Trial Outcomes & Findings for Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents (NCT NCT02212457)

Last Updated: 2019-06-27

Results Overview

The non-inferiority of the Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant (MenABCWY) vaccine to Meningococcal (group B) multicomponent recombinant adsorbed (Bexsero) vaccine, administered according to 0, 2 month schedule, as measured by hSBA GMTs against N.meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, is reported. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. This outcome measure was evaluated in the rMenB\_0\_2 and ABCWY\_ 0\_2 Groups.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1063 participants

Primary outcome timeframe

At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)

Results posted on

2019-06-27

Participant Flow

Subjects were recruited from 32 centers from Finland, Poland and United States.

All subjects were included in the trial.

Participant milestones

Participant milestones
Measure	rMenB_0_2 Group Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_ 0_2 Group Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_1 Group Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.	ABCWY_0_6 Group Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Overall Study STARTED	228	232	157	134	152	160
Overall Study COMPLETED	209	211	141	123	137	147
Overall Study NOT COMPLETED	19	21	16	11	15	13

Reasons for withdrawal

Reasons for withdrawal
Measure	rMenB_0_2 Group Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_ 0_2 Group Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_1 Group Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.	ABCWY_0_6 Group Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Overall Study Adverse Event	1	2	2	2	0	1
Overall Study Withdrawal by Subject	8	10	8	6	5	4
Overall Study Lost to Follow-up	6	7	4	1	8	4
Overall Study Protocol Violation	2	1	0	1	2	3
Overall Study Other	2	1	2	1	0	1

Baseline Characteristics

Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rMenB_0_2 Group n=228 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_ 0_2 Group n=232 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_1 Group n=157 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.	ABCWY_0_6 Group n=134 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=152 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=160 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.	Total n=1063 Participants Total of all reporting groups
Age, Continuous	14.5 Years STANDARD_DEVIATION 3.09 • n=5 Participants	14.2 Years STANDARD_DEVIATION 3.17 • n=7 Participants	14.4 Years STANDARD_DEVIATION 3.01 • n=5 Participants	14.4 Years STANDARD_DEVIATION 3.06 • n=4 Participants	14.5 Years STANDARD_DEVIATION 3.1 • n=21 Participants	14.3 Years STANDARD_DEVIATION 3.16 • n=10 Participants	14.4 Years STANDARD_DEVIATION 3.1 • n=115 Participants
Sex: Female, Male Female	130 Participants n=5 Participants	119 Participants n=7 Participants	101 Participants n=5 Participants	76 Participants n=4 Participants	89 Participants n=21 Participants	96 Participants n=10 Participants	611 Participants n=115 Participants
Sex: Female, Male Male	98 Participants n=5 Participants	113 Participants n=7 Participants	56 Participants n=5 Participants	58 Participants n=4 Participants	63 Participants n=21 Participants	64 Participants n=10 Participants	452 Participants n=115 Participants

PRIMARY outcome

Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)

Population: Analysis was done on Per Protocol Set (PPS)-Month 3, which included all screened subjects who received a study vaccination, provided evaluable serum samples at pre- \& post-vaccination, with results available for at least 1 serogroup B test strain \& who was not excluded due to protocol deviations/other reasons defined before unblinding/analysis

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=158 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=150 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. M14459 strain (Month 0)	1.28 Titers Interval 1.07 to 1.53	1.31 Titers Interval 1.09 to 1.57	—	—	—	—
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. M07-0241084 strain (Month 0)	2.12 Titers Interval 1.6 to 2.82	2.16 Titers Interval 1.61 to 2.89	—	—	—	—
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. NZ98/254 strain (Month 3)	11.95 Titers Interval 9.1 to 16.0	24.31 Titers Interval 18.0 to 32.0	—	—	—	—
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. M14459 strain (Month 3)	11.64 Titers Interval 8.61 to 16.0	15.78 Titers Interval 12.0 to 22.0	—	—	—	—
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. M07-0241084 strain (Month 3)	8.19 Titers Interval 6.31 to 11.0	11.56 Titers Interval 8.86 to 15.0	—	—	—	—
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. 96217 strain (Month 0)	2.93 Titers Interval 2.13 to 4.03	2.36 Titers Interval 1.7 to 3.28	—	—	—	—
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. 96217 strain (Month 3)	150.82 Titers Interval 118.0 to 192.0	229.29 Titers Interval 179.0 to 294.0	—	—	—	—
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. NZ98/254 strain (Month 0)	1.27 Titers Interval 1.06 to 1.53	1.15 Titers Interval 0.95 to 1.39	—	—	—	—

SECONDARY outcome

Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group)

Population: Analysis was done on the FAS-1 month after the last meningococcal vaccination.All subjects in All Enrolled Set who received a study meningococcal vaccination \& provided evaluable serum samples at pre- \& at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.

The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule was compared with those administered according to 0, 2 months schedule, as measured by hSBA GMTs against N. meningitidis serogroup B test strains and serogroups A,C, W and Y at 1 month after the last meningococcal vaccination. The B test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. This outcome measure was evaluated in the ABCWY\_ 0\_2 and ABCWY\_0\_2\_6 Groups. 1 month post last meningococcal vaccination corresponds to Month 3 for ABCWY\_0\_2 Group and Month 7 for ABCWY\_0\_2\_6 Group.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=213 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=151 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. M14459 strain (Month 0)	1.21 Titers Interval 1.07 to 1.37	1.12 Titers Interval 0.98 to 1.28	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. M07-0241084 strain (Month 0)	2.36 Titers Interval 1.85 to 3.01	2.05 Titers Interval 1.58 to 2.67	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. 96217 strain (Month 0)	2.31 Titers Interval 1.75 to 3.06	2.28 Titers Interval 1.68 to 3.07	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. 96217 strain (Month 3/Month7)	174.27 Titers Interval 142.0 to 215.0	298.76 Titers Interval 239.0 to 374.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. NZ98/254 strain (Month 0)	1.24 Titers Interval 1.09 to 1.41	1.07 Titers Interval 0.93 to 1.23	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. NZ98/254 strain (Month 3/Month7)	12.57 Titers Interval 9.81 to 16.0	17.55 Titers Interval 13.0 to 23.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. A human serogroup (Month 0)	1.19 Titers Interval 1.04 to 1.36	1.10 Titers Interval 0.95 to 1.27	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. A human serogroup (Month 3/Month7)	66.73 Titers Interval 54.0 to 83.0	125.45 Titers Interval 99.0 to 159.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. C human serogroup (Month 0)	3.59 Titers Interval 2.85 to 4.53	3.19 Titers Interval 2.48 to 4.1	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. W human serogroup (Month 3/Month7)	206.62 Titers Interval 175.0 to 244.0	295.9 Titers Interval 246.0 to 356.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. Y human serogroup (Month 0)	1.33 Titers Interval 1.1 to 1.6	1.26 Titers Interval 1.03 to 1.55	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. Y human serogroup (Month 3/Month7)	79.84 Titers Interval 62.0 to 103.0	163.69 Titers Interval 124.0 to 216.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. M14459 strain (Month 3/Month 7)	12.17 Titers Interval 9.6 to 15.0	27.09 Titers Interval 21.0 to 35.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. M07-0241084 strain (Month 3/Month 7)	8.91 Titers Interval 7.1 to 11.0	18.03 Titers Interval 14.0 to 23.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. C human serogroup (Month 3/Month7)	158.8 Titers Interval 127.0 to 199.0	376.44 Titers Interval 295.0 to 481.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. W human serogroup (Month 0)	5.20 Titers Interval 3.56 to 7.59	4.64 Titers Interval 3.05 to 7.05	—	—	—	—

SECONDARY outcome

Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group)

The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 month schedule, was compared with those, administered according to 0, 2 month schedule, as measured by the percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=213 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=151 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. NZ98/254 strain (Month 3/7)	63 Percentages of subjects Interval 55.85 to 69.26	74 Percentages of subjects Interval 65.72 to 80.35	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. M14459 strain (Month 3/Month 7)	70 Percentages of subjects Interval 63.48 to 76.23	89 Percentages of subjects Interval 83.36 to 93.82	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. M07-0241084 strain (Month 0)	18 Percentages of subjects Interval 13.3 to 24.47	18 Percentages of subjects Interval 12.06 to 25.16	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. M07-0241084 strain (Month 3/7)	49 Percentages of subjects Interval 41.54 to 55.59	72 Percentages of subjects Interval 64.35 to 79.33	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. 96217 strain (Month 0)	28 Percentages of subjects Interval 22.24 to 34.99	27 Percentages of subjects Interval 20.02 to 35.11	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. 96217 strain (Month 3/7)	97 Percentages of subjects Interval 93.25 to 98.65	99 Percentages of subjects Interval 96.34 to 99.98	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. Serogroup A (Month 0)	3 Percentages of subjects Interval 1.08 to 6.23	1 Percentages of subjects Interval 0.02 to 3.76	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. Serogroup A (Month 3/7)	88 Percentages of subjects Interval 83.01 to 92.18	95 Percentages of subjects Interval 89.56 to 97.62	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. Serogroup C (Month 0)	44 Percentages of subjects Interval 37.28 to 51.24	41 Percentages of subjects Interval 32.62 to 49.15	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. Serogroup C (Month 3/7)	99 Percentages of subjects Interval 96.63 to 99.89	100 Percentages of subjects Interval 97.55 to 100.0	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. Serogroup W (Month 0)	27 Percentages of subjects Interval 21.2 to 34.04	22 Percentages of subjects Interval 15.17 to 29.56	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. Serogroup W (Month 3/7)	97 Percentages of subjects Interval 93.19 to 98.64	99 Percentages of subjects Interval 96.08 to 99.98	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. Serogroup Y (Month 0)	9 Percentages of subjects Interval 5.37 to 13.72	6 Percentages of subjects Interval 2.78 to 11.08	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. NZ98/254 strain (Month 0)	6 Percentages of subjects Interval 3.37 to 10.45	2 Percentages of subjects Interval 0.41 to 5.7	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. M14459 strain (Month 0)	5 Percentages of subjects Interval 2.68 to 9.31	2 Percentages of subjects Interval 0.41 to 5.7	—	—	—	—
Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule. Serogroup Y (Month 3/7)	92 Percentages of subjects Interval 86.97 to 94.91	97 Percentages of subjects Interval 93.31 to 99.27	—	—	—	—

SECONDARY outcome

Timeframe: At 1 Month after the last vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group, Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group)

Population: Analysis was done on the FAS- 1 month after last meningococcal vaccination, which included all screened subjects who provided informed consent, received a study vaccination \& provided evaluable serum samples at 1 month after last vaccination whose results were available for atleast 1 serogroup or B strain

The immunogenicity of MenABCWY vaccine, administered according to 0, 2 months schedule, was compared with those, administered according to 0, 1 month, 0, 6 month and 0, 11 month schedules as measured by hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the second meningococcal vaccination.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=213 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=143 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=123 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=133 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0, 11 Month Schedule. Y human serogroup	71.66 Titers Interval 55.0 to 93.0	57.45 Titers Interval 42.0 to 78.0	120.76 Titers Interval 88.0 to 166.0	209.53 Titers Interval 153.0 to 286.0	—	—
hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0, 11 Month Schedule. NZ98/254 strain	12.32 Titers Interval 9.82 to 15.0	6.33 Titers Interval 4.86 to 8.23	13.64 Titers Interval 10.0 to 18.0	15.87 Titers Interval 12.0 to 21.0	—	—
hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0, 11 Month Schedule. M14459 strain	12.72 Titers Interval 10.0 to 16.0	9.19 Titers Interval 7.11 to 12.0	26.48 Titers Interval 20.0 to 35.0	29.57 Titers Interval 23.0 to 39.0	—	—
hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0, 11 Month Schedule. M07-0241084 strain	9.15 Titers Interval 7.52 to 11.0	6.59 Titers Interval 5.25 to 8.27	15.04 Titers Interval 12.0 to 19.0	16.22 Titers Interval 13.0 to 21.0	—	—
hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0, 11 Month Schedule. 96217 strain	165.47 Titers Interval 133.0 to 206.0	117.28 Titers Interval 91.0 to 151.0	237.89 Titers Interval 182.0 to 310.0	244.97 Titers Interval 189.0 to 317.0	—	—
hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0, 11 Month Schedule. A human serogroup	69.61 Titers Interval 56.0 to 87.0	79.87 Titers Interval 62.0 to 103.0	140.76 Titers Interval 108.0 to 184.0	162.76 Titers Interval 126.0 to 211.0	—	—
hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0, 11 Month Schedule. C human serogroup	162.57 Titers Interval 132.0 to 201.0	145.73 Titers Interval 114.0 to 186.0	225.00 Titers Interval 174.0 to 290.0	292.61 Titers Interval 227.0 to 376.0	—	—
hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0, 11 Month Schedule. W human serogroup	215.72 Titers Interval 182.0 to 256.0	197.69 Titers Interval 162.0 to 241.0	376.03 Titers Interval 306.0 to 462.0	531.79 Titers Interval 434.0 to 652.0	—	—

SECONDARY outcome

Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)

Population: Analysis was done on Full Analysis Set(FAS)- 1 month post meningococcal vaccination. Subjects in All Enrolled Set who received a study meningococcal vaccination \& provided evaluable serum samples at pre- \& at 1 month post last meningococcal vaccination whose result is available for at least one A,C,W or Y serogroup or serogroup B test strain.

A sufficient immune response following Bexsero vaccine, administered according to 0, 2 month schedule, as measured by the percentage of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, was to be demonstrated. Criterion: the immune response was to be considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titers ≥ LLQ was greater than 75% for each of the four serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=188 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=185 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. NZ98/254 strain - month 0 (LLQ = 8.2)	7 Percentages of subjects Interval 3.73 to 11.53	6 Percentages of subjects Interval 3.4 to 11.06	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. M14459 strain - month 0 (LLQ = 8.0)	7 Percentages of subjects Interval 3.41 to 11.11	5 Percentages of subjects Interval 2.32 to 9.33	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. M07-0241084 strain - month 0 (LLQ = 8.9)	21 Percentages of subjects Interval 15.19 to 27.25	18 Percentages of subjects Interval 12.78 to 24.69	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. 96217 strain - month 0 (LLQ = 8.6)	23 Percentages of subjects Interval 17.26 to 29.85	29 Percentages of subjects Interval 22.14 to 35.89	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. NZ98/254 strain - month 3 (LLQ = 8.2)	88 Percentages of subjects Interval 82.82 to 92.52	61 Percentages of subjects Interval 53.65 to 68.15	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. M14459 strain - month 3 (LLQ = 8.0)	82 Percentages of subjects Interval 75.75 to 87.32	68 Percentages of subjects Interval 60.21 to 74.39	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. M07-0241084 strain - month 3 (LLQ = 8.9)	66 Percentages of subjects Interval 59.26 to 73.19	47 Percentages of subjects Interval 39.6 to 54.81	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule. 96217 strain - month 3 (LLQ = 8.6)	99 Percentages of subjects Interval 97.04 to 99.99	97 Percentages of subjects Interval 92.81 to 98.75	—	—	—	—

SECONDARY outcome

Timeframe: At 1 month after last vaccination (Month 7)

The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule was compared with those administered according to 0, 6 months schedule, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the last meningococcal vaccination.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=123 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=151 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. M14459 strain	27.82 Titers Interval 21.0 to 36.0	29.27 Titers Interval 23.0 to 37.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. Serogroup W	341.90 Titers Interval 283.0 to 413.0	282.74 Titers Interval 237.0 to 338.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. NZ98/254 strain	13.62 Titers Interval 9.98 to 19.0	17.13 Titers Interval 13.0 to 23.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. M07-0241084 strain	17.43 Titers Interval 13.0 to 23.0	20.92 Titers Interval 16.0 to 27.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. 96217 strain	240.13 Titers Interval 186.0 to 310.0	291.63 Titers Interval 232.0 to 367.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. Serogroup A	140.14 Titers Interval 107.0 to 184.0	128.75 Titers Interval 101.0 to 164.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. Serogroup C	246.48 Titers Interval 191.0 to 318.0	413.60 Titers Interval 328.0 to 522.0	—	—	—	—
hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. Serogroup Y	123.96 Titers Interval 91.0 to 169.0	151.36 Titers Interval 115.0 to 200.0	—	—	—	—

SECONDARY outcome

Timeframe: At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 7)

The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 month schedule, was compared with those, administered according to 0, 6 month schedule, as measured by the percentages of subjects with hSBA titers ≥ LLQ against serogroups A, C, W and Y and serogroup B test strains at 1 month after the last meningococcal vaccination.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=123 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=151 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. M14459 strain - month 7 (LLQ=8.0)	87 Percentages of subjects Interval 79.58 to 92.31	89 Percentages of subjects Interval 83.36 to 93.82	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. NZ98/254 strain - month 0 (LLQ=8.2)	5 Percentages of subjects Interval 1.86 to 10.57	2 Percentages of subjects Interval 0.41 to 5.7	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. NZ98/254 strain - month 7 (LLQ=8.2)	64 Percentages of subjects Interval 55.25 to 72.95	74 Percentages of subjects Interval 65.72 to 80.35	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. M14459 strain - month 0 (LLQ=8.0)	5 Percentages of subjects Interval 1.84 to 10.48	2 Percentages of subjects Interval 0.41 to 5.7	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. M07-0241084 strain - month 0 (LLQ=8.9)	14 Percentages of subjects Interval 8.33 to 21.37	18 Percentages of subjects Interval 12.06 to 25.16	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. M07-0241084 strain - month 7 (LLQ=8.9)	66 Percentages of subjects Interval 56.76 to 74.16	72 Percentages of subjects Interval 64.35 to 79.33	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. 96217 strain - month 0 (LLQ=8.6)	27 Percentages of subjects Interval 19.18 to 35.79	27 Percentages of subjects Interval 20.02 to 35.11	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. 996217 strain - month 7 (LLQ=8.6)	98 Percentages of subjects Interval 92.93 to 99.49	99 Percentages of subjects Interval 96.34 to 99.98	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. A human serogroup - month 0 (LLQ=22.7)	2 Percentages of subjects Interval 0.21 to 5.99	1 Percentages of subjects Interval 0.02 to 3.76	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. A human serogroup - month 7 (LLQ=22.7)	94 Percentages of subjects Interval 88.63 to 97.68	95 Percentages of subjects Interval 89.56 to 97.62	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. C human serogroup - month 0 (LLQ=5.2)	42 Percentages of subjects Interval 32.94 to 51.07	41 Percentages of subjects Interval 32.62 to 49.15	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. C human serogroup - month 7 (LLQ=5.2)	99 Percentages of subjects Interval 95.55 to 99.98	100 Percentages of subjects Interval 97.55 to 100.0	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. W human serogroup - month 0 (LLQ=39.6)	20 Percentages of subjects Interval 13.37 to 28.51	22 Percentages of subjects Interval 15.17 to 29.56	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. W human serogroup -month 7 (LLQ=39.6)	99 Percentages of subjects Interval 95.55 to 99.98	99 Percentages of subjects Interval 96.08 to 99.98	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. Y human serogroup - month 0 (LLQ=14.7)	7 Percentages of subjects Interval 2.92 to 12.71	6 Percentages of subjects Interval 2.78 to 11.08	—	—	—	—
Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule. Y human serogroup - month 7 (LLQ=14.7)	94 Percentages of subjects Interval 88.63 to 97.68	97 Percentages of subjects Interval 93.31 to 99.27	—	—	—	—

SECONDARY outcome

Timeframe: At 1 month after second vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group , Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group)

The immunogenicity of MenABCWY vaccine, administered according to 0, 2 month schedule, was compared with those, administered according to 0, 1 month, 0, 6 month and 0, 11 month schedules, as measured by the percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the second meningococcal vaccination.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=213 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=143 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=123 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=133 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0_11 Month Schedule. M14459 strain (LLQ=8.0)	70 Percentages of subjects Interval 63.48 to 76.23	62 Percentages of subjects Interval 53.56 to 70.2	87 Percentages of subjects Interval 79.58 to 92.31	89 Percentages of subjects Interval 82.08 to 93.55	—	—
Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0_11 Month Schedule. Serogroup A (LLQ=22.7)	88 Percentages of subjects Interval 83.01 to 92.18	92 Percentages of subjects Interval 85.7 to 95.56	94 Percentages of subjects Interval 88.63 to 97.68	94 Percentages of subjects Interval 88.49 to 97.37	—	—
Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0_11 Month Schedule. NZ98/254 strain (LLQ=8.2)	63 Percentages of subjects Interval 55.85 to 69.26	44 Percentages of subjects Interval 35.36 to 52.23	64 Percentages of subjects Interval 55.25 to 72.95	73 Percentages of subjects Interval 64.85 to 80.63	—	—
Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0_11 Month Schedule. M07-0241084 strain (LLQ=8.9)	49 Percentages of subjects Interval 41.54 to 55.59	40 Percentages of subjects Interval 31.82 to 48.61	66 Percentages of subjects Interval 56.76 to 74.16	69 Percentages of subjects Interval 60.82 to 77.21	—	—
Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0_11 Month Schedule. 96217 strain (LLQ=8.6)	97 Percentages of subjects Interval 93.25 to 98.65	97 Percentages of subjects Interval 92.99 to 99.23	98 Percentages of subjects Interval 92.93 to 99.49	98 Percentages of subjects Interval 93.55 to 99.53	—	—
Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0_11 Month Schedule. Serogroup C (LLQ=5.2)	99 Percentages of subjects Interval 96.63 to 99.89	100 Percentages of subjects Interval 97.44 to 100.0	99 Percentages of subjects Interval 95.55 to 99.99	100 Percentages of subjects Interval 97.22 to 100.0	—	—
Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0_11 Month Schedule. Serogroup W (LLQ=39.6)	97 Percentages of subjects Interval 93.19 to 98.64	96 Percentages of subjects Interval 91.09 to 98.44	99 Percentages of subjects Interval 95.55 to 99.98	98 Percentages of subjects Interval 93.45 to 99.53	—	—
Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0_11 Month Schedule. Serogroup Y (LLQ=14.7)	92 Percentages of subjects Interval 86.97 to 94.91	85 Percentages of subjects Interval 78.29 to 90.61	94 Percentages of subjects Interval 88.63 to 97.68	97 Percentages of subjects Interval 92.42 to 99.17	—	—

SECONDARY outcome

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13

Population: Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination \& provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the adjusted hSBA GMTs against serogroups A,C, W and Y and serogroup B test strains was assessed.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=188 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=185 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=122 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=114 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=128 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=137 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. M14459 strain(Month 0)	1.37 Titers Interval 1.21 to 1.56	1.22 Titers Interval 1.08 to 1.39	1.22 Titers Interval 1.04 to 1.42	1.21 Titers Interval 1.04 to 1.41	1.34 Titers Interval 1.15 to 1.55	1.17 Titers Interval 1.02 to 1.35
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. M14459 strain (Month 3)	18.29 Titers Interval 15.0 to 23.0	12.85 Titers Interval 10.0 to 16.0	5.30 Titers Interval 4.04 to 6.93	2.15 Titers Interval 1.64 to 2.82	3.11 Titers Interval 2.4 to 4.02	15.24 Titers Interval 12.0 to 20.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. M07-0241084 strain (Month 7)	5.42 Titers Interval 4.51 to 6.51	4.68 Titers Interval 3.88 to 5.63	3.36 Titers Interval 2.69 to 4.2	15.70 Titers Interval 13.0 to 20.0	2.96 Titers Interval 2.38 to 3.67	19.18 Titers Interval 16.0 to 24.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. 96217 strain (Month 13)	33.07 Titers Interval 27.0 to 41.0	22.48 Titers Interval 18.0 to 28.0	24.00 Titers Interval 18.0 to 31.0	42.27 Titers Interval 32.0 to 55.0	264.32 Titers Interval 205.0 to 341.0	47.22 Titers Interval 37.0 to 61.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup C (Month 2)	9.47 Titers Interval 7.18 to 13.0	31.56 Titers Interval 24.0 to 42.0	163.28 Titers Interval 118.0 to 227.0	37.24 Titers Interval 27.0 to 52.0	54.75 Titers Interval 40.0 to 76.0	40.29 Titers Interval 29.0 to 55.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup C (Month 3)	41.25 Titers Interval 32.0 to 52.0	184.05 Titers Interval 145.0 to 234.0	119.71 Titers Interval 90.0 to 159.0	31.50 Titers Interval 24.0 to 42.0	41.15 Titers Interval 31.0 to 54.0	236.97 Titers Interval 180.0 to 312.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup C (Month 7)	11.03 Titers Interval 8.81 to 14.0	80.70 Titers Interval 65.0 to 101.0	76.97 Titers Interval 59.0 to 100.0	260.57 Titers Interval 199.0 to 342.0	24.59 Titers Interval 19.0 to 32.0	476.44 Titers Interval 369.0 to 615.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup C (Month 13)	8.45 Titers Interval 6.79 to 11.0	37.45 Titers Interval 30.0 to 47.0	38.42 Titers Interval 30.0 to 50.0	57.48 Titers Interval 44.0 to 75.0	303.63 Titers Interval 235.0 to 392.0	113.72 Titers Interval 89.0 to 146.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup W (Month 0)	6.43 Titers Interval 4.46 to 9.27	4.75 Titers Interval 3.35 to 6.73	4.54 Titers Interval 2.98 to 6.9	4.29 Titers Interval 2.8 to 6.58	4.95 Titers Interval 3.3 to 7.44	4.46 Titers Interval 2.97 to 6.69
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup W (Month 7)	22.53 Titers Interval 18.0 to 29.0	79.96 Titers Interval 63.0 to 101.0	74.84 Titers Interval 57.0 to 99.0	340.85 Titers Interval 256.0 to 453.0	58.19 Titers Interval 44.0 to 76.0	270.12 Titers Interval 206.0 to 354.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup W (Month 13)	12.63 Titers Interval 9.86 to 16.0	45.63 Titers Interval 36.0 to 58.0	46.83 Titers Interval 35.0 to 62.0	96.43 Titers Interval 72.0 to 129.0	478.73 Titers Interval 363.0 to 631.0	95.90 Titers Interval 73.0 to 126.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup Y (Month 3)	3.12 Titers Interval 2.34 to 4.17	90.61 Titers Interval 68.0 to 121.0	42.97 Titers Interval 30.0 to 61.0	15.95 Titers Interval 11.0 to 23.0	18.76 Titers Interval 13.0 to 26.0	97.12 Titers Interval 70.0 to 134.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. 96217 strain (Month 7)	61.46 Titers Interval 50.0 to 75.0	43.01 Titers Interval 35.0 to 53.0	37.26 Titers Interval 29.0 to 47.0	264.85 Titers Interval 207.0 to 340.0	5.19 Titers Interval 4.1 to 6.58	306.14 Titers Interval 242.0 to 388.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup A (Month 0)	1.37 Titers Interval 1.18 to 1.59	1.17 Titers Interval 1.02 to 1.36	1.38 Titers Interval 1.15 to 1.65	1.08 Titers Interval 0.9 to 1.3	1.19 Titers Interval 1.0 to 1.41	1.06 Titers Interval 0.9 to 1.25
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup A (Month 2)	4.05 Titers Interval 2.97 to 5.54	8.35 Titers Interval 6.14 to 11.0	85.49 Titers Interval 59.0 to 125.0	7.64 Titers Interval 5.22 to 11.0	22.54 Titers Interval 16.0 to 32.0	5.18 Titers Interval 3.65 to 7.34
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup A (Month 3)	106.70 Titers Interval 82.0 to 139.0	68.85 Titers Interval 53.0 to 89.0	52.42 Titers Interval 38.0 to 72.0	5.31 Titers Interval 3.86 to 7.31	8.77 Titers Interval 6.49 to 12.0	78.30 Titers Interval 58.0 to 105.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup A (Month 7)	14.15 Titers Interval 11.0 to 19.0	11.49 Titers Interval 8.71 to 15.0	9.88 Titers Interval 7.04 to 14.0	165.14 Titers Interval 117.0 to 233.0	3.25 Titers Interval 2.35 to 4.49	140.73 Titers Interval 103.0 to 193.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup A (Month 13)	5.80 Titers Interval 4.3 to 7.82	4.64 Titers Interval 3.45 to 6.23	5.90 Titers Interval 4.11 to 8.46	15.20 Titers Interval 11.0 to 22.0	168.23 Titers Interval 119.0 to 238.0	13.32 Titers Interval 9.52 to 19.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup C (Month 0)	3.46 Titers Interval 2.76 to 4.33	3.38 Titers Interval 2.71 to 4.23	3.87 Titers Interval 2.96 to 5.04	3.36 Titers Interval 2.56 to 4.4	3.80 Titers Interval 2.92 to 4.94	2.99 Titers Interval 2.32 to 3.87
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup W (Month 2)	17.43 Titers Interval 13.0 to 23.0	50.71 Titers Interval 39.0 to 66.0	175.57 Titers Interval 128.0 to 241.0	59.37 Titers Interval 43.0 to 82.0	94.34 Titers Interval 69.0 to 128.0	47.54 Titers Interval 35.0 to 65.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup W (Month 3)	138.43 Titers Interval 111.0 to 173.0	214.70 Titers Interval 173.0 to 266.0	125.70 Titers Interval 97.0 to 162.0	59.26 Titers Interval 46.0 to 77.0	86.66 Titers Interval 68.0 to 111.0	200.91 Titers Interval 157.0 to 258.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup Y (Month 0)	1.72 Titers Interval 1.41 to 2.1	1.40 Titers Interval 1.14 to 1.71	1.68 Titers Interval 1.32 to 2.13	1.24 Titers Interval 0.97 to 1.59	1.79 Titers Interval 1.42 to 2.25	1.34 Titers Interval 1.07 to 1.67
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup Y (Month 2)	2.36 Titers Interval 1.72 to 3.23	19.43 Titers Interval 14.0 to 27.0	63.45 Titers Interval 44.0 to 93.0	16.41 Titers Interval 11.0 to 24.0	27.00 Titers Interval 19.0 to 39.0	19.82 Titers Interval 14.0 to 28.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup Y (Month 7)	2.44 Titers Interval 1.87 to 3.17	34.27 Titers Interval 26.0 to 45.0	27.86 Titers Interval 20.0 to 38.0	152.73 Titers Interval 111.0 to 211.0	14.29 Titers Interval 11.0 to 19.0	180.33 Titers Interval 135.0 to 242.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. Serogroup Y (Month 13)	2.28 Titers Interval 1.75 to 2.96	18.13 Titers Interval 14.0 to 24.0	15.19 Titers Interval 11.0 to 21.0	42.14 Titers Interval 31.0 to 58.0	231.39 Titers Interval 171.0 to 313.0	53.78 Titers Interval 40.0 to 72.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. NZ98/254 strain (Month 0)	1.22 Titers Interval 1.08 to 1.38	1.22 Titers Interval 1.08 to 1.38	1.21 Titers Interval 1.04 to 1.4	1.13 Titers Interval 0.97 to 1.31	1.12 Titers Interval 0.97 to 1.29	1.06 Titers Interval 0.93 to 1.22
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. NZ98/254 strain (Month 2)	2.67 Titers Interval 2.14 to 3.34	2.27 Titers Interval 1.82 to 2.84	6.50 Titers Interval 4.98 to 8.48	1.92 Titers Interval 1.46 to 2.51	3.87 Titers Interval 2.98 to 5.01	2.20 Titers Interval 1.71 to 2.82
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. NZ98/254 strain (Month 3)	27.17 Titers Interval 22.0 to 34.0	11.46 Titers Interval 9.28 to 14.0	3.15 Titers Interval 2.44 to 4.05	1.69 Titers Interval 1.31 to 2.19	2.38 Titers Interval 1.86 to 3.05	12.80 Titers Interval 10.0 to 16.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. NZ98/254 strain (Month 7)	3.00 Titers Interval 2.44 to 3.67	2.41 Titers Interval 1.97 to 2.95	1.88 Titers Interval 1.47 to 2.4	14.30 Titers Interval 11.0 to 18.0	1.75 Titers Interval 1.38 to 2.22	18.24 Titers Interval 14.0 to 23.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. NZ98/254 strain (Month 13)	2.33 Titers Interval 1.92 to 2.83	1.93 Titers Interval 1.59 to 2.33	1.81 Titers Interval 1.44 to 2.27	2.57 Titers Interval 2.04 to 3.25	17.08 Titers Interval 14.0 to 21.0	2.82 Titers Interval 2.28 to 3.51
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. M14459 strain (Month 2)	2.83 Titers Interval 2.31 to 3.46	2.55 Titers Interval 2.08 to 3.13	9.23 Titers Interval 7.21 to 12.0	2.34 Titers Interval 1.82 to 2.99	3.94 Titers Interval 3.11 to 4.98	2.40 Titers Interval 1.92 to 3.01
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. M14459 strain (Month 7)	3.52 Titers Interval 2.91 to 4.26	3.24 Titers Interval 2.68 to 3.93	2.19 Titers Interval 1.74 to 2.77	27.47 Titers Interval 22.0 to 35.0	1.95 Titers Interval 1.56 to 2.43	28.56 Titers Interval 23.0 to 35.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. M14459 strain (Month 13)	2.46 Titers Interval 2.03 to 2.97	2.29 Titers Interval 1.89 to 2.78	1.95 Titers Interval 1.54 to 2.45	3.22 Titers Interval 2.55 to 4.06	29.01 Titers Interval 23.0 to 36.0	3.17 Titers Interval 2.57 to 3.92
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. M07-0241084 strain (Month 0)	2.26 Titers Interval 1.81 to 2.82	2.07 Titers Interval 1.65 to 2.59	2.01 Titers Interval 1.53 to 2.63	2.06 Titers Interval 1.57 to 2.71	2.59 Titers Interval 1.99 to 3.37	1.83 Titers Interval 1.42 to 2.36
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. M07-0241084 strain (Month 2)	5.09 Titers Interval 4.26 to 6.07	4.30 Titers Interval 3.59 to 5.14	6.73 Titers Interval 5.44 to 8.34	3.51 Titers Interval 2.83 to 4.35	4.90 Titers Interval 3.97 to 6.04	4.20 Titers Interval 3.43 to 5.15
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. M07-0241084 strain(Month 3)	13.91 Titers Interval 12.0 to 17.0	8.82 Titers Interval 7.29 to 11.0	4.39 Titers Interval 3.49 to 5.5	3.30 Titers Interval 2.62 to 4.15	3.55 Titers Interval 2.84 to 4.43	9.29 Titers Interval 7.49 to 12.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. M07-0241084 strain(Month 13)	4.45 Titers Interval 3.71 to 5.35	4.01 Titers Interval 3.34 to 4.83	3.07 Titers Interval 2.46 to 3.83	5.42 Titers Interval 4.33 to 6.77	15.68 Titers Interval 13.0 to 19.0	5.80 Titers Interval 4.7 to 7.16
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. 96217 strain (Month 0)	2.32 Titers Interval 1.82 to 2.95	2.84 Titers Interval 2.23 to 3.62	2.88 Titers Interval 2.16 to 3.83	2.39 Titers Interval 1.78 to 3.21	2.78 Titers Interval 2.11 to 3.68	2.57 Titers Interval 1.94 to 3.4
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. 96217 strain(Month 2)	16.48 Titers Interval 13.0 to 21.0	11.62 Titers Interval 8.96 to 15.0	124.75 Titers Interval 92.0 to 169.0	11.61 Titers Interval 8.49 to 16.0	11.94 Titers Interval 8.87 to 16.0	8.54 Titers Interval 6.33 to 12.0
hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules. 96217 strain(Month 3)	263.56 Titers Interval 211.0 to 329.0	169.65 Titers Interval 136.0 to 212.0	82.23 Titers Interval 63.0 to 107.0	8.61 Titers Interval 6.57 to 11.0	7.72 Titers Interval 5.97 to 9.99	162.27 Titers Interval 125.0 to 210.0

SECONDARY outcome

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against NZ98/254 B strain was assessed.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=188 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=185 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=120 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=112 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=126 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=134 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 0) ≥ LLQ (8.2)	7 Percentages of subjects Interval 3.73 to 11.53	6 Percentages of subjects Interval 3.4 to 11.06	6 Percentages of subjects Interval 2.38 to 11.65	5 Percentages of subjects Interval 1.99 to 11.3	4 Percentages of subjects Interval 1.3 to 9.02	2 Percentages of subjects Interval 0.46 to 6.4
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 7) ≥ 128	2 Percentages of subjects Interval 0.33 to 4.59	4 Percentages of subjects Interval 1.53 to 7.64	5 Percentages of subjects Interval 1.86 to 10.57	7 Percentages of subjects Interval 3.13 to 13.59	1 Percentages of subjects Interval 0.02 to 4.34	5 Percentages of subjects Interval 2.13 to 10.47
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 0) ≥ 5	9 Percentages of subjects Interval 4.94 to 13.45	7 Percentages of subjects Interval 3.79 to 11.72	7 Percentages of subjects Interval 2.92 to 12.71	5 Percentages of subjects Interval 1.99 to 11.3	6 Percentages of subjects Interval 2.26 to 11.11	3 Percentages of subjects Interval 0.82 to 7.47
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 0) ≥ 8	7 Percentages of subjects Interval 4.13 to 12.18	6 Percentages of subjects Interval 3.4 to 11.06	6 Percentages of subjects Interval 2.38 to 11.65	5 Percentages of subjects Interval 1.99 to 11.3	4 Percentages of subjects Interval 1.3 to 9.02	2 Percentages of subjects Interval 0.46 to 6.4
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 0) ≥ 16	4 Percentages of subjects Interval 1.85 to 8.21	5 Percentages of subjects Interval 2.62 to 9.72	4 Percentages of subjects Interval 1.37 to 9.46	4 Percentages of subjects Interval 0.98 to 8.89	2 Percentages of subjects Interval 0.19 to 5.62	1 Percentages of subjects Interval 0.02 to 4.09
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 0) ≥ 32	2 Percentages of subjects Interval 0.33 to 4.59	3 Percentages of subjects Interval 0.88 to 6.19	3 Percentages of subjects Interval 0.52 to 7.13	1 Percentages of subjects Interval 0.02 to 4.87	0 Percentages of subjects Interval 0.0 to 2.89	0 Percentages of subjects Interval 0.0 to 2.72
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 0) ≥ 64	0 Percentages of subjects Interval 0.0 to 1.94	3 Percentages of subjects Interval 0.34 to 4.67	0 Percentages of subjects Interval 0.0 to 3.03	1 Percentages of subjects Interval 0.02 to 4.87	0 Percentages of subjects Interval 0.0 to 2.89	0 Percentages of subjects Interval 0.0 to 2.72
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 0) ≥ 128	0 Percentages of subjects Interval 0.0 to 1.94	0 Percentages of subjects Interval 0.0 to 1.97	0 Percentages of subjects Interval 0.0 to 3.03	0 Percentages of subjects Interval 0.0 to 3.24	0 Percentages of subjects Interval 0.0 to 2.89	0 Percentages of subjects Interval 0.0 to 2.72
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 2) ≥ LLQ (8.2)	23 Percentages of subjects Interval 17.55 to 30.12	20 Percentages of subjects Interval 14.49 to 26.5	43 Percentages of subjects Interval 33.53 to 51.85	17 Percentages of subjects Interval 10.53 to 25.22	27 Percentages of subjects Interval 19.47 to 35.62	18 Percentages of subjects Interval 11.83 to 25.47
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 2) ≥ 5	29 Percentages of subjects Interval 22.86 to 36.32	24 Percentages of subjects Interval 18.33 to 31.16	58 Percentages of subjects Interval 48.98 to 67.26	18 Percentages of subjects Interval 11.26 to 26.22	36 Percentages of subjects Interval 27.38 to 44.74	20 Percentages of subjects Interval 13.72 to 27.95
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 2) ≥ 8	23 Percentages of subjects Interval 17.55 to 30.12	20 Percentages of subjects Interval 14.49 to 26.5	43 Percentages of subjects Interval 33.53 to 51.85	17 Percentages of subjects Interval 10.53 to 25.22	28 Percentages of subjects Interval 20.17 to 36.46	18 Percentages of subjects Interval 11.83 to 25.47
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 2) ≥ 16	19 Percentages of subjects Interval 13.79 to 25.51	15 Percentages of subjects Interval 10.3 to 21.13	28 Percentages of subjects Interval 20.49 to 37.28	11 Percentages of subjects Interval 5.66 to 17.97	23 Percentages of subjects Interval 15.99 to 31.35	13 Percentages of subjects Interval 7.57 to 19.53
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 2) ≥ 32	15 Percentages of subjects Interval 10.13 to 20.8	10 Percentages of subjects Interval 5.87 to 14.94	20 Percentages of subjects Interval 13.25 to 28.28	9 Percentages of subjects Interval 4.36 to 15.81	17 Percentages of subjects Interval 10.62 to 24.34	7 Percentages of subjects Interval 3.64 to 13.3
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 2) ≥ 64	9 Percentages of subjects Interval 4.94 to 13.45	7 Percentages of subjects Interval 3.79 to 11.72	12 Percentages of subjects Interval 6.53 to 18.8	4 Percentages of subjects Interval 0.98 to 8.89	13 Percentages of subjects Interval 7.44 to 19.8	2 Percentages of subjects Interval 0.46 to 6.4
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 2) ≥ 128	2 Percentages of subjects Interval 0.33 to 4.59	5 Percentages of subjects Interval 2.25 to 9.03	5 Percentages of subjects Interval 1.86 to 10.57	3 Percentages of subjects Interval 0.56 to 7.63	6 Percentages of subjects Interval 2.78 to 12.13	1 Percentages of subjects Interval 0.18 to 5.29
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 3) ≥ LLQ (8.2)	88 Percentages of subjects Interval 82.82 to 92.52	61 Percentages of subjects Interval 53.65 to 68.15	30 Percentages of subjects Interval 21.98 to 39.04	14 Percentages of subjects Interval 8.39 to 22.16	20 Percentages of subjects Interval 13.27 to 27.88	68 Percentages of subjects Interval 59.3 to 75.71
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 3) ≥ 5	94 Percentages of subjects Interval 89.12 to 96.66	76 Percentages of subjects Interval 68.84 to 81.67	38 Percentages of subjects Interval 29.61 to 47.65	17 Percentages of subjects Interval 10.53 to 25.22	27 Percentages of subjects Interval 19.47 to 35.62	78 Percentages of subjects Interval 70.42 to 85.0
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 3) ≥ 8	88 Percentages of subjects Interval 82.82 to 92.52	63 Percentages of subjects Interval 55.3 to 69.69	30 Percentages of subjects Interval 21.98 to 39.04	14 Percentages of subjects Interval 8.39 to 22.16	21 Percentages of subjects Interval 13.94 to 28.75	69 Percentages of subjects Interval 60.86 to 77.07
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 3) ≥ 16	74 Percentages of subjects Interval 67.05 to 80.05	44 Percentages of subjects Interval 37.04 to 51.79	18 Percentages of subjects Interval 11.86 to 26.43	11 Percentages of subjects Interval 5.66 to 17.97	14 Percentages of subjects Interval 8.69 to 21.63	46 Percentages of subjects Interval 37.62 to 55.08
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 3) ≥ 32	50 Percentages of subjects Interval 42.64 to 57.36	23 Percentages of subjects Interval 17.36 to 30.0	13 Percentages of subjects Interval 7.17 to 19.78	5 Percentages of subjects Interval 1.99 to 11.3	10 Percentages of subjects Interval 5.02 to 16.05	19 Percentages of subjects Interval 12.45 to 26.3
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 3) ≥ 64	29 Percentages of subjects Interval 22.86 to 36.32	12 Percentages of subjects Interval 7.6 to 17.45	6 Percentages of subjects Interval 2.38 to 11.65	4 Percentages of subjects Interval 0.98 to 8.89	6 Percentages of subjects Interval 2.26 to 11.11	14 Percentages of subjects Interval 8.76 to 21.25
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 3) ≥ 128	12 Percentages of subjects Interval 7.48 to 17.18	6 Percentages of subjects Interval 3.4 to 11.06	4 Percentages of subjects Interval 1.37 to 9.46	2 Percentages of subjects Interval 0.22 to 6.3	4 Percentages of subjects Interval 1.3 to 9.02	4 Percentages of subjects Interval 1.66 to 9.49
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 7) ≥ LLQ (8.2)	27 Percentages of subjects Interval 20.43 to 33.52	19 Percentages of subjects Interval 14.02 to 25.91	14 Percentages of subjects Interval 8.47 to 21.71	63 Percentages of subjects Interval 53.76 to 72.29	13 Percentages of subjects Interval 7.44 to 19.8	72 Percentages of subjects Interval 64.0 to 79.76
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 7) ≥ 5	33 Percentages of subjects Interval 26.31 to 40.19	27 Percentages of subjects Interval 20.77 to 34.03	18 Percentages of subjects Interval 11.86 to 26.43	80 Percentages of subjects Interval 71.78 to 87.26	17 Percentages of subjects Interval 11.28 to 25.23	82 Percentages of subjects Interval 74.53 to 88.17
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 7) ≥ 8	27 Percentages of subjects Interval 20.43 to 33.52	20 Percentages of subjects Interval 14.49 to 26.5	14 Percentages of subjects Interval 8.47 to 21.71	69 Percentages of subjects Interval 59.3 to 77.17	13 Percentages of subjects Interval 7.44 to 19.8	74 Percentages of subjects Interval 65.59 to 81.08
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 7) ≥ 16	21 Percentages of subjects Interval 15.19 to 27.25	14 Percentages of subjects Interval 9.39 to 19.91	12 Percentages of subjects Interval 6.53 to 18.8	46 Percentages of subjects Interval 36.1 to 55.22	10 Percentages of subjects Interval 5.02 to 16.05	55 Percentages of subjects Interval 46.4 to 63.82
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 7) ≥ 32	12 Percentages of subjects Interval 7.92 to 17.79	10 Percentages of subjects Interval 6.3 to 15.57	9 Percentages of subjects Interval 4.67 to 15.81	26 Percentages of subjects Interval 18.08 to 35.03	4 Percentages of subjects Interval 1.3 to 9.02	34 Percentages of subjects Interval 25.66 to 42.25
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 7) ≥ 64	6 Percentages of subjects Interval 3.34 to 10.88	6 Percentages of subjects Interval 3.4 to 11.06	6 Percentages of subjects Interval 2.38 to 11.65	13 Percentages of subjects Interval 7.69 to 21.13	2 Percentages of subjects Interval 0.19 to 5.62	16 Percentages of subjects Interval 10.58 to 23.8
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 13) ≥ LLQ (8.2)	21 Percentages of subjects Interval 15.19 to 27.25	16 Percentages of subjects Interval 11.22 to 22.33	15 Percentages of subjects Interval 9.14 to 22.67	18 Percentages of subjects Interval 11.26 to 26.22	73 Percentages of subjects Interval 64.38 to 80.53	19 Percentages of subjects Interval 13.08 to 27.12
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 13) ≥ 5	27 Percentages of subjects Interval 20.43 to 33.52	19 Percentages of subjects Interval 14.02 to 25.91	16 Percentages of subjects Interval 9.81 to 23.62	28 Percentages of subjects Interval 19.64 to 36.93	85 Percentages of subjects Interval 77.46 to 90.67	25 Percentages of subjects Interval 17.6 to 32.81
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 13) ≥ 8	21 Percentages of subjects Interval 15.19 to 27.25	16 Percentages of subjects Interval 11.22 to 22.33	15 Percentages of subjects Interval 9.14 to 22.67	18 Percentages of subjects Interval 11.26 to 26.22	74 Percentages of subjects Interval 65.23 to 81.24	19 Percentages of subjects Interval 13.08 to 27.12
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 13) ≥ 16	15 Percentages of subjects Interval 10.13 to 20.8	12 Percentages of subjects Interval 8.05 to 18.07	8 Percentages of subjects Interval 4.07 to 14.79	12 Percentages of subjects Interval 6.33 to 19.03	49 Percentages of subjects Interval 40.19 to 58.26	14 Percentages of subjects Interval 8.76 to 21.25
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 13) ≥ 32	7 Percentages of subjects Interval 4.13 to 12.18	7 Percentages of subjects Interval 3.79 to 11.72	8 Percentages of subjects Interval 3.49 to 13.76	8 Percentages of subjects Interval 3.74 to 14.71	30 Percentages of subjects Interval 22.31 to 38.97	4 Percentages of subjects Interval 1.66 to 9.49
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 13) ≥ 64	3 Percentages of subjects Interval 0.87 to 6.1	5 Percentages of subjects Interval 2.25 to 9.03	5 Percentages of subjects Interval 1.86 to 10.57	5 Percentages of subjects Interval 1.99 to 11.3	13 Percentages of subjects Interval 8.06 to 20.72	3 Percentages of subjects Interval 0.82 to 7.47
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules. NZ98/254 Strain (At Month 13) ≥ 128	2 Percentages of subjects Interval 0.33 to 4.59	3 Percentages of subjects Interval 0.88 to 6.19	3 Percentages of subjects Interval 0.92 to 8.31	3 Percentages of subjects Interval 0.56 to 7.63	6 Percentages of subjects Interval 2.78 to 12.13	2 Percentages of subjects Interval 0.46 to 6.4

SECONDARY outcome

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=184 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=179 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=112 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=108 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=123 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=134 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 0) ≥ 5	12 Percentages of subjects Interval 7.65 to 17.54	7 Percentages of subjects Interval 3.92 to 12.1	6 Percentages of subjects Interval 2.55 to 12.45	6 Percentages of subjects Interval 2.65 to 12.9	11 Percentages of subjects Interval 6.36 to 18.36	4 Percentages of subjects Interval 1.22 to 8.49
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 0) ≥ LLQ (8.0)	7 Percentages of subjects Interval 3.41 to 11.11	5 Percentages of subjects Interval 2.32 to 9.33	6 Percentages of subjects Interval 2.55 to 12.45	4 Percentages of subjects Interval 1.02 to 9.21	7 Percentages of subjects Interval 2.85 to 12.41	2 Percentages of subjects Interval 0.46 to 6.4
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 2) ≥ 8	28 Percentages of subjects Interval 21.88 to 35.35	24 Percentages of subjects Interval 17.96 to 30.96	61 Percentages of subjects Interval 51.04 to 69.81	17 Percentages of subjects Interval 10.19 to 25.06	34 Percentages of subjects Interval 25.84 to 43.24	17 Percentages of subjects Interval 11.2 to 24.63
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 2) ≥ 16	17 Percentages of subjects Interval 11.74 to 23.05	13 Percentages of subjects Interval 8.32 to 18.65	34 Percentages of subjects Interval 25.25 to 43.48	11 Percentages of subjects Interval 5.87 to 18.06	25 Percentages of subjects Interval 17.81 to 33.83	12 Percentages of subjects Interval 6.98 to 18.67
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 2) ≥ 32	9 Percentages of subjects Interval 5.05 to 13.74	6 Percentages of subjects Interval 3.11 to 10.73	19 Percentages of subjects Interval 12.0 to 27.22	6 Percentages of subjects Interval 2.07 to 11.7	13 Percentages of subjects Interval 7.62 to 20.26	5 Percentages of subjects Interval 2.13 to 10.47
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 0) ≥ 8	7 Percentages of subjects Interval 3.41 to 11.11	5 Percentages of subjects Interval 2.32 to 9.33	6 Percentages of subjects Interval 2.55 to 12.45	4 Percentages of subjects Interval 1.02 to 9.21	7 Percentages of subjects Interval 2.85 to 12.41	2 Percentages of subjects Interval 0.46 to 6.4
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 0) ≥ 16	3 Percentages of subjects Interval 0.89 to 6.23	2 Percentages of subjects Interval 0.35 to 4.82	2 Percentages of subjects Interval 0.22 to 6.3	3 Percentages of subjects Interval 0.58 to 7.9	2 Percentages of subjects Interval 0.51 to 6.96	1 Percentages of subjects Interval 0.18 to 5.29
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 0) ≥ 32	2 Percentages of subjects Interval 0.34 to 4.69	0 Percentages of subjects Interval 0.0 to 2.04	1 Percentages of subjects Interval 0.02 to 4.87	1 Percentages of subjects Interval 0.02 to 5.05	0 Percentages of subjects Interval 0.0 to 2.95	1 Percentages of subjects Interval 0.02 to 4.09
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 0) ≥ 64	1 Percentages of subjects Interval 0.13 to 3.87	0 Percentages of subjects Interval 0.0 to 2.04	0 Percentages of subjects Interval 0.0 to 3.24	0 Percentages of subjects Interval 0.0 to 3.36	0 Percentages of subjects Interval 0.0 to 2.95	1 Percentages of subjects Interval 0.02 to 4.09
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 0) ≥ 128	0 Percentages of subjects Interval 0.0 to 1.98	0 Percentages of subjects Interval 0.0 to 2.04	0 Percentages of subjects Interval 0.0 to 3.24	0 Percentages of subjects Interval 0.0 to 3.36	0 Percentages of subjects Interval 0.0 to 2.95	0 Percentages of subjects Interval 0.0 to 2.72
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 2) ≥ LLQ (8.0)	28 Percentages of subjects Interval 21.88 to 35.35	24 Percentages of subjects Interval 17.96 to 30.96	61 Percentages of subjects Interval 51.04 to 69.81	17 Percentages of subjects Interval 10.19 to 25.06	34 Percentages of subjects Interval 25.84 to 43.24	17 Percentages of subjects Interval 11.2 to 24.63
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 2) ≥ 5	38 Percentages of subjects Interval 30.49 to 44.92	30 Percentages of subjects Interval 23.03 to 36.88	75 Percentages of subjects Interval 65.93 to 82.7	26 Percentages of subjects Interval 17.97 to 35.25	42 Percentages of subjects Interval 33.42 to 51.51	22 Percentages of subjects Interval 15.64 to 30.39
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 13) ≥ 16	15 Percentages of subjects Interval 9.9 to 20.63	9 Percentages of subjects Interval 5.63 to 14.77	7 Percentages of subjects Interval 3.13 to 13.59	13 Percentages of subjects Interval 7.27 to 20.79	76 Percentages of subjects Interval 67.05 to 82.9	13 Percentages of subjects Interval 7.57 to 19.53
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 13) ≥ 32	5 Percentages of subjects Interval 2.64 to 9.77	4 Percentages of subjects Interval 1.95 to 8.62	4 Percentages of subjects Interval 0.98 to 8.89	7 Percentages of subjects Interval 3.25 to 14.07	54 Percentages of subjects Interval 45.25 to 63.47	6 Percentages of subjects Interval 2.61 to 11.42
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 13) ≥ 64	2 Percentages of subjects Interval 0.34 to 4.69	2 Percentages of subjects Interval 0.61 to 5.62	3 Percentages of subjects Interval 0.56 to 7.63	1 Percentages of subjects Interval 0.02 to 5.05	29 Percentages of subjects Interval 21.41 to 38.15	1 Percentages of subjects Interval 0.18 to 5.29
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 7) ≥ 64	3 Percentages of subjects Interval 1.21 to 6.96	4 Percentages of subjects Interval 1.59 to 7.89	3 Percentages of subjects Interval 0.56 to 7.63	23 Percentages of subjects Interval 15.57 to 32.25	4 Percentages of subjects Interval 1.33 to 9.23	22 Percentages of subjects Interval 15.64 to 30.39
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 7) ≥ 128	0 Percentages of subjects Interval 0.0 to 1.98	1 Percentages of subjects Interval 0.01 to 3.07	1 Percentages of subjects Interval 0.02 to 4.87	10 Percentages of subjects Interval 5.2 to 17.49	2 Percentages of subjects Interval 0.2 to 5.75	7 Percentages of subjects Interval 3.12 to 12.37
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 13) ≥ LLQ (8.0)	23 Percentages of subjects Interval 17.46 to 30.16	20 Percentages of subjects Interval 14.01 to 26.13	13 Percentages of subjects Interval 7.01 to 20.08	23 Percentages of subjects Interval 15.57 to 32.25	89 Percentages of subjects Interval 81.64 to 93.64	27 Percentages of subjects Interval 19.58 to 35.2
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 13) ≥ 5	30 Percentages of subjects Interval 23.88 to 37.63	26 Percentages of subjects Interval 19.47 to 32.75	20 Percentages of subjects Interval 12.74 to 28.22	37 Percentages of subjects Interval 27.94 to 46.86	93 Percentages of subjects Interval 86.56 to 96.6	38 Percentages of subjects Interval 29.82 to 46.84
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 13) ≥ 8	23 Percentages of subjects Interval 17.46 to 30.16	20 Percentages of subjects Interval 14.01 to 26.13	13 Percentages of subjects Interval 7.01 to 20.08	23 Percentages of subjects Interval 15.57 to 32.25	89 Percentages of subjects Interval 81.64 to 93.64	27 Percentages of subjects Interval 19.58 to 35.2
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 2) ≥ 64	4 Percentages of subjects Interval 1.9 to 8.39	2 Percentages of subjects Interval 0.61 to 5.62	4 Percentages of subjects Interval 0.98 to 8.89	2 Percentages of subjects Interval 0.23 to 6.53	8 Percentages of subjects Interval 3.97 to 14.44	2 Percentages of subjects Interval 0.46 to 6.4
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 2) ≥ 128	1 Percentages of subjects Interval 0.01 to 2.99	2 Percentages of subjects Interval 0.35 to 4.82	2 Percentages of subjects Interval 0.22 to 6.3	1 Percentages of subjects Interval 0.02 to 5.05	5 Percentages of subjects Interval 1.81 to 10.32	1 Percentages of subjects Interval 0.18 to 5.29
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 3) ≥ LLQ (8.0)	82 Percentages of subjects Interval 75.75 to 87.32	68 Percentages of subjects Interval 60.21 to 74.39	44 Percentages of subjects Interval 34.39 to 53.44	16 Percentages of subjects Interval 9.45 to 24.0	28 Percentages of subjects Interval 20.69 to 37.29	73 Percentages of subjects Interval 64.8 to 80.42
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 3) ≥ 5	84 Percentages of subjects Interval 78.16 to 89.18	74 Percentages of subjects Interval 66.66 to 80.03	54 Percentages of subjects Interval 44.78 to 63.9	20 Percentages of subjects Interval 13.23 to 29.2	35 Percentages of subjects Interval 26.58 to 44.08	80 Percentages of subjects Interval 72.05 to 86.28
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 3) ≥ 8	82 Percentages of subjects Interval 75.75 to 87.32	68 Percentages of subjects Interval 60.21 to 74.39	44 Percentages of subjects Interval 34.39 to 53.44	16 Percentages of subjects Interval 9.45 to 24.0	28 Percentages of subjects Interval 20.69 to 37.29	73 Percentages of subjects Interval 64.8 to 80.42
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 3) ≥ 16	66 Percentages of subjects Interval 58.98 to 73.09	51 Percentages of subjects Interval 43.83 to 58.92	24 Percentages of subjects Interval 16.53 to 33.1	9 Percentages of subjects Interval 4.53 to 16.37	18 Percentages of subjects Interval 11.56 to 25.82	51 Percentages of subjects Interval 41.98 to 59.48
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 3) ≥ 32	39 Percentages of subjects Interval 32.03 to 46.58	30 Percentages of subjects Interval 23.54 to 37.46	6 Percentages of subjects Interval 2.55 to 12.45	4 Percentages of subjects Interval 1.02 to 9.21	9 Percentages of subjects Interval 4.55 to 15.44	28 Percentages of subjects Interval 20.91 to 36.79
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 3) ≥ 64	18 Percentages of subjects Interval 12.68 to 24.25	11 Percentages of subjects Interval 6.51 to 16.08	3 Percentages of subjects Interval 0.56 to 7.63	1 Percentages of subjects Interval 0.02 to 5.05	4 Percentages of subjects Interval 1.33 to 9.23	10 Percentages of subjects Interval 5.83 to 16.91
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 3) ≥ 128	7 Percentages of subjects Interval 3.41 to 11.11	2 Percentages of subjects Interval 0.61 to 5.62	2 Percentages of subjects Interval 0.22 to 6.3	1 Percentages of subjects Interval 0.02 to 5.05	3 Percentages of subjects Interval 0.89 to 8.12	3 Percentages of subjects Interval 0.82 to 7.47
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 7) ≥ LLQ (8.0)	34 Percentages of subjects Interval 26.91 to 41.02	30 Percentages of subjects Interval 23.03 to 36.88	17 Percentages of subjects Interval 10.53 to 25.22	86 Percentages of subjects Interval 78.13 to 92.01	15 Percentages of subjects Interval 9.56 to 23.07	89 Percentages of subjects Interval 82.21 to 93.6
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 7) ≥ 5	44 Percentages of subjects Interval 36.73 to 51.51	35 Percentages of subjects Interval 28.22 to 42.67	21 Percentages of subjects Interval 14.24 to 30.19	92 Percentages of subjects Interval 84.77 to 96.12	20 Percentages of subjects Interval 12.92 to 27.63	93 Percentages of subjects Interval 87.63 to 96.88
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 7) ≥ 8	34 Percentages of subjects Interval 26.91 to 41.02	30 Percentages of subjects Interval 23.03 to 36.88	17 Percentages of subjects Interval 10.53 to 25.22	86 Percentages of subjects Interval 78.13 to 92.01	15 Percentages of subjects Interval 9.56 to 23.07	89 Percentages of subjects Interval 82.21 to 93.6
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 7) ≥ 16	19 Percentages of subjects Interval 13.62 to 25.45	14 Percentages of subjects Interval 9.25 to 19.92	10 Percentages of subjects Interval 5.01 to 16.89	69 Percentages of subjects Interval 59.84 to 77.95	8 Percentages of subjects Interval 3.97 to 14.44	72 Percentages of subjects Interval 63.21 to 79.09
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 7) ≥ 32	11 Percentages of subjects Interval 7.21 to 16.92	7 Percentages of subjects Interval 3.51 to 11.42	5 Percentages of subjects Interval 1.99 to 11.3	50 Percentages of subjects Interval 40.22 to 59.78	6 Percentages of subjects Interval 2.32 to 11.37	49 Percentages of subjects Interval 40.52 to 58.02
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules. M14459 Strain (At Month 13) ≥ 128	0 Percentages of subjects Interval 0.0 to 1.98	1 Percentages of subjects Interval 0.01 to 3.07	2 Percentages of subjects Interval 0.22 to 6.3	1 Percentages of subjects Interval 0.02 to 5.05	11 Percentages of subjects Interval 5.75 to 17.4	1 Percentages of subjects Interval 0.02 to 4.09

SECONDARY outcome

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=188 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=176 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=117 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=113 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=121 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=128 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 2) ≥ 8	42 Percentages of subjects Interval 34.88 to 49.42	32 Percentages of subjects Interval 25.54 to 39.84	43 Percentages of subjects Interval 33.63 to 52.21	31 Percentages of subjects Interval 22.61 to 40.36	43 Percentages of subjects Interval 34.01 to 52.29	35 Percentages of subjects Interval 26.93 to 44.09
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 3) ≥ 8	69 Percentages of subjects Interval 62.02 to 75.67	55 Percentages of subjects Interval 47.45 to 62.6	34 Percentages of subjects Interval 25.67 to 43.53	31 Percentages of subjects Interval 22.61 to 40.36	34 Percentages of subjects Interval 25.53 to 43.05	56 Percentages of subjects Interval 47.21 to 65.0
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 7) ≥ 32	21 Percentages of subjects Interval 15.19 to 27.25	14 Percentages of subjects Interval 8.94 to 19.61	9 Percentages of subjects Interval 4.79 to 16.2	28 Percentages of subjects Interval 20.24 to 37.57	8 Percentages of subjects Interval 4.03 to 14.67	34 Percentages of subjects Interval 25.49 to 42.48
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 7) ≥ 64	6 Percentages of subjects Interval 2.96 to 10.23	8 Percentages of subjects Interval 4.42 to 12.99	6 Percentages of subjects Interval 2.44 to 11.94	10 Percentages of subjects Interval 4.96 to 16.75	4 Percentages of subjects Interval 1.36 to 9.38	17 Percentages of subjects Interval 11.1 to 24.86
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 7) ≥ 128	1 Percentages of subjects Interval 0.01 to 2.93	2 Percentages of subjects Interval 0.35 to 4.9	1 Percentages of subjects Interval 0.02 to 4.67	3 Percentages of subjects Interval 0.55 to 7.56	1 Percentages of subjects Interval 0.02 to 4.52	4 Percentages of subjects Interval 1.28 to 8.88
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 13) ≥ 16	26 Percentages of subjects Interval 19.46 to 32.39	23 Percentages of subjects Interval 16.76 to 29.64	17 Percentages of subjects Interval 10.77 to 25.16	19 Percentages of subjects Interval 12.62 to 27.98	55 Percentages of subjects Interval 45.24 to 63.62	26 Percentages of subjects Interval 18.46 to 34.26
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 13) ≥ 32	16 Percentages of subjects Interval 11.03 to 21.99	13 Percentages of subjects Interval 8.47 to 18.96	11 Percentages of subjects Interval 6.05 to 18.25	12 Percentages of subjects Interval 6.27 to 18.87	35 Percentages of subjects Interval 26.29 to 43.9	12 Percentages of subjects Interval 6.71 to 18.59
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 13) ≥ 64	6 Percentages of subjects Interval 3.34 to 10.88	3 Percentages of subjects Interval 1.26 to 7.27	4 Percentages of subjects Interval 1.4 to 9.69	5 Percentages of subjects Interval 1.97 to 11.2	20 Percentages of subjects Interval 13.14 to 28.06	5 Percentages of subjects Interval 1.74 to 9.92
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 13) ≥ 128	2 Percentages of subjects Interval 0.58 to 5.36	1 Percentages of subjects Interval 0.01 to 3.12	2 Percentages of subjects Interval 0.21 to 6.04	1 Percentages of subjects Interval 0.02 to 4.83	9 Percentages of subjects Interval 4.63 to 15.68	1 Percentages of subjects Interval 0.02 to 4.28
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 13) ≥ 8	37 Percentages of subjects Interval 29.81 to 44.02	34 Percentages of subjects Interval 26.6 to 41.01	27 Percentages of subjects Interval 19.52 to 36.36	39 Percentages of subjects Interval 29.91 to 48.56	74 Percentages of subjects Interval 64.76 to 81.16	42 Percentages of subjects Interval 33.51 to 51.23
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 0) ≥ 8	22 Percentages of subjects Interval 16.13 to 28.4	20 Percentages of subjects Interval 14.26 to 26.56	18 Percentages of subjects Interval 11.47 to 26.12	19 Percentages of subjects Interval 12.62 to 27.98	24 Percentages of subjects Interval 16.68 to 32.57	20 Percentages of subjects Interval 13.72 to 28.33
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 0) ≥ 16	13 Percentages of subjects Interval 8.79 to 19.0	14 Percentages of subjects Interval 9.41 to 20.25	12 Percentages of subjects Interval 6.7 to 19.26	6 Percentages of subjects Interval 2.53 to 12.35	16 Percentages of subjects Interval 9.73 to 23.43	15 Percentages of subjects Interval 9.18 to 22.21
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 0) ≥ LLQ (8.9)	21 Percentages of subjects Interval 15.19 to 27.25	18 Percentages of subjects Interval 12.78 to 24.69	17 Percentages of subjects Interval 10.77 to 25.16	14 Percentages of subjects Interval 8.32 to 21.97	21 Percentages of subjects Interval 14.54 to 29.88	19 Percentages of subjects Interval 12.4 to 26.6
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 0) ≥ 5	30 Percentages of subjects Interval 23.35 to 36.87	28 Percentages of subjects Interval 21.36 to 35.08	25 Percentages of subjects Interval 17.27 to 33.62	27 Percentages of subjects Interval 19.46 to 36.63	30 Percentages of subjects Interval 21.79 to 38.74	21 Percentages of subjects Interval 14.38 to 29.19
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 0) ≥ 128	0 Percentages of subjects Interval 0.0 to 1.94	0 Percentages of subjects Interval 0.0 to 2.07	0 Percentages of subjects Interval 0.0 to 3.1	2 Percentages of subjects Interval 0.22 to 6.25	1 Percentages of subjects Interval 0.02 to 4.52	1 Percentages of subjects Interval 0.02 to 4.28
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 2) ≥ LLQ (8.9)	38 Percentages of subjects Interval 30.81 to 45.11	29 Percentages of subjects Interval 22.4 to 36.28	37 Percentages of subjects Interval 28.03 to 46.16	28 Percentages of subjects Interval 20.24 to 37.57	39 Percentages of subjects Interval 30.12 to 48.13	30 Percentages of subjects Interval 22.65 to 39.22
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 0) ≥ 32	8 Percentages of subjects Interval 4.53 to 12.82	6 Percentages of subjects Interval 3.16 to 10.91	7 Percentages of subjects Interval 3.0 to 13.03	4 Percentages of subjects Interval 0.97 to 8.82	9 Percentages of subjects Interval 4.63 to 15.68	6 Percentages of subjects Interval 2.74 to 11.94
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 0) ≥ 64	3 Percentages of subjects Interval 1.18 to 6.82	2 Percentages of subjects Interval 0.35 to 4.9	3 Percentages of subjects Interval 0.53 to 7.31	2 Percentages of subjects Interval 0.22 to 6.25	3 Percentages of subjects Interval 0.91 to 8.25	3 Percentages of subjects Interval 0.86 to 7.81
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 2) ≥ 16	31 Percentages of subjects Interval 24.33 to 37.98	22 Percentages of subjects Interval 16.26 to 29.02	29 Percentages of subjects Interval 21.04 to 38.17	16 Percentages of subjects Interval 9.72 to 24.0	30 Percentages of subjects Interval 21.79 to 38.74	19 Percentages of subjects Interval 12.4 to 26.6
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 2) ≥ 32	20 Percentages of subjects Interval 14.72 to 26.67	15 Percentages of subjects Interval 10.36 to 21.53	17 Percentages of subjects Interval 10.77 to 25.16	7 Percentages of subjects Interval 3.11 to 13.47	19 Percentages of subjects Interval 12.45 to 27.14	9 Percentages of subjects Interval 4.37 to 14.86
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 2) ≥ 64	10 Percentages of subjects Interval 5.77 to 14.71	7 Percentages of subjects Interval 3.99 to 12.3	9 Percentages of subjects Interval 4.17 to 15.16	2 Percentages of subjects Interval 0.22 to 6.25	9 Percentages of subjects Interval 4.63 to 15.68	5 Percentages of subjects Interval 1.74 to 9.92
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 2) ≥ 128	3 Percentages of subjects Interval 1.18 to 6.82	2 Percentages of subjects Interval 0.35 to 4.9	3 Percentages of subjects Interval 0.53 to 7.31	1 Percentages of subjects Interval 0.02 to 4.83	5 Percentages of subjects Interval 1.84 to 10.48	0 Percentages of subjects Interval 0.0 to 2.84
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 3) ≥ LLQ (8.9)	66 Percentages of subjects Interval 59.26 to 73.19	47 Percentages of subjects Interval 39.6 to 54.81	28 Percentages of subjects Interval 20.28 to 37.27	28 Percentages of subjects Interval 20.24 to 37.57	30 Percentages of subjects Interval 21.79 to 38.74	53 Percentages of subjects Interval 44.11 to 62.0
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 3) ≥ 5	79 Percentages of subjects Interval 72.75 to 84.81	69 Percentages of subjects Interval 61.94 to 76.04	43 Percentages of subjects Interval 33.63 to 52.21	40 Percentages of subjects Interval 30.73 to 49.46	43 Percentages of subjects Interval 34.01 to 52.29	62 Percentages of subjects Interval 52.72 to 70.17
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 2) ≥ 5	47 Percentages of subjects Interval 40.03 to 54.74	43 Percentages of subjects Interval 35.75 to 50.85	54 Percentages of subjects Interval 44.39 to 63.1	40 Percentages of subjects Interval 30.73 to 49.46	54 Percentages of subjects Interval 44.43 to 62.83	41 Percentages of subjects Interval 32.04 to 49.66
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 3) ≥ 16	52 Percentages of subjects Interval 44.74 to 59.45	33 Percentages of subjects Interval 26.07 to 40.43	21 Percentages of subjects Interval 14.33 to 29.91	12 Percentages of subjects Interval 6.27 to 18.87	21 Percentages of subjects Interval 14.54 to 29.88	40 Percentages of subjects Interval 31.3 to 48.87
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 3) ≥ 32	33 Percentages of subjects Interval 26.31 to 40.19	18 Percentages of subjects Interval 12.78 to 24.69	15 Percentages of subjects Interval 9.38 to 23.22	5 Percentages of subjects Interval 1.97 to 11.2	15 Percentages of subjects Interval 9.06 to 22.49	23 Percentages of subjects Interval 15.73 to 30.89
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 3) ≥ 64	18 Percentages of subjects Interval 12.4 to 23.76	11 Percentages of subjects Interval 7.08 to 17.0	5 Percentages of subjects Interval 1.9 to 10.83	1 Percentages of subjects Interval 0.02 to 4.83	4 Percentages of subjects Interval 1.36 to 9.38	13 Percentages of subjects Interval 7.32 to 19.5
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 3) ≥ 128	5 Percentages of subjects Interval 2.21 to 8.89	3 Percentages of subjects Interval 0.93 to 6.5	3 Percentages of subjects Interval 0.53 to 7.31	1 Percentages of subjects Interval 0.02 to 4.83	2 Percentages of subjects Interval 0.51 to 7.07	2 Percentages of subjects Interval 0.49 to 6.7
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 7) ≥ LLQ (8.9)	40 Percentages of subjects Interval 32.84 to 47.27	30 Percentages of subjects Interval 22.92 to 36.88	26 Percentages of subjects Interval 18.02 to 34.54	66 Percentages of subjects Interval 56.88 to 74.99	26 Percentages of subjects Interval 18.12 to 34.35	70 Percentages of subjects Interval 61.6 to 78.06
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 7) ≥ 5	50 Percentages of subjects Interval 42.64 to 57.36	44 Percentages of subjects Interval 36.3 to 51.42	32 Percentages of subjects Interval 24.11 to 41.76	83 Percentages of subjects Interval 74.99 to 89.56	36 Percentages of subjects Interval 27.81 to 45.6	80 Percentages of subjects Interval 72.53 to 86.94
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 7) ≥ 8	42 Percentages of subjects Interval 34.88 to 49.42	32 Percentages of subjects Interval 25.54 to 39.84	27 Percentages of subjects Interval 19.52 to 36.36	70 Percentages of subjects Interval 60.57 to 78.18	28 Percentages of subjects Interval 20.31 to 36.99	77 Percentages of subjects Interval 68.26 to 83.59
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 7) ≥ 16	29 Percentages of subjects Interval 22.37 to 35.76	24 Percentages of subjects Interval 18.28 to 31.47	19 Percentages of subjects Interval 12.18 to 27.07	53 Percentages of subjects Interval 43.48 to 62.55	18 Percentages of subjects Interval 11.76 to 26.22	58 Percentages of subjects Interval 48.77 to 66.49
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 13) ≥ LLQ (8.9)	34 Percentages of subjects Interval 26.81 to 40.74	27 Percentages of subjects Interval 20.84 to 34.48	23 Percentages of subjects Interval 15.79 to 31.77	34 Percentages of subjects Interval 25.01 to 43.12	69 Percentages of subjects Interval 59.53 to 76.73	37 Percentages of subjects Interval 28.38 to 45.69
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules. M07-0241084 Strain (At Month 13) ≥ 5	46 Percentages of subjects Interval 38.48 to 53.15	39 Percentages of subjects Interval 31.95 to 46.83	36 Percentages of subjects Interval 27.24 to 45.29	57 Percentages of subjects Interval 46.99 to 65.93	82 Percentages of subjects Interval 73.78 to 88.24	51 Percentages of subjects Interval 41.8 to 59.72

SECONDARY outcome

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=186 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=178 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=120 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=112 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=128 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=121 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 2) ≥ 64	11 Percentages of subjects Interval 6.69 to 16.12	15 Percentages of subjects Interval 9.77 to 20.67	73 Percentages of subjects Interval 63.6 to 80.25	9 Percentages of subjects Interval 4.36 to 15.81	14 Percentages of subjects Interval 8.55 to 21.31	12 Percentages of subjects Interval 6.47 to 18.65
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 7) ≥ 8	95 Percentages of subjects Interval 91.01 to 97.76	91 Percentages of subjects Interval 85.81 to 94.77	88 Percentages of subjects Interval 80.22 to 92.83	97 Percentages of subjects Interval 92.37 to 99.44	40 Percentages of subjects Interval 31.3 to 48.87	99 Percentages of subjects Interval 95.48 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 0) ≥ 128	1 Percentages of subjects Interval 0.01 to 2.96	1 Percentages of subjects Interval 0.14 to 4.0	0 Percentages of subjects Interval 0.0 to 3.03	0 Percentages of subjects Interval 0.0 to 3.24	1 Percentages of subjects Interval 0.02 to 4.28	2 Percentages of subjects Interval 0.2 to 5.84
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 2) ≥ 5	75 Percentages of subjects Interval 68.42 to 81.29	67 Percentages of subjects Interval 60.0 to 74.24	97 Percentages of subjects Interval 91.69 to 99.08	66 Percentages of subjects Interval 56.52 to 74.75	66 Percentages of subjects Interval 56.72 to 73.79	53 Percentages of subjects Interval 43.61 to 62.03
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 2) ≥ 8	70 Percentages of subjects Interval 63.31 to 76.88	64 Percentages of subjects Interval 56.53 to 71.09	97 Percentages of subjects Interval 91.69 to 99.08	63 Percentages of subjects Interval 53.76 to 72.29	59 Percentages of subjects Interval 50.34 to 67.96	51 Percentages of subjects Interval 41.99 to 60.43
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 3) ≥ LLQ (8.6)	99 Percentages of subjects Interval 97.04 to 99.99	97 Percentages of subjects Interval 92.81 to 98.75	94 Percentages of subjects Interval 88.35 to 97.62	58 Percentages of subjects Interval 48.34 to 67.3	47 Percentages of subjects Interval 38.0 to 55.89	97 Percentages of subjects Interval 91.75 to 99.09
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 3) ≥ 5	99 Percentages of subjects Interval 97.04 to 99.99	97 Percentages of subjects Interval 93.57 to 99.08	96 Percentages of subjects Interval 90.54 to 98.53	61 Percentages of subjects Interval 51.04 to 69.81	56 Percentages of subjects Interval 47.21 to 65.0	98 Percentages of subjects Interval 92.93 to 99.49
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 3) ≥ 8	99 Percentages of subjects Interval 97.04 to 99.99	97 Percentages of subjects Interval 92.81 to 98.75	95 Percentages of subjects Interval 89.43 to 98.14	58 Percentages of subjects Interval 48.34 to 67.3	52 Percentages of subjects Interval 43.34 to 61.24	97 Percentages of subjects Interval 91.75 to 99.09
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 3) ≥ 64	90 Percentages of subjects Interval 84.51 to 93.74	81 Percentages of subjects Interval 74.34 to 86.39	62 Percentages of subjects Interval 52.35 to 70.39	6 Percentages of subjects Interval 2.55 to 12.45	11 Percentages of subjects Interval 6.11 to 17.67	84 Percentages of subjects Interval 76.57 to 90.27
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 7) ≥ 5	96 Percentages of subjects Interval 92.4 to 98.47	93 Percentages of subjects Interval 87.83 to 96.05	91 Percentages of subjects Interval 84.19 to 95.33	97 Percentages of subjects Interval 92.37 to 99.44	44 Percentages of subjects Interval 35.0 to 52.79	99 Percentages of subjects Interval 95.48 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 7) ≥ 16	93 Percentages of subjects Interval 88.34 to 96.23	85 Percentages of subjects Interval 79.33 to 90.23	76 Percentages of subjects Interval 67.17 to 83.18	96 Percentages of subjects Interval 91.11 to 99.02	30 Percentages of subjects Interval 22.65 to 39.22	99 Percentages of subjects Interval 95.48 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 13) ≥ 8	88 Percentages of subjects Interval 82.03 to 92.0	83 Percentages of subjects Interval 76.82 to 88.33	81 Percentages of subjects Interval 72.64 to 87.44	90 Percentages of subjects Interval 83.11 to 94.99	98 Percentages of subjects Interval 94.47 to 99.81	93 Percentages of subjects Interval 87.39 to 97.1
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 3) ≥ 32	98 Percentages of subjects Interval 95.36 to 99.67	89 Percentages of subjects Interval 83.83 to 93.45	83 Percentages of subjects Interval 75.44 to 89.51	21 Percentages of subjects Interval 13.49 to 29.2	23 Percentages of subjects Interval 15.73 to 30.89	92 Percentages of subjects Interval 85.33 to 95.97
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 3) ≥ 128	74 Percentages of subjects Interval 67.28 to 80.32	63 Percentages of subjects Interval 55.38 to 70.03	34 Percentages of subjects Interval 25.76 to 43.38	4 Percentages of subjects Interval 1.47 to 10.11	4 Percentages of subjects Interval 1.28 to 8.88	60 Percentages of subjects Interval 51.04 to 69.11
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 2) ≥ 16	48 Percentages of subjects Interval 41.01 to 55.81	48 Percentages of subjects Interval 40.78 to 55.91	94 Percentages of subjects Interval 88.35 to 97.62	48 Percentages of subjects Interval 38.67 to 57.85	42 Percentages of subjects Interval 33.51 to 51.23	39 Percentages of subjects Interval 30.12 to 48.13
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 2) ≥ 32	27 Percentages of subjects Interval 21.15 to 34.43	21 Percentages of subjects Interval 15.57 to 28.1	84 Percentages of subjects Interval 76.38 to 90.19	20 Percentages of subjects Interval 12.74 to 28.22	26 Percentages of subjects Interval 18.46 to 34.26	24 Percentages of subjects Interval 16.68 to 32.57
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 2) ≥ 128	7 Percentages of subjects Interval 3.77 to 11.66	4 Percentages of subjects Interval 1.96 to 8.66	45 Percentages of subjects Interval 35.91 to 54.35	4 Percentages of subjects Interval 1.47 to 10.11	9 Percentages of subjects Interval 4.94 to 15.8	7 Percentages of subjects Interval 3.46 to 13.65
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 7) ≥ 32	75 Percentages of subjects Interval 67.85 to 80.8	65 Percentages of subjects Interval 57.68 to 72.14	57 Percentages of subjects Interval 47.31 to 65.68	96 Percentages of subjects Interval 89.89 to 98.53	18 Percentages of subjects Interval 11.74 to 25.73	98 Percentages of subjects Interval 94.16 to 99.8
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 7) ≥ 64	43 Percentages of subjects Interval 35.79 to 50.46	34 Percentages of subjects Interval 26.81 to 41.16	32 Percentages of subjects Interval 23.48 to 40.78	87 Percentages of subjects Interval 78.87 to 92.31	7 Percentages of subjects Interval 3.27 to 12.93	98 Percentages of subjects Interval 92.93 to 99.49
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 7) ≥ 128	11 Percentages of subjects Interval 7.13 to 16.74	7 Percentages of subjects Interval 3.53 to 11.48	12 Percentages of subjects Interval 6.53 to 18.8	73 Percentages of subjects Interval 64.02 to 81.14	2 Percentages of subjects Interval 0.49 to 6.7	85 Percentages of subjects Interval 77.51 to 90.94
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 13) ≥ LLQ (8.6)	87 Percentages of subjects Interval 81.41 to 91.55	83 Percentages of subjects Interval 76.2 to 87.85	81 Percentages of subjects Interval 72.64 to 87.44	90 Percentages of subjects Interval 83.11 to 94.99	98 Percentages of subjects Interval 93.3 to 99.51	93 Percentages of subjects Interval 87.39 to 97.1
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 13) ≥ 5	90 Percentages of subjects Interval 85.14 to 94.16	85 Percentages of subjects Interval 78.7 to 89.76	83 Percentages of subjects Interval 75.44 to 89.51	92 Percentages of subjects Interval 85.29 to 96.26	98 Percentages of subjects Interval 94.47 to 99.81	93 Percentages of subjects Interval 87.39 to 97.1
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 7) ≥ LLQ (8.6)	95 Percentages of subjects Interval 91.01 to 97.76	91 Percentages of subjects Interval 85.81 to 94.77	88 Percentages of subjects Interval 80.22 to 92.83	97 Percentages of subjects Interval 92.37 to 99.44	39 Percentages of subjects Interval 30.56 to 48.08	99 Percentages of subjects Interval 95.48 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 3) ≥ 16	99 Percentages of subjects Interval 97.04 to 99.99	95 Percentages of subjects Interval 90.62 to 97.66	91 Percentages of subjects Interval 84.19 to 95.33	40 Percentages of subjects Interval 31.03 to 49.86	36 Percentages of subjects Interval 27.65 to 44.89	95 Percentages of subjects Interval 89.52 to 98.16
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 13) ≥ 16	76 Percentages of subjects Interval 69.0 to 81.77	69 Percentages of subjects Interval 61.75 to 75.8	66 Percentages of subjects Interval 56.62 to 74.24	79 Percentages of subjects Interval 70.8 to 86.51	98 Percentages of subjects Interval 93.3 to 99.51	88 Percentages of subjects Interval 80.38 to 92.89
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 13) ≥ 64	23 Percentages of subjects Interval 17.26 to 29.85	13 Percentages of subjects Interval 8.37 to 18.76	23 Percentages of subjects Interval 15.38 to 31.02	30 Percentages of subjects Interval 22.02 to 39.76	85 Percentages of subjects Interval 77.79 to 90.82	36 Percentages of subjects Interval 27.81 to 45.6
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 13) ≥ 128	4 Percentages of subjects Interval 1.87 to 8.3	3 Percentages of subjects Interval 0.92 to 6.43	8 Percentages of subjects Interval 3.49 to 13.76	13 Percentages of subjects Interval 7.69 to 21.13	73 Percentages of subjects Interval 64.08 to 80.16	12 Percentages of subjects Interval 7.11 to 19.62
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 13) ≥ 32	52 Percentages of subjects Interval 44.72 to 59.51	40 Percentages of subjects Interval 32.64 to 47.48	41 Percentages of subjects Interval 31.95 to 50.18	57 Percentages of subjects Interval 47.45 to 66.45	96 Percentages of subjects Interval 91.12 to 98.72	64 Percentages of subjects Interval 55.25 to 72.95
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 0) ≥ 5	26 Percentages of subjects Interval 19.68 to 32.72	35 Percentages of subjects Interval 28.38 to 42.9	35 Percentages of subjects Interval 26.52 to 44.24	29 Percentages of subjects Interval 21.23 to 38.82	35 Percentages of subjects Interval 26.93 to 44.09	29 Percentages of subjects Interval 21.05 to 37.87
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 0) ≥ 16	16 Percentages of subjects Interval 11.15 to 22.22	17 Percentages of subjects Interval 11.67 to 23.18	22 Percentages of subjects Interval 14.67 to 30.11	19 Percentages of subjects Interval 12.0 to 27.22	18 Percentages of subjects Interval 11.74 to 25.73	16 Percentages of subjects Interval 9.73 to 23.43
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 0) ≥ LLQ (8.6)	23 Percentages of subjects Interval 17.26 to 29.85	29 Percentages of subjects Interval 22.14 to 35.89	29 Percentages of subjects Interval 21.23 to 38.16	28 Percentages of subjects Interval 19.64 to 36.93	25 Percentages of subjects Interval 17.77 to 33.42	27 Percentages of subjects Interval 19.57 to 36.12
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 0) ≥ 8	24 Percentages of subjects Interval 18.23 to 31.0	30 Percentages of subjects Interval 23.68 to 37.66	31 Percentages of subjects Interval 22.73 to 39.91	28 Percentages of subjects Interval 19.64 to 36.93	25 Percentages of subjects Interval 17.77 to 33.42	27 Percentages of subjects Interval 19.57 to 36.12
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 0) ≥ 32	6 Percentages of subjects Interval 3.38 to 11.0	8 Percentages of subjects Interval 4.37 to 12.84	8 Percentages of subjects Interval 4.07 to 14.79	4 Percentages of subjects Interval 1.47 to 10.11	8 Percentages of subjects Interval 3.81 to 13.9	7 Percentages of subjects Interval 2.9 to 12.61
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 0) ≥ 64	2 Percentages of subjects Interval 0.33 to 4.64	2 Percentages of subjects Interval 0.62 to 5.65	3 Percentages of subjects Interval 0.52 to 7.13	0 Percentages of subjects Interval 0.0 to 3.24	2 Percentages of subjects Interval 0.49 to 6.7	5 Percentages of subjects Interval 1.84 to 10.48
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules. 96217 Strain (At Month 2) ≥ LLQ (8.6)	69 Percentages of subjects Interval 61.63 to 75.39	64 Percentages of subjects Interval 56.53 to 71.09	97 Percentages of subjects Interval 91.69 to 99.08	62 Percentages of subjects Interval 51.94 to 70.64	58 Percentages of subjects Interval 48.77 to 66.49	50 Percentages of subjects Interval 40.37 to 58.82

SECONDARY outcome

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=172 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=178 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=107 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=105 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=120 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=127 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 7) ≥ 32	42 Percentages of subjects Interval 34.95 to 50.2	37 Percentages of subjects Interval 29.44 to 44.05	35 Percentages of subjects Interval 25.65 to 44.39	91 Percentages of subjects Interval 84.35 to 96.01	14 Percentages of subjects Interval 8.47 to 21.71	93 Percentages of subjects Interval 86.97 to 96.71
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 7) ≥ 64	19 Percentages of subjects Interval 13.59 to 25.88	19 Percentages of subjects Interval 13.61 to 25.66	18 Percentages of subjects Interval 11.04 to 26.33	76 Percentages of subjects Interval 66.89 to 83.96	7 Percentages of subjects Interval 2.92 to 12.71	80 Percentages of subjects Interval 72.33 to 86.84
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 7) ≥ 128	5 Percentages of subjects Interval 2.42 to 9.7	6 Percentages of subjects Interval 2.73 to 10.09	10 Percentages of subjects Interval 5.24 to 17.65	63 Percentages of subjects Interval 52.88 to 72.09	3 Percentages of subjects Interval 0.52 to 7.13	54 Percentages of subjects Interval 44.48 to 62.44
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 13) ≥ LLQ (22.7)	33 Percentages of subjects Interval 26.16 to 40.71	26 Percentages of subjects Interval 20.09 to 33.52	34 Percentages of subjects Interval 24.8 to 43.42	51 Percentages of subjects Interval 41.47 to 61.3	93 Percentages of subjects Interval 87.29 to 97.08	54 Percentages of subjects Interval 45.26 to 63.19
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 0) ≥ LLQ (22.7)	6 Percentages of subjects Interval 2.82 to 10.43	3 Percentages of subjects Interval 1.25 to 7.19	5 Percentages of subjects Interval 1.53 to 10.57	2 Percentages of subjects Interval 0.23 to 6.71	3 Percentages of subjects Interval 0.52 to 7.13	1 Percentages of subjects Interval 0.02 to 4.31
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 0) ≥ 5	10 Percentages of subjects Interval 6.32 to 16.03	6 Percentages of subjects Interval 3.12 to 10.79	10 Percentages of subjects Interval 5.24 to 17.65	4 Percentages of subjects Interval 1.05 to 9.47	8 Percentages of subjects Interval 3.49 to 13.76	3 Percentages of subjects Interval 0.86 to 7.87
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 0) ≥ 8	10 Percentages of subjects Interval 5.86 to 15.35	6 Percentages of subjects Interval 2.73 to 10.09	10 Percentages of subjects Interval 5.24 to 17.65	3 Percentages of subjects Interval 0.59 to 8.12	5 Percentages of subjects Interval 1.86 to 10.57	2 Percentages of subjects Interval 0.49 to 6.75
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 0) ≥ 16	7 Percentages of subjects Interval 3.66 to 11.87	4 Percentages of subjects Interval 1.96 to 8.66	7 Percentages of subjects Interval 3.28 to 14.2	2 Percentages of subjects Interval 0.23 to 6.71	4 Percentages of subjects Interval 1.37 to 9.46	2 Percentages of subjects Interval 0.19 to 5.57
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 0) ≥ 32	4 Percentages of subjects Interval 1.65 to 8.21	2 Percentages of subjects Interval 0.62 to 5.65	3 Percentages of subjects Interval 0.58 to 7.98	1 Percentages of subjects Interval 0.02 to 5.19	2 Percentages of subjects Interval 0.2 to 5.89	1 Percentages of subjects Interval 0.02 to 4.31
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 0) ≥ 64	1 Percentages of subjects Interval 0.14 to 4.14	1 Percentages of subjects Interval 0.14 to 4.0	2 Percentages of subjects Interval 0.23 to 6.59	1 Percentages of subjects Interval 0.02 to 5.19	0 Percentages of subjects Interval 0.0 to 3.03	1 Percentages of subjects Interval 0.02 to 4.31
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 0) ≥ 128	1 Percentages of subjects Interval 0.01 to 3.2	1 Percentages of subjects Interval 0.01 to 3.09	1 Percentages of subjects Interval 0.02 to 5.1	0 Percentages of subjects Interval 0.0 to 3.45	0 Percentages of subjects Interval 0.0 to 3.03	1 Percentages of subjects Interval 0.02 to 4.31
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 2) ≥ LLQ (22.7)	22 Percentages of subjects Interval 16.13 to 29.04	35 Percentages of subjects Interval 27.86 to 42.32	93 Percentages of subjects Interval 85.8 to 96.72	33 Percentages of subjects Interval 24.43 to 43.2	54 Percentages of subjects Interval 44.83 to 63.29	28 Percentages of subjects Interval 20.01 to 36.19
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 2) ≥ 5	37 Percentages of subjects Interval 29.97 to 44.89	53 Percentages of subjects Interval 45.76 to 60.87	95 Percentages of subjects Interval 89.43 to 98.47	48 Percentages of subjects Interval 37.78 to 57.59	75 Percentages of subjects Interval 66.27 to 82.45	39 Percentages of subjects Interval 30.08 to 47.63
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 2) ≥ 8	37 Percentages of subjects Interval 29.43 to 44.3	51 Percentages of subjects Interval 42.98 to 58.12	94 Percentages of subjects Interval 88.19 to 97.91	46 Percentages of subjects Interval 35.96 to 55.72	74 Percentages of subjects Interval 65.38 to 81.72	38 Percentages of subjects Interval 29.35 to 46.83
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 2) ≥ 16	28 Percentages of subjects Interval 21.35 to 35.24	44 Percentages of subjects Interval 36.41 to 51.44	93 Percentages of subjects Interval 86.98 to 97.33	41 Percentages of subjects Interval 31.45 to 50.98	67 Percentages of subjects Interval 57.48 to 75.01	31 Percentages of subjects Interval 22.83 to 39.51
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 2) ≥ 64	12 Percentages of subjects Interval 7.72 to 18.06	19 Percentages of subjects Interval 13.12 to 25.04	69 Percentages of subjects Interval 59.5 to 77.73	18 Percentages of subjects Interval 11.26 to 26.81	33 Percentages of subjects Interval 24.23 to 41.65	14 Percentages of subjects Interval 8.62 to 21.47
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 2) ≥ 128	4 Percentages of subjects Interval 1.65 to 8.21	10 Percentages of subjects Interval 5.66 to 14.85	34 Percentages of subjects Interval 24.8 to 43.42	9 Percentages of subjects Interval 3.99 to 15.65	14 Percentages of subjects Interval 8.47 to 21.71	6 Percentages of subjects Interval 2.76 to 12.03
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 3) ≥ LLQ (22.7)	94 Percentages of subjects Interval 89.57 to 97.18	87 Percentages of subjects Interval 80.61 to 91.17	80 Percentages of subjects Interval 71.58 to 87.42	30 Percentages of subjects Interval 21.02 to 39.22	38 Percentages of subjects Interval 28.83 to 46.8	92 Percentages of subjects Interval 86.0 to 96.16
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 3) ≥ 5	97 Percentages of subjects Interval 93.35 to 99.05	94 Percentages of subjects Interval 89.21 to 96.88	92 Percentages of subjects Interval 84.63 to 96.08	40 Percentages of subjects Interval 30.56 to 50.02	55 Percentages of subjects Interval 45.65 to 64.09	94 Percentages of subjects Interval 88.97 to 97.76
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 3) ≥ 8	97 Percentages of subjects Interval 93.35 to 99.05	93 Percentages of subjects Interval 87.83 to 96.05	91 Percentages of subjects Interval 83.48 to 95.43	39 Percentages of subjects Interval 29.67 to 49.06	53 Percentages of subjects Interval 43.18 to 61.69	94 Percentages of subjects Interval 87.97 to 97.24
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 3) ≥ 16	95 Percentages of subjects Interval 90.3 to 97.58	91 Percentages of subjects Interval 85.81 to 94.77	86 Percentages of subjects Interval 77.93 to 91.94	33 Percentages of subjects Interval 24.43 to 43.2	42 Percentages of subjects Interval 32.74 to 51.02	92 Percentages of subjects Interval 86.0 to 96.16
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 3) ≥ 32	91 Percentages of subjects Interval 85.33 to 94.59	83 Percentages of subjects Interval 76.2 to 87.85	74 Percentages of subjects Interval 64.45 to 81.85	27 Percentages of subjects Interval 18.51 to 36.19	31 Percentages of subjects Interval 22.73 to 39.91	90 Percentages of subjects Interval 83.13 to 94.44
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 3) ≥ 64	71 Percentages of subjects Interval 63.53 to 77.59	57 Percentages of subjects Interval 49.69 to 64.67	46 Percentages of subjects Interval 36.12 to 55.7	12 Percentages of subjects Interval 6.76 to 20.24	19 Percentages of subjects Interval 12.56 to 27.36	61 Percentages of subjects Interval 51.57 to 69.18
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 3) ≥ 128	45 Percentages of subjects Interval 37.76 to 53.1	30 Percentages of subjects Interval 23.17 to 37.07	21 Percentages of subjects Interval 14.14 to 30.49	6 Percentages of subjects Interval 2.13 to 12.02	10 Percentages of subjects Interval 5.27 to 16.82	29 Percentages of subjects Interval 21.41 to 37.85
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 7) ≥ LLQ (22.7)	53 Percentages of subjects Interval 45.74 to 61.12	46 Percentages of subjects Interval 38.04 to 53.12	41 Percentages of subjects Interval 31.7 to 51.05	95 Percentages of subjects Interval 89.24 to 98.44	21 Percentages of subjects Interval 13.96 to 29.2	94 Percentages of subjects Interval 87.97 to 97.24
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 7) ≥ 5	70 Percentages of subjects Interval 62.31 to 76.53	62 Percentages of subjects Interval 54.8 to 69.5	60 Percentages of subjects Interval 49.89 to 69.18	97 Percentages of subjects Interval 91.88 to 99.41	29 Percentages of subjects Interval 21.23 to 38.16	98 Percentages of subjects Interval 93.25 to 99.51
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 7) ≥ 8	68 Percentages of subjects Interval 60.5 to 74.92	58 Percentages of subjects Interval 50.82 to 65.75	58 Percentages of subjects Interval 48.01 to 67.42	97 Percentages of subjects Interval 91.88 to 99.41	28 Percentages of subjects Interval 19.75 to 36.4	98 Percentages of subjects Interval 93.25 to 99.51
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 7) ≥ 16	61 Percentages of subjects Interval 53.33 to 68.38	51 Percentages of subjects Interval 43.53 to 58.67	49 Percentages of subjects Interval 38.82 to 58.46	97 Percentages of subjects Interval 91.88 to 99.41	22 Percentages of subjects Interval 14.67 to 30.11	97 Percentages of subjects Interval 92.13 to 99.14
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 13) ≥ 5	51 Percentages of subjects Interval 42.87 to 58.28	42 Percentages of subjects Interval 34.25 to 49.18	48 Percentages of subjects Interval 37.92 to 57.54	68 Percentages of subjects Interval 57.79 to 76.43	98 Percentages of subjects Interval 92.87 to 99.48	65 Percentages of subjects Interval 55.59 to 72.85
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 13) ≥ 8	48 Percentages of subjects Interval 40.59 to 55.99	39 Percentages of subjects Interval 31.57 to 46.34	47 Percentages of subjects Interval 37.02 to 56.62	66 Percentages of subjects Interval 55.81 to 74.7	98 Percentages of subjects Interval 92.87 to 99.48	64 Percentages of subjects Interval 54.78 to 72.12
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 13) ≥ 16	38 Percentages of subjects Interval 30.52 to 45.49	30 Percentages of subjects Interval 23.68 to 37.66	41 Percentages of subjects Interval 31.7 to 51.05	59 Percentages of subjects Interval 49.02 to 68.55	95 Percentages of subjects Interval 89.43 to 98.14	60 Percentages of subjects Interval 50.78 to 68.44
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 13) ≥ 32	24 Percentages of subjects Interval 17.68 to 30.92	20 Percentages of subjects Interval 14.09 to 26.27	27 Percentages of subjects Interval 18.96 to 36.55	44 Percentages of subjects Interval 34.14 to 53.83	88 Percentages of subjects Interval 81.2 to 93.47	41 Percentages of subjects Interval 32.3 to 50.02
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 13) ≥ 64	13 Percentages of subjects Interval 8.67 to 19.39	8 Percentages of subjects Interval 4.79 to 13.52	13 Percentages of subjects Interval 7.34 to 20.98	27 Percentages of subjects Interval 18.51 to 36.19	81 Percentages of subjects Interval 72.64 to 87.44	16 Percentages of subjects Interval 9.89 to 23.27
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 13) ≥ 128	4 Percentages of subjects Interval 1.65 to 8.21	2 Percentages of subjects Interval 0.35 to 4.85	6 Percentages of subjects Interval 2.09 to 11.81	8 Percentages of subjects Interval 3.35 to 14.46	61 Percentages of subjects Interval 51.5 to 69.61	6 Percentages of subjects Interval 2.24 to 11.03
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules. A human Serogroup (At Month 2) ≥ 32	19 Percentages of subjects Interval 13.09 to 25.24	33 Percentages of subjects Interval 26.28 to 40.58	88 Percentages of subjects Interval 80.12 to 93.37	30 Percentages of subjects Interval 21.02 to 39.22	42 Percentages of subjects Interval 32.74 to 51.02	22 Percentages of subjects Interval 15.18 to 30.26

SECONDARY outcome

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=186 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=185 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=122 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=114 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=123 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=130 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 7) ≥ LLQ (5.2)	69 Percentages of subjects Interval 61.63 to 75.39	96 Percentages of subjects Interval 92.36 to 98.47	97 Percentages of subjects Interval 91.82 to 99.1	99 Percentages of subjects Interval 95.21 to 99.98	82 Percentages of subjects Interval 74.18 to 88.44	100 Percentages of subjects Interval 97.2 to 100.0
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 0) ≥ LLQ (5.2)	43 Percentages of subjects Interval 35.79 to 50.46	45 Percentages of subjects Interval 38.09 to 52.87	48 Percentages of subjects Interval 38.43 to 56.78	41 Percentages of subjects Interval 32.09 to 50.83	48 Percentages of subjects Interval 38.88 to 57.16	41 Percentages of subjects Interval 32.24 to 49.73
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 0) ≥ 5	46 Percentages of subjects Interval 38.91 to 53.68	45 Percentages of subjects Interval 38.09 to 52.87	49 Percentages of subjects Interval 40.02 to 58.38	43 Percentages of subjects Interval 33.75 to 52.59	49 Percentages of subjects Interval 39.67 to 57.95	42 Percentages of subjects Interval 32.97 to 50.51
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 0) ≥ 8	34 Percentages of subjects Interval 27.61 to 41.71	30 Percentages of subjects Interval 23.75 to 37.44	36 Percentages of subjects Interval 27.57 to 45.25	30 Percentages of subjects Interval 21.62 to 39.11	36 Percentages of subjects Interval 27.33 to 44.91	30 Percentages of subjects Interval 22.28 to 38.66
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 0) ≥ 16	19 Percentages of subjects Interval 13.47 to 25.19	14 Percentages of subjects Interval 8.94 to 19.3	20 Percentages of subjects Interval 13.03 to 27.84	14 Percentages of subjects Interval 8.24 to 21.79	24 Percentages of subjects Interval 17.1 to 32.95	8 Percentages of subjects Interval 3.75 to 13.69
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 0) ≥ 32	5 Percentages of subjects Interval 2.61 to 9.66	6 Percentages of subjects Interval 3.4 to 11.06	9 Percentages of subjects Interval 4.59 to 15.56	4 Percentages of subjects Interval 0.96 to 8.74	7 Percentages of subjects Interval 3.4 to 13.44	3 Percentages of subjects Interval 0.84 to 7.69
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 0) ≥ 64	2 Percentages of subjects Interval 0.59 to 5.41	2 Percentages of subjects Interval 0.34 to 4.67	2 Percentages of subjects Interval 0.2 to 5.8	3 Percentages of subjects Interval 0.55 to 7.5	3 Percentages of subjects Interval 0.89 to 8.12	1 Percentages of subjects Interval 0.02 to 4.21
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 0) ≥ 128	1 Percentages of subjects Interval 0.01 to 2.96	2 Percentages of subjects Interval 0.34 to 4.67	0 Percentages of subjects Interval 0.0 to 2.98	1 Percentages of subjects Interval 0.02 to 4.79	1 Percentages of subjects Interval 0.02 to 4.45	0 Percentages of subjects Interval 0.0 to 2.8
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 2) ≥ LLQ (5.2)	61 Percentages of subjects Interval 53.89 to 68.33	84 Percentages of subjects Interval 78.27 to 89.24	100 Percentages of subjects Interval 97.02 to 100.0	84 Percentages of subjects Interval 76.2 to 90.37	89 Percentages of subjects Interval 82.6 to 94.25	88 Percentages of subjects Interval 80.78 to 92.8
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 2) ≥ 5	62 Percentages of subjects Interval 54.98 to 69.35	84 Percentages of subjects Interval 78.27 to 89.24	100 Percentages of subjects Interval 97.02 to 100.0	84 Percentages of subjects Interval 76.2 to 90.37	89 Percentages of subjects Interval 82.6 to 94.25	88 Percentages of subjects Interval 80.78 to 92.8
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 2) ≥ 8	53 Percentages of subjects Interval 45.25 to 60.04	78 Percentages of subjects Interval 71.16 to 83.6	98 Percentages of subjects Interval 94.2 to 99.8	80 Percentages of subjects Interval 71.28 to 86.76	86 Percentages of subjects Interval 78.8 to 91.74	78 Percentages of subjects Interval 69.56 to 84.52
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 2) ≥ 16	35 Percentages of subjects Interval 28.62 to 42.82	65 Percentages of subjects Interval 57.52 to 71.73	95 Percentages of subjects Interval 89.6 to 98.17	64 Percentages of subjects Interval 54.51 to 72.81	72 Percentages of subjects Interval 62.71 to 79.31	61 Percentages of subjects Interval 51.82 to 69.21
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 2) ≥ 32	18 Percentages of subjects Interval 13.0 to 24.6	40 Percentages of subjects Interval 32.88 to 47.44	89 Percentages of subjects Interval 81.5 to 93.58	44 Percentages of subjects Interval 34.58 to 53.46	55 Percentages of subjects Interval 46.06 to 64.25	44 Percentages of subjects Interval 35.16 to 52.82
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 2) ≥ 64	8 Percentages of subjects Interval 4.58 to 12.95	23 Percentages of subjects Interval 17.36 to 30.0	79 Percentages of subjects Interval 70.35 to 85.58	29 Percentages of subjects Interval 20.84 to 38.19	39 Percentages of subjects Interval 30.36 to 48.23	25 Percentages of subjects Interval 17.49 to 32.94
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 2) ≥ 128	3 Percentages of subjects Interval 0.88 to 6.16	16 Percentages of subjects Interval 10.76 to 21.73	53 Percentages of subjects Interval 44.03 to 62.36	17 Percentages of subjects Interval 10.34 to 24.8	26 Percentages of subjects Interval 18.52 to 34.7	19 Percentages of subjects Interval 12.85 to 27.07
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 3) ≥ LLQ (5.2)	97 Percentages of subjects Interval 93.84 to 99.12	99 Percentages of subjects Interval 96.15 to 99.87	98 Percentages of subjects Interval 94.2 to 99.8	81 Percentages of subjects Interval 72.25 to 87.49	88 Percentages of subjects Interval 80.68 to 93.01	99 Percentages of subjects Interval 95.79 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 3) ≥ 5	97 Percentages of subjects Interval 93.84 to 99.12	99 Percentages of subjects Interval 96.15 to 99.87	98 Percentages of subjects Interval 94.2 to 99.8	81 Percentages of subjects Interval 72.25 to 87.49	88 Percentages of subjects Interval 80.68 to 93.01	100 Percentages of subjects Interval 97.2 to 100.0
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 3) ≥ 8	94 Percentages of subjects Interval 89.0 to 96.62	98 Percentages of subjects Interval 94.56 to 99.41	98 Percentages of subjects Interval 92.98 to 99.49	77 Percentages of subjects Interval 68.4 to 84.53	84 Percentages of subjects Interval 76.01 to 89.78	99 Percentages of subjects Interval 95.79 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 3) ≥ 16	78 Percentages of subjects Interval 71.89 to 84.17	96 Percentages of subjects Interval 92.36 to 98.47	95 Percentages of subjects Interval 89.6 to 98.17	62 Percentages of subjects Interval 52.72 to 71.19	63 Percentages of subjects Interval 54.25 to 71.91	98 Percentages of subjects Interval 93.4 to 99.52
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 3) ≥ 32	56 Percentages of subjects Interval 48.46 to 63.17	90 Percentages of subjects Interval 84.43 to 93.7	86 Percentages of subjects Interval 78.63 to 91.67	43 Percentages of subjects Interval 33.75 to 52.59	46 Percentages of subjects Interval 36.53 to 54.75	94 Percentages of subjects Interval 88.23 to 97.31
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 3) ≥ 64	26 Percentages of subjects Interval 19.68 to 32.72	78 Percentages of subjects Interval 71.16 to 83.6	67 Percentages of subjects Interval 58.13 to 75.44	25 Percentages of subjects Interval 17.75 to 34.45	30 Percentages of subjects Interval 22.14 to 39.0	85 Percentages of subjects Interval 77.24 to 90.34
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 3) ≥ 128	11 Percentages of subjects Interval 6.69 to 16.12	58 Percentages of subjects Interval 50.92 to 65.57	40 Percentages of subjects Interval 31.39 to 49.42	18 Percentages of subjects Interval 11.06 to 25.79	21 Percentages of subjects Interval 14.3 to 29.42	60 Percentages of subjects Interval 51.05 to 68.49
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 7) ≥ 5	69 Percentages of subjects Interval 62.19 to 75.89	96 Percentages of subjects Interval 92.36 to 98.47	97 Percentages of subjects Interval 91.82 to 99.1	99 Percentages of subjects Interval 95.21 to 99.98	82 Percentages of subjects Interval 74.18 to 88.44	100 Percentages of subjects Interval 97.2 to 100.0
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 7) ≥ 8	58 Percentages of subjects Interval 50.62 to 65.24	96 Percentages of subjects Interval 92.36 to 98.47	96 Percentages of subjects Interval 90.69 to 98.66	99 Percentages of subjects Interval 95.21 to 99.98	73 Percentages of subjects Interval 64.43 to 80.76	99 Percentages of subjects Interval 95.79 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 7) ≥ 16	38 Percentages of subjects Interval 30.65 to 45.02	90 Percentages of subjects Interval 85.06 to 94.13	91 Percentages of subjects Interval 84.44 to 95.41	98 Percentages of subjects Interval 93.81 to 99.79	55 Percentages of subjects Interval 46.06 to 64.25	99 Percentages of subjects Interval 95.79 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 7) ≥ 32	23 Percentages of subjects Interval 16.79 to 29.27	74 Percentages of subjects Interval 66.54 to 79.72	77 Percentages of subjects Interval 68.57 to 84.18	95 Percentages of subjects Interval 88.9 to 98.04	35 Percentages of subjects Interval 26.58 to 44.08	98 Percentages of subjects Interval 94.55 to 99.81
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 7) ≥ 64	9 Percentages of subjects Interval 5.0 to 13.59	53 Percentages of subjects Interval 45.51 to 60.34	53 Percentages of subjects Interval 44.03 to 62.36	86 Percentages of subjects Interval 78.21 to 91.76	26 Percentages of subjects Interval 18.52 to 34.7	96 Percentages of subjects Interval 91.25 to 98.74
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 7) ≥ 128	3 Percentages of subjects Interval 0.88 to 6.16	30 Percentages of subjects Interval 23.75 to 37.44	25 Percentages of subjects Interval 17.96 to 34.09	74 Percentages of subjects Interval 64.61 to 81.49	16 Percentages of subjects Interval 10.22 to 23.99	85 Percentages of subjects Interval 78.12 to 90.97
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 13) ≥ LLQ (5.2)	60 Percentages of subjects Interval 52.25 to 66.79	92 Percentages of subjects Interval 87.63 to 95.8	94 Percentages of subjects Interval 88.54 to 97.66	97 Percentages of subjects Interval 92.5 to 99.45	100 Percentages of subjects Interval 97.05 to 100.0	99 Percentages of subjects Interval 95.79 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 13) ≥ 5	61 Percentages of subjects Interval 53.34 to 67.82	92 Percentages of subjects Interval 87.63 to 95.8	94 Percentages of subjects Interval 88.54 to 97.66	98 Percentages of subjects Interval 93.81 to 99.79	100 Percentages of subjects Interval 97.05 to 100.0	99 Percentages of subjects Interval 95.79 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 13) ≥ 8	48 Percentages of subjects Interval 41.01 to 55.81	88 Percentages of subjects Interval 82.55 to 92.4	89 Percentages of subjects Interval 82.47 to 94.2	91 Percentages of subjects Interval 84.46 to 95.71	98 Percentages of subjects Interval 94.25 to 99.8	98 Percentages of subjects Interval 93.4 to 99.52
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 13) ≥ 16	30 Percentages of subjects Interval 23.61 to 37.25	78 Percentages of subjects Interval 71.26 to 83.6	79 Percentages of subjects Interval 70.35 to 85.58	83 Percentages of subjects Interval 75.2 to 89.66	98 Percentages of subjects Interval 93.04 to 99.49	94 Percentages of subjects Interval 88.23 to 97.31
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 13) ≥ 32	15 Percentages of subjects Interval 10.24 to 21.02	51 Percentages of subjects Interval 43.37 to 58.22	57 Percentages of subjects Interval 48.1 to 66.28	61 Percentages of subjects Interval 51.83 to 70.37	97 Percentages of subjects Interval 91.88 to 99.11	81 Percentages of subjects Interval 72.93 to 87.15
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 13) ≥ 64	9 Percentages of subjects Interval 5.0 to 13.59	28 Percentages of subjects Interval 21.76 to 35.17	25 Percentages of subjects Interval 17.25 to 33.21	38 Percentages of subjects Interval 28.81 to 47.28	93 Percentages of subjects Interval 87.59 to 97.15	58 Percentages of subjects Interval 49.49 to 67.03
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules. C human Serogroup (At Month 13) ≥ 128	2 Percentages of subjects Interval 0.59 to 5.41	16 Percentages of subjects Interval 10.76 to 21.73	16 Percentages of subjects Interval 10.31 to 24.18	25 Percentages of subjects Interval 16.98 to 33.51	85 Percentages of subjects Interval 76.93 to 90.44	40 Percentages of subjects Interval 31.51 to 48.95

SECONDARY outcome

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=162 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=180 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=119 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=108 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=123 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=123 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 13) ≥ 5	62 Percentages of subjects Interval 54.4 to 69.83	93 Percentages of subjects Interval 87.97 to 96.1	90 Percentages of subjects Interval 83.05 to 94.68	99 Percentages of subjects Interval 94.95 to 99.98	99 Percentages of subjects Interval 95.55 to 99.98	98 Percentages of subjects Interval 94.25 to 99.8
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 13) ≥ 8	60 Percentages of subjects Interval 52.52 to 68.07	90 Percentages of subjects Interval 84.66 to 93.96	90 Percentages of subjects Interval 83.05 to 94.68	98 Percentages of subjects Interval 93.47 to 99.77	99 Percentages of subjects Interval 95.55 to 99.98	98 Percentages of subjects Interval 94.25 to 99.8
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 0) ≥ LLQ (39.6)	30 Percentages of subjects Interval 23.29 to 37.95	26 Percentages of subjects Interval 19.86 to 33.17	29 Percentages of subjects Interval 21.42 to 38.46	20 Percentages of subjects Interval 13.23 to 29.2	29 Percentages of subjects Interval 21.41 to 38.15	22 Percentages of subjects Interval 14.99 to 30.31
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 0) ≥ 5	51 Percentages of subjects Interval 43.27 to 59.15	43 Percentages of subjects Interval 35.98 to 50.91	41 Percentages of subjects Interval 32.24 to 50.57	42 Percentages of subjects Interval 32.25 to 51.55	45 Percentages of subjects Interval 35.75 to 53.94	45 Percentages of subjects Interval 35.75 to 53.94
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 0) ≥ 8	49 Percentages of subjects Interval 41.45 to 57.34	41 Percentages of subjects Interval 33.85 to 48.67	40 Percentages of subjects Interval 31.45 to 49.72	41 Percentages of subjects Interval 31.38 to 50.62	45 Percentages of subjects Interval 35.75 to 53.94	43 Percentages of subjects Interval 34.2 to 52.32
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 0) ≥ 16	44 Percentages of subjects Interval 36.05 to 51.83	39 Percentages of subjects Interval 31.73 to 46.42	39 Percentages of subjects Interval 30.66 to 48.87	34 Percentages of subjects Interval 25.4 to 44.01	41 Percentages of subjects Interval 31.89 to 49.88	38 Percentages of subjects Interval 29.6 to 47.41
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 0) ≥ 32	35 Percentages of subjects Interval 27.86 to 43.07	31 Percentages of subjects Interval 24.43 to 38.42	31 Percentages of subjects Interval 22.93 to 40.23	24 Percentages of subjects Interval 16.37 to 33.25	33 Percentages of subjects Interval 25.09 to 42.4	26 Percentages of subjects Interval 18.52 to 34.7
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 0) ≥ 64	21 Percentages of subjects Interval 14.99 to 28.07	19 Percentages of subjects Interval 13.45 to 25.38	20 Percentages of subjects Interval 13.37 to 28.51	13 Percentages of subjects Interval 7.27 to 20.79	21 Percentages of subjects Interval 14.3 to 29.42	12 Percentages of subjects Interval 6.99 to 19.32
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 0) ≥ 128	8 Percentages of subjects Interval 4.34 to 13.33	9 Percentages of subjects Interval 5.17 to 14.03	10 Percentages of subjects Interval 5.32 to 16.95	10 Percentages of subjects Interval 5.2 to 17.49	7 Percentages of subjects Interval 2.85 to 12.41	4 Percentages of subjects Interval 1.33 to 9.23
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 2) ≥ LLQ (39.6)	48 Percentages of subjects Interval 40.24 to 56.12	65 Percentages of subjects Interval 57.55 to 71.95	96 Percentages of subjects Interval 90.47 to 98.62	67 Percentages of subjects Interval 56.95 to 75.45	77 Percentages of subjects Interval 68.81 to 84.31	60 Percentages of subjects Interval 50.95 to 68.88
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 2) ≥ 5	66 Percentages of subjects Interval 58.21 to 73.29	90 Percentages of subjects Interval 84.66 to 93.96	99 Percentages of subjects Interval 95.41 to 99.98	92 Percentages of subjects Interval 84.77 to 96.12	93 Percentages of subjects Interval 86.56 to 96.6	93 Percentages of subjects Interval 86.56 to 96.6
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 2) ≥ 8	64 Percentages of subjects Interval 56.3 to 71.57	86 Percentages of subjects Interval 80.18 to 90.81	99 Percentages of subjects Interval 95.41 to 99.98	92 Percentages of subjects Interval 84.77 to 96.12	93 Percentages of subjects Interval 86.56 to 96.6	89 Percentages of subjects Interval 81.64 to 93.64
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 2) ≥ 16	60 Percentages of subjects Interval 52.52 to 68.07	82 Percentages of subjects Interval 75.84 to 87.51	99 Percentages of subjects Interval 95.41 to 99.98	81 Percentages of subjects Interval 72.86 to 88.31	89 Percentages of subjects Interval 82.6 to 94.25	80 Percentages of subjects Interval 72.37 to 87.08
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 2) ≥ 32	52 Percentages of subjects Interval 44.49 to 60.36	69 Percentages of subjects Interval 62.16 to 76.08	98 Percentages of subjects Interval 94.06 to 99.8	72 Percentages of subjects Interval 62.78 to 80.41	78 Percentages of subjects Interval 69.69 to 85.01	65 Percentages of subjects Interval 55.92 to 73.42
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 2) ≥ 64	44 Percentages of subjects Interval 36.05 to 51.83	50 Percentages of subjects Interval 42.47 to 57.53	84 Percentages of subjects Interval 76.19 to 90.1	52 Percentages of subjects Interval 42.03 to 61.57	67 Percentages of subjects Interval 58.45 to 75.65	44 Percentages of subjects Interval 34.97 to 53.13
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 2) ≥ 128	29 Percentages of subjects Interval 22.16 to 36.65	31 Percentages of subjects Interval 23.92 to 37.84	62 Percentages of subjects Interval 52.84 to 70.91	33 Percentages of subjects Interval 24.55 to 43.05	49 Percentages of subjects Interval 39.67 to 57.95	27 Percentages of subjects Interval 19.24 to 35.57
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 3) ≥ LLQ (39.6)	89 Percentages of subjects Interval 83.01 to 93.28	97 Percentages of subjects Interval 92.89 to 98.77	85 Percentages of subjects Interval 77.15 to 90.78	68 Percentages of subjects Interval 57.91 to 76.28	77 Percentages of subjects Interval 68.81 to 84.31	97 Percentages of subjects Interval 91.88 to 99.11
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 3) ≥ 5	96 Percentages of subjects Interval 92.11 to 98.63	99 Percentages of subjects Interval 96.04 to 99.87	98 Percentages of subjects Interval 94.06 to 99.8	94 Percentages of subjects Interval 87.1 to 97.35	92 Percentages of subjects Interval 85.56 to 96.03	100 Percentages of subjects Interval 97.05 to 100.0
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 3) ≥ 8	96 Percentages of subjects Interval 92.11 to 98.63	99 Percentages of subjects Interval 96.04 to 99.87	97 Percentages of subjects Interval 92.81 to 99.48	90 Percentages of subjects Interval 82.51 to 94.8	90 Percentages of subjects Interval 83.58 to 94.86	100 Percentages of subjects Interval 97.05 to 100.0
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 3) ≥ 16	96 Percentages of subjects Interval 91.3 to 98.25	99 Percentages of subjects Interval 96.04 to 99.87	96 Percentages of subjects Interval 90.47 to 98.62	81 Percentages of subjects Interval 71.83 to 87.54	86 Percentages of subjects Interval 78.8 to 91.74	99 Percentages of subjects Interval 95.55 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 3) ≥ 32	91 Percentages of subjects Interval 85.19 to 94.72	98 Percentages of subjects Interval 94.41 to 99.39	91 Percentages of subjects Interval 84.06 to 95.29	73 Percentages of subjects Interval 63.76 to 81.22	78 Percentages of subjects Interval 69.69 to 85.01	98 Percentages of subjects Interval 93.04 to 99.49
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 3) ≥ 64	80 Percentages of subjects Interval 73.27 to 86.08	93 Percentages of subjects Interval 88.64 to 96.51	77 Percentages of subjects Interval 68.73 to 84.48	50 Percentages of subjects Interval 40.22 to 59.78	64 Percentages of subjects Interval 55.09 to 72.67	91 Percentages of subjects Interval 84.56 to 95.45
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 3) ≥ 128	61 Percentages of subjects Interval 53.15 to 68.66	74 Percentages of subjects Interval 66.83 to 80.14	50 Percentages of subjects Interval 41.11 to 59.71	33 Percentages of subjects Interval 24.55 to 43.05	44 Percentages of subjects Interval 34.97 to 53.13	70 Percentages of subjects Interval 61.0 to 77.86
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 7) ≥ LLQ (39.6)	60 Percentages of subjects Interval 51.9 to 67.49	82 Percentages of subjects Interval 75.23 to 87.03	79 Percentages of subjects Interval 70.57 to 85.92	99 Percentages of subjects Interval 94.95 to 99.98	74 Percentages of subjects Interval 65.3 to 81.48	99 Percentages of subjects Interval 95.55 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 7) ≥ 5	71 Percentages of subjects Interval 63.35 to 77.84	97 Percentages of subjects Interval 92.89 to 98.77	96 Percentages of subjects Interval 90.47 to 98.62	100 Percentages of subjects Interval 96.64 to 100.0	93 Percentages of subjects Interval 86.56 to 96.6	100 Percentages of subjects Interval 97.05 to 100.0
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 7) ≥ 8	70 Percentages of subjects Interval 62.7 to 77.28	95 Percentages of subjects Interval 90.72 to 97.69	95 Percentages of subjects Interval 89.35 to 98.13	100 Percentages of subjects Interval 96.64 to 100.0	91 Percentages of subjects Interval 84.56 to 95.45	100 Percentages of subjects Interval 97.05 to 100.0
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 7) ≥ 16	69 Percentages of subjects Interval 61.41 to 76.15	92 Percentages of subjects Interval 87.29 to 95.68	91 Percentages of subjects Interval 84.06 to 95.29	100 Percentages of subjects Interval 96.64 to 100.0	87 Percentages of subjects Interval 79.74 to 92.38	100 Percentages of subjects Interval 97.05 to 100.0
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 7) ≥ 32	63 Percentages of subjects Interval 55.03 to 70.41	84 Percentages of subjects Interval 78.31 to 89.41	84 Percentages of subjects Interval 76.19 to 90.1	100 Percentages of subjects Interval 96.64 to 100.0	76 Percentages of subjects Interval 67.93 to 83.61	99 Percentages of subjects Interval 95.55 to 99.98
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 7) ≥ 64	49 Percentages of subjects Interval 40.85 to 56.73	68 Percentages of subjects Interval 60.42 to 74.54	67 Percentages of subjects Interval 58.02 to 75.55	97 Percentages of subjects Interval 92.1 to 99.42	59 Percentages of subjects Interval 49.31 to 67.35	98 Percentages of subjects Interval 93.04 to 99.49
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 7) ≥ 128	31 Percentages of subjects Interval 23.85 to 38.59	41 Percentages of subjects Interval 33.31 to 48.11	34 Percentages of subjects Interval 25.98 to 43.72	87 Percentages of subjects Interval 79.21 to 92.73	34 Percentages of subjects Interval 25.84 to 43.24	82 Percentages of subjects Interval 74.18 to 88.44
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 13) ≥ LLQ (39.6)	47 Percentages of subjects Interval 39.04 to 54.9	64 Percentages of subjects Interval 56.41 to 70.9	66 Percentages of subjects Interval 56.28 to 74.02	82 Percentages of subjects Interval 73.9 to 89.06	98 Percentages of subjects Interval 93.04 to 99.49	84 Percentages of subjects Interval 76.01 to 89.78
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 13) ≥ 16	57 Percentages of subjects Interval 48.79 to 64.54	84 Percentages of subjects Interval 77.69 to 88.94	81 Percentages of subjects Interval 72.42 to 87.34	94 Percentages of subjects Interval 87.1 to 97.35	99 Percentages of subjects Interval 95.55 to 99.98	96 Percentages of subjects Interval 90.77 to 98.67
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 13) ≥ 32	50 Percentages of subjects Interval 42.05 to 57.95	71 Percentages of subjects Interval 63.9 to 77.61	72 Percentages of subjects Interval 63.32 to 80.08	85 Percentages of subjects Interval 77.06 to 91.29	98 Percentages of subjects Interval 94.25 to 99.8	89 Percentages of subjects Interval 82.6 to 94.25
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 13) ≥ 64	35 Percentages of subjects Interval 27.28 to 42.43	44 Percentages of subjects Interval 36.52 to 51.47	48 Percentages of subjects Interval 38.66 to 57.25	73 Percentages of subjects Interval 63.76 to 81.22	98 Percentages of subjects Interval 93.04 to 99.49	68 Percentages of subjects Interval 59.29 to 76.39
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules. W human Serogroup (At Month 13) ≥ 128	21 Percentages of subjects Interval 14.99 to 28.07	22 Percentages of subjects Interval 16.38 to 29.01	28 Percentages of subjects Interval 19.92 to 36.68	43 Percentages of subjects Interval 33.13 to 52.47	94 Percentages of subjects Interval 88.63 to 97.68	45 Percentages of subjects Interval 35.75 to 53.94

SECONDARY outcome

Timeframe: At Month 0, Month 2, Month 3, Month 7 and Month 13.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=188 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=180 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=120 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=110 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=127 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=137 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 13) ≥ 8	24 Percentages of subjects Interval 18.03 to 30.69	71 Percentages of subjects Interval 63.9 to 77.61	63 Percentages of subjects Interval 54.05 to 71.94	84 Percentages of subjects Interval 75.38 to 90.0	97 Percentages of subjects Interval 92.13 to 99.14	87 Percentages of subjects Interval 80.03 to 92.02
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 13) ≥ 16	18 Percentages of subjects Interval 12.4 to 23.76	61 Percentages of subjects Interval 53.58 to 68.27	55 Percentages of subjects Interval 45.65 to 64.09	76 Percentages of subjects Interval 67.32 to 83.94	97 Percentages of subjects Interval 92.13 to 99.14	81 Percentages of subjects Interval 73.44 to 87.21
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 13) ≥ 32	10 Percentages of subjects Interval 5.77 to 14.71	43 Percentages of subjects Interval 35.45 to 50.35	40 Percentages of subjects Interval 31.17 to 49.34	60 Percentages of subjects Interval 50.22 to 69.22	93 Percentages of subjects Interval 86.97 to 96.71	69 Percentages of subjects Interval 60.13 to 76.27
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 3) ≥ 16	26 Percentages of subjects Interval 19.95 to 32.95	92 Percentages of subjects Interval 86.63 to 95.26	79 Percentages of subjects Interval 70.8 to 86.04	57 Percentages of subjects Interval 47.48 to 66.66	59 Percentages of subjects Interval 49.98 to 67.7	90 Percentages of subjects Interval 83.45 to 94.3
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 3) ≥ 32	18 Percentages of subjects Interval 12.86 to 24.34	84 Percentages of subjects Interval 77.69 to 88.94	68 Percentages of subjects Interval 58.35 to 75.77	44 Percentages of subjects Interval 34.2 to 53.42	44 Percentages of subjects Interval 35.3 to 53.17	83 Percentages of subjects Interval 75.88 to 89.05
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 0) ≥ LLQ (14.7)	15 Percentages of subjects Interval 10.13 to 20.8	10 Percentages of subjects Interval 6.04 to 15.34	13 Percentages of subjects Interval 7.82 to 20.75	6 Percentages of subjects Interval 2.6 to 12.67	13 Percentages of subjects Interval 7.38 to 19.65	7 Percentages of subjects Interval 3.05 to 12.1
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 0) ≥ 5	16 Percentages of subjects Interval 11.03 to 21.99	11 Percentages of subjects Interval 6.92 to 16.64	15 Percentages of subjects Interval 9.14 to 22.67	7 Percentages of subjects Interval 3.19 to 13.83	17 Percentages of subjects Interval 10.54 to 24.16	9 Percentages of subjects Interval 4.61 to 14.8
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 0) ≥ 8	16 Percentages of subjects Interval 11.03 to 21.99	11 Percentages of subjects Interval 6.92 to 16.64	14 Percentages of subjects Interval 8.47 to 21.71	7 Percentages of subjects Interval 3.19 to 13.83	16 Percentages of subjects Interval 9.89 to 23.27	9 Percentages of subjects Interval 4.61 to 14.8
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 0) ≥ 16	15 Percentages of subjects Interval 10.13 to 20.8	10 Percentages of subjects Interval 6.04 to 15.34	13 Percentages of subjects Interval 7.17 to 19.78	6 Percentages of subjects Interval 2.6 to 12.67	12 Percentages of subjects Interval 6.76 to 18.73	6 Percentages of subjects Interval 2.55 to 11.18
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 0) ≥ 32	9 Percentages of subjects Interval 5.36 to 14.08	3 Percentages of subjects Interval 0.91 to 6.36	8 Percentages of subjects Interval 4.07 to 14.79	3 Percentages of subjects Interval 0.57 to 7.76	8 Percentages of subjects Interval 3.84 to 14.0	4 Percentages of subjects Interval 1.62 to 9.29
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 0) ≥ 64	2 Percentages of subjects Interval 0.58 to 5.36	2 Percentages of subjects Interval 0.35 to 4.79	4 Percentages of subjects Interval 1.37 to 9.46	0 Percentages of subjects Interval 0.0 to 3.3	5 Percentages of subjects Interval 1.75 to 10.0	3 Percentages of subjects Interval 0.8 to 7.31
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 0) ≥ 128	0 Percentages of subjects Interval 0.0 to 1.94	1 Percentages of subjects Interval 0.01 to 3.06	1 Percentages of subjects Interval 0.02 to 4.56	0 Percentages of subjects Interval 0.0 to 3.3	1 Percentages of subjects Interval 0.02 to 4.31	1 Percentages of subjects Interval 0.02 to 4.0
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 2) ≥ LLQ (14.7)	21 Percentages of subjects Interval 15.19 to 27.25	66 Percentages of subjects Interval 58.7 to 72.99	85 Percentages of subjects Interval 77.33 to 90.86	60 Percentages of subjects Interval 50.22 to 69.22	72 Percentages of subjects Interval 62.98 to 79.29	61 Percentages of subjects Interval 52.62 to 69.51
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 2) ≥ 5	27 Percentages of subjects Interval 20.91 to 34.08	72 Percentages of subjects Interval 64.48 to 78.12	90 Percentages of subjects Interval 83.18 to 94.73	65 Percentages of subjects Interval 55.79 to 74.26	78 Percentages of subjects Interval 69.74 to 84.82	65 Percentages of subjects Interval 56.35 to 72.91
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 2) ≥ 8	26 Percentages of subjects Interval 19.95 to 32.95	70 Percentages of subjects Interval 62.74 to 76.59	89 Percentages of subjects Interval 82.19 to 94.1	62 Percentages of subjects Interval 52.07 to 70.92	76 Percentages of subjects Interval 68.03 to 83.46	64 Percentages of subjects Interval 54.85 to 71.56
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 2) ≥ 16	20 Percentages of subjects Interval 14.72 to 26.67	64 Percentages of subjects Interval 56.41 to 70.9	85 Percentages of subjects Interval 77.33 to 90.86	58 Percentages of subjects Interval 48.39 to 67.52	69 Percentages of subjects Interval 60.49 to 77.17	60 Percentages of subjects Interval 51.14 to 68.13
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 2) ≥ 32	13 Percentages of subjects Interval 8.35 to 18.4	47 Percentages of subjects Interval 39.75 to 54.79	75 Percentages of subjects Interval 66.27 to 82.45	47 Percentages of subjects Interval 37.68 to 57.02	54 Percentages of subjects Interval 44.48 to 62.44	50 Percentages of subjects Interval 41.7 to 59.01
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 2) ≥ 64	5 Percentages of subjects Interval 2.21 to 8.89	31 Percentages of subjects Interval 23.92 to 37.84	59 Percentages of subjects Interval 49.82 to 68.05	30 Percentages of subjects Interval 21.63 to 39.48	39 Percentages of subjects Interval 30.08 to 47.63	39 Percentages of subjects Interval 31.18 to 48.12
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 2) ≥ 128	1 Percentages of subjects Interval 0.13 to 3.79	14 Percentages of subjects Interval 9.19 to 19.82	39 Percentages of subjects Interval 30.39 to 48.5	12 Percentages of subjects Interval 6.45 to 19.36	23 Percentages of subjects Interval 15.86 to 31.12	23 Percentages of subjects Interval 16.56 to 31.34
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 3) ≥ LLQ (14.7)	27 Percentages of subjects Interval 20.43 to 33.52	92 Percentages of subjects Interval 87.29 to 95.68	80 Percentages of subjects Interval 71.72 to 86.75	58 Percentages of subjects Interval 48.39 to 67.52	62 Percentages of subjects Interval 53.17 to 70.65	90 Percentages of subjects Interval 83.45 to 94.3
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 3) ≥ 5	33 Percentages of subjects Interval 26.31 to 40.19	94 Percentages of subjects Interval 89.33 to 96.91	84 Percentages of subjects Interval 76.38 to 90.19	65 Percentages of subjects Interval 54.85 to 73.43	70 Percentages of subjects Interval 61.32 to 77.88	93 Percentages of subjects Interval 86.99 to 96.44
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 3) ≥ 8	30 Percentages of subjects Interval 23.84 to 37.43	93 Percentages of subjects Interval 88.64 to 96.51	83 Percentages of subjects Interval 75.44 to 89.51	60 Percentages of subjects Interval 50.22 to 69.22	67 Percentages of subjects Interval 58.03 to 75.02	93 Percentages of subjects Interval 86.99 to 96.44
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 3) ≥ 64	9 Percentages of subjects Interval 4.94 to 13.45	68 Percentages of subjects Interval 61.0 to 75.05	47 Percentages of subjects Interval 37.51 to 55.99	24 Percentages of subjects Interval 16.06 to 32.68	31 Percentages of subjects Interval 23.55 to 40.33	65 Percentages of subjects Interval 56.35 to 72.91
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 3) ≥ 128	2 Percentages of subjects Interval 0.58 to 5.36	39 Percentages of subjects Interval 32.25 to 46.99	28 Percentages of subjects Interval 19.75 to 36.4	16 Percentages of subjects Interval 10.0 to 24.62	23 Percentages of subjects Interval 15.86 to 31.12	47 Percentages of subjects Interval 38.15 to 55.43
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 7) ≥ LLQ (14.7)	23 Percentages of subjects Interval 17.07 to 29.55	78 Percentages of subjects Interval 70.99 to 83.62	72 Percentages of subjects Interval 62.72 to 79.51	95 Percentages of subjects Interval 88.51 to 97.97	54 Percentages of subjects Interval 44.48 to 62.44	97 Percentages of subjects Interval 92.69 to 99.2
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 7) ≥ 5	26 Percentages of subjects Interval 19.95 to 32.95	86 Percentages of subjects Interval 79.56 to 90.34	80 Percentages of subjects Interval 71.72 to 86.75	95 Percentages of subjects Interval 89.71 to 98.51	69 Percentages of subjects Interval 59.67 to 76.45	99 Percentages of subjects Interval 94.83 to 99.82
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 7) ≥ 8	26 Percentages of subjects Interval 19.46 to 32.39	84 Percentages of subjects Interval 77.69 to 88.94	77 Percentages of subjects Interval 68.07 to 83.9	95 Percentages of subjects Interval 89.71 to 98.51	64 Percentages of subjects Interval 54.78 to 72.12	98 Percentages of subjects Interval 93.73 to 99.55
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 7) ≥ 16	22 Percentages of subjects Interval 16.13 to 28.4	74 Percentages of subjects Interval 66.83 to 80.14	69 Percentages of subjects Interval 60.09 to 77.27	94 Percentages of subjects Interval 87.33 to 97.4	52 Percentages of subjects Interval 42.93 to 60.91	97 Percentages of subjects Interval 92.69 to 99.2
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 7) ≥ 32	13 Percentages of subjects Interval 8.35 to 18.4	63 Percentages of subjects Interval 55.27 to 69.85	54 Percentages of subjects Interval 44.83 to 63.29	87 Percentages of subjects Interval 79.57 to 92.86	40 Percentages of subjects Interval 31.56 to 49.22	91 Percentages of subjects Interval 85.2 to 95.39
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 7) ≥ 64	3 Percentages of subjects Interval 0.87 to 6.1	37 Percentages of subjects Interval 30.15 to 44.73	35 Percentages of subjects Interval 26.52 to 44.24	79 Percentages of subjects Interval 70.3 to 86.26	27 Percentages of subjects Interval 19.31 to 35.35	75 Percentages of subjects Interval 67.08 to 82.16
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 7) ≥ 128	1 Percentages of subjects Interval 0.01 to 2.93	14 Percentages of subjects Interval 9.66 to 20.44	22 Percentages of subjects Interval 14.67 to 30.11	57 Percentages of subjects Interval 47.48 to 66.66	13 Percentages of subjects Interval 8.0 to 20.56	57 Percentages of subjects Interval 48.2 to 65.36
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 13) ≥ LLQ (14.7)	19 Percentages of subjects Interval 13.32 to 24.93	64 Percentages of subjects Interval 56.41 to 70.9	58 Percentages of subjects Interval 48.15 to 66.47	78 Percentages of subjects Interval 69.3 to 85.49	97 Percentages of subjects Interval 92.13 to 99.14	82 Percentages of subjects Interval 75.06 to 88.44
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 13) ≥ 5	25 Percentages of subjects Interval 18.98 to 31.82	76 Percentages of subjects Interval 68.61 to 81.64	73 Percentages of subjects Interval 64.49 to 80.99	91 Percentages of subjects Interval 83.92 to 95.55	97 Percentages of subjects Interval 92.13 to 99.14	91 Percentages of subjects Interval 85.2 to 95.39
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 13) ≥ 64	3 Percentages of subjects Interval 1.18 to 6.82	21 Percentages of subjects Interval 15.39 to 27.81	23 Percentages of subjects Interval 15.38 to 31.02	41 Percentages of subjects Interval 31.63 to 50.69	92 Percentages of subjects Interval 86.0 to 96.16	46 Percentages of subjects Interval 37.44 to 54.7
Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules. Y human Serogroup (At Month 13) ≥ 128	1 Percentages of subjects Interval 0.13 to 3.79	9 Percentages of subjects Interval 5.17 to 14.03	11 Percentages of subjects Interval 5.9 to 17.81	21 Percentages of subjects Interval 13.74 to 29.7	73 Percentages of subjects Interval 64.65 to 80.69	28 Percentages of subjects Interval 21.09 to 36.8

SECONDARY outcome

Timeframe: At Month 2, Month 3, Month 7 and Month 13

The kinetic of immune response (at Months 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with two-, three- and four-fold titer rise against serogroups A, C, W and Y and serogroup B test strains was assessed. The two/three/four fold titer rise is defined as: a) for subjects with prevaccination hSBA titers ≤ LLQ, a postvaccination hSBA ≥ 2/3/4 LLQ; b) for subjects with a prevaccination hSBA titers ≥ LLQ, an increase of at least 2/3/4 times of the prevaccination hSBA titer.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=188 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=185 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=122 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=114 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=128 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=137 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. C human Serogroup ≥ 2-fold (At Month 2)	24 Percentages of subjects Interval 18.23 to 31.0	64 Percentages of subjects Interval 56.41 to 70.71	95 Percentages of subjects Interval 89.6 to 98.17	55 Percentages of subjects Interval 45.66 to 64.58	73 Percentages of subjects Interval 64.43 to 80.76	62 Percentages of subjects Interval 52.61 to 69.93
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M14459 Strain ≥ 4-fold (At Month 2)	7 Percentages of subjects Interval 3.82 to 11.78	6 Percentages of subjects Interval 2.71 to 10.03	15 Percentages of subjects Interval 9.1 to 23.19	4 Percentages of subjects Interval 1.02 to 9.21	12 Percentages of subjects Interval 6.99 to 19.32	4 Percentages of subjects Interval 1.22 to 8.49
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. C human Serogroup ≥ 2-fold (At Month 3)	80 Percentages of subjects Interval 73.05 to 85.12	94 Percentages of subjects Interval 89.61 to 96.99	93 Percentages of subjects Interval 86.46 to 96.57	58 Percentages of subjects Interval 48.29 to 67.08	65 Percentages of subjects Interval 55.92 to 73.42	98 Percentages of subjects Interval 93.4 to 99.52
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. NZ98/254 Strain ≥ 2-fold (At Month 2)	18 Percentages of subjects Interval 12.86 to 24.34	13 Percentages of subjects Interval 8.49 to 18.69	28 Percentages of subjects Interval 19.75 to 36.4	9 Percentages of subjects Interval 4.36 to 15.81	21 Percentages of subjects Interval 14.62 to 29.62	12 Percentages of subjects Interval 6.98 to 18.67
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. NZ98/254 Strain ≥ 3-fold (At Month 2)	14 Percentages of subjects Interval 9.24 to 19.6	9 Percentages of subjects Interval 5.44 to 14.3	19 Percentages of subjects Interval 12.56 to 27.36	9 Percentages of subjects Interval 4.36 to 15.81	17 Percentages of subjects Interval 11.28 to 25.23	7 Percentages of subjects Interval 3.64 to 13.3
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. NZ98/254 Strain ≥ 4-fold (At Month 2)	11 Percentages of subjects Interval 7.05 to 16.57	8 Percentages of subjects Interval 4.61 to 13.02	17 Percentages of subjects Interval 10.49 to 24.56	7 Percentages of subjects Interval 3.13 to 13.59	17 Percentages of subjects Interval 10.62 to 24.34	7 Percentages of subjects Interval 3.12 to 12.37
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. NZ98/254 Strain ≥ 2-fold (At Month 3)	73 Percentages of subjects Interval 66.48 to 79.57	42 Percentages of subjects Interval 34.43 to 49.08	18 Percentages of subjects Interval 11.17 to 25.5	9 Percentages of subjects Interval 4.36 to 15.81	13 Percentages of subjects Interval 8.06 to 20.72	43 Percentages of subjects Interval 34.76 to 52.11
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. NZ98/254 Strain ≥ 3-fold (At Month 3)	61 Percentages of subjects Interval 53.81 to 68.18	32 Percentages of subjects Interval 25.25 to 39.13	13 Percentages of subjects Interval 7.17 to 19.78	5 Percentages of subjects Interval 1.99 to 11.3	10 Percentages of subjects Interval 5.61 to 17.0	28 Percentages of subjects Interval 20.91 to 36.79
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. NZ98/254 Strain ≥ 4-fold (At Month 3)	47 Percentages of subjects Interval 39.51 to 54.21	22 Percentages of subjects Interval 15.92 to 28.26	9 Percentages of subjects Interval 4.67 to 15.81	4 Percentages of subjects Interval 0.98 to 8.89	9 Percentages of subjects Interval 4.44 to 15.08	19 Percentages of subjects Interval 12.45 to 26.3
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. NZ98/254 Strain ≥ 2-fold (At Month 7)	19 Percentages of subjects Interval 13.32 to 24.93	12 Percentages of subjects Interval 8.05 to 18.07	11 Percentages of subjects Interval 5.9 to 17.81	45 Percentages of subjects Interval 35.24 to 54.33	7 Percentages of subjects Interval 3.32 to 13.13	54 Percentages of subjects Interval 44.92 to 62.38
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. NZ98/254 Strain ≥ 3-fold (At Month 7)	11 Percentages of subjects Interval 7.05 to 16.57	10 Percentages of subjects Interval 6.3 to 15.57	7 Percentages of subjects Interval 2.92 to 12.71	33 Percentages of subjects Interval 24.44 to 42.56	6 Percentages of subjects Interval 2.78 to 12.13	43 Percentages of subjects Interval 34.76 to 52.11
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. NZ98/254 Strain ≥ 4-fold (At Month 7)	9 Percentages of subjects Interval 5.36 to 14.08	8 Percentages of subjects Interval 4.61 to 13.02	6 Percentages of subjects Interval 2.38 to 11.65	24 Percentages of subjects Interval 16.53 to 33.1	4 Percentages of subjects Interval 1.3 to 9.02	33 Percentages of subjects Interval 24.97 to 41.47
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. NZ98/254 Strain ≥ 2-fold (At Month 13)	11 Percentages of subjects Interval 6.62 to 15.95	9 Percentages of subjects Interval 5.44 to 14.3	7 Percentages of subjects Interval 2.92 to 12.71	10 Percentages of subjects Interval 5.01 to 16.89	49 Percentages of subjects Interval 40.19 to 58.26	14 Percentages of subjects Interval 8.76 to 21.25
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. NZ98/254 Strain ≥ 3-fold (At Month 13)	5 Percentages of subjects Interval 2.58 to 9.56	7 Percentages of subjects Interval 3.79 to 11.72	6 Percentages of subjects Interval 2.38 to 11.65	9 Percentages of subjects Interval 4.36 to 15.81	37 Percentages of subjects Interval 28.12 to 45.55	7 Percentages of subjects Interval 3.64 to 13.3
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M14459 Strain ≥ 2-fold (At Month 3)	65 Percentages of subjects Interval 57.86 to 72.07	50 Percentages of subjects Interval 42.72 to 57.82	24 Percentages of subjects Interval 16.53 to 33.1	6 Percentages of subjects Interval 2.65 to 12.9	14 Percentages of subjects Interval 8.26 to 21.2	50 Percentages of subjects Interval 41.25 to 58.75
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M14459 Strain ≥ 3-fold (At Month 3)	49 Percentages of subjects Interval 41.49 to 56.37	39 Percentages of subjects Interval 31.38 to 46.1	10 Percentages of subjects Interval 5.01 to 16.89	3 Percentages of subjects Interval 0.58 to 7.9	11 Percentages of subjects Interval 5.75 to 17.4	39 Percentages of subjects Interval 30.52 to 47.6
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M14459 Strain ≥ 4-fold (At Month 3)	38 Percentages of subjects Interval 30.49 to 44.92	28 Percentages of subjects Interval 22.01 to 35.7	4 Percentages of subjects Interval 1.47 to 10.11	3 Percentages of subjects Interval 0.58 to 7.9	7 Percentages of subjects Interval 3.4 to 13.44	28 Percentages of subjects Interval 20.24 to 36.0
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M14459 Strain ≥ 2-fold (At Month 7)	16 Percentages of subjects Interval 11.28 to 22.45	14 Percentages of subjects Interval 9.25 to 19.92	9 Percentages of subjects Interval 4.36 to 15.81	69 Percentages of subjects Interval 58.88 to 77.12	7 Percentages of subjects Interval 2.85 to 12.41	72 Percentages of subjects Interval 63.21 to 79.09
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M14459 Strain ≥ 3-fold (At Month 7)	12 Percentages of subjects Interval 7.65 to 17.54	7 Percentages of subjects Interval 3.92 to 12.1	6 Percentages of subjects Interval 2.55 to 12.45	55 Percentages of subjects Interval 44.76 to 64.24	6 Percentages of subjects Interval 2.32 to 11.37	54 Percentages of subjects Interval 45.65 to 63.1
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M14459 Strain ≥ 4-fold (At Month 7)	8 Percentages of subjects Interval 4.22 to 12.44	6 Percentages of subjects Interval 3.11 to 10.73	4 Percentages of subjects Interval 0.98 to 8.89	48 Percentages of subjects Interval 38.43 to 57.97	5 Percentages of subjects Interval 1.81 to 10.32	49 Percentages of subjects Interval 39.79 to 57.29
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M14459 Strain ≥ 2-fold (At Month 13)	11 Percentages of subjects Interval 7.21 to 16.92	9 Percentages of subjects Interval 5.63 to 14.77	6 Percentages of subjects Interval 2.55 to 12.45	10 Percentages of subjects Interval 5.2 to 17.49	74 Percentages of subjects Interval 65.3 to 81.48	12 Percentages of subjects Interval 6.98 to 18.67
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M14459 Strain ≥ 3-fold (At Month 13)	8 Percentages of subjects Interval 4.22 to 12.44	4 Percentages of subjects Interval 1.95 to 8.62	4 Percentages of subjects Interval 1.47 to 10.11	7 Percentages of subjects Interval 3.25 to 14.07	59 Percentages of subjects Interval 50.12 to 68.11	6 Percentages of subjects Interval 2.61 to 11.42
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M14459 Strain ≥ 4-fold (At Month 13)	3 Percentages of subjects Interval 1.21 to 6.96	4 Percentages of subjects Interval 1.59 to 7.89	3 Percentages of subjects Interval 0.56 to 7.63	6 Percentages of subjects Interval 2.07 to 11.7	51 Percentages of subjects Interval 42.05 to 60.33	4 Percentages of subjects Interval 1.66 to 9.49
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M07-0241084 Strain ≥ 2-fold (At Month 2)	16 Percentages of subjects Interval 11.49 to 22.58	11 Percentages of subjects Interval 6.63 to 16.34	20 Percentages of subjects Interval 12.89 to 28.02	5 Percentages of subjects Interval 1.97 to 11.2	19 Percentages of subjects Interval 12.45 to 27.14	8 Percentages of subjects Interval 3.81 to 13.9
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M07-0241084 Strain ≥ 3-fold (At Month 2)	12 Percentages of subjects Interval 7.92 to 17.79	7 Percentages of subjects Interval 3.57 to 11.61	9 Percentages of subjects Interval 4.79 to 16.2	2 Percentages of subjects Interval 0.22 to 6.25	12 Percentages of subjects Interval 6.47 to 18.65	4 Percentages of subjects Interval 1.28 to 8.88
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M07-0241084 Strain ≥ 4-fold (At Month 2)	8 Percentages of subjects Interval 4.53 to 12.82	5 Percentages of subjects Interval 1.98 to 8.76	7 Percentages of subjects Interval 3.0 to 13.03	2 Percentages of subjects Interval 0.22 to 6.25	9 Percentages of subjects Interval 4.63 to 15.68	1 Percentages of subjects Interval 0.02 to 4.28
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M07-0241084 Strain ≥ 2-fold (At Month 3)	37 Percentages of subjects Interval 29.81 to 44.02	22 Percentages of subjects Interval 16.26 to 29.02	11 Percentages of subjects Interval 6.05 to 18.25	2 Percentages of subjects Interval 0.22 to 6.25	8 Percentages of subjects Interval 4.03 to 14.67	21 Percentages of subjects Interval 14.38 to 29.19
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M07-0241084 Strain ≥ 3-fold (At Month 3)	28 Percentages of subjects Interval 21.4 to 34.64	12 Percentages of subjects Interval 7.54 to 17.66	7 Percentages of subjects Interval 3.0 to 13.03	1 Percentages of subjects Interval 0.02 to 4.83	5 Percentages of subjects Interval 1.84 to 10.48	17 Percentages of subjects Interval 11.1 to 24.86
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M07-0241084 Strain ≥ 4-fold (At Month 3)	19 Percentages of subjects Interval 13.32 to 24.93	9 Percentages of subjects Interval 5.29 to 14.34	4 Percentages of subjects Interval 1.4 to 9.69	0 Percentages of subjects Interval 0.0 to 3.21	4 Percentages of subjects Interval 1.36 to 9.38	13 Percentages of subjects Interval 7.93 to 20.41
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M07-0241084 Strain ≥ 2-fold (At Month 7)	19 Percentages of subjects Interval 13.32 to 24.93	13 Percentages of subjects Interval 8.0 to 18.31	8 Percentages of subjects Interval 3.58 to 14.1	43 Percentages of subjects Interval 34.07 to 53.01	4 Percentages of subjects Interval 1.36 to 9.38	42 Percentages of subjects Interval 33.51 to 51.23
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M07-0241084 Strain ≥ 3-fold (At Month 7)	11 Percentages of subjects Interval 7.05 to 16.57	7 Percentages of subjects Interval 3.99 to 12.3	6 Percentages of subjects Interval 2.44 to 11.94	31 Percentages of subjects Interval 22.61 to 40.36	1 Percentages of subjects Interval 0.02 to 4.52	32 Percentages of subjects Interval 24.06 to 40.85
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M07-0241084 Strain ≥ 4-fold (At Month 7)	7 Percentages of subjects Interval 4.13 to 12.18	6 Percentages of subjects Interval 2.76 to 10.2	3 Percentages of subjects Interval 0.94 to 8.52	19 Percentages of subjects Interval 12.62 to 27.98	1 Percentages of subjects Interval 0.02 to 4.52	22 Percentages of subjects Interval 15.05 to 30.04
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M07-0241084 Strain ≥ 2-fold (At Month 13)	13 Percentages of subjects Interval 8.35 to 18.4	11 Percentages of subjects Interval 7.08 to 17.0	8 Percentages of subjects Interval 3.58 to 14.1	13 Percentages of subjects Interval 7.62 to 20.95	41 Percentages of subjects Interval 32.45 to 50.63	15 Percentages of subjects Interval 9.18 to 22.21
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M07-0241084 Strain ≥ 3-fold (At Month 13)	9 Percentages of subjects Interval 4.94 to 13.45	7 Percentages of subjects Interval 3.99 to 12.3	5 Percentages of subjects Interval 1.9 to 10.83	9 Percentages of subjects Interval 4.33 to 15.67	34 Percentages of subjects Interval 25.53 to 43.05	10 Percentages of subjects Interval 5.52 to 16.74
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M07-0241084 Strain ≥ 4-fold (At Month 13)	5 Percentages of subjects Interval 2.58 to 9.56	6 Percentages of subjects Interval 2.76 to 10.2	4 Percentages of subjects Interval 1.4 to 9.69	6 Percentages of subjects Interval 2.53 to 12.35	21 Percentages of subjects Interval 13.84 to 28.97	6 Percentages of subjects Interval 2.74 to 11.94
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. 96217 Strain ≥ 2-fold (At Month 2)	34 Percentages of subjects Interval 27.61 to 41.71	29 Percentages of subjects Interval 22.65 to 36.48	88 Percentages of subjects Interval 81.2 to 93.47	32 Percentages of subjects Interval 23.63 to 41.63	31 Percentages of subjects Interval 23.35 to 40.04	26 Percentages of subjects Interval 18.84 to 35.24
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. 96217 Strain ≥ 3-fold (At Month 2)	26 Percentages of subjects Interval 19.68 to 32.72	20 Percentages of subjects Interval 14.09 to 26.27	81 Percentages of subjects Interval 72.64 to 87.44	19 Percentages of subjects Interval 12.0 to 27.22	18 Percentages of subjects Interval 11.74 to 25.73	19 Percentages of subjects Interval 12.45 to 27.14
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. 96217 Strain ≥ 4-fold (At Month 2)	18 Percentages of subjects Interval 12.54 to 24.0	13 Percentages of subjects Interval 8.37 to 18.76	76 Percentages of subjects Interval 67.17 to 83.18	12 Percentages of subjects Interval 6.33 to 19.03	14 Percentages of subjects Interval 8.55 to 21.31	16 Percentages of subjects Interval 9.73 to 23.43
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. 96217 Strain ≥ 2-fold (At Month 3)	97 Percentages of subjects Interval 93.84 to 99.12	92 Percentages of subjects Interval 87.16 to 95.63	85 Percentages of subjects Interval 77.33 to 90.86	28 Percentages of subjects Interval 19.64 to 36.93	23 Percentages of subjects Interval 16.41 to 31.74	91 Percentages of subjects Interval 84.32 to 95.37
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. 96217 Strain ≥ 3-fold (At Month 3)	96 Percentages of subjects Interval 92.4 to 98.47	89 Percentages of subjects Interval 83.18 to 93.0	76 Percentages of subjects Interval 67.17 to 83.18	14 Percentages of subjects Interval 8.39 to 22.16	17 Percentages of subjects Interval 11.1 to 24.86	88 Percentages of subjects Interval 81.35 to 93.53
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. 96217 Strain ≥ 4-fold (At Month 3)	94 Percentages of subjects Interval 89.66 to 97.01	83 Percentages of subjects Interval 76.2 to 87.85	69 Percentages of subjects Interval 60.09 to 77.27	11 Percentages of subjects Interval 5.66 to 17.97	13 Percentages of subjects Interval 7.93 to 20.41	83 Percentages of subjects Interval 75.63 to 89.6
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. 96217 Strain ≥ 2-fold (At Month 7)	81 Percentages of subjects Interval 74.81 to 86.53	74 Percentages of subjects Interval 66.48 to 79.91	64 Percentages of subjects Interval 54.9 to 72.71	96 Percentages of subjects Interval 91.11 to 99.02	16 Percentages of subjects Interval 10.45 to 23.98	97 Percentages of subjects Interval 91.75 to 99.09
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. 96217 Strain ≥ 3-fold (At Month 7)	73 Percentages of subjects Interval 65.57 to 78.85	63 Percentages of subjects Interval 55.38 to 70.03	52 Percentages of subjects Interval 42.37 to 60.88	96 Percentages of subjects Interval 91.11 to 99.02	9 Percentages of subjects Interval 4.94 to 15.8	96 Percentages of subjects Interval 90.62 to 98.64
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. 96217 Strain ≥ 4-fold (At Month 7)	61 Percentages of subjects Interval 53.89 to 68.33	50 Percentages of subjects Interval 42.43 to 57.57	42 Percentages of subjects Interval 32.74 to 51.02	95 Percentages of subjects Interval 88.7 to 98.01	7 Percentages of subjects Interval 3.27 to 12.93	94 Percentages of subjects Interval 88.44 to 97.64
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. 96217 Strain ≥ 2-fold (At Month 13)	65 Percentages of subjects Interval 57.73 to 71.88	54 Percentages of subjects Interval 46.32 to 61.42	52 Percentages of subjects Interval 42.37 to 60.88	72 Percentages of subjects Interval 63.07 to 80.36	96 Percentages of subjects Interval 91.12 to 98.72	77 Percentages of subjects Interval 68.32 to 84.04
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. NZ98/254 Strain ≥ 4-fold (At Month 13)	4 Percentages of subjects Interval 1.85 to 8.21	5 Percentages of subjects Interval 2.62 to 9.72	5 Percentages of subjects Interval 1.86 to 10.57	6 Percentages of subjects Interval 2.55 to 12.45	26 Percentages of subjects Interval 18.76 to 34.77	4 Percentages of subjects Interval 1.66 to 9.49
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M14459 Strain ≥ 2-fold (At Month 2)	14 Percentages of subjects Interval 9.44 to 20.02	13 Percentages of subjects Interval 8.32 to 18.65	34 Percentages of subjects Interval 25.25 to 43.48	8 Percentages of subjects Interval 3.88 to 15.23	23 Percentages of subjects Interval 15.69 to 31.19	11 Percentages of subjects Interval 6.4 to 17.79
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. 96217 Strain ≥ 3-fold (At Month 13)	53 Percentages of subjects Interval 45.78 to 60.56	39 Percentages of subjects Interval 32.1 to 46.91	34 Percentages of subjects Interval 25.76 to 43.38	54 Percentages of subjects Interval 44.78 to 63.9	95 Percentages of subjects Interval 89.06 to 97.77	62 Percentages of subjects Interval 52.71 to 70.65
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. 96217 Strain ≥ 4-fold (At Month 13)	35 Percentages of subjects Interval 28.62 to 42.82	22 Percentages of subjects Interval 16.57 to 29.32	28 Percentages of subjects Interval 19.75 to 36.4	45 Percentages of subjects Interval 35.24 to 54.33	93 Percentages of subjects Interval 87.07 to 96.73	51 Percentages of subjects Interval 41.99 to 60.43
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. A human Serogroup ≥ 2-fold (At Month 2)	12 Percentages of subjects Interval 7.72 to 18.06	23 Percentages of subjects Interval 17.07 to 29.92	78 Percentages of subjects Interval 68.49 to 85.07	21 Percentages of subjects Interval 13.62 to 29.99	38 Percentages of subjects Interval 28.83 to 46.8	17 Percentages of subjects Interval 10.54 to 24.16
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. A human Serogroup ≥ 3-fold (At Month 2)	9 Percentages of subjects Interval 5.41 to 14.67	16 Percentages of subjects Interval 11.19 to 22.55	64 Percentages of subjects Interval 53.69 to 72.64	14 Percentages of subjects Interval 8.22 to 22.47	30 Percentages of subjects Interval 21.98 to 39.04	13 Percentages of subjects Interval 7.38 to 19.65
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. A human Serogroup ≥ 4-fold (At Month 2)	6 Percentages of subjects Interval 2.82 to 10.43	11 Percentages of subjects Interval 6.55 to 16.17	50 Percentages of subjects Interval 39.72 to 59.37	11 Percentages of subjects Interval 6.05 to 19.11	20 Percentages of subjects Interval 13.25 to 28.28	7 Percentages of subjects Interval 3.29 to 13.03
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. A human Serogroup ≥ 2-fold (At Month 3)	80 Percentages of subjects Interval 72.85 to 85.4	71 Percentages of subjects Interval 63.52 to 77.35	61 Percentages of subjects Interval 50.84 to 70.05	20 Percentages of subjects Interval 12.83 to 28.93	24 Percentages of subjects Interval 16.82 to 32.83	74 Percentages of subjects Interval 65.49 to 81.39
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. A human Serogroup ≥ 3-fold (At Month 3)	66 Percentages of subjects Interval 58.09 to 72.76	52 Percentages of subjects Interval 44.64 to 59.77	41 Percentages of subjects Interval 31.7 to 51.05	12 Percentages of subjects Interval 6.76 to 20.24	18 Percentages of subjects Interval 11.86 to 26.43	56 Percentages of subjects Interval 46.83 to 64.7
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. A human Serogroup ≥ 4-fold (At Month 3)	56 Percentages of subjects Interval 48.64 to 63.93	42 Percentages of subjects Interval 34.79 to 49.75	31 Percentages of subjects Interval 22.27 to 40.5	7 Percentages of subjects Interval 2.72 to 13.25	14 Percentages of subjects Interval 8.47 to 21.71	40 Percentages of subjects Interval 31.56 to 49.22
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. A human Serogroup ≥ 2-fold (At Month 7)	27 Percentages of subjects Interval 20.82 to 34.63	28 Percentages of subjects Interval 21.11 to 34.71	25 Percentages of subjects Interval 17.33 to 34.55	87 Percentages of subjects Interval 78.64 to 92.51	8 Percentages of subjects Interval 3.49 to 13.76	88 Percentages of subjects Interval 81.27 to 93.24
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. A human Serogroup ≥ 3-fold (At Month 7)	17 Percentages of subjects Interval 11.59 to 23.31	16 Percentages of subjects Interval 11.19 to 22.55	16 Percentages of subjects Interval 9.54 to 24.21	76 Percentages of subjects Interval 66.89 to 83.96	6 Percentages of subjects Interval 2.38 to 11.65	77 Percentages of subjects Interval 68.88 to 84.14
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. A human Serogroup ≥ 4-fold (At Month 7)	11 Percentages of subjects Interval 6.78 to 16.71	10 Percentages of subjects Interval 5.66 to 14.85	13 Percentages of subjects Interval 7.34 to 20.98	70 Percentages of subjects Interval 60.78 to 78.98	5 Percentages of subjects Interval 1.86 to 10.57	70 Percentages of subjects Interval 61.32 to 77.88
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. A human Serogroup ≥ 2-fold (At Month 13)	16 Percentages of subjects Interval 10.61 to 22.01	12 Percentages of subjects Interval 7.91 to 18.11	18 Percentages of subjects Interval 11.04 to 26.33	31 Percentages of subjects Interval 22.72 to 41.22	85 Percentages of subjects Interval 77.33 to 90.86	28 Percentages of subjects Interval 20.71 to 37.02
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. A human Serogroup ≥ 3-fold (At Month 13)	9 Percentages of subjects Interval 5.41 to 14.67	8 Percentages of subjects Interval 4.37 to 12.84	11 Percentages of subjects Interval 5.93 to 18.77	25 Percentages of subjects Interval 16.86 to 34.14	80 Percentages of subjects Interval 71.72 to 86.75	15 Percentages of subjects Interval 9.25 to 22.37
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. A human Serogroup ≥ 4-fold (At Month 13)	5 Percentages of subjects Interval 2.42 to 9.7	4 Percentages of subjects Interval 1.6 to 7.93	9 Percentages of subjects Interval 4.57 to 16.52	15 Percentages of subjects Interval 8.97 to 23.56	78 Percentages of subjects Interval 68.98 to 84.62	7 Percentages of subjects Interval 3.29 to 13.03
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. C human Serogroup ≥ 3-fold (At Month 2)	15 Percentages of subjects Interval 10.24 to 21.02	50 Percentages of subjects Interval 42.84 to 57.69	91 Percentages of subjects Interval 84.44 to 95.41	48 Percentages of subjects Interval 38.79 to 57.8	59 Percentages of subjects Interval 49.31 to 67.35	54 Percentages of subjects Interval 44.89 to 62.62
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. C human Serogroup ≥ 4-fold (At Month 2)	9 Percentages of subjects Interval 5.0 to 13.59	42 Percentages of subjects Interval 34.43 to 49.08	88 Percentages of subjects Interval 80.53 to 92.95	44 Percentages of subjects Interval 34.58 to 53.46	50 Percentages of subjects Interval 40.46 to 58.75	42 Percentages of subjects Interval 32.97 to 50.51
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. C human Serogroup ≥ 3-fold (At Month 3)	64 Percentages of subjects Interval 56.63 to 70.87	90 Percentages of subjects Interval 85.06 to 94.13	90 Percentages of subjects Interval 83.45 to 94.81	47 Percentages of subjects Interval 37.94 to 56.94	50 Percentages of subjects Interval 40.46 to 58.75	96 Percentages of subjects Interval 91.25 to 98.74
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. C human Serogroup ≥ 4-fold (At Month 3)	49 Percentages of subjects Interval 41.54 to 56.34	87 Percentages of subjects Interval 81.31 to 91.51	83 Percentages of subjects Interval 74.9 to 89.02	41 Percentages of subjects Interval 32.09 to 50.83	42 Percentages of subjects Interval 33.42 to 51.51	92 Percentages of subjects Interval 85.36 to 95.7
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. C human Serogroup ≥ 2-fold (At Month 7)	29 Percentages of subjects Interval 22.62 to 36.12	86 Percentages of subjects Interval 80.7 to 91.06	89 Percentages of subjects Interval 81.5 to 93.58	97 Percentages of subjects Interval 92.5 to 99.45	50 Percentages of subjects Interval 40.46 to 58.75	98 Percentages of subjects Interval 94.55 to 99.81
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. C human Serogroup ≥ 3-fold (At Month 7)	16 Percentages of subjects Interval 10.7 to 21.62	80 Percentages of subjects Interval 73.5 to 85.51	79 Percentages of subjects Interval 70.35 to 85.58	94 Percentages of subjects Interval 87.76 to 97.5	37 Percentages of subjects Interval 28.09 to 45.75	98 Percentages of subjects Interval 94.55 to 99.81
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. M14459 Strain ≥ 3-fold (At Month 2)	10 Percentages of subjects Interval 5.9 to 15.02	10 Percentages of subjects Interval 6.07 to 15.43	23 Percentages of subjects Interval 15.76 to 32.14	6 Percentages of subjects Interval 2.07 to 11.7	15 Percentages of subjects Interval 9.56 to 23.07	6 Percentages of subjects Interval 2.61 to 11.42
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. C human Serogroup ≥ 4-fold (At Month 7)	10 Percentages of subjects Interval 6.26 to 15.49	71 Percentages of subjects Interval 64.26 to 77.75	72 Percentages of subjects Interval 63.29 to 79.87	92 Percentages of subjects Interval 85.54 to 96.33	28 Percentages of subjects Interval 19.96 to 36.43	98 Percentages of subjects Interval 93.4 to 99.52
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. C human Serogroup ≥ 2-fold (At Month 13)	19 Percentages of subjects Interval 13.94 to 25.77	73 Percentages of subjects Interval 65.97 to 79.23	74 Percentages of subjects Interval 65.04 to 81.32	82 Percentages of subjects Interval 73.23 to 88.22	97 Percentages of subjects Interval 91.88 to 99.11	92 Percentages of subjects Interval 86.31 to 96.25
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. C human Serogroup ≥ 3-fold (At Month 13)	13 Percentages of subjects Interval 8.89 to 19.2	64 Percentages of subjects Interval 56.41 to 70.71	61 Percentages of subjects Interval 52.24 to 70.14	70 Percentages of subjects Interval 60.89 to 78.38	96 Percentages of subjects Interval 90.77 to 98.67	89 Percentages of subjects Interval 82.59 to 93.99
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. C human Serogroup ≥ 4-fold (At Month 13)	10 Percentages of subjects Interval 5.84 to 14.86	51 Percentages of subjects Interval 43.91 to 58.75	53 Percentages of subjects Interval 44.03 to 62.36	56 Percentages of subjects Interval 46.54 to 65.42	93 Percentages of subjects Interval 87.59 to 97.15	85 Percentages of subjects Interval 77.24 to 90.34
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. W human Serogroup ≥ 2-fold (At Month 2)	24 Percentages of subjects Interval 17.71 to 31.41	32 Percentages of subjects Interval 24.95 to 39.0	65 Percentages of subjects Interval 55.42 to 73.24	35 Percentages of subjects Interval 26.24 to 44.96	50 Percentages of subjects Interval 41.25 to 59.54	33 Percentages of subjects Interval 25.09 to 42.4
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. W human Serogroup ≥ 3-fold (At Month 2)	17 Percentages of subjects Interval 11.28 to 23.31	19 Percentages of subjects Interval 13.93 to 25.99	52 Percentages of subjects Interval 42.75 to 61.34	25 Percentages of subjects Interval 17.17 to 34.25	40 Percentages of subjects Interval 31.12 to 49.05	22 Percentages of subjects Interval 14.99 to 30.31
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. W human Serogroup ≥ 4-fold (At Month 2)	11 Percentages of subjects Interval 6.72 to 16.99	16 Percentages of subjects Interval 11.06 to 22.31	42 Percentages of subjects Interval 33.03 to 51.41	18 Percentages of subjects Interval 10.94 to 26.1	34 Percentages of subjects Interval 25.84 to 43.24	18 Percentages of subjects Interval 11.56 to 25.82
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. W human Serogroup ≥ 2-fold (At Month 3)	67 Percentages of subjects Interval 59.48 to 74.44	78 Percentages of subjects Interval 71.59 to 84.12	55 Percentages of subjects Interval 46.07 to 64.57	34 Percentages of subjects Interval 25.4 to 44.01	46 Percentages of subjects Interval 37.31 to 55.56	76 Percentages of subjects Interval 67.93 to 83.61
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. W human Serogroup ≥ 3-fold (At Month 3)	54 Percentages of subjects Interval 46.32 to 62.16	65 Percentages of subjects Interval 57.55 to 71.95	39 Percentages of subjects Interval 29.87 to 48.02	23 Percentages of subjects Interval 15.57 to 32.25	34 Percentages of subjects Interval 25.84 to 43.24	67 Percentages of subjects Interval 58.45 to 75.65
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. W human Serogroup ≥ 4-fold (At Month 3)	43 Percentages of subjects Interval 34.87 to 50.59	57 Percentages of subjects Interval 49.09 to 64.02	30 Percentages of subjects Interval 22.17 to 39.35	19 Percentages of subjects Interval 12.46 to 28.17	28 Percentages of subjects Interval 20.69 to 37.29	56 Percentages of subjects Interval 46.87 to 65.03
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. W human Serogroup ≥ 2-fold (At Month 7)	31 Percentages of subjects Interval 24.42 to 39.23	51 Percentages of subjects Interval 43.57 to 58.62	43 Percentages of subjects Interval 33.83 to 52.25	90 Percentages of subjects Interval 82.51 to 94.8	41 Percentages of subjects Interval 31.89 to 49.88	89 Percentages of subjects Interval 81.64 to 93.64
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. W human Serogroup ≥ 3-fold (At Month 7)	22 Percentages of subjects Interval 15.53 to 28.74	30 Percentages of subjects Interval 23.41 to 37.26	29 Percentages of subjects Interval 20.67 to 37.57	81 Percentages of subjects Interval 71.83 to 87.54	28 Percentages of subjects Interval 19.96 to 36.43	80 Percentages of subjects Interval 72.37 to 87.08
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. W human Serogroup ≥ 4-fold (At Month 7)	13 Percentages of subjects Interval 8.21 to 19.13	21 Percentages of subjects Interval 14.91 to 27.2	17 Percentages of subjects Interval 10.58 to 24.76	73 Percentages of subjects Interval 63.76 to 81.22	20 Percentages of subjects Interval 13.61 to 28.52	73 Percentages of subjects Interval 64.43 to 80.76
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. W human Serogroup ≥ 2-fold (At Month 13)	20 Percentages of subjects Interval 13.92 to 26.73	26 Percentages of subjects Interval 19.36 to 32.58	32 Percentages of subjects Interval 23.69 to 41.1	56 Percentages of subjects Interval 46.6 to 66.0	94 Percentages of subjects Interval 88.63 to 97.68	61 Percentages of subjects Interval 51.77 to 69.64
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. W human Serogroup ≥ 3-fold (At Month 13)	9 Percentages of subjects Interval 4.81 to 14.07	13 Percentages of subjects Interval 8.28 to 18.55	17 Percentages of subjects Interval 10.58 to 24.76	38 Percentages of subjects Interval 28.8 to 47.81	92 Percentages of subjects Interval 85.56 to 96.03	46 Percentages of subjects Interval 36.53 to 54.75
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. W human Serogroup ≥ 4-fold (At Month 13)	7 Percentages of subjects Interval 3.44 to 11.82	11 Percentages of subjects Interval 6.48 to 15.99	13 Percentages of subjects Interval 7.88 to 20.91	27 Percentages of subjects Interval 18.78 to 36.24	89 Percentages of subjects Interval 82.6 to 94.25	29 Percentages of subjects Interval 21.41 to 38.15
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. Y human Serogroup ≥ 2-fold (At Month 2)	6 Percentages of subjects Interval 2.96 to 10.23	49 Percentages of subjects Interval 41.38 to 56.43	74 Percentages of subjects Interval 65.38 to 81.72	47 Percentages of subjects Interval 37.68 to 57.02	53 Percentages of subjects Interval 43.7 to 61.68	51 Percentages of subjects Interval 42.42 to 59.73
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. Y human Serogroup ≥ 3-fold (At Month 2)	4 Percentages of subjects Interval 1.51 to 7.52	39 Percentages of subjects Interval 32.25 to 46.99	64 Percentages of subjects Interval 54.9 to 72.71	40 Percentages of subjects Interval 30.78 to 49.78	41 Percentages of subjects Interval 32.3 to 50.02	43 Percentages of subjects Interval 34.64 to 51.8
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. Y human Serogroup ≥ 4-fold (At Month 2)	2 Percentages of subjects Interval 0.58 to 5.36	32 Percentages of subjects Interval 25.46 to 39.58	58 Percentages of subjects Interval 48.15 to 66.47	33 Percentages of subjects Interval 24.08 to 42.33	36 Percentages of subjects Interval 27.88 to 45.22	37 Percentages of subjects Interval 29.13 to 45.89
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. Y human Serogroup ≥ 2-fold (At Month 3)	10 Percentages of subjects Interval 5.77 to 14.71	84 Percentages of subjects Interval 78.31 to 89.41	66 Percentages of subjects Interval 56.62 to 74.24	45 Percentages of subjects Interval 35.93 to 55.23	46 Percentages of subjects Interval 36.81 to 54.74	83 Percentages of subjects Interval 75.88 to 89.05
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. Y human Serogroup ≥ 3-fold (At Month 3)	7 Percentages of subjects Interval 3.73 to 11.53	80 Percentages of subjects Interval 73.4 to 85.58	55 Percentages of subjects Interval 45.65 to 64.09	35 Percentages of subjects Interval 25.74 to 44.21	35 Percentages of subjects Interval 26.43 to 43.6	75 Percentages of subjects Interval 67.08 to 82.16
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. Y human Serogroup ≥ 4-fold (At Month 3)	4 Percentages of subjects Interval 1.85 to 8.21	68 Percentages of subjects Interval 61.0 to 75.05	48 Percentages of subjects Interval 39.12 to 57.63	29 Percentages of subjects Interval 20.82 to 38.52	31 Percentages of subjects Interval 23.55 to 40.33	66 Percentages of subjects Interval 57.86 to 74.26
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. Y human Serogroup ≥ 2-fold (At Month 7)	5 Percentages of subjects Interval 2.21 to 8.89	60 Percentages of subjects Interval 52.45 to 67.22	51 Percentages of subjects Interval 41.55 to 60.07	90 Percentages of subjects Interval 82.81 to 94.9	39 Percentages of subjects Interval 30.08 to 47.63	92 Percentages of subjects Interval 86.09 to 95.92
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. Y human Serogroup ≥ 3-fold (At Month 7)	3 Percentages of subjects Interval 1.18 to 6.82	48 Percentages of subjects Interval 40.29 to 55.34	44 Percentages of subjects Interval 35.11 to 53.52	83 Percentages of subjects Interval 74.35 to 89.27	28 Percentages of subjects Interval 20.71 to 37.02	87 Percentages of subjects Interval 80.03 to 92.02
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. Y human Serogroup ≥ 4-fold (At Month 7)	3 Percentages of subjects Interval 0.87 to 6.1	41 Percentages of subjects Interval 33.31 to 48.11	38 Percentages of subjects Interval 29.61 to 47.65	79 Percentages of subjects Interval 70.3 to 86.26	23 Percentages of subjects Interval 15.86 to 31.12	76 Percentages of subjects Interval 67.87 to 82.8
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. Y human Serogroup ≥ 2-fold (At Month 13)	5 Percentages of subjects Interval 2.21 to 8.89	43 Percentages of subjects Interval 35.45 to 50.35	38 Percentages of subjects Interval 29.61 to 47.65	60 Percentages of subjects Interval 50.22 to 69.22	94 Percentages of subjects Interval 88.97 to 97.76	72 Percentages of subjects Interval 63.2 to 78.91
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. Y human Serogroup ≥ 3-fold (At Month 13)	3 Percentages of subjects Interval 1.18 to 6.82	34 Percentages of subjects Interval 27.01 to 41.3	28 Percentages of subjects Interval 20.49 to 37.28	48 Percentages of subjects Interval 38.55 to 57.91	91 Percentages of subjects Interval 84.08 to 95.02	54 Percentages of subjects Interval 45.3 to 62.56
Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules. Y human Serogroup ≥ 4-fold (At Month 13)	2 Percentages of subjects Interval 0.58 to 5.36	25 Percentages of subjects Interval 18.86 to 31.99	23 Percentages of subjects Interval 16.1 to 31.93	45 Percentages of subjects Interval 35.93 to 55.23	89 Percentages of subjects Interval 82.2 to 93.84	47 Percentages of subjects Interval 38.15 to 55.43

SECONDARY outcome

Timeframe: From Month 0 to Month 13

Population: Analysis was done on the FAS Month 13 Over Time. All subjects in All Enrolled Set who received a study meningococcal vaccination \& provided evaluable serum samples at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.

The area under the curve for percentage of subjects with hSBA titers ≥ LLQ for all serogroups (A, C, W and Y) and for all serogroup B test strains (M14459, 96217, NZ98/254 and M07-0241084) was summarized overall (from Month 0 to Month 13) and by period (from Month 0 to Month 2, Month 2 to Month 3, Month 3 to Month 7 and Month 7 to Month 13) by vaccine groups. It was computed as the sum of the trapezoidal areas and the time unit used was the month. AUC 0\_13 = (r0+r2)(2-0)/2 + (r2+r3)(3-2)/2 + (r3+r7)(7-3)/2 + (r7+r13)(13-7)/2 with ri = percentages of subjects with both hSBA titers \>= LLQ against N. meningitis for all serogroups A, C, W and Y and for all serogroup B test strains at Month 1.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=200 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=196 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=131 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=118 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=132 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=140 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B 96217- Month 3-7 (LLQ-8.6)	388.93 Percentage of subjects	373.02 Percentage of subjects	361.75 Percentage of subjects	307.65 Percentage of subjects	172.73 Percentage of subjects	392.59 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B 96217- Month 7-13 (LLQ-8.6)	545.92 Percentage of subjects	515.49 Percentage of subjects	495.00 Percentage of subjects	561.47 Percentage of subjects	411.36 Percentage of subjects	578.42 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B NZ98/254- Month 0-2 (LLQ-8.2)	30.27 Percentage of subjects	25.84 Percentage of subjects	48.92 Percentage of subjects	22.37 Percentage of subjects	31.33 Percentage of subjects	20.13 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B NZ98/254- Month 2-3 (LLQ-8.2)	55.56 Percentage of subjects	40.77 Percentage of subjects	37.21 Percentage of subjects	15.89 Percentage of subjects	24.05 Percentage of subjects	42.93 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B NZ98/254- Month 3-7 (LLQ-8.2)	227.81 Percentage of subjects	162.89 Percentage of subjects	92.78 Percentage of subjects	156.65 Percentage of subjects	65.46 Percentage of subjects	282.91 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B NZ98/254- Month 7-13 (LLQ-8.2)	142.59 Percentage of subjects	105.40 Percentage of subjects	90.34 Percentage of subjects	242.66 Percentage of subjects	257.90 Percentage of subjects	277.24 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B M07-0241084- Month 0-2 (LLQ-8.9)	57.74 Percentage of subjects	43.20 Percentage of subjects	53.67 Percentage of subjects	42.74 Percentage of subjects	58.93 Percentage of subjects	47.53 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B M07-0241084- Month 2-3 (LLQ-8.9)	52.46 Percentage of subjects	37.16 Percentage of subjects	34.01 Percentage of subjects	28.33 Percentage of subjects	34.47 Percentage of subjects	41.65 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B M07-0241084- Month 3-7 (LLQ-8.9)	213.53 Percentage of subjects	151.20 Percentage of subjects	111.63 Percentage of subjects	190.79 Percentage of subjects	110.94 Percentage of subjects	251.09 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B M07-0241084- Month 7-13 (LLQ-8.9)	217.26 Percentage of subjects	159.73 Percentage of subjects	145.97 Percentage of subjects	301.71 Percentage of subjects	282.69 Percentage of subjects	320.48 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup C- Month 0-2(LLQ-5.2)	102.82 Percentage of subjects	129.30 Percentage of subjects	148.03 Percentage of subjects	126.63 Percentage of subjects	135.79 Percentage of subjects	128.34 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup Y-Month 7-13(LLQ-14.7)	125.13 Percentage of subjects	425.13 Percentage of subjects	389.69 Percentage of subjects	520.64 Percentage of subjects	454.48 Percentage of subjects	537.41 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup Y-Month 3-7(LLQ-14.7)	100.05 Percentage of subjects	339.26 Percentage of subjects	339.26 Percentage of subjects	303.62 Percentage of subjects	234.85 Percentage of subjects	373.95 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup C- Month 2-3(LLQ-5.2)	78.78 Percentage of subjects	91.97 Percentage of subjects	99.22 Percentage of subjects	82.97 Percentage of subjects	88.21 Percentage of subjects	92.85 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup C- Month 3-7(LLQ-5.2)	331.60 Percentage of subjects	390.80 Percentage of subjects	390.79 Percentage of subjects	360.70 Percentage of subjects	339.12 Percentage of subjects	398.53 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup C- Month 7-13(LLQ-5.2)	382.55 Percentage of subjects	567.41 Percentage of subjects	574.69 Percentage of subjects	589.70 Percentage of subjects	545.04 Percentage of subjects	595.68 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup A- Month 0-2 (LLQ-22.7)	26.52 Percentage of subjects	38.01 Percentage of subjects	98.62 Percentage of subjects	38.05 Percentage of subjects	57.12 Percentage of subjects	27.86 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup A- Month 2-3 (LLQ-22.7)	57.69 Percentage of subjects	60.98 Percentage of subjects	86.91 Percentage of subjects	33.40 Percentage of subjects	47.00 Percentage of subjects	59.13 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup A- Month 3-7 (LLQ-22.7)	292.53 Percentage of subjects	264.81 Percentage of subjects	243.86 Percentage of subjects	252.54 Percentage of subjects	119.41 Percentage of subjects	370.46 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup A- Month 7-13 (LLQ-22.7)	256.04 Percentage of subjects	214.62 Percentage of subjects	217.88 Percentage of subjects	446.58 Percentage of subjects	343.24 Percentage of subjects	436.76 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup W-Month 0-2(LLQ-39.6)	75.66 Percentage of subjects	93.12 Percentage of subjects	124.89 Percentage of subjects	85.71 Percentage of subjects	103.94 Percentage of subjects	84.23 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup W-Month 2-3(LLQ-39.6)	68.51 Percentage of subjects	81.75 Percentage of subjects	90.33 Percentage of subjects	65.66 Percentage of subjects	75.19 Percentage of subjects	78.97 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup W-Month 3-7(LLQ-39.6)	293.42 Percentage of subjects	359.84 Percentage of subjects	327.79 Percentage of subjects	331.64 Percentage of subjects	297.71 Percentage of subjects	392.61 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup W-Month 7-13(LLQ-39.6)	305.31 Percentage of subjects	444.54 Percentage of subjects	434.34 Percentage of subjects	543.61 Percentage of subjects	512.92 Percentage of subjects	550.19 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B M14459- Month 0-2 (LLQ-8.0)	35.10 Percentage of subjects	27.81 Percentage of subjects	67.02 Percentage of subjects	21.09 Percentage of subjects	40.10 Percentage of subjects	18.57 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B M14459- Month 2-3 (LLQ-8.0)	55.45 Percentage of subjects	46.06 Percentage of subjects	52.36 Percentage of subjects	16.53 Percentage of subjects	30.88 Percentage of subjects	44.90 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B M14459- Month 3-7 (LLQ-8.0)	228.61 Percentage of subjects	196.15 Percentage of subjects	117.62 Percentage of subjects	206.84 Percentage of subjects	84.60 Percentage of subjects	325.33 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup Y-Month 0-2(LLQ-14.7)	36.25 Percentage of subjects	76.31 Percentage of subjects	99.44 Percentage of subjects	67.83 Percentage of subjects	84.92 Percentage of subjects	67.58 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. Serogroup Y-Month 2-3(LLQ-14.7)	24.51 Percentage of subjects	79.32 Percentage of subjects	83.26 Percentage of subjects	58.88 Percentage of subjects	67.70 Percentage of subjects	75.50 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B M14459- Month 7-13 (LLQ-8.0)	162.94 Percentage of subjects	141.79 Percentage of subjects	82.51 Percentage of subjects	329.36 Percentage of subjects	309.09 Percentage of subjects	347.86 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B 96217- Month 0-2 (LLQ-8.6)	93.52 Percentage of subjects	91.00 Percentage of subjects	124.70 Percentage of subjects	88.27 Percentage of subjects	83.08 Percentage of subjects	79.10 Percentage of subjects
The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains. B 96217- Month 2-3 (LLQ-8.6)	85.03 Percentage of subjects	80.02 Percentage of subjects	95.77 Percentage of subjects	58.55 Percentage of subjects	52.33 Percentage of subjects	74.25 Percentage of subjects

SECONDARY outcome

Timeframe: Within 30 minutes after vaccination

Population: Analysis was done on subjects in Solicited Safety Set - all screened subjects who provided informed consent \& provided demographic \&/or other baseline screening measurements, regardless of the subject's randomization \& vaccination status in the trial, received a subject ID,provided post-vaccination reactogenicity data \& received a study vaccination

Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after each vaccination. Assessed solicited symptoms were Pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C).

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=228 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=232 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=155 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=134 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=151 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=159 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Pain(3rd vaccination)	10 Participants	11 Participants	8 Participants	7 Participants	5 Participants	13 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Pain(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Pain(4th vaccination)	28 Participants	22 Participants	7 Participants	14 Participants	8 Participants	17 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Pain(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Pain(5th vaccination)	19 Participants	16 Participants	12 Participants	15 Participants	13 Participants	12 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Pain(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Headache(1st vaccination)	2 Participants	3 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Headache(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Nausea(1st vaccination)	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Nausea(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Nausea(2nd vaccination)	2 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Nausea(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Induration(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Nausea(3rd vaccination)	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Nausea(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Nausea(4th vaccination)	2 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Nausea(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Nausea(5th vaccination)	1 Participants	0 Participants	3 Participants	1 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Nausea(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Fatigue (1st vaccination)	4 Participants	6 Participants	6 Participants	1 Participants	2 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Fatigue(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Fatigue (2nd vaccination)	4 Participants	3 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Fatigue(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Fatigue(3rd vaccination)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Myalgia(1st vaccination)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Myalgia(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Myalgia(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Myalgia(3rd vaccination)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Myalgia(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Myalgia(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Arthralgia(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Arthralgia(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Induration(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Induration(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Induration(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Induration(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Induration(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Induration(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Induration(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Induration(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Induration(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Erythema(1st vaccination)	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Erythema(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Erythema(2nd vaccination)	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Arthralgia(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Arthralgia(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Arthralgia(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Arthralgia(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Arthralgia(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Arthralgia(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Headache(2nd vaccination)	3 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Headache(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Headache(3rd vaccination)	2 Participants	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Headache(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Headache(4th vaccination)	3 Participants	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Headache(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Headache(5th vaccination)	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Headache(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Chills(1st vaccination)	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Chills(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Chills(2nd vaccination)	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Gradec3 Chills(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Chills(3rd vaccination)	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Chills(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Chills(4th vaccination)	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Chills(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Chills(5th vaccination)	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Chills(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Appetite Loss(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Appetite Loss(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Appetite Loss(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Appetite Loss(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Appetite Loss(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Appetite Loss(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Appetite Loss(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Appetite Loss(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. AnyAppetiteLoss(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Appetite Loss(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Fever(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Fever(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Fever(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Fever(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Fever(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Pain/Fever prevention(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Pain/Fever prevention(2nd vaccination)	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Pain/Fever treatment(2nd vaccination)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Pain/Fever treatment(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Pain/Fever treatment(4th vaccination)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Erythema(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Erythema(3rd vaccination)	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Erythema(3rd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Erythema(4th vaccination)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Erythema(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Erythema(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Erythema(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Pain(1st vaccination)	19 Participants	4 Participants	12 Participants	8 Participants	17 Participants	13 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Pain(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Pain(2nd vaccination)	10 Participants	12 Participants	11 Participants	9 Participants	14 Participants	9 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Pain(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Fatigue (3rd vaccination)	2 Participants	4 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Fatigue (4th vaccination)	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Fatigue(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Fatigue (5th vaccination)	1 Participants	2 Participants	1 Participants	3 Participants	1 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Fatigue(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Myalgia(2nd vaccination)	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Myalgia(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Myalgia(5th vaccination)	0 Participants	4 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Myalgia(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Any Arthralgia(1st vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Grade 3 Arthralgia(2nd vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Pain/Fever prevention(3rd vaccination)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Pain/Fever prevention(4th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Pain/Fever prevention(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Pain/Fever treatment(1st vaccination)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination. Pain/Fever treatment(5th vaccination)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 30 minutes after vaccination

Population: Analysis was done on subjects in the Unsolicited Safety Set-all screened subjects who provided informed consent \& demographic \&/or other baseline screening measurements, regardless of the subject's randomization \& vaccination status, received a subject ID, received a study vaccination \& have either post-vaccination reactogenicity data or records.

An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a participant and/or parent/legal guardian who has signed the informed consent. Number of participants reporting any unsolicited AE within 30 minutes after each vaccination.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=221 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=228 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=151 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=129 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=147 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=157 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Injection site pain	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Asthenia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Dyspnoea	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Fatigue	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Headache	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Hypoaesthesia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Pain	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Pruritus allergic	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Dizziness	3 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Presyncope	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Syncope	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Injection site bruising	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Injection site warmth	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination. Paraesthesia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 30 after any vaccination

Population: Analysis was done on subjects in the Unsolicited Safety Set -all screened subjects who provided informed consent \& provided demographic \&/or other baseline screening measurements, regardless of the subject's randomization \& vaccination status, received a subject ID, received a study vaccination \& have either post-vaccination reactogenicity records.

The number of participants reporting unsolicited AEs and possibly or probably related unsolicited AEs were assessed.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=221 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=228 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=151 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=129 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=147 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=157 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Number of Participants Reporting Unsolicited AEs From Day 1 to Day 30 After Any Vaccination. Any AE(s)	146 Participants	148 Participants	93 Participants	76 Participants	97 Participants	104 Participants
Number of Participants Reporting Unsolicited AEs From Day 1 to Day 30 After Any Vaccination. Possibly or Probably Related AE(s)	25 Participants	31 Participants	23 Participants	16 Participants	18 Participants	27 Participants

SECONDARY outcome

Timeframe: At Day 1 (6 hours) to Day 7 after vaccination

Population: Analysis was done on all subjects in the Solicited Safety Set-all screened subjects who provided informed consent \& provided demographic \&/ other baseline screening measurements,regardless of the subject's randomization \& vaccination status in the trial,received a subject ID,provided post-vaccination reactogenicity data \& received study vaccination

Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=228 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=231 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=155 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=134 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=151 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=159 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Nausea (1st vacc)	42 Participants	36 Participants	28 Participants	17 Participants	26 Participants	21 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Nausea(1stvacc)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. AnyAppetiteLoss(5vacc)	18 Participants	14 Participants	9 Participants	9 Participants	22 Participants	7 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Erythema (5th vacc)	1 Participants	1 Participants	1 Participants	0 Participants	11 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. AnyInduration(1st vacc)	21 Participants	20 Participants	12 Participants	13 Participants	3 Participants	19 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Induration(1vacc)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. AnyInduration(2nd vacc)	2 Participants	2 Participants	10 Participants	0 Participants	11 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. AnyInduration(3rd vacc)	24 Participants	17 Participants	0 Participants	0 Participants	1 Participants	20 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Induration(3vacc)	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. AnyInduration(5th vacc)	2 Participants	3 Participants	1 Participants	2 Participants	16 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Induration(5th vacc)	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Fatigue (1st vacc)	126 Participants	121 Participants	84 Participants	68 Participants	68 Participants	76 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Fatigue(1st vacc)	7 Participants	7 Participants	4 Participants	3 Participants	3 Participants	4 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Fatigue(2nd vacc)	0 Participants	3 Participants	4 Participants	2 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Garde 3 Fatigue(3rd vacc)	4 Participants	5 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Fatigue (4th vacc)	50 Participants	56 Participants	37 Participants	51 Participants	35 Participants	73 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Fatigue(4th vacc)	2 Participants	3 Participants	0 Participants	5 Participants	2 Participants	3 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Fatigue (5th vacc)	62 Participants	59 Participants	37 Participants	41 Participants	51 Participants	46 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Headache (1st vacc)	103 Participants	92 Participants	65 Participants	52 Participants	63 Participants	64 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Headache(1stvacc)	4 Participants	3 Participants	5 Participants	2 Participants	2 Participants	3 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Headache (2nd vacc)	67 Participants	47 Participants	70 Participants	36 Participants	63 Participants	41 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Headache(2ndvacc)	1 Participants	2 Participants	3 Participants	2 Participants	4 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Headache (3rd vacc)	90 Participants	76 Participants	42 Participants	28 Participants	30 Participants	53 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Headache(3rdvacc)	3 Participants	4 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Headache (4th vacc)	49 Participants	35 Participants	26 Participants	44 Participants	26 Participants	52 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Headache (5th vacc)	64 Participants	40 Participants	33 Participants	33 Participants	52 Participants	37 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Headache(5thvacc)	1 Participants	1 Participants	2 Participants	1 Participants	2 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Myalgia (1st vacc)	62 Participants	53 Participants	39 Participants	34 Participants	33 Participants	40 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Myalgia(1st vacc)	2 Participants	4 Participants	2 Participants	2 Participants	0 Participants	3 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Myalgia (2nd vacc)	15 Participants	20 Participants	27 Participants	15 Participants	37 Participants	18 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Myalgia(2nd vacc)	0 Participants	3 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Myalgia (3rd vacc)	52 Participants	40 Participants	13 Participants	10 Participants	13 Participants	34 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Myalgia(3rd vacc)	2 Participants	2 Participants	0 Participants	0 Participants	2 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Myalgia (4th vacc)	17 Participants	20 Participants	11 Participants	26 Participants	13 Participants	39 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Myalgia(4th vacc)	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Myalgia (5th vacc)	16 Participants	26 Participants	19 Participants	12 Participants	21 Participants	19 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Myalgia(5th vacc)	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any AE	225 Participants	228 Participants	153 Participants	131 Participants	151 Participants	157 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Local AE	224 Participants	227 Participants	148 Participants	129 Participants	148 Participants	156 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Systemic AE	201 Participants	201 Participants	143 Participants	117 Participants	134 Participants	143 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Pain (1st vacc)	213 Participants	223 Participants	142 Participants	126 Participants	80 Participants	146 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Pain (1st vacc)	9 Participants	13 Participants	2 Participants	10 Participants	0 Participants	6 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Pain (2nd vacc)	32 Participants	34 Participants	122 Participants	41 Participants	135 Participants	51 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Pain (2nd vacc)	0 Participants	1 Participants	5 Participants	0 Participants	11 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Pain (3rd vacc)	193 Participants	185 Participants	38 Participants	26 Participants	16 Participants	133 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Pain (3rd vacc)	11 Participants	7 Participants	0 Participants	0 Participants	0 Participants	5 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Pain (4th vacc)	79 Participants	77 Participants	19 Participants	106 Participants	44 Participants	138 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Pain (4th vacc)	1 Participants	0 Participants	0 Participants	10 Participants	0 Participants	9 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Pain (5th vacc)	83 Participants	80 Participants	58 Participants	48 Participants	119 Participants	64 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Pain (5th vacc)	0 Participants	1 Participants	1 Participants	0 Participants	11 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Erythema (1st vacc)	23 Participants	21 Participants	16 Participants	11 Participants	1 Participants	23 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Erythema (1st vacc)	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Erythema (2nd vacc)	3 Participants	5 Participants	8 Participants	1 Participants	17 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Erythema(2ndvacc)	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Erythema (3rd vacc)	32 Participants	27 Participants	0 Participants	2 Participants	0 Participants	19 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Erythema(3rdvacc)	2 Participants	6 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3AppetiteLoss(1vacc)	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. AnyAppetiteLoss(3vacc)	28 Participants	28 Participants	7 Participants	7 Participants	11 Participants	17 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3AppetiteLoss(3vacc)	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3AppetiteLoss(5vacc)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Nausea (2nd vacc)	17 Participants	15 Participants	20 Participants	10 Participants	26 Participants	15 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Nausea(2nd vacc)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Nausea (3rd vacc)	35 Participants	24 Participants	10 Participants	8 Participants	4 Participants	21 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Nausea(3rd vacc)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Nausea (5th vacc)	16 Participants	15 Participants	8 Participants	11 Participants	21 Participants	12 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Nausea(5th vacc)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Chills (2nd vacc)	17 Participants	26 Participants	26 Participants	12 Participants	32 Participants	15 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Chills(2ndvacc)	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Chills(3rd vacc)	33 Participants	33 Participants	9 Participants	7 Participants	12 Participants	22 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Chills(3rdvacc)	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Chills(5vacc)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Fever (1st vacc)	5 Participants	4 Participants	5 Participants	1 Participants	2 Participants	3 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Fever (2nd vacc)	2 Participants	6 Participants	4 Participants	2 Participants	9 Participants	3 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Fever (4th vacc)	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants	7 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Fever (5th vacc)	5 Participants	1 Participants	2 Participants	0 Participants	3 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Pain/Fever prevention(5)	5 Participants	9 Participants	4 Participants	1 Participants	26 Participants	3 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Pain/Fever treatment(5)	3 Participants	8 Participants	2 Participants	3 Participants	29 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Arthralgia(1st vacc)	25 Participants	14 Participants	13 Participants	17 Participants	12 Participants	14 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Arthralgia(1stvacc)	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Arthralgia (2nd vacc)	7 Participants	11 Participants	10 Participants	9 Participants	8 Participants	7 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Arthralgia(2ndvacc)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Arthralgia(3rd vacc)	16 Participants	7 Participants	4 Participants	3 Participants	6 Participants	11 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Arthralgia(3rdvacc)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Arthralgia(4thvacc)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Arthralgia(5th vacc)	8 Participants	9 Participants	8 Participants	6 Participants	11 Participants	11 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Arthralgia(5thvacc)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Erythema (4th vacc)	1 Participants	1 Participants	0 Participants	10 Participants	0 Participants	13 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Erythema(4thvacc)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Erythema(5thvacc)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Induration(2vacc)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. AnyInduration(4th vacc)	2 Participants	3 Participants	0 Participants	10 Participants	0 Participants	14 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Induration(4vacc)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Fatigue (2nd vacc)	61 Participants	64 Participants	64 Participants	40 Participants	64 Participants	49 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Fatigue (3rd vacc)	106 Participants	96 Participants	44 Participants	32 Participants	32 Participants	55 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Fatigue(5th vacc)	1 Participants	2 Participants	4 Participants	0 Participants	6 Participants	3 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3Headache(4thvacc)	3 Participants	3 Participants	0 Participants	2 Participants	0 Participants	4 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. AnyAppetite Loss(1vacc)	41 Participants	33 Participants	28 Participants	22 Participants	14 Participants	18 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. AnyAppetiteLoss(2vacc)	17 Participants	11 Participants	15 Participants	12 Participants	19 Participants	9 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3AppetiteLoss(2vacc)	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. AnyAppetiteLoss(4vacc)	11 Participants	10 Participants	4 Participants	13 Participants	11 Participants	23 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade3AppetiteLoss(4vacc)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Nausea (4th vacc)	21 Participants	13 Participants	9 Participants	11 Participants	14 Participants	23 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Nausea(4th vacc)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Chills (1st vacc)	45 Participants	36 Participants	41 Participants	24 Participants	27 Participants	40 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Chills(1stvacc)	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Chills(4thvacc)	11 Participants	11 Participants	10 Participants	12 Participants	9 Participants	31 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Grade 3 Chills(4thvacc)	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Chills (5th vacc)	19 Participants	23 Participants	17 Participants	11 Participants	22 Participants	13 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Fever (3rd vacc)	6 Participants	3 Participants	2 Participants	0 Participants	4 Participants	4 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Pain/Fever prevention(1)	28 Participants	34 Participants	21 Participants	26 Participants	5 Participants	34 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Pain/Fever prevention(2)	5 Participants	7 Participants	18 Participants	5 Participants	24 Participants	7 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Pain/Fever prevention(3)	32 Participants	34 Participants	3 Participants	2 Participants	3 Participants	21 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Pain/Fever prevention(4)	6 Participants	5 Participants	3 Participants	19 Participants	3 Participants	25 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Pain/Fever treatment(1)	31 Participants	45 Participants	27 Participants	32 Participants	6 Participants	31 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Pain/Fever treatment(2)	3 Participants	4 Participants	20 Participants	3 Participants	29 Participants	4 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Pain/Fever treatment(3)	38 Participants	37 Participants	2 Participants	4 Participants	2 Participants	23 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Pain/Fever treatment(4)	7 Participants	4 Participants	2 Participants	22 Participants	2 Participants	27 Participants
Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7. Any Arthralgia(4th vacc)	8 Participants	10 Participants	5 Participants	10 Participants	7 Participants	18 Participants

SECONDARY outcome

Timeframe: During the entire study period (Month 0 to Month 13)

Population: Analysis was done on all subjects in the Unsolicited Safety Set-all screened subjects who provided informed consent \& provided demographic \&/or other baseline screening measurements, regardless of the subject's randomization \& vaccination status, received a subject ID, received a study vaccination and have post-vaccination unsolicited AE records.

The number of participants reporting any SAE, possibly or probably related SAE(s), medically-attended AEs, AEs leading to premature withdrawal, AEs leading to death, AEs leading to hospitalization and AEs leading to dose reduction, interruption and delay in study vaccination during the entire study period is reported.

Outcome measures

Outcome measures
Measure	ABCWY_ 0_2 Group n=221 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	rMenB_0_2 Group n=228 Participants Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_6 Group n=151 Participants Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=129 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=147 Participants Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=157 Participants Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Number of Participants Reporting Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal Any SAE(s)	9 Participants	3 Participants	8 Participants	7 Participants	2 Participants	6 Participants
Number of Participants Reporting Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal Possibly or Probably Related SAE(s)	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal AE(s) leading to premature withdrawal	2 Participants	6 Participants	4 Participants	2 Participants	1 Participants	3 Participants
Number of Participants Reporting Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal AE(s) leading to Death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal AE(s) leading to Hospitalization	9 Participants	1 Participants	7 Participants	6 Participants	1 Participants	6 Participants
Number of Participants Reporting Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal AE(s)leadingtodosereduction,interruption,vaccdelay	8 Participants	8 Participants	7 Participants	2 Participants	4 Participants	5 Participants
Number of Participants Reporting Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal Medically Attended AE(s)	103 Participants	97 Participants	68 Participants	57 Participants	67 Participants	79 Participants

Adverse Events

rMenB_0_2 Group

Serious events: 9 serious events

Other events: 226 other events

Deaths: 0 deaths

ABCWY_ 0_2 Group

Serious events: 3 serious events

Other events: 229 other events

Deaths: 0 deaths

ABCWY_0_1 Group

Serious events: 8 serious events

Other events: 153 other events

Deaths: 0 deaths

ABCWY_0_6 Group

Serious events: 7 serious events

Other events: 131 other events

Deaths: 0 deaths

ABCWY_0_11 Group

Serious events: 2 serious events

Other events: 151 other events

Deaths: 0 deaths

ABCWY_0_2_6 Group

Serious events: 6 serious events

Other events: 158 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	rMenB_0_2 Group n=228 participants at risk Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_ 0_2 Group n=231 participants at risk Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_1 Group n=155 participants at risk Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.	ABCWY_0_6 Group n=134 participants at risk Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=151 participants at risk Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=159 participants at risk Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Blood and lymphatic system disorders Iron deficiency anaemia	0.88% 2/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Cardiac disorders Atrioventricular block second degree	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Endocrine disorders Hypothyroidism	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.63% 1/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Gastrointestinal disorders Abdominal migraine	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Gastrointestinal disorders Abdominal pain	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.65% 1/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.75% 1/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Gastrointestinal disorders Abdominal pain upper	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Gastrointestinal disorders Crohn's disease	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.75% 1/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
General disorders Chest pain	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
General disorders Fatigue	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.75% 1/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Appendicitis	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	1.3% 2/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Escherichia urinary tract infection	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Gastroenteritis	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.75% 1/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Infectious mononucleosis	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Nasopharyngitis	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Pelvic inflammatory disease	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.63% 1/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Peritonsillar abscess	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.65% 1/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Tonsillitis	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.75% 1/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Urinary tract infection	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.43% 1/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.63% 1/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Injury, poisoning and procedural complications Forearm fracture	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.63% 1/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.65% 1/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Metabolism and nutrition disorders Obesity	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.63% 1/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.75% 1/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.65% 1/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Musculoskeletal and connective tissue disorders Connective tissue disorder	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.65% 1/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.63% 1/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.65% 1/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Nervous system disorders Partial seizures	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.66% 1/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Nervous system disorders Seizure	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.43% 1/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Nervous system disorders Syncope	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.66% 1/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Psychiatric disorders Depression	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Psychiatric disorders Mental disorder	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.75% 1/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Psychiatric disorders Suicidal ideation	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.43% 1/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.65% 1/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Renal and urinary disorders Tubulointerstitial nephritis	0.44% 1/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Reproductive system and breast disorders Testicular torsion	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.63% 1/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Surgical and medical procedures Tooth extraction	0.00% 0/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.75% 1/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.00% 0/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.

Other adverse events

Other adverse events
Measure	rMenB_0_2 Group n=228 participants at risk Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_ 0_2 Group n=231 participants at risk Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.	ABCWY_0_1 Group n=155 participants at risk Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.	ABCWY_0_6 Group n=134 participants at risk Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.	ABCWY_0_11 Group n=151 participants at risk Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.	ABCWY_0_2_6 Group n=159 participants at risk Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.
Gastrointestinal disorders Abdominal pain upper	7.0% 16/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	3.9% 9/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	3.9% 6/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	3.7% 5/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	6.0% 9/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	5.7% 9/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Gastrointestinal disorders Nausea	32.5% 74/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	29.4% 68/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	32.9% 51/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	35.1% 47/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	37.1% 56/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	39.0% 62/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
General disorders Chills	35.1% 80/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	32.9% 76/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	39.4% 61/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	29.9% 40/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	41.1% 62/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	44.0% 70/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
General disorders Fatigue	74.1% 169/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	71.4% 165/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	76.8% 119/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	73.1% 98/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	69.5% 105/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	75.5% 120/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
General disorders Injection site erythema	57.5% 131/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	56.7% 131/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	51.6% 80/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	59.7% 80/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	58.9% 89/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	61.0% 97/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
General disorders Injection site induration	48.2% 110/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	42.4% 98/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	43.2% 67/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	39.6% 53/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	46.4% 70/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	53.5% 85/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
General disorders Injection site pain	96.9% 221/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	97.4% 225/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	95.5% 148/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	96.3% 129/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	98.0% 148/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	96.9% 154/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
General disorders Pyrexia	11.8% 27/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	11.7% 27/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	12.9% 20/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	9.7% 13/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	16.6% 25/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	16.4% 26/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Gastroenteritis	6.6% 15/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	4.8% 11/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	8.4% 13/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	6.7% 9/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	6.6% 10/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	6.3% 10/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Nasopharyngitis	16.2% 37/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	13.0% 30/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	18.1% 28/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	15.7% 21/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	15.9% 24/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	15.7% 25/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Pharyngitis	7.0% 16/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	9.1% 21/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	4.5% 7/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	6.0% 8/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	7.3% 11/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	9.4% 15/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Injury, poisoning and procedural complications Respiratory tract infection	6.6% 15/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	5.2% 12/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	6.5% 10/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	3.7% 5/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	4.0% 6/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	6.3% 10/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Rhinitis	6.6% 15/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	7.8% 18/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	4.5% 7/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	4.5% 6/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	3.3% 5/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	6.9% 11/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Tonsillitis	3.1% 7/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	4.3% 10/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	1.9% 3/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	4.5% 6/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	6.0% 9/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	3.1% 5/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Infections and infestations Upper respiratory tract infection	23.2% 53/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	25.1% 58/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	23.9% 37/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	23.1% 31/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	23.2% 35/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	23.3% 37/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Metabolism and nutrition disorders Decreased appetite	30.3% 69/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	27.7% 64/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	29.0% 45/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	32.1% 43/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	29.8% 45/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	32.7% 52/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Arthralgia	21.1% 48/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	20.8% 48/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	18.1% 28/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	23.1% 31/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	17.9% 27/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	23.9% 38/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Musculoskeletal and connective tissue disorders Myalgia	45.2% 103/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	42.9% 99/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	44.5% 69/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	40.3% 54/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	43.0% 65/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	50.9% 81/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Nervous system disorders Headache	72.4% 165/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	64.5% 149/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	73.5% 114/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	69.4% 93/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	72.8% 110/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	73.6% 117/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 12/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	2.2% 5/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	3.9% 6/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.75% 1/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	0.66% 1/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	1.9% 3/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.3% 12/228 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	5.6% 13/231 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	5.8% 9/155 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	5.2% 7/134 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	3.3% 5/151 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.	4.4% 7/159 • Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period. Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.

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Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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