Trial Outcomes & Findings for Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine (NCT NCT01027351)

Last Updated: 2018-10-09

Results Overview

Persistence of geometric mean titers (GMTs) against N.meningitidis B strains in children (at 40 months of age) who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

163 participants

Primary outcome timeframe

28 months after last vaccination; Baseline for Naïve

Results posted on

2018-10-09

Participant Flow

Subjects were enrolled from 1 center in the United Kingdom.

All subjects were included in the trial.

Participant milestones

Participant milestones
Measure	5rMenB Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	3rMenB Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Overall Study STARTED	29	19	14	8	43	50
Overall Study COMPLETED	26	18	13	6	32	45
Overall Study NOT COMPLETED	3	1	1	2	11	5

Reasons for withdrawal

Reasons for withdrawal
Measure	5rMenB Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	3rMenB Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Overall Study Withdrawal by Subject	1	0	1	0	3	5
Overall Study Lost to Follow-up	1	1	0	1	6	0
Overall Study Inappropriate enrollment	0	0	0	0	1	0
Overall Study Protocol Violation	1	0	0	1	1	0

Baseline Characteristics

Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5rMenB n=29 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=19 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	3rMenB n=14 Participants Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.	3rMenB+OMV NZ n=8 Participants Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 n=43 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 n=50 Participants Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study	Total n=163 Participants Total of all reporting groups
Age, Continuous	41.4 months STANDARD_DEVIATION 1.5 • n=5 Participants	41.8 months STANDARD_DEVIATION 1.4 • n=7 Participants	41.4 months STANDARD_DEVIATION 1.5 • n=5 Participants	40.4 months STANDARD_DEVIATION 0.7 • n=4 Participants	41.8 months STANDARD_DEVIATION 1.7 • n=21 Participants	61.3 months STANDARD_DEVIATION 0.9 • n=10 Participants	47.6 months STANDARD_DEVIATION 9.2 • n=115 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	23 Participants n=21 Participants	27 Participants n=10 Participants	84 Participants n=115 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	5 Participants n=4 Participants	20 Participants n=21 Participants	23 Participants n=10 Participants	79 Participants n=115 Participants
Region of Enrollment United Kingdom	29 Subjects n=5 Participants	19 Subjects n=7 Participants	14 Subjects n=5 Participants	8 Subjects n=4 Participants	43 Subjects n=21 Participants	50 Subjects n=10 Participants	163 Subjects n=115 Participants

PRIMARY outcome

Timeframe: 28 months after last vaccination; Baseline for Naïve

Population: The analysis was done on the Modified- Intended to treat (MITT), 40 months of age, antibody persistence population.

Outcome measures

Outcome measures
Measure	5rMenB n=29 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=17 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=40 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. H 44/76 strain	3.24 Titers Interval 2.33 to 4.52	5.34 Titers Interval 3.47 to 8.23	4.25 Titers Interval 3.22 to 5.6	—	—	—
Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. 5/99 strain (N=28, 17, 40)	5.11 Titers Interval 2.33 to 11.0	28 Titers Interval 10.0 to 77.0	1.11 Titers Interval 0.9 to 1.36	—	—	—
Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. NZ 98/254 strain	1.09 Titers Interval 0.79 to 1.51	2.77 Titers Interval 1.81 to 4.23	1 Titers Interval 1.0 to 1.0	—	—	—
Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. M10713 strain (N=28, 15, 40)	9.15 Titers Interval 5.01 to 17.0	5.34 Titers Interval 2.35 to 12.0	8.75 Titers Interval 5.22 to 15.0	—	—	—

PRIMARY outcome

Timeframe: 28 months after last vaccination; baseline for naïve

Population: The analysis was done on the MITT , 40 months of age, antibody persistence population.

The percentages of subjects with persisting human serum bactericidal antibodies (hSBA) titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains at 40 months of age; who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study are reported. The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).

Outcome measures

Outcome measures
Measure	5rMenB n=29 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=17 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=40 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age. hSBA ≥1:4 (H44/76 strain)	45 Percentages of subjects Interval 26.0 to 64.0	65 Percentages of subjects Interval 38.0 to 86.0	63 Percentages of subjects Interval 46.0 to 77.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age. hSBA≥1:4 (5/99 strain; N=28, 17, 40)	43 Percentages of subjects Interval 24.0 to 63.0	76 Percentages of subjects Interval 50.0 to 93.0	3 Percentages of subjects Interval 0.063 to 13.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age. hSBA≥1:4 (NZ 98/254 strain)	3 Percentages of subjects Interval 0.087 to 18.0	41 Percentages of subjects Interval 18.0 to 67.0	0 Percentages of subjects Interval 0.0 to 9.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age. hSBA≥1:4 (M10713 strain; N=28, 15, 40)	68 Percentages of subjects Interval 48.0 to 84.0	67 Percentages of subjects Interval 38.0 to 88.0	68 Percentages of subjects Interval 51.0 to 81.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age. hSBA ≥1:8 (H44/76 strain)	14 Percentages of subjects Interval 4.0 to 32.0	35 Percentages of subjects Interval 14.0 to 62.0	30 Percentages of subjects Interval 17.0 to 47.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age. hSBA≥1:8 (5/99 strain; N=28, 17, 40)	43 Percentages of subjects Interval 24.0 to 63.0	76 Percentages of subjects Interval 50.0 to 93.0	3 Percentages of subjects Interval 0.063 to 13.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age. hSBA≥1:8 (NZ 98/254 strain)	0 Percentages of subjects Interval 0.0 to 12.0	24 Percentages of subjects Interval 7.0 to 50.0	0 Percentages of subjects Interval 0.0 to 9.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age. hSBA≥1:8 (M10713 strain; N=28, 15, 40)	61 Percentages of subjects Interval 41.0 to 78.0	40 Percentages of subjects Interval 16.0 to 68.0	45 Percentages of subjects Interval 29.0 to 62.0	—	—	—

PRIMARY outcome

Timeframe: Day 1-7 after booster vaccination

Population: Analysis was done on the safety population i.e all subjects who received at least one Men B vaccination and provided post-baseline safety data.

The safety and tolerability of one or two booster doses of rMen B or rMenB+OMV NZ vaccine administered at 40 months of age in children who had previously received one or four doses of the same vaccine as infants in parent study is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.

Outcome measures

Outcome measures
Measure	5rMenB n=29 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=19 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=14 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ n=8 Participants Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Local	28 participants	19 participants	14 participants	8 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Injection-site pain	17 participants	14 participants	8 participants	8 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Injection-site erythema	28 participants	19 participants	14 participants	8 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Injection-site swelling	13 participants	5 participants	9 participants	4 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Injection-site induration	14 participants	9 participants	8 participants	6 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Systemic	19 participants	13 participants	11 participants	8 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Changes in eating habits	5 participants	10 participants	5 participants	4 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Sleepiness	13 participants	12 participants	8 participants	6 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Vomiting	1 participants	3 participants	3 participants	0 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Diarrhea	3 participants	1 participants	3 participants	1 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Irritability	14 participants	10 participants	9 participants	8 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Headache	1 participants	0 participants	2 participants	1 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Arthralgia	0 participants	6 participants	4 participants	4 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Rash	3 participants	0 participants	2 participants	1 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Fever (≥38°C)	1 participants	1 participants	4 participants	0 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Other	10 participants	12 participants	5 participants	7 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Antipyretic preventive medication used	10 participants	12 participants	3 participants	7 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Antipyretic treatment medication used	1 participants	2 participants	4 participants	0 participants	—	—
Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. Medically attended fever	0 participants	0 participants	1 participants	0 participants	—	—

SECONDARY outcome

Timeframe: 28 months after vaccination; Baseline for Naïve

Population: The analysis was done on the MITT, 40 months of age, antibody persistence population.

Persisting GMTs against N.meningitidis B strains in children (at 40 months of age) who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.

Outcome measures

Outcome measures
Measure	5rMenB n=14 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=8 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=40 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. H44/76 strain	3.59 Titers Interval 1.8 to 7.15	3.47 Titers Interval 1.39 to 8.64	4.25 Titers Interval 3.22 to 5.6	—	—	—
Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. 5/99 strain	9.57 Titers Interval 3.88 to 24.0	1 Titers Interval 0.3 to 3.3	1.11 Titers Interval 0.9 to 1.36	—	—	—
Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. NZ 98/254 strain	1.23 Titers Interval 0.96 to 1.57	1 Titers Interval 0.72 to 1.38	1 Titers Interval 1.0 to 1.0	—	—	—
Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. M10713 strain (N=13, 8, 40)	3.26 Titers Interval 1.49 to 7.11	3 Titers Interval 1.11 to 8.11	8.75 Titers Interval 5.22 to 15.0	—	—	—

SECONDARY outcome

Timeframe: 28 months after vaccination; baseline for naïve

Population: The analysis was done on the MITT, 40 months of age, antibody persistence population.

The percentages of subjects with persisting hSBA titers ≥ 1:4 and ≥1:8, against N.meningitidis B strains at 40 months of age; who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study are reported.

Outcome measures

Outcome measures
Measure	5rMenB n=14 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=8 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=40 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age. hSBA≥1:8 (M10713 strain; N=13, 8, 40)	15 percentage of subjects Interval 2.0 to 45.0	13 percentage of subjects Interval 0.0 to 53.0	45 percentage of subjects Interval 29.0 to 62.0	—	—	—
Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age. hSBA ≥1:4 (H44/76 strain)	57 percentage of subjects Interval 29.0 to 82.0	38 percentage of subjects Interval 9.0 to 76.0	63 percentage of subjects Interval 46.0 to 77.0	—	—	—
Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age. hSBA≥1:4 (5/99 strain)	57 percentage of subjects Interval 29.0 to 82.0	0 percentage of subjects Interval 0.0 to 37.0	3 percentage of subjects Interval 0.063 to 13.0	—	—	—
Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age. hSBA≥1:4 (NZ 98/254 strain)	7 percentage of subjects Interval 0.0 to 34.0	0 percentage of subjects Interval 0.0 to 37.0	0 percentage of subjects Interval 0.0 to 9.0	—	—	—
Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age. hSBA≥1:4 (M10713 strain; N=13, 8, 40)	54 percentage of subjects Interval 25.0 to 81.0	25 percentage of subjects Interval 3.0 to 65.0	68 percentage of subjects Interval 51.0 to 81.0	—	—	—
Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age. hSBA ≥1:8 (H44/76 strain)	7 percentage of subjects Interval 0.0 to 34.0	13 percentage of subjects Interval 0.0 to 53.0	30 percentage of subjects Interval 17.0 to 47.0	—	—	—
Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age. hSBA≥1:8 (5/99 strain)	43 percentage of subjects Interval 18.0 to 71.0	0 percentage of subjects Interval 0.0 to 37.0	3 percentage of subjects Interval 0.063 to 13.0	—	—	—
Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age. hSBA≥1:8 (NZ 98/254 strain)	0 percentage of subjects Interval 0.0 to 23.0	0 percentage of subjects Interval 0.0 to 37.0	0 percentage of subjects Interval 0.0 to 9.0	—	—	—

SECONDARY outcome

Timeframe: 1 month post- booster/ dose 1 for Naïve

Population: The analysis was done on the MITT population, booster response.

The GMTs against N.meningitidis B strains in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.

Outcome measures

Outcome measures
Measure	5rMenB n=29 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=19 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=38 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. H44/76 strain	99 Titers Interval 67.0 to 145.0	89 Titers Interval 56.0 to 141.0	12 Titers Interval 7.96 to 19.0	—	—	—
Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. 5/99 strain (N=28, 18, 38)	778 Titers Interval 448.0 to 1349.0	1708 Titers Interval 859.0 to 3396.0	22 Titers Interval 12.0 to 40.0	—	—	—
Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. NZ 98/254 strain	1.64 Titers Interval 0.95 to 2.85	47 Titers Interval 24.0 to 91.0	7.73 Titers Interval 4.62 to 13.0	—	—	—
Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. M10713 strain (N=28, 18, 38)	38 Titers Interval 24.0 to 59.0	39 Titers Interval 22.0 to 67.0	11 Titers Interval 6.7 to 19.0	—	—	—

SECONDARY outcome

Timeframe: 1 month post- booster/ dose 1 for Naïve

Population: The analysis was done on the MITT population, booster response.

The percentages of subjects (who had previously received four doses MenB vaccine in parent study) with hSBA titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects .

Outcome measures

Outcome measures
Measure	5rMenB n=28 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=19 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=38 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. hSBA ≥1:4 (H44/76 strain)	100 Percentage of subjects Interval 88.0 to 100.0	100 Percentage of subjects Interval 82.0 to 100.0	89 Percentage of subjects Interval 75.0 to 97.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. hSBA≥1:4 (5/99 strain; N=28, 18, 38)	100 Percentage of subjects Interval 88.0 to 100.0	100 Percentage of subjects Interval 81.0 to 100.0	76 Percentage of subjects Interval 60.0 to 89.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. hSBA≥1:4 (NZ 98/254 strain)	14 Percentage of subjects Interval 4.0 to 33.0	89 Percentage of subjects Interval 67.0 to 99.0	66 Percentage of subjects Interval 49.0 to 80.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. hSBA≥1:4 (M10713 strain; N=28, 18, 38)	96 Percentage of subjects Interval 82.0 to 100.0	94 Percentage of subjects Interval 73.0 to 100.0	76 Percentage of subjects Interval 60.0 to 89.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. hSBA ≥1:8 ( H44/76 strain)	96 Percentage of subjects Interval 82.0 to 100.0	100 Percentage of subjects Interval 82.0 to 100.0	63 Percentage of subjects Interval 46.0 to 78.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. hSBA≥1:8 (5/99 strain; N=28, 18, 38)	100 Percentage of subjects Interval 88.0 to 100.0	100 Percentage of subjects Interval 81.0 to 100.0	71 Percentage of subjects Interval 54.0 to 85.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. hSBA≥1:8 (NZ 98/254 strain)	11 Percentage of subjects Interval 2.0 to 28.0	89 Percentage of subjects Interval 67.0 to 99.0	58 Percentage of subjects Interval 41.0 to 74.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. hSBA≥1:8 (M10713 strain; N=28, 18, 38)	89 Percentage of subjects Interval 72.0 to 98.0	94 Percentage of subjects Interval 73.0 to 100.0	61 Percentage of subjects Interval 43.0 to 76.0	—	—	—

SECONDARY outcome

Timeframe: 1 month post - booster/ -dose 1 for Naïve

Population: The analysis was done on the MITT population, booster response.

The percentages of subjects (who had previously received four doses MenB vaccine in parent study) showing a 4-fold increase in hSBA titers over baseline against N.meningitidis B strains, after receiving a booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects. Baseline is defined as either the time that the (first) booster dose was given or the time of the first vaccination in this study.

Outcome measures

Outcome measures
Measure	5rMenB n=28 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=17 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=37 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. H44/76 strain	89 Percentage of subjects Interval 72.0 to 98.0	94 Percentage of subjects Interval 71.0 to 100.0	41 Percentage of subjects Interval 25.0 to 58.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. 5/99 strain (N=27, 16, 37)	100 Percentage of subjects Interval 87.0 to 100.0	94 Percentage of subjects Interval 70.0 to 100.0	68 Percentage of subjects Interval 50.0 to 82.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. NZ 98/254 strain	11 Percentage of subjects Interval 2.0 to 28.0	82 Percentage of subjects Interval 57.0 to 96.0	57 Percentage of subjects Interval 39.0 to 73.0	—	—	—
Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. M10713 strain (N=27, 15, 37)	41 Percentage of subjects Interval 22.0 to 61.0	67 Percentage of subjects Interval 38.0 to 88.0	14 Percentage of subjects Interval 5.0 to 29.0	—	—	—

SECONDARY outcome

Timeframe: 1 month post vaccination

Population: The analysis was done on the MITT population, booster response.

The GMTs against N.meningitidis B strains in children (who had previously received one dose MenB vaccine in parent study) after a two booster doses of either rMenB or rMenB+OMV NZ vaccine given at 40 \& 42 months of age.

Outcome measures

Outcome measures
Measure	5rMenB n=13 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=8 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=38 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. H44/76 strain (dose 1; N=13, 7, 38)	94 Titers Interval 48.0 to 185.0	76 Titers Interval 30.0 to 190.0	12 Titers Interval 7.96 to 19.0	—	—	—
Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. H44/76 strain (dose 2; N=13, 8, 36)	127 Titers Interval 81.0 to 198.0	145 Titers Interval 82.0 to 255.0	88 Titers Interval 66.0 to 117.0	—	—	—
Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. 5/99 strain (dose 1; N=13, 7, 38)	2379 Titers Interval 1164.0 to 4859.0	509 Titers Interval 192.0 to 1348.0	22 Titers Interval 12.0 to 40.0	—	—	—
Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. 5/99 strain (dose 2; N=13, 8, 36)	5240 Titers Interval 3082.0 to 8911.0	2413 Titers Interval 1226.0 to 4747.0	1019 Titers Interval 762.0 to 1362.0	—	—	—
Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. NZ 98/254 strain (dose 1; N=13, 7, 38)	1.73 Titers Interval 0.86 to 3.48	148 Titers Interval 57.0 to 384.0	7.73 Titers Interval 4.62 to 13.0	—	—	—
Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. NZ 98/254 strain (dose 2; N=13, 8, 36)	1.86 Titers Interval 0.89 to 3.88	65 Titers Interval 25.0 to 165.0	47 Titers Interval 31.0 to 72.0	—	—	—
Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. M10713 strain (dose 1; N=13, 7, 38)	35 Titers Interval 18.0 to 68.0	30 Titers Interval 12.0 to 74.0	11 Titers Interval 6.7 to 19.0	—	—	—
Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. M10713 strain (dose 2; N=12, 8, 36)	21 Titers Interval 9.25 to 47.0	36 Titers Interval 13.0 to 98.0	33 Titers Interval 22.0 to 51.0	—	—	—

SECONDARY outcome

Timeframe: 1 month post vaccination

Population: The analysis was done on the MITT population, booster response.

The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) with hSBA ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 \& 42 months of age.

Outcome measures

Outcome measures
Measure	5rMenB n=13 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=8 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=38 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. H44/76 strain (≥1:4 - dose 1; N=13, 7, 38)	100 Percentages of subjects Interval 75.0 to 100.0	100 Percentages of subjects Interval 59.0 to 100.0	89 Percentages of subjects Interval 75.0 to 97.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. H44/76 strain (≥1:4 - dose 2; N=13, 8, 36)	100 Percentages of subjects Interval 75.0 to 100.0	100 Percentages of subjects Interval 63.0 to 100.0	100 Percentages of subjects Interval 90.0 to 100.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. H44/76 strain (≥1:8 - dose 1; N=13, 7, 38)	100 Percentages of subjects Interval 75.0 to 100.0	100 Percentages of subjects Interval 59.0 to 100.0	63 Percentages of subjects Interval 46.0 to 78.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. H44/76 strain (≥1:8 - dose 2; N=13, 8, 36)	100 Percentages of subjects Interval 75.0 to 100.0	100 Percentages of subjects Interval 63.0 to 100.0	100 Percentages of subjects Interval 90.0 to 100.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. 5/99 strain (≥1:4 - dose 1; N=13, 7, 38)	100 Percentages of subjects Interval 75.0 to 100.0	100 Percentages of subjects Interval 59.0 to 100.0	76 Percentages of subjects Interval 60.0 to 89.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. 5/99 strain (≥1:4 - dose 2; N=13, 8, 36)	100 Percentages of subjects Interval 75.0 to 100.0	100 Percentages of subjects Interval 63.0 to 100.0	100 Percentages of subjects Interval 90.0 to 100.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. 5/99 strain (≥1:8 - dose 1; N=13, 7, 38)	100 Percentages of subjects Interval 75.0 to 100.0	100 Percentages of subjects Interval 59.0 to 100.0	71 Percentages of subjects Interval 54.0 to 85.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. 5/99 strain (≥1:8 - dose 2; N=13, 8, 36)	100 Percentages of subjects Interval 75.0 to 100.0	100 Percentages of subjects Interval 63.0 to 100.0	100 Percentages of subjects Interval 90.0 to 100.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. NZ 98/254 strain (≥1:4 - dose 1; N=13, 7, 38)	15 Percentages of subjects Interval 2.0 to 45.0	100 Percentages of subjects Interval 59.0 to 100.0	66 Percentages of subjects Interval 49.0 to 80.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. NZ 98/254 strain (≥1:4 - dose 2; N=13, 8, 36)	15 Percentages of subjects Interval 2.0 to 45.0	100 Percentages of subjects Interval 63.0 to 100.0	94 Percentages of subjects Interval 81.0 to 99.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. NZ 98/254 strain (≥1:8 - dose 1; N=13, 7, 38)	15 Percentages of subjects Interval 2.0 to 45.0	100 Percentages of subjects Interval 59.0 to 100.0	58 Percentages of subjects Interval 41.0 to 74.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. NZ 98/254 strain (≥1:8 - dose 2; N=13, 8, 36)	15 Percentages of subjects Interval 2.0 to 45.0	100 Percentages of subjects Interval 63.0 to 100.0	94 Percentages of subjects Interval 81.0 to 99.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. M10713 strain (≥1:4 - dose 1; N=13, 7, 38)	100 Percentages of subjects Interval 75.0 to 100.0	86 Percentages of subjects Interval 42.0 to 100.0	76 Percentages of subjects Interval 60.0 to 89.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. M10713 strain (≥1:4 - dose 2; N=12, 8, 36)	83 Percentages of subjects Interval 52.0 to 98.0	100 Percentages of subjects Interval 63.0 to 100.0	89 Percentages of subjects Interval 74.0 to 97.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. M10713 strain (≥1:8 - dose 1; N=13, 7, 38)	85 Percentages of subjects Interval 55.0 to 98.0	86 Percentages of subjects Interval 42.0 to 100.0	61 Percentages of subjects Interval 43.0 to 76.0	—	—	—
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. M10713 strain (≥1:8 - dose 2; N=12, 8, 36)	75 Percentages of subjects Interval 43.0 to 95.0	100 Percentages of subjects Interval 63.0 to 100.0	86 Percentages of subjects Interval 71.0 to 95.0	—	—	—

SECONDARY outcome

Timeframe: 1 month post vaccination

Population: The analysis was done on the MITT population, booster response.

The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) displaying 4-fold increase in antibody titers over baseline against N.meningitidis B strains, after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 \& 42 months of age.

Outcome measures

Outcome measures
Measure	5rMenB n=13 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=8 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=37 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. H44/76 strain (dose 1; N=13, 7, 37)	100 Percentages of subjects Interval 75.0 to 100.0	86 Percentages of subjects Interval 42.0 to 100.0	41 Percentages of subjects Interval 25.0 to 58.0	—	—	—
Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. 5/99 strain (dose 1; N=13, 7, 37)	100 Percentages of subjects Interval 75.0 to 100.0	100 Percentages of subjects Interval 59.0 to 100.0	68 Percentages of subjects Interval 50.0 to 82.0	—	—	—
Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. NZ 98/254 strain (dose 1; N=13, 7, 37)	15 Percentages of subjects Interval 2.0 to 45.0	100 Percentages of subjects Interval 59.0 to 100.0	57 Percentages of subjects Interval 39.0 to 73.0	—	—	—
Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. M10713 strain (dose 1; N=12, 7, 37)	58 Percentages of subjects Interval 28.0 to 85.0	57 Percentages of subjects Interval 18.0 to 90.0	14 Percentages of subjects Interval 5.0 to 29.0	—	—	—
Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. H44/76 strain (dose 2; N=13, 8, 34)	100 Percentages of subjects Interval 75.0 to 100.0	88 Percentages of subjects Interval 47.0 to 100.0	97 Percentages of subjects Interval 85.0 to 100.0	—	—	—
Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. 5/99 strain (dose 2; N=13, 8, 34)	100 Percentages of subjects Interval 75.0 to 100.0	100 Percentages of subjects Interval 63.0 to 100.0	100 Percentages of subjects Interval 90.0 to 100.0	—	—	—
Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. NZ 98/254 strain (dose 2; N=13, 8, 34)	15 Percentages of subjects Interval 2.0 to 45.0	100 Percentages of subjects Interval 63.0 to 100.0	94 Percentages of subjects Interval 80.0 to 99.0	—	—	—
Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. M10713 strain (dose 2; N=11, 8, 34)	64 Percentages of subjects Interval 31.0 to 89.0	75 Percentages of subjects Interval 35.0 to 97.0	53 Percentages of subjects Interval 35.0 to 70.0	—	—	—

SECONDARY outcome

Timeframe: 1 month post -vaccine dose two

Population: The analysis was done on the MITT population, 2-dose catch-up regimen.

The percentage of subjects with hSBA ≥ 1:4 and ≥ 1:8 after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 \& 42 months or 60 \& 62 months of age are reported.

Outcome measures

Outcome measures
Measure	5rMenB n=36 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=42 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. hSBA ≥1:4 ( H44/76 strain)	100 Percentages of subjects Interval 90.0 to 100.0	93 Percentages of subjects Interval 81.0 to 99.0	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. hSBA ≥1:8 (H44/76 strain)	100 Percentages of subjects Interval 90.0 to 100.0	93 Percentages of subjects Interval 81.0 to 99.0	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. hSBA ≥1:4 (5/99 strain)	100 Percentages of subjects Interval 90.0 to 100.0	100 Percentages of subjects Interval 92.0 to 100.0	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. hSBA ≥1:8 (5/99 strain)	100 Percentages of subjects Interval 90.0 to 100.0	100 Percentages of subjects Interval 92.0 to 100.0	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. hSBA ≥1:4 (NZ 98/254 strain)	94 Percentages of subjects Interval 81.0 to 99.0	100 Percentages of subjects Interval 92.0 to 100.0	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. hSBA ≥1:8 (NZ 98/254 strain)	94 Percentages of subjects Interval 81.0 to 99.0	90 Percentages of subjects Interval 77.0 to 97.0	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. hSBA ≥1:4 (M10713 strain; N=36, 41)	89 Percentages of subjects Interval 74.0 to 97.0	100 Percentages of subjects Interval 91.0 to 100.0	—	—	—	—
Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. hSBA ≥1:8 (M10713 strain; N=36, 41)	86 Percentages of subjects Interval 71.0 to 95.0	98 Percentages of subjects Interval 87.0 to 100.0	—	—	—	—

SECONDARY outcome

Timeframe: 1 month post vaccine dose two

Population: The analysis was done on the MITT population, 2-dose catch-up regimen.

The geometric mean antibody titers in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 \& 42 months or 60 \& 62 months of age are reported.

Outcome measures

Outcome measures
Measure	5rMenB n=36 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=42 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age. H44/76 strain	88 Titers Interval 63.0 to 123.0	34 Titers Interval 25.0 to 47.0	—	—	—	—
Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age. 5/99 strain	1019 Titers Interval 688.0 to 1510.0	865 Titers Interval 601.0 to 1244.0	—	—	—	—
Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age. NZ 98/254 strain	47 Titers Interval 32.0 to 69.0	29 Titers Interval 20.0 to 41.0	—	—	—	—
Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age. M10713 strain (N=36, 41)	33 Titers Interval 24.0 to 47.0	43 Titers Interval 31.0 to 59.0	—	—	—	—

SECONDARY outcome

Timeframe: 1 month post vaccine dose 2

Population: The analysis was done on the MITT population, 2-dose catch-up regimen.

The percentages of subjects with four-fold increase in hSBA titers over baseline against N.meningitidis B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 \& 42 months or 60 \& 62 months of age.

Outcome measures

Outcome measures
Measure	5rMenB n=34 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=38 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age. NZ 98/254 strain	94 percentage of subjects Interval 80.0 to 99.0	89 percentage of subjects Interval 75.0 to 97.0	—	—	—	—
Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age. H44/76 strain	97 percentage of subjects Interval 85.0 to 100.0	71 percentage of subjects Interval 54.0 to 85.0	—	—	—	—
Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age. 5/99 strain	100 percentage of subjects Interval 90.0 to 100.0	100 percentage of subjects Interval 91.0 to 100.0	—	—	—	—
Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age. M10713 strain	53 percentage of subjects Interval 35.0 to 70.0	21 percentage of subjects Interval 10.0 to 37.0	—	—	—	—

SECONDARY outcome

Timeframe: 18-20 months after last Men B vaccine; baseline for naïve_6062

Population: The analysis was done on the MITT, 60 months of age, antibody persistence population.

The persisting GMTs against N.meningitidis B strains in children at 60 months of age who had received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present study are compared with GMTs in vaccine-naïve subjects.

Outcome measures

Outcome measures
Measure	5rMenB n=24 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=16 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=13 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ n=5 Participants Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 n=29 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 n=46 Participants Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. H44/76 strain (N=24, 16, 13, 5, 28, 46)	3.13 Titers Interval 1.75 to 5.59	4.68 Titers Interval 2.3 to 9.52	18 Titers Interval 8.08 to 39.0	13 Titers Interval 3.52 to 45.0	12 Titers Interval 6.27 to 23.0	2.98 Titers Interval 1.86 to 4.78
Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. 5/99 strain (N=23, 16, 13, 5, 28, 46)	43 Titers Interval 19.0 to 99.0	136 Titers Interval 51.0 to 365.0	369 Titers Interval 123.0 to 1103.0	210 Titers Interval 36.0 to 1227.0	44 Titers Interval 29.0 to 67.0	1.14 Titers Interval 0.88 to 1.47
Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. NZ 98/254 strain	1.05 Titers Interval 0.8 to 1.38	4.95 Titers Interval 3.54 to 6.92	1 Titers Interval 0.69 to 1.45	11 Titers Interval 5.93 to 20.0	2.42 Titers Interval 1.59 to 3.66	1.04 Titers Interval 0.96 to 1.14
Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. M10713 strain (N=22, 16, 12, 5, 27, 46)	12 Titers Interval 7.22 to 20.0	10 Titers Interval 5.67 to 19.0	12 Titers Interval 5.85 to 24.0	25 Titers Interval 8.47 to 74.0	8.52 Titers Interval 5.09 to 14.0	18 Titers Interval 12.0 to 28.0

SECONDARY outcome

Timeframe: 18-20 months after last Men B vaccine; baseline for naïve_6062

Population: The analysis was done on the MITT, 60 months of age, antibody persistence population.

The percentage of subjects with persisting hSBA titers ≥1:4 and ≥1:8 at 60 months of age against N.meningitidis B strains after having received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present are reported.

Outcome measures

Outcome measures
Measure	5rMenB n=24 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=16 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=13 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ n=5 Participants Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 n=29 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 n=46 Participants Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. hSBA ≥1:8 (H44/76 strain; N=24, 16, 13, 5, 28, 46)	25 Percentage of subjects Interval 10.0 to 47.0	31 Percentage of subjects Interval 11.0 to 59.0	77 Percentage of subjects Interval 46.0 to 95.0	60 Percentage of subjects Interval 15.0 to 95.0	61 Percentage of subjects Interval 41.0 to 78.0	26 Percentage of subjects Interval 14.0 to 41.0
Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. hSBA ≥1:4 (H44/76 strain; N=24, 16, 13, 5, 28, 46)	46 Percentage of subjects Interval 26.0 to 67.0	44 Percentage of subjects Interval 20.0 to 70.0	85 Percentage of subjects Interval 55.0 to 98.0	80 Percentage of subjects Interval 28.0 to 99.0	71 Percentage of subjects Interval 51.0 to 87.0	33 Percentage of subjects Interval 20.0 to 48.0
Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. hSBA ≥1:4 (5/99 strain; N=23, 16, 13, 5, 28, 46)	83 Percentage of subjects Interval 61.0 to 95.0	88 Percentage of subjects Interval 62.0 to 98.0	100 Percentage of subjects Interval 75.0 to 100.0	100 Percentage of subjects Interval 48.0 to 100.0	100 Percentage of subjects Interval 88.0 to 100.0	2 Percentage of subjects Interval 0.055 to 12.0
Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. hSBA ≥1:4 (NZ 98/254 strain)	0 Percentage of subjects Interval 0.0 to 14.0	69 Percentage of subjects Interval 41.0 to 89.0	0 Percentage of subjects Interval 0.0 to 25.0	80 Percentage of subjects Interval 28.0 to 99.0	31 Percentage of subjects Interval 15.0 to 51.0	2 Percentage of subjects Interval 0.055 to 12.0
Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. hSBA ≥1:4 (M10713 strain; N=22, 16, 12, 5, 27, 46)	77 Percentage of subjects Interval 55.0 to 92.0	88 Percentage of subjects Interval 62.0 to 98.0	92 Percentage of subjects Interval 62.0 to 100.0	100 Percentage of subjects Interval 48.0 to 100.0	81 Percentage of subjects Interval 62.0 to 94.0	83 Percentage of subjects Interval 69.0 to 92.0
Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. hSBA ≥1:8 (5/99 strain; N=23, 16, 13, 5, 28, 46)	74 Percentage of subjects Interval 52.0 to 90.0	88 Percentage of subjects Interval 62.0 to 98.0	100 Percentage of subjects Interval 75.0 to 100.0	100 Percentage of subjects Interval 48.0 to 100.0	93 Percentage of subjects Interval 76.0 to 99.0	2 Percentage of subjects Interval 0.055 to 12.0
Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. hSBA ≥1:8 (NZ 98/254 strain)	0 Percentage of subjects Interval 0.0 to 14.0	31 Percentage of subjects Interval 11.0 to 59.0	0 Percentage of subjects Interval 0.0 to 25.0	40 Percentage of subjects Interval 5.0 to 85.0	21 Percentage of subjects Interval 8.0 to 40.0	0 Percentage of subjects Interval 0.0 to 8.0
Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. hSBA ≥1:8 (M10713 strain; N=22, 16, 12, 5, 27, 46)	59 Percentage of subjects Interval 36.0 to 79.0	63 Percentage of subjects Interval 35.0 to 85.0	67 Percentage of subjects Interval 35.0 to 90.0	80 Percentage of subjects Interval 28.0 to 99.0	48 Percentage of subjects Interval 29.0 to 68.0	70 Percentage of subjects Interval 54.0 to 82.0

SECONDARY outcome

Timeframe: 28 months after last Men B vaccination; Baseline for Naïve_4042 group

Population: The analysis was done on the MITT, 40 months of age, antibody persistence population.

The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 4 doses of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children. GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	5rMenB n=28 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=17 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=38 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine in Parent Study) at 40 Months of Age.	82 AU/mL Interval 59.0 to 113.0	62 AU/mL Interval 41.0 to 94.0	23 AU/mL Interval 19.0 to 26.0	—	—	—

SECONDARY outcome

Timeframe: 28 months after last Men B vaccination; baseline for naïve_4042 group

Population: The analysis was done on the MITT, 40 months of age, antibody persistence population.

The persisting GMCs against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children. GMCs against vaccine antigen 287-953 were measure using ELISA.

Outcome measures

Outcome measures
Measure	5rMenB n=14 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=8 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=40 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 1dose of MenB Vaccine in Parent Study) at 40 Months of Age.	32 AU/mL Interval 21.0 to 49.0	28 AU/mL Interval 16.0 to 50.0	23 AU/mL Interval 19.0 to 26.0	—	—	—

SECONDARY outcome

Timeframe: 1 month post booster; 1 month post dose for naïve_4042 group

Population: The analysis was done on the MITT, 40 months of age, antibody persistence population.

The GMCs against vaccine antigen 287-953 in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of either rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the GMCs following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.

Outcome measures

Outcome measures
Measure	5rMenB n=28 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=19 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=38 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine) After Receiving One Booster Dose of Either rMenB or rMenB+OMV NZ at 40 Months of Age.	5592 AU/mL Interval 3900.0 to 8017.0	3934 AU/mL Interval 2540.0 to 6093.0	64 AU/mL Interval 44.0 to 94.0	—	—	—

SECONDARY outcome

Timeframe: 1 month after each booster/ vaccine dose

Population: The analysis was done on the MITT population, booster response.

The GMCs against vaccine antigen 287-953 in children (who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study) , are compared with the GMCs in children who received to catch-up doses of rMenB+OMV NZ at 40 \& 42 months .

Outcome measures

Outcome measures
Measure	5rMenB n=13 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=8 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=38 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ at 40 & 42 Months of Age. after 1st booster/vaccine dose (N=13, N=7, N=38)	2100 AU/mL Interval 1100.0 to 4007.0	1764 AU/mL Interval 731.0 to 4256.0	64 AU/mL Interval 44.0 to 94.0	—	—	—
Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ at 40 & 42 Months of Age. after 2nd booster/vaccine dose (N=13, N=8, N=36)	3790 AU/mL Interval 2265.0 to 6342.0	3660 AU/mL Interval 1899.0 to 7055.0	3464 AU/mL Interval 2782.0 to 4313.0	—	—	—

SECONDARY outcome

Timeframe: 1 month post vaccine dose two

Population: The analysis was done on the MITT population, Booster response.

The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at - 40 \& 42 months or 60 \& 62 months of age are reported.

Outcome measures

Outcome measures
Measure	5rMenB n=36 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=42 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given Either at 40 or 60 Months of Age.	3464 AU/mL Interval 2672.0 to 4489.0	1744 AU/mL Interval 1372.0 to 2218.0	—	—	—	—

SECONDARY outcome

Timeframe: 18-20 months after last Men B vaccine; baseline for naïve_6062

Population: The analysis was done on the MITT, 60 months of age, antibody persistence population population.

The persisting GMCs against vaccine antigen 287-953 in children at 60 months of age who had either received one or two booster doses of either rMenB or rMenB+OMV NZ vaccine or had received two catch-up doses of rMenB+OMV NZ vaccine at 40 months of age in the present are compared with GMCs in vaccine-naïve subjects.

Outcome measures

Outcome measures
Measure	5rMenB n=24 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=16 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 n=13 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ n=5 Participants Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 n=28 Participants Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 n=47 Participants Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age.	670 AU/mL Interval 475.0 to 945.0	320 AU/mL Interval 210.0 to 487.0	280 AU/mL Interval 175.0 to 447.0	250 AU/mL Interval 118.0 to 532.0	121 AU/mL Interval 88.0 to 166.0	25 AU/mL Interval 20.0 to 32.0

SECONDARY outcome

Timeframe: Day 1-7 after any vaccination

Population: Analysis was done on the MITT - Two Dose Catch Up Schedule population.

The safety and tolerability of two catch-up doses of rMenB+OMV NZ vaccine when administered either at 40 \& 42 months or 60 \& 62 months of age in children is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.

Outcome measures

Outcome measures
Measure	5rMenB n=42 Participants Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=50 Participants Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	3rMenB+OMV NZ Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Local	42 Number of subjects	49 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Injection-site pain	41 Number of subjects	46 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Injection-site erythema	42 Number of subjects	48 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Injection-site induration	23 Number of subjects	29 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Injection-site swelling	31 Number of subjects	27 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Systemic	38 Number of subjects	42 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Changes in eating habits	21 Number of subjects	23 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Sleepiness	25 Number of subjects	23 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Vomiting	1 Number of subjects	8 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Diarrhea	7 Number of subjects	7 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Irritability	35 Number of subjects	31 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Headache	8 Number of subjects	8 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Arthralgia	16 Number of subjects	16 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Rash	2 Number of subjects	4 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Fever (≥38°C)	7 Number of subjects	6 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Other	31 Number of subjects	33 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Antipyretic preventive medication used	30 Number of subjects	33 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Antipyretic treatment medication used	7 Number of subjects	7 Number of subjects	—	—	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. Medically attended fever	0 Number of subjects	1 Number of subjects	—	—	—	—

Adverse Events

5rMenB

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

5rMenB+OMV NZ

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

3rMenB

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

3rMenB+OMV NZ

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Naive_4042

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

Naive_6062

Serious events: 2 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	5rMenB n=29 participants at risk Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=19 participants at risk Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	3rMenB n=14 participants at risk Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.	3rMenB+OMV NZ n=8 participants at risk Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 n=42 participants at risk Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 n=50 participants at risk Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Blood and lymphatic system disorders lymphadenitis	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.4% 1/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Congenital, familial and genetic disorders cystic lymphangioma	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	12.5% 1/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Gastrointestinal disorders abdominal pain	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.4% 1/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations bronchopneumonia	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	5.3% 1/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations oral herpes	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.0% 1/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations urinary tract infection	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.0% 1/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) haemangioma	3.4% 1/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Nervous system disorders migraine	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.4% 1/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Respiratory, thoracic and mediastinal disorders asthma	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	12.5% 1/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.

Other adverse events

Other adverse events
Measure	5rMenB n=29 participants at risk Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.	5rMenB+OMV NZ n=19 participants at risk Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.	3rMenB n=14 participants at risk Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.	3rMenB+OMV NZ n=8 participants at risk Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.	Naive_4042 n=42 participants at risk Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.	Naive_6062 n=50 participants at risk Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	5.3% 1/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Ear and labyrinth disorders Ear pain	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.0% 1/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Gastrointestinal disorders Abdominal pain upper	3.4% 1/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.0% 1/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Gastrointestinal disorders Constipation	6.9% 2/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Gastrointestinal disorders Diarrhoea	10.3% 3/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	5.3% 1/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	21.4% 3/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	12.5% 1/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	19.0% 8/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	14.0% 7/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Gastrointestinal disorders Faeces discoloured	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Gastrointestinal disorders Vomiting	3.4% 1/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	15.8% 3/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	21.4% 3/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.4% 1/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	16.0% 8/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
General disorders Hyperpyrexia	3.4% 1/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
General disorders Injection site erythema	96.6% 28/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	100.0% 19/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	100.0% 14/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	100.0% 8/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	100.0% 42/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	96.0% 48/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
General disorders Injection site induration	48.3% 14/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	47.4% 9/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	57.1% 8/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	75.0% 6/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	54.8% 23/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	58.0% 29/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
General disorders Injection site pain	58.6% 17/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	73.7% 14/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	57.1% 8/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	100.0% 8/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	97.6% 41/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	92.0% 46/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
General disorders Injection site swelling	44.8% 13/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	26.3% 5/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	64.3% 9/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	50.0% 4/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	73.8% 31/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	54.0% 27/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
General disorders Irritability	48.3% 14/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	52.6% 10/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	64.3% 9/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	100.0% 8/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	83.3% 35/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	62.0% 31/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
General disorders Local swelling	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	12.5% 1/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
General disorders Pain	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	12.5% 1/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
General disorders Pyrexia	3.4% 1/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	5.3% 1/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	50.0% 7/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	16.7% 7/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	12.0% 6/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Ear infection	6.9% 2/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	5.3% 1/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	14.3% 2/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	12.5% 1/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	9.5% 4/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.0% 1/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Eczema infected	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Fungal skin infection	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Impetigo	3.4% 1/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.4% 1/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.0% 1/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Localised infection	3.4% 1/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	12.5% 1/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Lower respiratory tract infection	10.3% 3/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.4% 1/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.0% 1/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Nasopharingitis	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	5.3% 1/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.4% 1/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Otitis media	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	5.3% 1/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Rhinitis	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	14.3% 2/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	9.5% 4/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.0% 1/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Skin infection	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Tonsillitis	6.9% 2/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.4% 1/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	4.0% 2/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Urinary tract infection	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	5.3% 1/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	4.8% 2/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Infections and infestations Varicella	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	5.3% 1/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.4% 1/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Injury, poisoning and procedural complications Fall	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	5.3% 1/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Injury, poisoning and procedural complications Heat stroke	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	12.5% 1/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Injury, poisoning and procedural complications Overdose	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	31.6% 6/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	28.6% 4/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	50.0% 4/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	38.1% 16/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	32.0% 16/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Nervous system disorders Headache	3.4% 1/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	14.3% 2/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	12.5% 1/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	19.0% 8/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	16.0% 8/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Nervous system disorders Lethargy	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Nervous system disorders Somnolence	44.8% 13/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	63.2% 12/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	57.1% 8/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	75.0% 6/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	59.5% 25/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	46.0% 23/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Psychiatric disorders Eating disorders	17.2% 5/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	52.6% 10/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	35.7% 5/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	50.0% 4/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	50.0% 21/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	46.0% 23/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Respiratory, thoracic and mediastinal disorders Cough	6.9% 2/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.4% 1/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	4.0% 2/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	5.3% 1/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.4% 1/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.0% 1/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Skin and subcutaneous tissue disorders Eczema	3.4% 1/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	7.1% 1/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	2.0% 1/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.
Skin and subcutaneous tissue disorders Rash	13.8% 4/29 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	0.00% 0/19 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	14.3% 2/14 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	12.5% 1/8 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	4.8% 2/42 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.	8.0% 4/50 • Day 1-7 after each vaccination for Solicited AEs; Unsolicited AEs were collected throughout the study period. The analyses for the data in this section are from the safety set. Non serious AEs are reported based on MedDRA version 17.0.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60