Trial Outcomes & Findings for Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28 (NCT NCT01894919)

Last Updated: 2021-11-30

Results Overview

The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules, is presented in terms of the percentage of subjects in each vaccine group, with hSBA titers ≥ 4 for what concerns the H44/76, 5/99 and NZ98/254 strains, and hSBA titers ≥ 5 for M10713 strain, alongside with the corresponding antibody responses in age-matched vaccine naïve subjects at baseline. The functional bactericidal antibodies directed against serogroup B meningococcal were assessed by the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

851 participants

Primary outcome timeframe

24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects

Results posted on

2021-11-30

Participant Flow

Subjects were recruited from 9 study sites in Hungary and 8 study sites in Spain.

All enrolled subjects were included in the study.

Participant milestones

Participant milestones
Measure	2H3H511_V In the parent study V72\_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	2H3H511_NV In the parent study V72\_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.	3H5_11_V In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	3H5_11_NV In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.	68_11_V In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	68_11_NV In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.	02_2_5_V In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	02_2_5_NV In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.	02_6_10_V In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	02_6_10_NV In the parent study V72\_28 (NCT01339923), these subjects received two catchup doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Study STARTED	98	47	89	43	81	39	32	36	91	90	100	55	50
Overall Study COMPLETED	96	47	89	43	78	39	32	36	91	89	98	55	50
Overall Study NOT COMPLETED	2	0	0	0	3	0	0	0	0	1	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	2H3H511_V In the parent study V72\_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	68_11_V In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	02_6_10_NV In the parent study V72\_28 (NCT01339923), these subjects received two catchup doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Study Withdrawal by Subject	1	1	1	1
Overall Study Adverse Event	0	0	0	1
Overall Study Other-Unspecified	1	0	0	0
Overall Study Lost to Follow-up	0	2	0	0

Baseline Characteristics

Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2H3H511_V n=98 Participants In the parent study V72\_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.	2H3H511_NV n=47 Participants In the parent study V72\_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.	3H5_11_V n=89 Participants In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	3H5_11_NV n=43 Participants In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.	68_11_V n=81 Participants In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.	68_11_NV n=39 Participants In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence.	02_2_5_V n=32 Participants In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	02_2_5_NV n=36 Participants In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.	02_6_10_V n=91 Participants In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.	02_6_10_NV n=90 Participants In the parent study V72\_28 (NCT01339923), these subjects received two catchup doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence.	NAIVE 123 n=100 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	NAIVE_4A n=55 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	NAIVE_4B n=50 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	Total n=851 Participants Total of all reporting groups
Age, Continuous	3.1 Years STANDARD_DEVIATION 0.2 • n=5 Participants	3 Years STANDARD_DEVIATION 0.18 • n=7 Participants	3.1 Years STANDARD_DEVIATION 0.23 • n=5 Participants	3.1 Years STANDARD_DEVIATION 0.22 • n=4 Participants	3.2 Years STANDARD_DEVIATION 0.29 • n=21 Participants	3.2 Years STANDARD_DEVIATION 0.26 • n=10 Participants	6.5 Years STANDARD_DEVIATION 1.15 • n=115 Participants	6.7 Years STANDARD_DEVIATION 1.16 • n=24 Participants	10.4 Years STANDARD_DEVIATION 1.43 • n=42 Participants	10.4 Years STANDARD_DEVIATION 1.44 • n=42 Participants	3.4 Years STANDARD_DEVIATION 0.29 • n=42 Participants	5.8 Years STANDARD_DEVIATION 1.12 • n=42 Participants	9.7 Years STANDARD_DEVIATION 1.38 • n=36 Participants	5.6 Years STANDARD_DEVIATION 3.20 • n=36 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	27 Participants n=7 Participants	48 Participants n=5 Participants	22 Participants n=4 Participants	35 Participants n=21 Participants	23 Participants n=10 Participants	19 Participants n=115 Participants	15 Participants n=24 Participants	44 Participants n=42 Participants	46 Participants n=42 Participants	46 Participants n=42 Participants	26 Participants n=42 Participants	27 Participants n=36 Participants	422 Participants n=36 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants	21 Participants n=4 Participants	46 Participants n=21 Participants	16 Participants n=10 Participants	13 Participants n=115 Participants	21 Participants n=24 Participants	47 Participants n=42 Participants	44 Participants n=42 Participants	54 Participants n=42 Participants	29 Participants n=42 Participants	23 Participants n=36 Participants	429 Participants n=36 Participants

PRIMARY outcome

Timeframe: 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects

Population: Analysis was done on Full Analysis Set (FAS)-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.

Outcome measures

Outcome measures
Measure	2H3H511 n=140 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=131 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=119 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 n=100 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 n=68 Participants Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A n=55 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 n=179 Participants Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B n=50 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains H44/76	51 Percentage of subjects Interval 42.8 to 60.0	53 Percentage of subjects Interval 43.8 to 61.5	61 Percentage of subjects Interval 52.0 to 70.1	38 Percentage of subjects Interval 28.5 to 48.3	52 Percentage of subjects Interval 39.7 to 64.6	27 Percentage of subjects Interval 16.1 to 41.0	58 Percentage of subjects Interval 50.3 to 65.2	20 Percentage of subjects Interval 10.0 to 33.7
Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains 5/99	84 Percentage of subjects Interval 77.2 to 89.9	88 Percentage of subjects Interval 80.9 to 92.9	93 Percentage of subjects Interval 87.2 to 97.1	3 Percentage of subjects Interval 0.6 to 8.5	79 Percentage of subjects Interval 67.4 to 88.1	4 Percentage of subjects Interval 0.44 to 12.5	85 Percentage of subjects Interval 79.4 to 90.3	8 Percentage of subjects Interval 2.2 to 19.2
Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains NZ98/254	45 Percentage of subjects Interval 36.6 to 53.6	38 Percentage of subjects Interval 29.8 to 47.1	56 Percentage of subjects Interval 46.9 to 65.4	2 Percentage of subjects Interval 0.24 to 7.0	29 Percentage of subjects Interval 19.0 to 41.7	7 Percentage of subjects Interval 2.0 to 17.6	50 Percentage of subjects Interval 42.2 to 57.3	6 Percentage of subjects Interval 1.3 to 16.5
Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains M10713	31 Percentage of subjects Interval 22.8 to 39.5	36 Percentage of subjects Interval 27.1 to 45.7	39 Percentage of subjects Interval 29.4 to 48.3	37 Percentage of subjects Interval 26.8 to 47.2	34 Percentage of subjects Interval 22.6 to 46.6	38 Percentage of subjects Interval 24.8 to 52.1	61 Percentage of subjects Interval 53.0 to 68.0	55 Percentage of subjects Interval 40.2 to 69.3

PRIMARY outcome

Timeframe: At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects

Population: Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.

The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules is presented in terms of the percentage of subjects in each vaccine group with hSBA titers ≥ 8, alongside with the corresponding antibody responses in age matched vaccine naïve subjects at baseline.

Outcome measures

Outcome measures
Measure	2H3H511 n=140 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=131 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=119 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 n=100 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 n=68 Participants Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A n=55 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 n=179 Participants Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B n=50 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains H44/76	28 Percentage of subjects Interval 20.6 to 36.1	26 Percentage of subjects Interval 18.7 to 34.3	32 Percentage of subjects Interval 23.7 to 41.1	18 Percentage of subjects Interval 11.0 to 26.9	24 Percentage of subjects Interval 14.3 to 35.9	16 Percentage of subjects Interval 7.8 to 28.8	34 Percentage of subjects Interval 26.8 to 41.2	10 Percentage of subjects Interval 3.3 to 21.8
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains 5/99	80 Percentage of subjects Interval 72.4 to 86.3	82 Percentage of subjects Interval 74.8 to 88.5	89 Percentage of subjects Interval 82.0 to 94.1	2 Percentage of subjects Interval 0.24 to 7.0	73 Percentage of subjects Interval 60.9 to 83.2	4 Percentage of subjects Interval 0.44 to 12.5	66 Percentage of subjects Interval 59.1 to 73.3	6 Percentage of subjects Interval 1.3 to 16.5
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains NZ98/254	21 Percentage of subjects Interval 14.9 to 29.2	18 Percentage of subjects Interval 12.1 to 26.0	29 Percentage of subjects Interval 20.7 to 37.6	0 Percentage of subjects Interval 0.0 to 3.6	15 Percentage of subjects Interval 7.3 to 25.4	2 Percentage of subjects Interval 0.05 to 9.7	28 Percentage of subjects Interval 21.5 to 35.1	0 Percentage of subjects Interval 0.0 to 7.1
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains M10713	24 Percentage of subjects Interval 16.5 to 32.0	22 Percentage of subjects Interval 14.4 to 30.4	28 Percentage of subjects Interval 20.2 to 37.9	26 Percentage of subjects Interval 17.3 to 35.9	31 Percentage of subjects Interval 19.9 to 43.4	36 Percentage of subjects Interval 23.1 to 50.2	54 Percentage of subjects Interval 46.0 to 61.4	49 Percentage of subjects Interval 34.4 to 63.7

PRIMARY outcome

Timeframe: 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects

Population: Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1. The number of participants analyzed is the number of subjects assessed for this particular endpoint.

The hSBA antibody titers in subjects, 24 to 36 months after completion of Bexsero® vaccination course according to different schedules in the parent study, are presented in terms of vaccine-group-specific GMTs, alongside with the corresponding antibody responses in age-matched vaccine-naïve subjects at baseline.

Outcome measures

Outcome measures
Measure	2H3H511 n=140 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=131 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=119 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 n=100 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 n=68 Participants Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A n=55 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 n=179 Participants Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B n=50 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains H44/76	4.17 Titers Interval 3.4 to 5.13	4.48 Titers Interval 3.6 to 5.57	5.62 Titers Interval 4.48 to 7.04	2.79 Titers Interval 2.25 to 3.45	3.97 Titers Interval 2.99 to 5.28	2.33 Titers Interval 1.77 to 3.07	5.75 Titers Interval 4.78 to 6.91	1.93 Titers Interval 1.39 to 2.68
The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains 5/99	44 Titers Interval 32.0 to 60.0	52 Titers Interval 37.0 to 72.0	83 Titers Interval 58.0 to 117.0	1.15 Titers Interval 1.03 to 1.29	21 Titers Interval 14.0 to 33.0	1.2 Titers Interval 0.96 to 1.51	21 Titers Interval 16.0 to 28.0	1.38 Titers Interval 1.1 to 1.73
The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains NZ98/254	3.48 Titers Interval 2.78 to 4.36	2.98 Titers Interval 2.35 to 3.78	4.86 Titers Interval 3.8 to 6.22	1.14 Titers Interval 1.06 to 1.22	2.81 Titers Interval 2.07 to 3.82	1.37 Titers Interval 1.17 to 1.61	4.57 Titers Interval 3.74 to 5.59	1.22 Titers Interval 1.06 to 1.41
The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains M10713	2.77 Titers Interval 2.06 to 3.71	3.03 Titers Interval 2.2 to 4.16	3.17 Titers Interval 2.3 to 4.38	3.3 Titers Interval 2.52 to 4.32	3.53 Titers Interval 2.38 to 5.25	4.26 Titers Interval 2.61 to 6.97	7.82 Titers Interval 6.04 to 10.0	6.95 Titers Interval 4.18 to 12.0

PRIMARY outcome

Timeframe: At Day 1 in this study over one month after the completion of the vaccination course in the parent study

The within-subjects GMR of GMTs at 24 to 36 months versus 1 month after completion of Bexsero® vaccination course according to different schedules vaccination in parent study are reported.

Outcome measures

Outcome measures
Measure	2H3H511 n=137 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=130 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=118 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 n=68 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 n=176 Participants Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. H44/76	0.029 Ratio Interval 0.023 to 0.036	0.022 Ratio Interval 0.017 to 0.028	0.03 Ratio Interval 0.023 to 0.038	0.028 Ratio Interval 0.021 to 0.038	0.042 Ratio Interval 0.035 to 0.052	—	—	—
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. 5/99	0.023 Ratio Interval 0.017 to 0.03	0.031 Ratio Interval 0.023 to 0.041	0.054 Ratio Interval 0.04 to 0.073	0.045 Ratio Interval 0.031 to 0.066	0.049 Ratio Interval 0.038 to 0.063	—	—	—
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. NZ98/254	0.059 Ratio Interval 0.047 to 0.074	0.038 Ratio Interval 0.03 to 0.048	0.07 Ratio Interval 0.055 to 0.09	0.061 Ratio Interval 0.044 to 0.083	0.095 Ratio Interval 0.077 to 0.12	—	—	—
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. M10713	0.19 Ratio Interval 0.13 to 0.28	0.16 Ratio Interval 0.11 to 0.25	0.19 Ratio Interval 0.12 to 0.29	0.17 Ratio Interval 0.11 to 0.28	0.24 Ratio Interval 0.17 to 0.32	—	—	—

PRIMARY outcome

Timeframe: At Day 1 in this study over visit 1 in the vaccination course in the parent study

Population: Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.This outcome measure applies to only groups 02\_2\_5 \& 02\_6\_10 as the GMRs were calculated at 24-36 months after completion of vaccination course in the parent study over subjects belonging to groups 02\_2\_5 \& 02\_6\_10.

The within-subjects GMR of GMTs at 24 to 36 months versus visit 1 in the vaccination course according to different schedules vaccination in the parent study are reported.

Outcome measures

Outcome measures
Measure	2H3H511 n=67 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=177 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. H44/76	1.88 Ratio Interval 1.32 to 2.69	2.94 Ratio Interval 2.33 to 3.71	—	—	—	—	—	—
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. 5/99	20 Ratio Interval 12.0 to 32.0	14 Ratio Interval 10.0 to 20.0	—	—	—	—	—	—
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. NZ98/254	2.48 Ratio Interval 1.76 to 3.49	3.06 Ratio Interval 2.44 to 3.83	—	—	—	—	—	—
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. M10713	0.89 Ratio Interval 0.49 to 1.61	0.94 Ratio Interval 0.64 to 1.37	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)

Population: Analysis was done on FAS - booster: All subjects in the Enrolled Set who receive a study vaccination and provide an evaluable serum sample at visit 2 (one month after the booster dose administration) and received all scheduled vaccinations in the parent study V72\_28 (excluding naïve groups).

The percentage of subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and with hSBA titers ≥ 5 against M10713 strain, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study), alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.

Outcome measures

Outcome measures
Measure	2H3H511 n=96 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=87 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=76 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 n=32 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 n=91 Participants Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A n=96 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 n=55 Participants Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B n=50 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. NZ98/254 (post-vacc.)	99 Percentage of subjects Interval 94.3 to 99.97	100 Percentage of subjects Interval 95.8 to 100.0	100 Percentage of subjects Interval 95.2 to 100.0	100 Percentage of subjects Interval 89.1 to 100.0	100 Percentage of subjects Interval 96.0 to 100.0	78 Percentage of subjects Interval 68.5 to 85.9	85 Percentage of subjects Interval 72.9 to 93.4	70 Percentage of subjects Interval 55.4 to 82.1
Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. H44/76 (pre-vacc.)	48 Percentage of subjects Interval 37.3 to 58.5	51 Percentage of subjects Interval 40.1 to 62.1	64 Percentage of subjects Interval 52.1 to 74.8	39 Percentage of subjects Interval 21.8 to 57.8	59 Percentage of subjects Interval 48.5 to 69.5	39 Percentage of subjects Interval 28.8 to 49.0	27 Percentage of subjects Interval 16.1 to 41.0	20 Percentage of subjects Interval 10.0 to 33.7
Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. H44/76 (post-vacc.)	99 Percentage of subjects Interval 94.3 to 99.97	100 Percentage of subjects Interval 95.8 to 100.0	100 Percentage of subjects Interval 95.2 to 100.0	97 Percentage of subjects Interval 83.8 to 99.92	99 Percentage of subjects Interval 94.0 to 99.97	95 Percentage of subjects Interval 88.3 to 98.3	91 Percentage of subjects Interval 80.0 to 97.0	80 Percentage of subjects Interval 66.3 to 90.0
Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. 5/99 (pre-vacc.)	84 Percentage of subjects Interval 74.5 to 90.6	91 Percentage of subjects Interval 82.7 to 95.9	95 Percentage of subjects Interval 87.1 to 98.5	74 Percentage of subjects Interval 55.4 to 88.1	86 Percentage of subjects Interval 76.8 to 92.2	3 Percentage of subjects Interval 0.6 to 8.9	4 Percentage of subjects Interval 0.44 to 12.5	8 Percentage of subjects Interval 2.2 to 19.2
Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. 5/99 (post-vacc.)	99 Percentage of subjects Interval 94.3 to 99.97	99 Percentage of subjects Interval 93.8 to 99.97	97 Percentage of subjects Interval 90.8 to 99.68	100 Percentage of subjects Interval 89.1 to 100.0	100 Percentage of subjects Interval 96.0 to 100.0	88 Percentage of subjects Interval 79.2 to 93.4	93 Percentage of subjects Interval 82.4 to 98.0	80 Percentage of subjects Interval 66.3 to 90.0
Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. NZ98/254 (pre-vacc.)	45 Percentage of subjects Interval 34.2 to 55.3	42 Percentage of subjects Interval 31.3 to 53.0	52 Percentage of subjects Interval 40.2 to 63.7	25 Percentage of subjects Interval 11.5 to 43.4	47 Percentage of subjects Interval 36.7 to 58.0	2 Percentage of subjects Interval 0.25 to 7.3	7 Percentage of subjects Interval 2.1 to 17.9	6 Percentage of subjects Interval 1.3 to 16.5
Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. M10713 (pre-vacc.)	36 Percentage of subjects Interval 25.3 to 47.6	35 Percentage of subjects Interval 24.1 to 47.8	45 Percentage of subjects Interval 32.3 to 57.5	21 Percentage of subjects Interval 8.0 to 39.7	63 Percentage of subjects Interval 52.2 to 73.3	39 Percentage of subjects Interval 28.8 to 50.5	41 Percentage of subjects Interval 27.0 to 55.8	59 Percentage of subjects Interval 43.2 to 73.0
Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. M10713 (post-vacc.)	70 Percentage of subjects Interval 59.8 to 79.7	81 Percentage of subjects Interval 70.6 to 89.0	97 Percentage of subjects Interval 89.6 to 99.64	97 Percentage of subjects Interval 77.9 to 99.2	96 Percentage of subjects Interval 88.9 to 98.8	47 Percentage of subjects Interval 35.9 to 57.5	59 Percentage of subjects Interval 44.2 to 72.4	60 Percentage of subjects Interval 44.3 to 73.6

SECONDARY outcome

Timeframe: At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)

Population: Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination \& provide an evaluable serum sample at visit 2(1 month post booster dose) \& received all scheduled vaccinations in V72\_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.

The percentage of subjects with hSBA titers ≥ 8, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.

Outcome measures

Outcome measures
Measure	2H3H511 n=96 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=87 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=76 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 n=32 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 n=91 Participants Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A n=96 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 n=55 Participants Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B n=50 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. H44/76 (pre-vacc.)	26 Percentage of subjects Interval 17.5 to 36.3	31 Percentage of subjects Interval 21.8 to 42.3	33 Percentage of subjects Interval 22.9 to 45.2	19 Percentage of subjects Interval 7.5 to 37.5	30 Percentage of subjects Interval 20.5 to 40.2	18 Percentage of subjects Interval 10.7 to 26.8	16 Percentage of subjects Interval 7.8 to 28.8	10 Percentage of subjects Interval 3.3 to 21.8
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. H44/76 (post-vacc.)	97 Percentage of subjects Interval 91.1 to 99.4	98 Percentage of subjects Interval 91.9 to 99.72	99 Percentage of subjects Interval 92.8 to 99.97	97 Percentage of subjects Interval 83.8 to 99.92	97 Percentage of subjects Interval 90.7 to 99.3	68 Percentage of subjects Interval 57.4 to 76.9	71 Percentage of subjects Interval 57.1 to 82.4	60 Percentage of subjects Interval 45.2 to 73.6
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. M10713 (post-vacc.)	64 Percentage of subjects Interval 52.7 to 73.6	71 Percentage of subjects Interval 59.6 to 80.6	94 Percentage of subjects Interval 85.4 to 98.3	90 Percentage of subjects Interval 73.5 to 97.9	92 Percentage of subjects Interval 84.5 to 96.8	34 Percentage of subjects Interval 24.3 to 45.0	51 Percentage of subjects Interval 36.6 to 65.2	57 Percentage of subjects Interval 42.2 to 71.7
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. 5/99 (pre-vacc.)	79 Percentage of subjects Interval 69.6 to 87.1	85 Percentage of subjects Interval 75.8 to 91.8	91 Percentage of subjects Interval 81.9 to 96.2	71 Percentage of subjects Interval 52.0 to 85.8	68 Percentage of subjects Interval 57.5 to 77.5	2 Percentage of subjects Interval 0.25 to 7.3	4 Percentage of subjects Interval 0.44 to 12.5	6 Percentage of subjects Interval 1.3 to 16.5
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. 5/99 (post-vacc.)	99 Percentage of subjects Interval 94.3 to 99.97	99 Percentage of subjects Interval 93.8 to 99.97	97 Percentage of subjects Interval 90.8 to 99.68	100 Percentage of subjects Interval 89.1 to 100.0	100 Percentage of subjects Interval 96.0 to 100.0	77 Percentage of subjects Interval 67.4 to 85.0	78 Percentage of subjects Interval 65.0 to 88.2	60 Percentage of subjects Interval 45.2 to 73.6
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. NZ98/254 (pre-vacc.)	22 Percentage of subjects Interval 13.8 to 31.6	19 Percentage of subjects Interval 11.0 to 28.4	28 Percentage of subjects Interval 18.2 to 39.6	13 Percentage of subjects Interval 3.5 to 29.0	26 Percentage of subjects Interval 17.7 to 36.7	0 Percentage of subjects Interval 0.0 to 3.8	2 Percentage of subjects Interval 0.05 to 9.9	0 Percentage of subjects Interval 0.0 to 7.1
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. NZ98/54 (post-vacc.)	97 Percentage of subjects Interval 91.1 to 99.4	98 Percentage of subjects Interval 91.9 to 99.72	100 Percentage of subjects Interval 95.2 to 100.0	97 Percentage of subjects Interval 83.8 to 99.92	97 Percentage of subjects Interval 90.7 to 99.3	34 Percentage of subjects Interval 25.0 to 44.8	54 Percentage of subjects Interval 39.6 to 67.4	40 Percentage of subjects Interval 26.4 to 54.8
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. M10713 (pre-vacc.)	28 Percentage of subjects Interval 18.6 to 39.5	22 Percentage of subjects Interval 12.9 to 33.8	34 Percentage of subjects Interval 22.6 to 46.6	17 Percentage of subjects Interval 5.8 to 35.8	55 Percentage of subjects Interval 44.1 to 65.9	27 Percentage of subjects Interval 18.2 to 38.2	39 Percentage of subjects Interval 25.2 to 53.8	52 Percentage of subjects Interval 36.9 to 67.1

SECONDARY outcome

Timeframe: One month after booster vaccination (day 31)/24-36 months (Visit 1)

The percentage of subjects with a four-fold rise in hSBA titers 1 month after receiving Bexsero® booster vaccination in this study to pre vaccination at visit 1 (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.

Outcome measures

Outcome measures
Measure	2H3H511 n=92 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=87 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=76 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 n=32 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 n=91 Participants Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A n=96 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 n=55 Participants Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B n=50 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. H44/76 (Day 31/PRE)	95 Percentage of subjects Interval 87.8 to 98.2	95 Percentage of subjects Interval 88.5 to 98.7	97 Percentage of subjects Interval 90.7 to 99.68	94 Percentage of subjects Interval 78.6 to 99.2	97 Percentage of subjects Interval 90.7 to 99.3	43 Percentage of subjects Interval 32.7 to 53.2	53 Percentage of subjects Interval 38.8 to 66.3	46 Percentage of subjects Interval 31.8 to 60.7
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. 5/99 (Day 31/PRE)	98 Percentage of subjects Interval 92.4 to 99.74	98 Percentage of subjects Interval 91.9 to 99.72	95 Percentage of subjects Interval 87.1 to 98.5	100 Percentage of subjects Interval 88.8 to 100.0	98 Percentage of subjects Interval 92.3 to 99.73	77 Percentage of subjects Interval 67.4 to 85.0	76 Percentage of subjects Interval 63.0 to 86.8	60 Percentage of subjects Interval 45.2 to 73.6
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. NZ98/254 (Day 31/PRE)	92 Percentage of subjects Interval 84.9 to 96.9	95 Percentage of subjects Interval 88.5 to 98.7	93 Percentage of subjects Interval 85.1 to 97.8	94 Percentage of subjects Interval 79.2 to 99.2	86 Percentage of subjects Interval 76.8 to 92.2	34 Percentage of subjects Interval 25.0 to 44.8	54 Percentage of subjects Interval 39.6 to 67.4	40 Percentage of subjects Interval 26.4 to 54.8
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. M10713 (Day 31/PRE)	41 Percentage of subjects Interval 30.0 to 52.7	50 Percentage of subjects Interval 37.6 to 62.4	68 Percentage of subjects Interval 54.9 to 78.8	72 Percentage of subjects Interval 52.8 to 87.3	53 Percentage of subjects Interval 41.9 to 63.7	11 Percentage of subjects Interval 5.0 to 19.4	20 Percentage of subjects Interval 10.2 to 34.3	13 Percentage of subjects Interval 4.9 to 26.3

SECONDARY outcome

Timeframe: From post primary visit in the parent study to visit 2 in this extension study

The percentage of subjects with a four-fold rise in hSBA titers one month after receiving Bexsero® booster vaccination (visit 2) in this study to post primary visit in the parent study V72\_28(1 month after last vaccination in the parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.

Outcome measures

Outcome measures
Measure	2H3H511 n=94 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=86 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=76 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 n=32 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 n=89 Participants Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study H44/76	5 Percentage of subjects Interval 1.7 to 12.0	5 Percentage of subjects Interval 1.3 to 11.7	13 Percentage of subjects Interval 6.6 to 23.2	22 Percentage of subjects Interval 9.3 to 40.0	17 Percentage of subjects Interval 9.9 to 26.6	—	—	—
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study 5/99	19 Percentage of subjects Interval 11.9 to 28.9	27 Percentage of subjects Interval 17.8 to 37.4	37 Percentage of subjects Interval 26.1 to 48.7	66 Percentage of subjects Interval 46.8 to 81.4	72 Percentage of subjects Interval 61.4 to 80.9	—	—	—
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study NZ98/254	25 Percentage of subjects Interval 16.4 to 34.8	15 Percentage of subjects Interval 8.5 to 25.0	27 Percentage of subjects Interval 17.6 to 39.1	13 Percentage of subjects Interval 3.5 to 29.0	18 Percentage of subjects Interval 10.8 to 27.8	—	—	—
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study M10713	15 Percentage of subjects Interval 7.7 to 25.0	21 Percentage of subjects Interval 11.4 to 33.9	24 Percentage of subjects Interval 13.1 to 38.2	21 Percentage of subjects Interval 8.0 to 39.7	11 Percentage of subjects Interval 5.2 to 20.0	—	—	—

SECONDARY outcome

Timeframe: From pre primary visit in the parent study (Visit 1) to visit 2 in this extension study

The percentage of subjects with a four-fold rise in hSBA titers one month after receiving Bexsero® booster vaccination in this study to pre primary visit in parent study V72\_28 (Visit 1). This outcome measure was analysed only for subjects belonging to groups 02\_2\_5\_V and 02\_6\_10\_V

Outcome measures

Outcome measures
Measure	2H3H511 n=32 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=91 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. H44/76	97 Percentage of subjects Interval 83.8 to 99.92	96 Percentage of subjects Interval 89.1 to 98.8	—	—	—	—	—	—
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. 5/99	100 Percentage of subjects Interval 89.1 to 100.0	100 Percentage of subjects Interval 96.0 to 100.0	—	—	—	—	—	—
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. NZ98/254	94 Percentage of subjects Interval 78.6 to 99.2	97 Percentage of subjects Interval 90.6 to 99.3	—	—	—	—	—	—
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. M10713	67 Percentage of subjects Interval 46.0 to 83.5	55 Percentage of subjects Interval 43.5 to 65.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Visit 1 and one month post booster vaccination (Day 31)

Population: Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination \& provide an evaluable serum sample at visit 2(1 month post booster dose) \& received all scheduled vaccinations in V72\_28(excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.

The hSBA antibody titers in subjects after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the 1st dose of Bexsero® vaccine in age matched vaccine-naïve subjects in terms of GMTs.

Outcome measures

Outcome measures
Measure	2H3H511 n=96 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=87 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=76 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 n=32 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 n=91 Participants Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A n=96 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 n=55 Participants Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B n=50 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.	3.91 Titers Interval 3.01 to 5.08	4.84 Titers Interval 3.66 to 6.41	6.21 Titers Interval 4.65 to 8.31	3.14 Titers Interval 2.08 to 4.75	6.15 Titers Interval 4.77 to 7.93	2.82 Titers Interval 2.26 to 3.5	2.33 Titers Interval 1.77 to 3.07	1.93 Titers Interval 1.39 to 2.68

SECONDARY outcome

Timeframe: At Day 31 versus Day 1

Population: Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination \& provide an evaluable serum sample at visit 2 (1 month post booster dose) \& received all scheduled vaccinations in V72\_28 (excluding naïve groups). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

The within-subjects GMR of hSBA antibody titers (one month post booster vaccination versus pre vaccination) after Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the within-subject GMR for the 1st dose of rMenB+OMV NZ vaccination of age matched naïve subjects.

Outcome measures

Outcome measures
Measure	2H3H511 n=92 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=87 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=76 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 n=32 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 n=91 Participants Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A n=96 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 n=55 Participants Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B n=50 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. H44/76 (Day 31/PRE)	41 Ratio Interval 30.0 to 55.0	43 Ratio Interval 31.0 to 59.0	46 Ratio Interval 33.0 to 65.0	50 Ratio Interval 31.0 to 80.0	42 Ratio Interval 31.0 to 56.0	4.81 Ratio Interval 3.81 to 6.07	7.08 Ratio Interval 5.07 to 9.88	6.87 Ratio Interval 4.62 to 10.0
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. 5/99 (Day 31/PRE)	75 Ratio Interval 54.0 to 104.0	67 Ratio Interval 47.0 to 96.0	41 Ratio Interval 29.0 to 60.0	160 Ratio Interval 95.0 to 270.0	135 Ratio Interval 98.0 to 186.0	34 Ratio Interval 24.0 to 46.0	22 Ratio Interval 15.0 to 34.0	14 Ratio Interval 9.11 to 23.0
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. NZ98/254 (Day 31/PRE)	28 Ratio Interval 20.0 to 38.0	29 Ratio Interval 21.0 to 41.0	27 Ratio Interval 19.0 to 39.0	24 Ratio Interval 15.0 to 40.0	18 Ratio Interval 13.0 to 25.0	6.07 Ratio Interval 4.97 to 7.41	9.58 Ratio Interval 6.8 to 13.0	7.01 Ratio Interval 4.54 to 11.0
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. M10713 (Day 31/PRE)	4.07 Ratio Interval 2.8 to 5.91	5.65 Ratio Interval 3.77 to 8.47	11 Ratio Interval 7.15 to 16.0	13 Ratio Interval 7.29 to 23.0	6.85 Ratio Interval 4.86 to 9.66	1.38 Ratio Interval 1.01 to 1.88	2.06 Ratio Interval 1.36 to 3.12	1.55 Ratio Interval 1.1 to 2.18

SECONDARY outcome

Timeframe: Visit 2 (day 31 in extension study) versus post primary vaccination visit in parent study

Population: Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination \& provide an evaluable serum sample at visit 2 (1 month post booster dose) \& received all scheduled vaccinations in V72\_28 (excluding naïve groups). The number of participants analyzed is the number of subjects assessed for this particular endpoint.

The within-subjects GMR of hSBA antibody titers (one month post booster vaccination in this study versus 1 month post last vaccination visit (post-primary vaccination visit) in parent study V72\_28.

Outcome measures

Outcome measures
Measure	2H3H511 n=94 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=86 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=76 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. H44/76	1.06 Ratio Interval 0.82 to 1.38	0.90 Ratio Interval 0.68 to 1.2	1.37 Ratio Interval 1.02 to 1.84	—	—	—	—	—
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. 5/99	1.60 Ratio Interval 1.2 to 2.13	2.07 Ratio Interval 1.52 to 2.82	2.33 Ratio Interval 1.69 to 3.2	—	—	—	—	—
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. NZ98/254	1.66 Ratio Interval 1.25 to 2.2	1.10 Ratio Interval 0.81 to 1.49	1.75 Ratio Interval 1.28 to 2.41	—	—	—	—	—
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. M10713	1.01 Ratio Interval 0.65 to 1.58	1.37 Ratio Interval 0.82 to 2.29	2.35 Ratio Interval 1.37 to 4.02	—	—	—	—	—

SECONDARY outcome

Timeframe: At Baseline and One month post second vaccination (Day 61)

Population: Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).

The percentage of vaccine-naïve subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and ≥ 5 against M10713 strain, one month after receiving two catch up doses of Bexsero® booster vaccination in this study.

Outcome measures

Outcome measures
Measure	2H3H511 n=98 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=54 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=49 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination M10713 (Day 61)	75 Percentage of subjects Interval 64.5 to 83.3	69 Percentage of subjects Interval 54.9 to 81.3	76 Percentage of subjects Interval 61.1 to 86.7	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination H44/76 (baseline)	38 Percentage of subjects Interval 28.2 to 48.1	26 Percentage of subjects Interval 15.0 to 39.7	20 Percentage of subjects Interval 10.2 to 34.3	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination H44/76 (Day 61)	100 Percentage of subjects Interval 96.3 to 100.0	98 Percentage of subjects Interval 90.1 to 99.95	100 Percentage of subjects Interval 92.7 to 100.0	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination M10713 (baseline)	34 Percentage of subjects Interval 24.6 to 45.4	40 Percentage of subjects Interval 26.4 to 54.8	55 Percentage of subjects Interval 40.2 to 69.3	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination 5/99 (baseline)	3 Percentage of subjects Interval 0.6 to 8.7	4 Percentage of subjects Interval 0.45 to 12.7	6 Percentage of subjects Interval 1.3 to 16.9	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination 5/99 (Day 61)	100 Percentage of subjects Interval 96.3 to 100.0	100 Percentage of subjects Interval 93.4 to 100.0	100 Percentage of subjects Interval 92.7 to 100.0	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination NZ98/254 (baseline)	2 Percentage of subjects Interval 0.25 to 7.2	7 Percentage of subjects Interval 2.1 to 17.9	6 Percentage of subjects Interval 1.3 to 17.2	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination NZ98/254 (Day 61)	100 Percentage of subjects Interval 96.3 to 100.0	100 Percentage of subjects Interval 93.4 to 100.0	100 Percentage of subjects Interval 92.6 to 100.0	—	—	—	—	—

SECONDARY outcome

Timeframe: At Baseline and One month post second vaccination (Day 61)

The percentage of vaccine-naïve subjects with hSBA titers ≥8, one month after receiving two catch up doses of Bexsero® booster vaccination in this study are reported.

Outcome measures

Outcome measures
Measure	2H3H511 n=98 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=54 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=49 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. H44/76 (baseline)	17 Percentage of subjects Interval 10.4 to 26.3	15 Percentage of subjects Interval 6.6 to 27.1	10 Percentage of subjects Interval 3.4 to 22.2	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. H44/76 (Day 61)	99 Percentage of subjects Interval 94.4 to 99.97	96 Percentage of subjects Interval 87.3 to 99.55	98 Percentage of subjects Interval 89.1 to 99.95	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. 5/99 (baseline)	2 Percentage of subjects Interval 0.25 to 7.2	4 Percentage of subjects Interval 0.45 to 12.7	4 Percentage of subjects Interval 0.5 to 14.0	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. 5/99 (Day 61)	100 Percentage of subjects Interval 96.3 to 100.0	100 Percentage of subjects Interval 93.4 to 100.0	98 Percentage of subjects Interval 89.1 to 99.95	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. NZ98/254 (baseline)	0 Percentage of subjects Interval 0.0 to 3.7	2 Percentage of subjects Interval 0.05 to 9.9	0 Percentage of subjects Interval 0.0 to 7.4	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. NZ98/254 (Day 61)	96 Percentage of subjects Interval 89.9 to 98.9	93 Percentage of subjects Interval 82.1 to 97.9	94 Percentage of subjects Interval 82.8 to 98.7	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. M10713 (baseline)	25 Percentage of subjects Interval 16.6 to 35.7	38 Percentage of subjects Interval 24.7 to 52.8	49 Percentage of subjects Interval 34.4 to 63.7	—	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. M10713 (Day 61)	65 Percentage of subjects Interval 54.1 to 74.6	63 Percentage of subjects Interval 49.0 to 76.4	69 Percentage of subjects Interval 54.6 to 81.7	—	—	—	—	—

SECONDARY outcome

Timeframe: One month post second vaccination (Day 61)

The percentage of vaccine-naïve subjects with a four-fold rise in hSBA titers from baseline, one month after receiving two catch up doses of Bexsero® booster vaccination in comparison to prevaccination in this study are reported.

Outcome measures

Outcome measures
Measure	2H3H511 n=98 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=54 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=49 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. H44/76	94 Percentage of subjects Interval 87.1 to 97.7	89 Percentage of subjects Interval 77.4 to 95.8	94 Percentage of subjects Interval 83.1 to 98.7	—	—	—	—	—
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. 5/99	100 Percentage of subjects Interval 96.3 to 100.0	100 Percentage of subjects Interval 93.4 to 100.0	98 Percentage of subjects Interval 89.1 to 99.95	—	—	—	—	—
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. NZ98/254	94 Percentage of subjects Interval 87.1 to 97.7	91 Percentage of subjects Interval 79.7 to 96.9	94 Percentage of subjects Interval 82.8 to 98.7	—	—	—	—	—
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. M10713	37 Percentage of subjects Interval 26.7 to 47.8	28 Percentage of subjects Interval 16.2 to 42.5	22 Percentage of subjects Interval 11.8 to 36.6	—	—	—	—	—

SECONDARY outcome

Timeframe: At Baseline and One month post second vaccination (Day 61)

The hSBA antibody titers in vaccine-naïve subjects , after receiving two catch up doses of Bexsero® vaccination in this study, are reported in terms of GMTs.

Outcome measures

Outcome measures
Measure	2H3H511 n=98 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=54 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=49 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. M10713 (Day 61)	12 Titers Interval 7.57 to 18.0	11 Titers Interval 6.87 to 19.0	14 Titers Interval 8.34 to 24.0	—	—	—	—	—
The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. H44/76 (baseline)	2.3 Titers Interval 1.75 to 3.01	2.15 Titers Interval 1.55 to 3.0	1.56 Titers Interval 1.11 to 2.2	—	—	—	—	—
The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. H44/76 (Day 61)	107 Titers Interval 84.0 to 135.0	74 Titers Interval 56.0 to 99.0	63 Titers Interval 47.0 to 85.0	—	—	—	—	—
The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. 5/99 (baseline)	1.13 Titers Interval 0.94 to 1.36	1.13 Titers Interval 0.9 to 1.41	1.31 Titers Interval 1.04 to 1.65	—	—	—	—	—
The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. 5/99 (Day 61)	631 Titers Interval 503.0 to 792.0	421 Titers Interval 319.0 to 555.0	317 Titers Interval 238.0 to 423.0	—	—	—	—	—
The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. NZ98/254 (baseline)	1.11 Titers Interval 0.98 to 1.26	1.34 Titers Interval 1.15 to 1.56	1.2 Titers Interval 1.02 to 1.4	—	—	—	—	—
The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. NZ98/254 (Day 61)	34 Titers Interval 27.0 to 42.0	37 Titers Interval 28.0 to 49.0	34 Titers Interval 26.0 to 46.0	—	—	—	—	—
The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. M10713 (baseline)	2.9 Titers Interval 1.94 to 4.34	4.12 Titers Interval 2.54 to 6.69	6.4 Titers Interval 3.91 to 10.0	—	—	—	—	—

SECONDARY outcome

Timeframe: At one month after receiving second vaccination (Day 61) versus baseline (Day 1)

The within-subject GMRs of hSBA titers at one month after receiving the second catch up dose to hSBA titers at baseline, for naïve subjects who received two catch up doses of Bexsero® vaccination in this study are reported.

Outcome measures

Outcome measures
Measure	2H3H511 n=98 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=54 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=49 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. H44/76	46 Ratio Interval 34.0 to 63.0	34 Ratio Interval 24.0 to 50.0	41 Ratio Interval 27.0 to 60.0	—	—	—	—	—
The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. 5/99	558 Ratio Interval 423.0 to 737.0	373 Ratio Interval 266.0 to 524.0	242 Ratio Interval 171.0 to 344.0	—	—	—	—	—
The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. NZ98/254	30 Ratio Interval 24.0 to 39.0	27 Ratio Interval 20.0 to 37.0	29 Ratio Interval 21.0 to 39.0	—	—	—	—	—
The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. M10713	3.86 Ratio Interval 2.62 to 5.69	2.93 Ratio Interval 1.84 to 4.67	2.2 Ratio Interval 1.37 to 3.53	—	—	—	—	—

SECONDARY outcome

Timeframe: From day 1 (6 hr) through day 7 after vaccination

Population: Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data

The number of subjects (35 months to 7 years of age) with solicited local and systemic adverse events after receiving Bexsero® booster vaccine in the present study.

Outcome measures

Outcome measures
Measure	2H3H511 n=97 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=89 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=80 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 n=32 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Treatment of Pain and/or Fever	38 Subjects	39 Subjects	41 Subjects	13 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Any local AEs	87 Subjects	81 Subjects	73 Subjects	31 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Erythema	60 Subjects	63 Subjects	42 Subjects	22 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Induration	48 Subjects	48 Subjects	33 Subjects	15 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Swelling	49 Subjects	50 Subjects	37 Subjects	20 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Tenderness	84 Subjects	80 Subjects	71 Subjects	31 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Any systemic AEs	66 Subjects	63 Subjects	54 Subjects	18 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Change in eating habits	31 Subjects	32 Subjects	30 Subjects	5 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Diarrhea	4 Subjects	8 Subjects	5 Subjects	0 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Irritability	54 Subjects	52 Subjects	46 Subjects	9 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Persistent Crying	31 Subjects	24 Subjects	25 Subjects	4 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Rash	13 Subjects	1 Subjects	3 Subjects	5 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Sleepiness	28 Subjects	23 Subjects	26 Subjects	5 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Vomiting	5 Subjects	5 Subjects	2 Subjects	1 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Fever (>38.0° C)	17 Subjects	18 Subjects	11 Subjects	2 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Medically-Attended Fever	1 Subjects	0 Subjects	2 Subjects	0 Subjects	—	—	—	—
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Prevention of Pain and/or Fever	23 Subjects	14 Subjects	15 Subjects	1 Subjects	—	—	—	—

SECONDARY outcome

Timeframe: From day 1 (6 hr) through day 7 after vaccination

Population: Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.

The number of newly recruited subjects (aged 35 months to 7 years) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.

Outcome measures

Outcome measures
Measure	2H3H511 n=100 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=55 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Any systemic AEs (1st vacc.)	64 Subjects	24 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Any local AEs (1st vacc.)	88 Subjects	55 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Erythema (1st vacc.)	54 Subjects	28 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Induration (1st vacc.)	38 Subjects	17 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Swelling (1st vacc.)	40 Subjects	24 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Change in Eating Habits (1st vacc.)	31 Subjects	5 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Diarrhea (1st vacc.)	4 Subjects	3 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Irritability (1st vacc.)	40 Subjects	16 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Persistent Crying (1st vacc.)	15 Subjects	4 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Rash (1st vacc.)	5 Subjects	3 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Sleepiness (1st vacc.)	18 Subjects	9 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Vomiting (1st vacc.)	7 Subjects	2 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Fever (>38.0° C) (1st vacc.)	15 Subjects	2 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Medically-Attended Fever (1st vacc.)	1 Subjects	0 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Prevention of Pain/Fever (1st vacc.)	18 Subjects	3 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Treatment of Pain/Fever (1st vacc.)	41 Subjects	22 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Any local AEs (2nd vacc.)	79 Subjects	51 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Erythema (2nd vacc.)	44 Subjects	32 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Induration (2nd vacc.)	29 Subjects	22 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Swelling (2nd vacc.)	32 Subjects	25 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Tenderness (2nd vacc.)	77 Subjects	51 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Any systemic AEs (2nd vacc.)	46 Subjects	18 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Change in Eating Habits (2nd vacc.)	15 Subjects	9 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Diarrhea (2nd vacc.)	2 Subjects	3 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Irritability (2nd vacc.)	25 Subjects	11 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Persistent Crying (2nd vacc.)	13 Subjects	6 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Rash (2nd vacc.)	2 Subjects	1 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Sleepiness (2nd vacc.)	12 Subjects	5 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Vomiting (2nd vacc.)	4 Subjects	2 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Fever (>38.0° C) (2nd vacc.)	12 Subjects	3 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Medically-Attended Fever (2nd vacc.)	0 Subjects	1 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Prevention of Pain/Fever (2nd vacc.)	21 Subjects	4 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Treatment of Pain/Fever (2nd vacc.)	30 Subjects	13 Subjects	—	—	—	—	—	—
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. Tenderness (1st vacc.)	87 Subjects	55 Subjects	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From day 1 (6 hr) through day 7 after vaccination

Population: Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.

Number of subjects (8 to 12 years of age) reporting solicited local and systemic adverse events after receiving Bexsero® booster vaccine.

Outcome measures

Outcome measures
Measure	2H3H511 n=91 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Any local AEs	85 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Erythema	57 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Induration	44 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Swelling	52 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Pain	84 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Any systemic AEs	57 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Arthralgia	18 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Chills	23 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Headache	27 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Malaise	35 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Myalgia	24 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Nausea	12 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Rash	10 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Fever (>38.0° C)	10 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Medically-Attended Fever	0 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Prevention of Pain and/or Fever	12 Subjects	—	—	—	—	—	—	—
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. Treatment of Pain and/or Fever	47 Subjects	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From day 1(6 hr) through day 7 after vaccination

Population: Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.

The number newly recruited naïve subjects (aged 8 to12 years of age) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.

Outcome measures

Outcome measures
Measure	2H3H511 n=50 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Any local AEs (1st vacc.)	49 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Erythema (1st vacc.)	31 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Induration (1st vacc.)	19 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Swelling (1st vacc.)	29 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Pain (1st vacc.)	47 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Any systemic AEs (1st vacc.)	24 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Arthralgia (1st vacc.)	6 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Chills (1st vacc.)	4 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Headache (1st vacc.)	15 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Malaise (1st vacc.)	7 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Myalgia (1st vacc.)	12 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Nausea (1st vacc.)	5 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Rash (1st vacc.)	1 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Fever (>38.0° C) (1st vacc.)	3 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Medically-Attended Fever (1st vacc.)	0 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Prevention of Pain and/or Fever (1st vacc.)	2 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Treatment of Pain and/or Fever (1st vacc.)	21 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Any local AEs (2nd vacc.)	43 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Erythema (2nd vacc.)	21 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Induration (2nd vacc.)	17 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Swelling (2nd vacc.)	21 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Pain (2nd vacc.)	41 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Any systemic AEs (2nd vacc.)	25 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Arthralgia (2nd vacc.)	3 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Chills (2nd vacc.)	5 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Headache (2nd vacc.)	10 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Malaise (2nd vacc.)	13 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Myalgia (2nd vacc.)	8 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Nausea (2nd vacc.)	4 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Rash (2nd vacc.)	3 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Fever (>38.0° C) (2nd vacc.)	1 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Medically-Attended Fever (2nd vacc.)	0 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Prevention of Pain and/or Fever (2nd vacc.)	3 Subjects	—	—	—	—	—	—	—
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. Treatment of Pain and/or Fever (2nd vacc.)	12 Subjects	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From day 1 through day 7 after any vaccination

Population: Analysis was done on unsolicited safety set: All subjects in the Exposed Set with unsolicited adverse event data.

The number of subjects reporting unsolicited adverse events after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in parent study) or two cach up schedule of Bexsero® vaccine is reported.

Outcome measures

Outcome measures
Measure	2H3H511 n=96 Participants Combined group 4D\_2-11M/B + group 4D\_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	3H5_11 n=89 Participants Combined group 3D\_3-11M/B + group 3D\_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	68_11 n=78 Participants Combined group 3D\_6-11Y/B + group 3D\_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE 123 n=32 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.	02_2_5 n=91 Participants Combined group 2D\_2-5Y/B + group 2D\_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4A n=100 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study	02_6_10 n=55 Participants Combined group 2D\_6-10Y/B + group 2D\_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72\_28 (NCT01339923).	NAIVE_4B n=50 Participants Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. Any AEs	26 Subjects	19 Subjects	26 Subjects	9 Subjects	14 Subjects	43 Subjects	25 Subjects	12 Subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. Possibly or Probably Related AEs	9 Subjects	7 Subjects	10 Subjects	6 Subjects	11 Subjects	12 Subjects	10 Subjects	6 Subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. AEs leading to Premature Withdrawal	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: Throughout the entire study period (up to 2 months)

Population: Analysis was done on unsolicited safety set: All subjects in the Exposed Set with unsolicited adverse event data.

The number of subjects reporting unsolicited SAEs, medically attended AEs and AEs leading to withdrawal after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in the parent study) or two catch-up schedule of Bexsero® vaccine is reported.