Trial Outcomes & Findings for Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine (NCT NCT00356369)

NCT ID: NCT00356369

Last Updated: 2018-07-03

Results Overview

Response to vaccine antigen was defined as: for initially seronegative subjects \[subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (\<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32\] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 500 participants
• Primary outcome timeframe: One month post vaccination
• Results posted on: 2018-07-03

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Measure	Nimenrix Group Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.	Mencevax Group Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Active Phase STARTED	374	126
Active Phase COMPLETED	372	125
Active Phase NOT COMPLETED	2	1
Year 1 STARTED	364	121
Year 1 COMPLETED	364	121
Year 1 NOT COMPLETED	0	0
Year 2 STARTED	354	117
Year 2 COMPLETED	354	117
Year 2 NOT COMPLETED	0	0
Year 3 STARTED	344	116
Year 3 COMPLETED	344	116
Year 3 NOT COMPLETED	0	0
Year 4 STARTED	317	109
Year 4 COMPLETED	317	109
Year 4 NOT COMPLETED	0	0
Year 5 STARTED	299	105
Year 5 COMPLETED	299	105
Year 5 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Nimenrix Group Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) by injection in the non-dominant deltoid region.	Mencevax Group Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Active Phase Withdrawal by Subject	2	1

Baseline Characteristics

Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine

Baseline characteristics by cohort

Measure	Nimenrix Group n=374 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=126 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.	Total n=500 Participants Total of all reporting groups
Age, Continuous	18.6 Years STANDARD_DEVIATION 7.62 • n=5 Participants	19.3 Years STANDARD_DEVIATION 8.58 • n=7 Participants	18.78 Years STANDARD_DEVIATION 7.86 • n=5 Participants
Sex: Female, Male Female	168 Participants n=5 Participants	60 Participants n=7 Participants	228 Participants n=5 Participants
Sex: Female, Male Male	206 Participants n=5 Participants	66 Participants n=7 Participants	272 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-East Asian heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-South East Asian heritage	298 Participants n=5 Participants	101 Participants n=7 Participants	399 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White-Arabic/North African heritage	75 Participants n=5 Participants	25 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month post vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Response to vaccine antigen was defined as: for initially seronegative subjects [subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.

Outcome measures

Measure	Nimenrix Group n=329 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=113 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) rSBA-MenA	82.7 Percentage of subjects Interval 77.8 to 86.9	69.7 Percentage of subjects Interval 59.6 to 78.5
Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) rSBA-MenC	94.4 Percentage of subjects Interval 91.4 to 96.7	90.3 Percentage of subjects Interval 83.2 to 95.0
Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) rSBA-MenW-135	96.3 Percentage of subjects Interval 93.7 to 98.1	91.7 Percentage of subjects Interval 84.9 to 96.2
Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) rSBA-MenY	93 Percentage of subjects Interval 89.7 to 95.5	85 Percentage of subjects Interval 77.0 to 91.0

PRIMARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (>) 50 millimeters (mm).

General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) >39.5 °C.

Outcome measures

Measure	Nimenrix Group n=374 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=126 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Occurrence of Any Grade 3 Systemic Symptoms Any Grade 3 unsolicited	12 Participants	1 Participants
Occurrence of Any Grade 3 Systemic Symptoms Grade 3 solicited general	5 Participants	0 Participants
Occurrence of Any Grade 3 Systemic Symptoms Grade 3 solicited local	9 Participants	1 Participants

SECONDARY outcome

Timeframe: Prior to and 1 Month after vaccination

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects from whom immunogenicity data were available.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and (≥) 1:128.

Outcome measures

Measure	Nimenrix Group n=341 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=114 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenA (PRE) ≥ 1:8	290 Participants	88 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI [M1]) ≥ 1:8	323 Participants	112 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenA (PRE) ≥ 1:128	273 Participants	81 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI [M1]) ≥ 1:128	322 Participants	112 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenC (PRE) ≥ 1:8	253 Participants	96 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI [M1]) ≥ 1:8	340 Participants	114 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenC (PRE) ≥ 1:128	172 Participants	56 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI [M1]) ≥ 1:128	340 Participants	112 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PRE) ≥ 1:8	247 Participants	89 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI [M1]) ≥ 1:8	339 Participants	114 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PRE) ≥ 1:128	191 Participants	67 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI [M1]) ≥ 1:128	338 Participants	114 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenY (PRE) ≥ 1:8	306 Participants	105 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI [M1]) ≥ 1:8	340 Participants	114 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenY (PRE) ≥ 1:128	264 Participants	88 Participants
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI [M1]) ≥ 1:128	339 Participants	114 Participants

SECONDARY outcome

Timeframe: Prior to and 1 Month after vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Antibody titers are presented as Geometric Mean Titers (GMTs).

Outcome measures

Measure	Nimenrix Group n=341 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=114 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PRE)	330.7 Titer Interval 285.8 to 382.7	227.8 Titer Interval 162.1 to 320.2
rSBA Antibody Titers rSBA-MenA (PI [M1])	4944.6 Titer Interval 4451.5 to 5492.5	2190.1 Titer Interval 1857.5 to 2582.2
rSBA Antibody Titers rSBA-MenC (PRE)	84.1 Titer Interval 68.5 to 103.4	114.1 Titer Interval 80.3 to 162.0
rSBA Antibody Titers rSBA-MenC (PI [M1])	10073.7 Titer Interval 8699.9 to 11664.5	6545.6 Titer Interval 5047.5 to 8488.4
rSBA Antibody Titers rSBA-MenW-135 (PRE)	93 Titer Interval 74.6 to 116.0	115.3 Titer Interval 81.6 to 162.9
rSBA Antibody Titers rSBA-MenW-135 (PI [M1])	8576.5 Titer Interval 7614.9 to 9659.5	2969.5 Titer Interval 2439.4 to 3614.9
rSBA Antibody Titers rSBA-MenY (PRE)	310 Titer Interval 261.2 to 367.9	282.8 Titer Interval 209.9 to 380.8
rSBA Antibody Titers rSBA-MenY (PI [M1])	10315.2 Titer Interval 9317.1 to 11420.2	4573.7 Titer Interval 3863.9 to 5413.9

SECONDARY outcome

Timeframe: Prior to and 1 Month after vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.

Outcome measures

Measure	Nimenrix Group n=341 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=114 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSA (PRE) ≥ 0.3 μg/mL	255 Participants	90 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSA (PI [M1]) ≥ 0.3 μg/mL	339 Participants	113 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSA (PRE) ≥ 2.0 μg/mL	137 Participants	53 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSA (PI [M1]) ≥ 2.0 μg/mL	339 Participants	113 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSC (PRE) ≥ 0.3 μg/mL	71 Participants	27 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSC (PI [M1]) ≥ 0.3 μg/mL	340 Participants	114 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSC (PRE) ≥ 2.0 μg/mL	30 Participants	16 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSC (PI [M1]) ≥ 2.0 μg/mL	333 Participants	113 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSW-135 (PRE) ≥ 0.3 μg/mL	41 Participants	17 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSW-135 (PI [M1]) ≥ 0.3 μg/mL	335 Participants	113 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSW-135 (PRE) ≥ 2.0 μg/mL	11 Participants	4 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSW-135 (PI [M1]) ≥ 2.0 μg/mL	314 Participants	106 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSY (PRE) ≥ 0.3 μg/mL	55 Participants	23 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSY (PI [M1]) ≥ 0.3 μg/mL	338 Participants	112 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSY (PRE) ≥ 2.0 μg/mL	25 Participants	8 Participants
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies Anti-PSY (PI [M1]) ≥ 2.0 μg/mL	328 Participants	109 Participants

SECONDARY outcome

Timeframe: Prior to and 1 Month after vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL).

Outcome measures

Measure	Nimenrix Group n=341 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=114 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Concentration of Anti-PS Antibodies Anti-PSA (PRE)	1.4 μg/mL Interval 1.2 to 1.7	1.7 μg/mL Interval 1.3 to 2.3
Concentration of Anti-PS Antibodies Anti-PSA (PI [M1])	107.3 μg/mL Interval 92.7 to 124.1	53.6 μg/mL Interval 41.9 to 68.5
Concentration of Anti-PS Antibodies Anti-PSC (PRE)	0.3 μg/mL Interval 0.2 to 0.3	0.3 μg/mL Interval 0.2 to 0.4
Concentration of Anti-PS Antibodies Anti-PSC (PI [M1])	23.9 μg/mL Interval 21.0 to 27.2	43.9 μg/mL Interval 35.6 to 54.1
Concentration of Anti-PS Antibodies Anti-PSW-135 (PRE)	0.2 μg/mL Interval 0.2 to 0.2	0.2 μg/mL Interval 0.2 to 0.3
Concentration of Anti-PS Antibodies Anti-PSW-135 (PI [M1])	18.6 μg/mL Interval 15.8 to 21.8	15.8 μg/mL Interval 12.1 to 20.7
Concentration of Anti-PS Antibodies Anti-PSY (PRE)	0.2 μg/mL Interval 0.2 to 0.3	0.2 μg/mL Interval 0.2 to 0.3
Concentration of Anti-PS Antibodies Anti-PSY (PI [M1])	23.2 μg/mL Interval 19.9 to 26.9	23.6 μg/mL Interval 18.4 to 30.2

SECONDARY outcome

Timeframe: Prior to and 1 Month after vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

Outcome measures

Measure	Nimenrix Group n=341 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=113 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies Anti-TT (PRE)	223 Participants	110 Participants
Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies Anti-TT (PI [M1])	326 Participants	113 Participants

SECONDARY outcome

Timeframe: Prior to and 1 Month after vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).

Outcome measures

Measure	Nimenrix Group n=341 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=113 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Concentration of Anti-TT Antibodies Anti-TT (PRE)	0.35 IU/mL Interval 0.29 to 0.43	0.28 IU/mL Interval 0.2 to 0.39
Concentration of Anti-TT Antibodies Anti-TT (PI [M1])	10.01 IU/mL Interval 8.34 to 12.03	0.27 IU/mL Interval 0.19 to 0.38

SECONDARY outcome

Timeframe: At Year 1

Population: The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.

The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128.

Outcome measures

Measure	Nimenrix Group n=356 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=117 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI [M12]) ≥ 1:8	355 Participants	117 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI [M12]) ≥ 1:128	354 Participants	111 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI [M12]) ≥ 1:8	353 Participants	113 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI [M12]) ≥ 1:128	352 Participants	112 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI [M12]) ≥ 1:8	352 Participants	114 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI [M12]) ≥ 1:128	343 Participants	110 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI [M12]) ≥ 1:8	355 Participants	116 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI [M12]) ≥ 1:128	354 Participants	114 Participants

SECONDARY outcome

Timeframe: At Year 1

Population: The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.

Antibody titers are presented as Geometric Mean Titers (GMTs).

Outcome measures

Measure	Nimenrix Group n=356 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=117 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PI [M12])	2084.9 Titer Interval 1888.3 to 2302.0	1099.1 Titer Interval 931.6 to 1296.7
rSBA Antibody Titers rSBA-MenC (PI [M12])	1848.6 Titer Interval 1620.3 to 2109.2	1876.5 Titer Interval 1400.7 to 2514.0
rSBA Antibody Titers rSBA-MenW-135 (PI [M12])	2993.5 Titer Interval 2618.8 to 3421.9	699.9 Titer Interval 569.3 to 860.4
rSBA Antibody Titers rSBA-MenY (PI [M12])	4207.1 Titer Interval 3767.3 to 4698.3	1386.5 Titer Interval 1104.2 to 1740.9

SECONDARY outcome

Timeframe: At Year 2

Population: The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.

Outcome measures

Measure	Nimenrix Group n=346 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=112 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI [M24]) ≥ 1:8	337 Participants	101 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI [M24]) ≥ 1:128	335 Participants	98 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI [M24]) ≥ 1:8	343 Participants	110 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI [M24]) ≥ 1:128	332 Participants	103 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI [M24]) ≥ 1:8	344 Participants	100 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI [M24]) ≥ 1:128	341 Participants	90 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI [M24]) ≥ 1:8	344 Participants	110 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI [M24]) ≥ 1:128	342 Participants	105 Participants

SECONDARY outcome

Timeframe: At Year 2

Population: The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.

Antibody titers are presented as Geometric Mean Titers (GMTs).

Outcome measures

Measure	Nimenrix Group n=346 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=112 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PI [M24])	1326.8 Titre Interval 1197.7 to 1469.7	698.9 Titre Interval 561.2 to 870.4
rSBA Antibody Titers rSBA-MenC (PI [M24])	1162 Titre Interval 1013.1 to 1332.9	1229.4 Titre Interval 876.4 to 1724.7
rSBA Antibody Titers rSBA-MenW-135 (PI [M24])	1984.6 Titre Interval 1757.1 to 2241.4	319.1 Titre Interval 228.0 to 446.5
rSBA Antibody Titers rSBA-MenY (PI [M24])	3042.1 Titre Interval 2692.2 to 3437.5	850.2 Titre Interval 667.5 to 1082.9

SECONDARY outcome

Timeframe: At Year 3

Population: The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.

Outcome measures

Measure	Nimenrix Group n=338 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=109 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI [M36]) ≥ 1:8	322 Participants	104 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI [M36]) ≥ 1:128	319 Participants	98 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI [M36]) ≥ 1:8	334 Participants	108 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI [M36]) ≥ 1:128	313 Participants	102 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI [M36]) ≥ 1:8	335 Participants	91 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI [M36]) ≥ 1:128	332 Participants	84 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI [M36]) ≥ 1:8	337 Participants	107 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI [M36]) ≥ 1:128	336 Participants	105 Participants

SECONDARY outcome

Timeframe: At Year 3

Population: The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.

Antibody titers are presented as Geometric Mean Titers (GMTs).

Outcome measures

Measure	Nimenrix Group n=338 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=109 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PI [M36])	1238.4 Titer Interval 1126.0 to 1361.9	596.9 Titer Interval 488.5 to 729.3
rSBA Antibody Titers rSBA-MenC (PI [M36])	870.3 Titer Interval 757.1 to 1000.4	1124.8 Titer Interval 812.3 to 1557.6
rSBA Antibody Titers rSBA-MenW-135 (PI [M36])	2109.2 Titer Interval 1842.5 to 2414.5	332.8 Titer Interval 224.4 to 493.8
rSBA Antibody Titers rSBA-MenY (PI [M36])	2567.3 Titer Interval 2288.6 to 2879.8	848 Titer Interval 682.6 to 1053.5

SECONDARY outcome

Timeframe: At Year 4

Population: The analysis was performed on the ATP cohort for persistence Year 4, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 4 time-point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.

Outcome measures

Measure	Nimenrix Group n=312 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=107 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI [M48]) ≥ 1:8	270 Participants	79 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI [M48]) ≥ 1:128	245 Participants	66 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI [M48]) ≥ 1:8	276 Participants	90 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI [M48]) ≥ 1:128	254 Participants	79 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI [M48]) ≥ 1:8	231 Participants	27 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI [M48]) ≥ 1:128	214 Participants	22 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI [M48]) ≥ 1:8	256 Participants	47 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI [M48]) ≥ 1:128	243 Participants	37 Participants

SECONDARY outcome

Timeframe: At Year 4

Population: The analysis was performed on the ATP cohort for persistence Year 4, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 4 time-point.

Antibody titers are presented as Geometric Mean Titers (GMTs).

Outcome measures

Measure	Nimenrix Group n=312 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=109 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PI [M48])	278.6 Titer Interval 219.7 to 353.2	105.4 Titer Interval 67.6 to 164.4
rSBA Antibody Titers rSBA-MenC (PI [M48])	273.6 Titer Interval 220.6 to 339.4	315 Titer Interval 196.8 to 504.1
rSBA Antibody Titers rSBA-MenW-135 (PI [M48])	175.1 Titer Interval 131.5 to 233.0	11.3 Titer Interval 7.8 to 16.3
rSBA Antibody Titers rSBA-MenY (PI [M48])	350.5 Titer Interval 268.9 to 456.7	26 Titer Interval 16.6 to 40.7

SECONDARY outcome

Timeframe: At Year 5

Population: The analysis was performed on the ATP cohort for persistence Year 5, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 5 time-point.

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.

Outcome measures

Measure	Nimenrix Group n=51 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=19 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI [M60]) ≥ 1:8	43 Participants	11 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenA (PI [M60]) ≥ 1:128	39 Participants	3 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI [M60]) ≥ 1:8	37 Participants	7 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenC (PI [M60]) ≥ 1:128	28 Participants	5 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI [M60]) ≥ 1:8	44 Participants	6 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenW-135 (PI [M60]) ≥ 1:128	38 Participants	6 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI [M60]) ≥ 1:8	47 Participants	12 Participants
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value rSBA-MenY (PI [M60]) ≥ 1:128	47 Participants	11 Participants

SECONDARY outcome

Timeframe: At Year 5

Population: The analysis was performed on the ATP cohort for persistence Year 5, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 5 time-point.

Antibody titers are presented as Geometric Mean Titers (GMTs).

Outcome measures

Measure	Nimenrix Group n=51 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=19 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
rSBA Antibody Titers rSBA-MenA (PI [M60])	189.8 Titer Interval 107.7 to 334.6	37 Titer Interval 12.6 to 108.7
rSBA Antibody Titers rSBA-MenC (PI [M60])	78.5 Titer Interval 41.8 to 147.4	17.3 Titer Interval 6.0 to 49.7
rSBA Antibody Titers rSBA-MenW-135 (PI [M60])	281.6 Titer Interval 145.9 to 543.2	15.4 Titer Interval 5.7 to 41.9
rSBA Antibody Titers rSBA-MenY (PI [M60])	769.7 Titer Interval 438.6 to 1351.0	74.1 Titer Interval 21.9 to 250.3

SECONDARY outcome

Timeframe: At Year 1

Population: The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.

The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.

Outcome measures

Measure	Nimenrix Group n=354 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=117 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With Anti-PS Antibodies Anti-PSA (PI [M12]) ≥ 0.3 μg/mL	351 Participants	116 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSA (PI [M12]) ≥ 2.0 μg/mL	332 Participants	115 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSC (PI [M12]) ≥ 0.3 μg/mL	349 Participants	117 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSC (PI [M12]) ≥ 2.0 μg/mL	262 Participants	113 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSW-135 (PI [M12]) ≥ 0.3 μg/mL	342 Participants	112 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSW-135 (PI [M12]) ≥ 2.0 μg/mL	264 Participants	102 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSY (PI [M12]) ≥ 0.3 μg/mL	350 Participants	116 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSY (PI [M12]) ≥ 2.0 μg/mL	289 Participants	110 Participants

SECONDARY outcome

Timeframe: At Year 1

Population: The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.

Outcome measures

Measure	Nimenrix Group n=354 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=117 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Concentration of Anti-PS Antibodies Anti-PSA (PI [M12])	23.25 μg/mL Interval 19.78 to 27.32	31.72 μg/mL Interval 24.77 to 40.63
Concentration of Anti-PS Antibodies Anti-PSC (PI [M12])	4.67 μg/mL Interval 4.08 to 5.33	24.53 μg/mL Interval 19.92 to 30.2
Concentration of Anti-PS Antibodies Anti-PSW-135 (PI [M12])	5.48 μg/mL Interval 4.68 to 6.4	10.39 μg/mL Interval 7.8 to 13.85
Concentration of Anti-PS Antibodies Anti-PSY (PI [M12])	6.68 μg/mL Interval 5.69 to 7.85	16.7 μg/mL Interval 12.9 to 21.6

SECONDARY outcome

Timeframe: At Year 2

Population: The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.

The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.

Outcome measures

Measure	Nimenrix Group n=343 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=112 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With Anti-PS Antibodies Anti-PSA (PI [M24]) ≥ 0.3 μg/mL	335 Participants	105 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSA (PI [M24]) ≥ 2.0 μg/mL	301 Participants	103 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSC (PI [M24]) ≥ 0.3 μg/mL	323 Participants	111 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSC (PI [M24]) ≥ 2.0 μg/mL	196 Participants	107 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSW-135 (PI [M24]) ≥ 0.3 μg/mL	316 Participants	108 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSW-135 (PI [M24]) ≥ 2.0 μg/mL	226 Participants	93 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSY (PI [M24]) ≥ 0.3 μg/mL	325 Participants	110 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSY (PI [M24]) ≥ 2.0 μg/mL	237 Participants	97 Participants

SECONDARY outcome

Timeframe: At Year 2

Population: The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point..

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.

Outcome measures

Measure	Nimenrix Group n=343 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=112 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Concentration of Anti-PS Antibodies Anti-PSA (PI [M24])	15.15 μg/mL Interval 12.76 to 17.98	24.85 μg/mL Interval 19.08 to 32.36
Concentration of Anti-PS Antibodies Anti-PSC (PI [M24])	2.62 μg/mL Interval 2.27 to 3.03	15.74 μg/mL Interval 12.56 to 19.72
Concentration of Anti-PS Antibodies Anti-PSW-135 (PI [M24])	3.51 μg/mL Interval 2.98 to 4.15	6.76 μg/mL Interval 5.08 to 9.01
Concentration of Anti-PS Antibodies Anti-PSY (PI [M24])	4.44 μg/mL Interval 3.73 to 5.3	11.11 μg/mL Interval 8.39 to 14.71

SECONDARY outcome

Timeframe: At Year 3

Population: The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.

The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.

Outcome measures

Measure	Nimenrix Group n=331 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=110 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With Anti-PS Antibodies Anti-PSA (PI [M36]) ≥ 0.3 μg/mL	328 Participants	109 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSA (PI [M36]) ≥ 2.0 μg/mL	300 Participants	108 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSC (PI [M36]) ≥ 0.3 μg/mL	318 Participants	110 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSC (PI [M36]) ≥ 2.0 μg/mL	200 Participants	106 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSW-135 (PI [M36]) ≥ 0.3 μg/mL	303 Participants	105 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSW-135 (PI [M36]) ≥ 2.0 μg/mL	204 Participants	87 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSY (PI [M36]) ≥ 0.3 μg/mL	299 Participants	108 Participants
Number of Subjects With Anti-PS Antibodies Anti-PSY (PI [M36]) ≥ 2.0 μg/mL	213 Participants	92 Participants

SECONDARY outcome

Timeframe: At Year 3

Population: The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.

Outcome measures

Measure	Nimenrix Group n=331 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=110 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Concentration of Anti-PS Antibodies Anti-PSA (PI [M36])	12.5 μg/mL Interval 10.7 to 14.6	19.8 μg/mL Interval 15.7 to 24.9
Concentration of Anti-PS Antibodies Anti-PSC (PI [M36])	2.7 μg/mL Interval 2.3 to 3.0	13.9 μg/mL Interval 11.2 to 17.2
Concentration of Anti-PS Antibodies Anti-PSW-135 (PI [M36])	2.9 μg/mL Interval 2.5 to 3.4	5.5 μg/mL Interval 4.2 to 7.2
Concentration of Anti-PS Antibodies Anti-PSY (PI [M36])	3.8 μg/mL Interval 3.2 to 4.5	8.2 μg/mL Interval 6.2 to 10.8

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness/Swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Outcome measures

Measure	Nimenrix Group n=370 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=124 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	143 Participants	40 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	7 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	57 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	42 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available and who had the symptoms sheet filled in.

Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	Nimenrix Group n=371 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=125 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	55 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	35 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms ≥ 37.5 ˚C Fever	16 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms >39.5 ˚C Fever	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	10 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal	13 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal	6 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	65 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	41 Participants	8 Participants

SECONDARY outcome

Timeframe: From Day 0 up to 6 Months after vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

Outcome measures

Measure	Nimenrix Group n=374 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=126 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 up to 6 Months after vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

Outcome measures

Measure	Nimenrix Group n=374 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=126 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With Rash	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 0 up to 6 Months after vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

Outcome measures

Measure	Nimenrix Group n=374 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=126 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With AEs Resulting in Emergency Rooms Visits	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 31 Days after vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Measure	Nimenrix Group n=374 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=126 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With Unsolicited AEs	18 Participants	8 Participants

SECONDARY outcome

Timeframe: From Day 0 up to 6 Months after vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	Nimenrix Group n=374 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=126 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With Serious Adverse Events (SAEs)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Year 1, Year 2, Year 3, Year 4 and Year 5

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	Nimenrix Group n=364 Participants Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=121 Participants Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Number of Subjects With SAEs Any (SAE)s Year 1	0 Participants	0 Participants
Number of Subjects With SAEs Any (SAE)s Year 2	0 Participants	0 Participants
Number of Subjects With SAEs Any (SAE)s Year 3	0 Participants	0 Participants
Number of Subjects With SAEs Any (SAE)s Year 4	0 Participants	0 Participants
Number of Subjects With SAEs Any (SAE)s Year 5	0 Participants	0 Participants

Adverse Events

Nimenrix Group

Serious events: 1 serious events

Other events: 186 other events

Deaths: 0 deaths

Mencevax Group

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nimenrix Group n=374 participants at risk Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=126 participants at risk Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
Psychiatric disorders Mental disorder	0.27% 1/374 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/126 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Musculoskeletal and connective tissue disorders Costochondritis	0.27% 1/374 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/126 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.

Other adverse events

Measure	Nimenrix Group n=374 participants at risk Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region.	Mencevax Group n=126 participants at risk Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm.
General disorders Any Pain	38.6% 143/370 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	32.3% 40/124 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
General disorders Any Redness	15.4% 57/370 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	6.5% 8/124 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
General disorders Any Swelling	11.4% 42/370 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	3.2% 4/124 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
General disorders Any Fatigue	14.8% 55/371 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	10.4% 13/125 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
General disorders Any Headache	17.5% 65/371 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	12.0% 15/125 • Occurrence of solicited local and general symptoms: during the 4-day (Days 0-3) post vaccination period; Occurrence of unsolicited AE(s): up to 31 days after vaccination; Occurrence of SAE(s): from Day 0 up to 6 months after vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.

Additional Information

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Restriction type: OTHER