 18.9 to 28.5
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 Serogroup W: Day 0	27.0 titers Interval 22.0 to 33.1	28.3 titers Interval 22.0 to 36.4	30.0 titers Interval 22.5 to 40.1	29.1 titers Interval 24.1 to 35.2

Adverse Events

Group 1: MenACYW Conjugate Vaccine

Serious events: 2 serious events

Other events: 129 other events

Deaths: 0 deaths

Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)

Serious events: 2 serious events

Other events: 116 other events

Deaths: 0 deaths

Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine

Serious events: 2 serious events

Other events: 83 other events

Deaths: 0 deaths

Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine

Serious events: 0 serious events

Other events: 88 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1: MenACYW Conjugate Vaccine n=186 participants at risk Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=184 participants at risk Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine n=93 participants at risk Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine n=92 participants at risk Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
Infections and infestations Appendicitis	0.54% 1/186 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	0.54% 1/184 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	0.00% 0/93 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	0.00% 0/92 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/186 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	0.00% 0/184 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	1.1% 1/93 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	0.00% 0/92 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.
Psychiatric disorders Major Depression	0.00% 0/186 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	0.00% 0/184 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	1.1% 1/93 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	0.00% 0/92 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.
Psychiatric disorders Suicidal Ideation	0.54% 1/186 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	0.54% 1/184 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	1.1% 1/93 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	0.00% 0/92 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.

Other adverse events

Other adverse events
Measure	Group 1: MenACYW Conjugate Vaccine n=186 participants at risk Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) n=184 participants at risk Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).	Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine n=93 participants at risk Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).	Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine n=92 participants at risk Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
General disorders Malaise	26.9% 50/186 • Number of events 50 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	25.5% 47/184 • Number of events 47 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	38.7% 36/93 • Number of events 36 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	40.2% 37/92 • Number of events 37 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.
General disorders Injection Site Erythema	6.5% 12/186 • Number of events 12 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	5.4% 10/184 • Number of events 10 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	16.1% 15/93 • Number of events 15 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	15.2% 14/92 • Number of events 19 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.
General disorders Injection Site Pain	38.2% 71/186 • Number of events 71 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	34.2% 63/184 • Number of events 63 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	82.8% 77/93 • Number of events 114 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	92.4% 85/92 • Number of events 123 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.
General disorders Injection Site Swelling	5.4% 10/186 • Number of events 10 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	1.6% 3/184 • Number of events 3 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	12.9% 12/93 • Number of events 13 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	16.3% 15/92 • Number of events 19 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.
Infections and infestations Nasopharyngitis	4.8% 9/186 • Number of events 10 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	3.3% 6/184 • Number of events 6 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	5.4% 5/93 • Number of events 5 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	2.2% 2/92 • Number of events 2 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.
Infections and infestations Upper Respiratory Tract Infection	5.4% 10/186 • Number of events 10 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	4.3% 8/184 • Number of events 8 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	1.1% 1/93 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	1.1% 1/92 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.
Musculoskeletal and connective tissue disorders Myalgia	32.8% 61/186 • Number of events 61 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	34.8% 64/184 • Number of events 64 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	64.5% 60/93 • Number of events 61 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	63.0% 58/92 • Number of events 58 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.
Nervous system disorders Headache	36.6% 68/186 • Number of events 69 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	36.4% 67/184 • Number of events 67 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	44.1% 41/93 • Number of events 42 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.	39.1% 36/92 • Number of events 36 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. The solicited reactions (SR) were collected within 7 days post-vaccination in MET59. Serious AEs data were collected up to 30 days post-vaccination in MET59. Analysis performed on SafAS population.

Additional Information

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Results disclosure agreements

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