Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1

A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fifth Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who Previously Participated in Study V72P12E1

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01717638

Enrollment

805

Registered

2012-10-30

Start date

2012-11-30

Completion date

2013-10-31

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Disease, Meningococcal Meningitis

Keywords

Meningococcal disease, vaccines, children, persistence

Brief summary

It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second extension study is to explore the bactericidal antibody persistence in 4-year-old children after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV NZ administered to toddlers as part of their respective vaccination courses in study V72P12E1. In addition, this study will characterize the antibody response to a fifth dose boost in all children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age (in parent study V72P12, NCT00721396), and only in a subset of children who received a three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12). Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ administered at approximately 4 years of age in all children who received a two catch-up doses of rMenB+OMV NZ as toddlers in study V72P12E1. Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2 months apart to healthy naïve children at 4 years of age will be assessed.

Interventions

BIOLOGICAL1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose

BIOLOGICAL2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

48 Months to 60 Months

Healthy volunteers

Yes

Inclusion criteria

A. Inclusion Criteria for naïve subjects, newly enrolled (B48\_50): 1. 4 years old (48 to 60 months) healthy male and female subjects will be recruited from the same sites as in study V72P12E1. The age window is defined as the first day the subject turns 4 years old up to the day before the subject turns 5 years old. 2. For whom parent/legal guardian(s) has given written informed consent after the nature of the study has been explained. 3. For whom parent/legal guardian(s) confirmed availability for the visit(s) scheduled in the study. 4. In good health as determined by medical history, physical examination, clinical judgment of the investigator. B. Inclusion Criteria for follow-on participants (Groups B+R246 12\_48, B+R246 18\_48, B+R246 24\_48, B246 12\_48, B246 18\_48, B246 24\_48, B+R234 12\_48, B+R234 18\_48, B+R234 24\_48, B12 14\_48, B18 20\_48, B24 26\_48): Inclusion criteria are the same as for Group B48\_50, with the addition that they are subjects who completed the vaccination course of V72P12E1 study.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	Day 1 (24-36 months post booster dose; baseline for naive)	The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	Day 1 (24-36 months post booster; baseline for naive)	The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8. The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	Day 1 (24-36 months post booster; baseline for naive)	The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).

Secondary

Measure	Time frame	Description
Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	Day 31 (1 month post vaccination)	The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.
GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	Day 31 (1 month post vaccination)	The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.
Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	Day 31 (1 month post vaccination)	The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.
Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	Day 31 (1 month post vaccination)	The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.
Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	Day 31 (1 month post vaccination)	The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.
GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	Day 31 (1 month post vaccination)	The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.
GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	Day 31 (1 month post vaccination)	The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.
Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	Day 31 (1 month post vaccination)	The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported. Fourfold increase is defined as- for subjects with a pre-vaccination titer \<1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer.
Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.	Day 91 (1 month post second vaccination)	The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age. Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains. Immune sufficiency was not applicable for M10713 strain.
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	Day 1 (22-34 months post last MenB vaccine)	The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.
GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Day 91 (1 month post second vaccination)	The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.
Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Day 91 (1 month post second vaccination)	The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	From day 1 to day 7 after vaccination	The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	From day 1 to day 7 after vaccination	The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	From day 1 to day 7 after any vaccination	The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local\* and systemic adverse events.
Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	From day 1 to study termination	The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.
Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	From day 1 to study termination	The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.
Number of Subjects Reporting Unsolicited AEs After Any Vaccination.	From day 1 to study termination	The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.
GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Day 91 (1 month post second vaccination)	The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	Day 1 (22-36 months post last MenB vaccine; baseline for naive)	The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.
GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	Day 1 (22-34 months post last MenB vaccine)	The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.

Countries

Czechia, Italy, Spain, United Kingdom

Participant flow

Recruitment details

Subjects were enrolled from 4 centers from the UK, 4 centers from Italy, 4 centers from Spain, 19 centers from Czech Republic.

Pre-assignment details

All subjects were included in the trial.

Participants by arm

Arm	Count
B+R246_12_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.	67
B+R246_18_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.	61
B+R246_24_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.	60
B246_12_48 Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.	66
B246_18_48 Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.	64
B246_24_48 Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.	55
B+R234_12_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.	43
B+R234_18_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.	29
B+R234_24_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.	28
B12 14_48 Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.	100
B18 20_48 Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.	11
B24 26_48 Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.	12
B48 50 Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.	209
Total	805

Withdrawals & dropouts

Period	Reason	FG001	FG002	FG004	FG005	FG006	FG007	FG008	FG009	FG012
Overall Study	Father in hospital	0	0	0	0	0	0	0	0	1
Overall Study	Lost to Follow-up	0	0	0	1	0	0	0	0	0
Overall Study	Withdrawal by Subject	1	1	1	0	2	1	2	1	18

Baseline characteristics

Characteristic	B+R246_12_48	B+R246_18_48	B+R246_24_48	B246_12_48	B246_18_48	B246_24_48	B+R234_12_48	B+R234_18_48	B+R234_24_48	B12 14_48	B18 20_48	B24 26_48	B48 50	Total
Age, Continuous	51.8 Months STANDARD_DEVIATION 3.4	52.1 Months STANDARD_DEVIATION 3.4	51.7 Months STANDARD_DEVIATION 3.5	51.7 Months STANDARD_DEVIATION 3.5	51.3 Months STANDARD_DEVIATION 3.7	52.3 Months STANDARD_DEVIATION 3.7	51.8 Months STANDARD_DEVIATION 3.4	51.4 Months STANDARD_DEVIATION 3.4	53.1 Months STANDARD_DEVIATION 3.5	51.7 Months STANDARD_DEVIATION 3.3	53.4 Months STANDARD_DEVIATION 4.3	56.8 Months STANDARD_DEVIATION 1.5	53.7 Months STANDARD_DEVIATION 3.6	52.4 Months STANDARD_DEVIATION 3.6
Sex: Female, Male Female	23 Participants	28 Participants	33 Participants	28 Participants	32 Participants	30 Participants	24 Participants	17 Participants	13 Participants	50 Participants	6 Participants	4 Participants	99 Participants	387 Participants
Sex: Female, Male Male	44 Participants	33 Participants	27 Participants	38 Participants	32 Participants	25 Participants	19 Participants	12 Participants	15 Participants	50 Participants	5 Participants	8 Participants	110 Participants	418 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	29 / 30	19 / 20	17 / 17	18 / 19	25 / 27	17 / 17	42 / 43	28 / 29	27 / 28	97 / 100	10 / 11	12 / 12	200 / 206
serious Total, serious adverse events	0 / 30	0 / 20	0 / 17	0 / 19	0 / 27	0 / 17	0 / 43	0 / 29	0 / 28	0 / 100	0 / 11	0 / 12	3 / 206

Outcome results

Primary

Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules

The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.

Time frame: Day 1 (24-36 months post booster dose; baseline for naive)

Population: FAS, Persistency.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B+R246_12_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	0.028 Ratio
B+R246_12_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=62,56,52,57,55,46,38,27,25,206	0.012 Ratio
B+R246_12_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=61,57,50,57,55,44,37,27,25,200	0.029 Ratio
B+R246_12_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=26,24,25	NA Ratio
B+R246_18_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=61,57,50,57,55,44,37,27,25,200	0.032 Ratio
B+R246_18_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	0.094 Ratio
B+R246_18_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=26,24,25	NA Ratio
B+R246_18_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=62,56,52,57,55,46,38,27,25,206	0.013 Ratio
B+R246_24_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=61,57,50,57,55,44,37,27,25,200	0.043 Ratio
B+R246_24_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	0.071 Ratio
B+R246_24_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=62,56,52,57,55,46,38,27,25,206	0.023 Ratio
B+R246_24_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=26,24,25	NA Ratio
B246_12_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	0.043 Ratio
B246_12_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=61,57,50,57,55,44,37,27,25,200	0.031 Ratio
B246_12_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=26,24,25	NA Ratio
B246_12_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=62,56,52,57,55,46,38,27,25,206	0.0092 Ratio
B246_18_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=26,24,25	NA Ratio
B246_18_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=62,56,52,57,55,46,38,27,25,206	0.013 Ratio
B246_18_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=61,57,50,57,55,44,37,27,25,200	0.034 Ratio
B246_18_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	0.081 Ratio
B246_24_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=26,24,25	NA Ratio
B246_24_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=62,56,52,57,55,46,38,27,25,206	0.023 Ratio
B246_24_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=61,57,50,57,55,44,37,27,25,200	0.054 Ratio
B246_24_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	0.11 Ratio
B+R234_12_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	0.03 Ratio
B+R234_12_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=61,57,50,57,55,44,37,27,25,200	0.035 Ratio
B+R234_12_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=62,56,52,57,55,46,38,27,25,206	0.0091 Ratio
B+R234_12_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=26,24,25	0.67 Ratio
B+R234_18_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=62,56,52,57,55,46,38,27,25,206	0.023 Ratio
B+R234_18_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	0.082 Ratio
B+R234_18_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=61,57,50,57,55,44,37,27,25,200	0.037 Ratio
B+R234_18_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=26,24,25	0.91 Ratio
B+R234_24_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=26,24,25	0.47 Ratio
B+R234_24_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=62,56,52,57,55,46,38,27,25,206	0.023 Ratio
B+R234_24_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=61,57,50,57,55,44,37,27,25,200	0.055 Ratio
B+R234_24_48	Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	0.066 Ratio

Primary

Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules

The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8. The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).

Time frame: Day 1 (24-36 months post booster; baseline for naive)

Population: Full Analysis Set (Fas), Persistency: All subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1). Persistence data sets include nonvaccination and vaccination subsets of subjects from different groups with different primary vaccination schedules of MenB+Routine vaccines and routine vaccines.

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:5	9 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200	93 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206	12 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192	54 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206	7 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200	91 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:8	4 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192	49 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200	97 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206	10 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192	53 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:5	8 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206	18 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200	98 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:8	5 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192	68 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200	97 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192	60 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:8	8 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200	93 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192	74 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:5	12 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206	17 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206	24 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:8	8 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206	11 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200	97 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192	48 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206	20 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200	94 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192	55 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:5	9 Percentages of subjects
B246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192	45 Percentages of subjects
B246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200	100 Percentages of subjects
B246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:8	3 Percentages of subjects
B246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206	27 Percentages of subjects
B246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:5	11 Percentages of subjects
B246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192	53 Percentages of subjects
B246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206	24 Percentages of subjects
B246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200	94 Percentages of subjects
B246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192	80 Percentages of subjects
B246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192	65 Percentages of subjects
B246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:5	9 Percentages of subjects
B246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200	100 Percentages of subjects
B246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206	28 Percentages of subjects
B246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206	35 Percentages of subjects
B246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200	100 Percentages of subjects
B246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:8	4 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192	60 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:8	2 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:5	10 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206	12 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200	90 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192	68 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206	7 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200	90 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206	25 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200	89 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:5	11 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192	75 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206	21 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192	61 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200	86 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:8	7 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:8	11 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192	75 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200	96 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:5	11 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206	21 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200	96 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206	21 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192	61 Percentages of subjects
B48 50	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192	60 Percentages of subjects
B48 50	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206	0 Percentages of subjects
B48 50	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:8	0 Percentages of subjects
B48 50	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192	56 Percentages of subjects
B48 50	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200	3 Percentages of subjects
B48 50	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 - ≥ 1:5	0 Percentages of subjects
B48 50	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200	5 Percentages of subjects
B48 50	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206	0 Percentages of subjects

Primary

Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules

The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).

Time frame: Day 1 (24-36 months post booster; baseline for naive)

Population: FAS, Persistency.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B+R246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=67,60,59,65,63,54,42,28,28,206	1.75 Titers
B+R246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=67,60,58,64,62,54,42,28,28,200	36 Titers
B+R246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	1.25 Titers
B+R246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=65,59,58,62,60,54,40,28,28,192	6.14 Titers
B+R246_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=67,60,58,64,62,54,42,28,28,200	69 Titers
B+R246_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=67,60,59,65,63,54,42,28,28,206	1.68 Titers
B+R246_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=65,59,58,62,60,54,40,28,28,192	7.36 Titers
B+R246_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	1.29 Titers
B+R246_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=67,60,58,64,62,54,42,28,28,200	69 Titers
B+R246_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=67,60,59,65,63,54,42,28,28,206	2.41 Titers
B+R246_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	1.38 Titers
B+R246_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=65,59,58,62,60,54,40,28,28,192	9.08 Titers
B246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=67,60,59,65,63,54,42,28,28,206	1.72 Titers
B246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=67,60,58,64,62,54,42,28,28,200	59 Titers
B246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	1.48 Titers
B246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=65,59,58,62,60,54,40,28,28,192	7.86 Titers
B246_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	1.34 Titers
B246_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=67,60,58,64,62,54,42,28,28,200	57 Titers
B246_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=65,59,58,62,60,54,40,28,28,192	7.77 Titers
B246_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=67,60,59,65,63,54,42,28,28,206	1.99 Titers
B246_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	1.52 Titers
B246_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=67,60,58,64,62,54,42,28,28,200	111 Titers
B246_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=67,60,59,65,63,54,42,28,28,206	2.69 Titers
B246_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=65,59,58,62,60,54,40,28,28,192	15 Titers
B+R234_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=67,60,58,64,62,54,42,28,28,200	52 Titers
B+R234_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	1.32 Titers
B+R234_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=65,59,58,62,60,54,40,28,28,192	9.61 Titers
B+R234_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=67,60,59,65,63,54,42,28,28,206	1.51 Titers
B+R234_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=67,60,59,65,63,54,42,28,28,206	2.2 Titers
B+R234_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=65,59,58,62,60,54,40,28,28,192	11 Titers
B+R234_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=67,60,58,64,62,54,42,28,28,200	62 Titers
B+R234_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	1.25 Titers
B+R234_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=65,59,58,62,60,54,40,28,28,192	11 Titers
B+R234_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=67,60,59,65,63,54,42,28,28,206	2.2 Titers
B+R234_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	1.62 Titers
B+R234_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=67,60,58,64,62,54,42,28,28,200	101 Titers
B48 50	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254	1.01 Titers
B48 50	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76; N=67,60,59,65,63,54,42,28,28,206	1.04 Titers
B48 50	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	M10713; N=65,59,58,62,60,54,40,28,28,192	8.75 Titers
B48 50	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules	5/99; N=67,60,58,64,62,54,42,28,28,200	1.15 Titers

Secondary

Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.

Time frame: Day 31 (1 month post vaccination)

Population: Analysis was done on FAS (Immunogenicity).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B+R246_12_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	60 Ratio
B+R246_12_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	32 Ratio
B+R246_12_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	17 Ratio
B+R246_12_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	3.15 Ratio
B+R246_18_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	23 Ratio
B+R246_18_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	72 Ratio
B+R246_18_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	4.46 Ratio
B+R246_18_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	10 Ratio
B+R246_24_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	15 Ratio
B+R246_24_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	41 Ratio
B+R246_24_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	19 Ratio
B+R246_24_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	3.36 Ratio
B246_12_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	77 Ratio
B246_12_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	30 Ratio
B246_12_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	8.93 Ratio
B246_12_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	3.49 Ratio
B246_18_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	17 Ratio
B246_18_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	20 Ratio
B246_18_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	3.74 Ratio
B246_18_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	88 Ratio
B246_24_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	13 Ratio
B246_24_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	18 Ratio
B246_24_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	46 Ratio
B246_24_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	4.21 Ratio
B+R234_12_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	33 Ratio
B+R234_12_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	19 Ratio
B+R234_12_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	5.35 Ratio
B+R234_12_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	109 Ratio
B+R234_18_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	63 Ratio
B+R234_18_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	3.86 Ratio
B+R234_18_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	20 Ratio
B+R234_18_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	14 Ratio
B+R234_24_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	4.04 Ratio
B+R234_24_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	64 Ratio
B+R234_24_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	17 Ratio
B+R234_24_48	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	12 Ratio
B48 50	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	2.25 Ratio
B48 50	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	10 Ratio
B48 50	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	2 Ratio
B48 50	Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	29 Ratio

Secondary

GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.

Time frame: Day 91 (1 month post second vaccination)

Population: Analysis was done on FAS (Immunogenicity).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B+R246_12_48	GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	H44/76 strain	105 Ratio
B+R246_12_48	GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	5/99 strain; N=172	299 Ratio
B+R246_12_48	GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	NZ 98/254 strain; N=174	17 Ratio
B+R246_12_48	GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	M10713 strain; N=171	5.12 Ratio

Secondary

GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules

The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.

Time frame: Day 1 (22-34 months post last MenB vaccine)

Population: FAS, Persistency.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B+R246_12_48	GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 strain	0.092 Ratio
B+R246_12_48	GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 strain; N=88, 9, 8	0.28 Ratio
B+R246_12_48	GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 strain; N=7, 7, 8	11 Ratio
B+R246_12_48	GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 strain	0.45 Ratio
B+R246_18_48	GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 strain	0.18 Ratio
B+R246_18_48	GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 strain	1.9 Ratio
B+R246_18_48	GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 strain; N=88, 9, 8	0.73 Ratio
B+R246_18_48	GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 strain; N=7, 7, 8	6.05 Ratio
B+R246_24_48	GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 strain; N=88, 9, 8	0.42 Ratio
B+R246_24_48	GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 strain	0.2 Ratio
B+R246_24_48	GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 strain	1.36 Ratio
B+R246_24_48	GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 strain; N=7, 7, 8	6.88 Ratio

Secondary

GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.

The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.

Time frame: Day 31 (1 month post vaccination)

Population: Analysis was done on FAS (Immunogenicity).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B+R246_12_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	H44/76 strain	99 Ratio
B+R246_12_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	5/99 strain; N=92,10,11,168	70 Ratio
B+R246_12_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	NZ 98/254 strain; N=93,10,11,173	27 Ratio
B+R246_12_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	M10713 strain; N=88,9,9,158	5.24 Ratio
B+R246_18_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	5/99 strain; N=92,10,11,168	51 Ratio
B+R246_18_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	NZ 98/254 strain; N=93,10,11,173	5.96 Ratio
B+R246_18_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	M10713 strain; N=88,9,9,158	7.06 Ratio
B+R246_18_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	H44/76 strain	67 Ratio
B+R246_24_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	NZ 98/254 strain; N=93,10,11,173	38 Ratio
B+R246_24_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	5/99 strain; N=92,10,11,168	55 Ratio
B+R246_24_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	M10713 strain; N=88,9,9,158	7.35 Ratio
B+R246_24_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	H44/76 strain	133 Ratio
B246_12_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	M10713 strain; N=88,9,9,158	2 Ratio
B246_12_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	5/99 strain; N=92,10,11,168	29 Ratio
B246_12_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	H44/76 strain	10 Ratio
B246_12_48	GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.	NZ 98/254 strain; N=93,10,11,173	2.25 Ratio

Secondary

GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.

Time frame: Day 91 (1 month post second vaccination)

Population: Analysis was done on FAS (Immunogenicity).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B+R246_12_48	GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	H44/76 strain	109 Titers
B+R246_12_48	GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	5/99 strain	343 Titers
B+R246_12_48	GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	NZ 98/254 strain; N=174	17 Titers
B+R246_12_48	GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	M10713 strain; N=171	47 Titers

Secondary

GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules

The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.

Time frame: Day 31 (1 month post vaccination)

Population: Analysis was done on FAS (Immunogenicity).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B+R246_12_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	H44/76 strain	154 Titers
B+R246_12_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	5/99 strain; N= 94,10,12,171	1575 Titers
B+R246_12_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=95,10,12,173	31 Titers
B+R246_12_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	M10713 strain; N=90,9,10,167	38 Titers
B+R246_18_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	5/99 strain; N= 94,10,12,171	2381 Titers
B+R246_18_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=95,10,12,173	18 Titers
B+R246_18_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	M10713 strain; N=90,9,10,167	74 Titers
B+R246_18_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	H44/76 strain	145 Titers
B+R246_24_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=95,10,12,173	47 Titers
B+R246_24_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	5/99 strain; N= 94,10,12,171	3604 Titers
B+R246_24_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	M10713 strain; N=90,9,10,167	84 Titers
B+R246_24_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	H44/76 strain	211 Titers
B246_12_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	M10713 strain; N=90,9,10,167	20 Titers
B246_12_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	5/99 strain; N= 94,10,12,171	34 Titers
B246_12_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	H44/76 strain	11 Titers
B246_12_48	GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=95,10,12,173	2.25 Titers

Secondary

GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.

Time frame: Day 31 (1 month post vaccination)

Population: Analysis was done on FAS (Immunogenicity).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B+R246_12_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,26,26,175	108 Titers
B+R246_12_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,16,26,15,38,26,26,171	754 Titers
B+R246_12_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,173	22 Titers
B+R246_12_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=25,18,16,14,25,15,36,25,25,167	22 Titers
B+R246_18_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,16,26,15,38,26,26,171	1719 Titers
B+R246_18_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,26,26,175	115 Titers
B+R246_18_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=25,18,16,14,25,15,36,25,25,167	19 Titers
B+R246_18_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,173	11 Titers
B+R246_24_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,16,26,15,38,26,26,171	933 Titers
B+R246_24_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,26,26,175	107 Titers
B+R246_24_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,173	28 Titers
B+R246_24_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=25,18,16,14,25,15,36,25,25,167	28 Titers
B246_12_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,26,26,175	173 Titers
B246_12_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,16,26,15,38,26,26,171	1959 Titers
B246_12_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,173	16 Titers
B246_12_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=25,18,16,14,25,15,36,25,25,167	32 Titers
B246_18_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,173	21 Titers
B246_18_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,16,26,15,38,26,26,171	1387 Titers
B246_18_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=25,18,16,14,25,15,36,25,25,167	37 Titers
B246_18_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,26,26,175	191 Titers
B246_24_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,173	15 Titers
B246_24_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,16,26,15,38,26,26,171	1954 Titers
B246_24_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,26,26,175	212 Titers
B246_24_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=25,18,16,14,25,15,36,25,25,167	33 Titers
B+R234_12_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,16,26,15,38,26,26,171	1711 Titers
B+R234_12_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,173	26 Titers
B+R234_12_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=25,18,16,14,25,15,36,25,25,167	53 Titers
B+R234_12_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,26,26,175	167 Titers
B+R234_18_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,26,26,175	146 Titers
B+R234_18_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=25,18,16,14,25,15,36,25,25,167	58 Titers
B+R234_18_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,16,26,15,38,26,26,171	1239 Titers
B+R234_18_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,173	18 Titers
B+R234_24_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=25,18,16,14,25,15,36,25,25,167	51 Titers
B+R234_24_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,26,26,175	135 Titers
B+R234_24_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,173	27 Titers
B+R234_24_48	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,16,26,15,38,26,26,171	1280 Titers
B48 50	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,173	2.25 Titers
B48 50	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,26,26,175	11 Titers
B48 50	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=25,18,16,14,25,15,36,25,25,167	20 Titers
B48 50	GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,16,26,15,38,26,26,171	34 Titers

Secondary

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local\* and systemic adverse events.

Time frame: From day 1 to day 7 after any vaccination

Population: Analysis was done on the safety population.

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Erythema (>100 mm; N= 204, 194)	1 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Pain (mild)	81 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Pain (moderate)	77 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Pain (severe)	27 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Erythema (25 - 50 mm; N= 204, 194)	34 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Erythema (51 - 100 mm; N= 204, 194)	8 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Any local	186 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Induration (25 - 50 mm; N= 204, 194	23 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Induration (51-100 mm; N= 204, 194)	3 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Induration(>100 mm; N= 204, 194	0 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Swelling (25 - 50 mm; N= 204, 194	26 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Swelling (51 - 100 mm; N= 204, 194)	3 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Swelling (>100 mm; N= 204, 194)	1 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Any Systemic	137 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Rash; N=201, 192	15 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Change in eating habits; N= 203, 194	49 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Headache; N= 204, 194	25 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Arthralagia; N= 203, 192	45 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Irritability; N= 204, 193	67 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Vomiting	8 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Diarrhea; N= 204, 193	11 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Fever (≥ 38.0 °C; N= 204, 189)	20 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Antipyretic used (prophylactically; N= 204, 193)	17 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Antipyretic used (therapeutically; N= 204, 193)	22 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Antipyretic used (prophylactically; N= 204, 193)	23 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Any local	161 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Swelling (>100 mm; N= 204, 194)	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Pain (mild)	70 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Irritability; N= 204, 193	58 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Pain (moderate)	66 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Any Systemic	108 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Pain (severe)	21 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Fever (≥ 38.0 °C; N= 204, 189)	16 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Erythema (25 - 50 mm; N= 204, 194)	15 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Rash; N=201, 192	10 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Erythema (51 - 100 mm; N= 204, 194)	19 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Vomiting	6 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Erythema (>100 mm; N= 204, 194)	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Change in eating habits; N= 203, 194	43 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Induration (25 - 50 mm; N= 204, 194	16 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Antipyretic used (therapeutically; N= 204, 193)	24 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Induration (51-100 mm; N= 204, 194)	4 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Headache; N= 204, 194	24 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Induration(>100 mm; N= 204, 194	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Diarrhea; N= 204, 193	8 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Swelling (25 - 50 mm; N= 204, 194	20 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Arthralagia; N= 203, 192	40 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	Injection site Swelling (51 - 100 mm; N= 204, 194)	4 Number of subjects

Secondary

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.

Time frame: From day 1 to day 7 after vaccination

Population: Analysis was done on the safety population.

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (>100 mm)	2 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (mild)	33 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (moderate)	42 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (severe)	19 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (25 - 50 mm)	12 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (51 - 100 mm)	7 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any local	94 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (25 - 50 mm)	8 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (51 - 100 mm)	0 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (>100 mm)	1 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (25 - 50 mm)	18 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (51 - 100 mm)	2 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (>100 mm)	0 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any Systemic	78 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Change in eating habits	42 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Rash	13 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Arthralagia	28 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Headache	20 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Irritability	53 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Diarrhea	5 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Vomiting	6 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Fever (≥ 38.0 °C)	16 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (prophylactically)	5 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (therapeutically)	18 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Fever (≥ 38.0 °C)	4 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any local	9 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (>100 mm)	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Arthralagia	1 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (mild)	2 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (25 - 50 mm)	2 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Vomiting	2 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (moderate)	6 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any Systemic	6 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (prophylactically)	2 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (severe)	1 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (>100 mm)	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Headache	2 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (25 - 50 mm)	2 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Change in eating habits	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (51 - 100 mm)	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (51 - 100 mm)	1 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (51 - 100 mm)	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (therapeutically)	4 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (>100 mm)	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Rash	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Irritability	4 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (25 - 50 mm)	1 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Diarrhea	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (25 - 50 mm)	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (51 - 100 mm)	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (>100 mm)	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (25 - 50 mm)	3 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Diarrhea	2 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (51 - 100 mm)	1 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (prophylactically)	2 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (>100 mm)	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any Systemic	9 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Vomiting	1 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Change in eating habits	3 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (therapeutically)	5 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Rash	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any local	11 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (mild)	2 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Arthralagia	6 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (moderate)	8 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Fever (≥ 38.0 °C)	5 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (severe)	1 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (25 - 50 mm)	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Headache	4 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (51 - 100 mm)	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (>100 mm)	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Irritability	5 Number of subjects

Secondary

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.

Time frame: From day 1 to day 7 after vaccination

Population: Analysis was done on the safety population, ie, all subjects in the Exposed population who provided post vaccination and post-baseline safety data.

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (>100 mm)	1 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any local	27 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (mild)	4 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (moderate)	18 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (severe)	5 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (25 - 50 mm)	2 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (51 - 100 mm)	5 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (25 - 50 mm)	2 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (51 - 100 mm)	1 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (>100 mm)	1 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (25 - 50 mm)	1 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (51 - 100 mm)	1 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (>100 mm)	1 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any Systemic	26 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Change in eating habits	12 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Rash	2 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Arthralagia	12 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Headache	5 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Irritability	18 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Diarrhea	4 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Vomiting	0 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Fever (≥ 38.0 °C)	6 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (prophylactically)	1 Number of subjects
B+R246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (therapeutically)	5 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Vomiting	1 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (25 - 50 mm)	3 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Arthralagia	4 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (therapeutically)	5 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (mild)	5 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Rash	1 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (moderate)	9 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (>100 mm)	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any local	18 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Diarrhea	1 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (>100 mm)	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Change in eating habits	6 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Irritability	9 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any Systemic	15 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Fever (≥ 38.0 °C)	3 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (prophylactically)	2 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (25 - 50 mm)	2 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Headache	1 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (severe)	4 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (>100 mm)	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (51 - 100 mm)	2 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (51 - 100 mm)	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (51 - 100 mm)	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (25 - 50 mm)	3 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any local	17 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (51 - 100 mm)	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (severe)	3 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (>100 mm)	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (moderate)	13 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Fever (≥ 38.0 °C)	3 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Vomiting	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (25 - 50 mm)	3 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Diarrhea	1 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Irritability	11 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Headache	6 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (51 - 100 mm)	1 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (therapeutically)	4 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Arthralagia	6 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Rash	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (prophylactically)	1 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (>100 mm)	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (mild)	1 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Change in eating habits	6 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any Systemic	14 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (>100 mm)	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (25 - 50 mm)	1 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (51 - 100 mm)	1 Number of subjects
B+R246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (25 - 50 mm)	3 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (51 - 100 mm)	2 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (severe)	6 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (25 - 50 mm)	5 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (>100 mm)	0 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (25 - 50 mm)	2 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (51 - 100 mm)	1 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (prophylactically)	1 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (>100 mm)	0 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (25 - 50 mm)	4 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (51 - 100 mm)	2 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (>100 mm)	0 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any Systemic	18 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Change in eating habits	12 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Rash	5 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Arthralagia	9 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Headache	3 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (therapeutically)	3 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Irritability	14 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Diarrhea	2 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Vomiting	0 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Fever (≥ 38.0 °C)	2 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any local	16 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (mild)	6 Number of subjects
B246_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (moderate)	4 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (25 - 50 mm)	5 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (51 - 100 mm)	7 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Arthralagia	8 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (prophylactically)	2 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Irritability	13 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Headache	2 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (25 - 50 mm)	5 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (>100 mm)	0 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (severe)	4 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (>100 mm)	0 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (51 - 100 mm)	2 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any local	24 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any Systemic	19 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Fever (≥ 38.0 °C)	1 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (>100 mm)	1 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (moderate)	14 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Change in eating habits	7 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (51 - 100 mm)	3 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Vomiting	1 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Diarrhea	4 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (25 - 50 mm)	6 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (mild)	5 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Rash	2 Number of subjects
B246_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (therapeutically)	3 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (moderate)	9 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (51 - 100 mm)	3 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Rash	4 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (mild)	2 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any Systemic	13 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Arthralagia	5 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Fever (≥ 38.0 °C)	1 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Irritability	8 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (severe)	5 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (>100 mm)	1 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Headache	3 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (51 - 100 mm)	2 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (prophylactically)	1 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Vomiting	0 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (>100 mm)	1 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (therapeutically)	1 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Diarrhea	2 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (>100 mm)	1 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (25 - 50 mm)	3 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (25 - 50 mm)	3 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (51 - 100 mm)	1 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any local	17 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Change in eating habits	8 Number of subjects
B246_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (25 - 50 mm)	2 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (mild)	4 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (25 - 50 mm)	6 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (51 - 100 mm)	7 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (prophylactically)	7 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (>100 mm)	1 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (>100 mm)	2 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any Systemic	36 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Change in eating habits	20 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Rash	7 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (51 - 100 mm)	10 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Arthralagia	11 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (moderate)	24 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (25 - 50 mm)	7 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Headache	7 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (25 - 50 mm)	5 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Irritability	23 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Fever (≥ 38.0 °C)	5 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Diarrhea	6 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Vomiting	5 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (therapeutically)	10 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (severe)	10 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (51 - 100 mm)	2 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any local	38 Number of subjects
B+R234_12_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (>100 mm)	1 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (>100 mm)	0 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Irritability	20 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Rash	5 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (51 - 100 mm)	6 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (>100 mm)	0 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Diarrhea	4 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Change in eating habits	11 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (51 - 100 mm)	5 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Vomiting	3 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (severe)	8 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (25 - 50 mm)	7 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (moderate)	14 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any Systemic	27 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Fever (≥ 38.0 °C)	4 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (>100 mm)	0 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (prophylactically)	1 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (51 - 100 mm)	1 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (25 - 50 mm)	7 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any local	28 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (therapeutically)	4 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Headache	5 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (mild)	6 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (25 - 50 mm)	6 Number of subjects
B+R234_18_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Arthralagia	8 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Headache	8 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any Systemic	23 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Irritability	16 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Rash	2 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (mild)	7 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (25 - 50 mm)	5 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Arthralagia	12 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (51 - 100 mm)	3 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (therapeutically)	3 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (>100 mm)	0 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Erythema (>100 mm)	0 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Diarrhea	3 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Change in eating habits	13 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Fever (≥ 38.0 °C)	2 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (severe)	3 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Pain (moderate)	17 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any local	27 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Antipyretic used (prophylactically)	1 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (51 - 100 mm)	1 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (51 - 100 mm)	1 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Vomiting	2 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Induration (25 - 50 mm)	6 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (25 - 50 mm)	4 Number of subjects
B+R234_24_48	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Injection site Swelling (>100 mm)	0 Number of subjects

Secondary

Number of Subjects Reporting Unsolicited AEs After Any Vaccination.

Time frame: From day 1 to study termination

Population: Analysis was done on the safety population.

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Number of Subjects Reporting Unsolicited AEs After Any Vaccination.	Any AEs	105 Number of participants
B+R246_12_48	Number of Subjects Reporting Unsolicited AEs After Any Vaccination.	SAEs	3 Number of participants
B+R246_12_48	Number of Subjects Reporting Unsolicited AEs After Any Vaccination.	AEs leading to premature withdrawal	1 Number of participants

Secondary

Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

Time frame: From day 1 to study termination

Population: Analysis was done on the safety population.

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	SAEs	0 Number of subjects
B+R246_12_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any AE	25 Number of subjects
B+R246_12_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	AEs leading to withdrawal	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	SAEs	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any AE	2 Number of subjects
B+R246_18_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	AEs leading to withdrawal	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any AE	4 Number of subjects
B+R246_24_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	AEs leading to withdrawal	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	SAEs	0 Number of subjects

Secondary

Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.

Time frame: From day 1 to study termination

Population: Analysis was done on the safety population.

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any AEs	8 Number of subjects
B+R246_12_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	AEs leading to withdrawal	0 Number of subjects
B+R246_12_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	SAEs	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	AEs leading to withdrawal	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	SAEs	0 Number of subjects
B+R246_18_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any AEs	4 Number of subjects
B+R246_24_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	SAEs	0 Number of subjects
B+R246_24_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any AEs	4 Number of subjects
B+R246_24_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	AEs leading to withdrawal	0 Number of subjects
B246_12_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	AEs leading to withdrawal	0 Number of subjects
B246_12_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any AEs	7 Number of subjects
B246_12_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	SAEs	0 Number of subjects
B246_18_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	SAEs	0 Number of subjects
B246_18_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any AEs	7 Number of subjects
B246_18_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	AEs leading to withdrawal	0 Number of subjects
B246_24_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	SAEs	0 Number of subjects
B246_24_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any AEs	3 Number of subjects
B246_24_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	AEs leading to withdrawal	0 Number of subjects
B+R234_12_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	AEs leading to withdrawal	0 Number of subjects
B+R234_12_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any AEs	11 Number of subjects
B+R234_12_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	SAEs	0 Number of subjects
B+R234_18_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	SAEs	0 Number of subjects
B+R234_18_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	AEs leading to withdrawal	0 Number of subjects
B+R234_18_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any AEs	11 Number of subjects
B+R234_24_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	SAEs	0 Number of subjects
B+R234_24_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	AEs leading to withdrawal	0 Number of subjects
B+R234_24_48	Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)	Any AEs	6 Number of subjects

Secondary

Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.

Time frame: Day 91 (1 month post second vaccination)

Population: Analysis was done on FAS (Immunogenicity).

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	H44/76 strain	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	5/99 strain; N=172	99 Percentages of subjects
B+R246_12_48	Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	NZ 98/254 strain; N=174	80 Percentages of subjects
B+R246_12_48	Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age	M10713 strain; N=161	51 Percentages of subjects

Secondary

Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine

The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported. Fourfold increase is defined as- for subjects with a pre-vaccination titer \<1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer.

Time frame: Day 31 (1 month post vaccination)

Population: Analysis was done on FAS (Immunogenicity).

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	H44/76 strain	99 Percentages of subjects
B+R246_12_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	5/99 strain; N=92,10,11,168	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	NZ 98/254 strain; N=93,10,11,173	94 Percentages of subjects
B+R246_12_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	M10713 strain; N=88,9,9,158	58 Percentages of subjects
B+R246_18_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	5/99 strain; N=92,10,11,168	90 Percentages of subjects
B+R246_18_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	NZ 98/254 strain; N=93,10,11,173	50 Percentages of subjects
B+R246_18_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	M10713 strain; N=88,9,9,158	67 Percentages of subjects
B+R246_18_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	H44/76 strain	90 Percentages of subjects
B+R246_24_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	NZ 98/254 strain; N=93,10,11,173	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	5/99 strain; N=92,10,11,168	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	M10713 strain; N=88,9,9,158	56 Percentages of subjects
B+R246_24_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	H44/76 strain	100 Percentages of subjects
B246_12_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	M10713 strain; N=88,9,9,158	21 Percentages of subjects
B246_12_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	5/99 strain; N=92,10,11,168	86 Percentages of subjects
B246_12_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	H44/76 strain	63 Percentages of subjects
B246_12_48	Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine	NZ 98/254 strain; N=93,10,11,173	17 Percentages of subjects

Secondary

Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.

Time frame: Day 31 (1 month post vaccination)

Population: Analysis was done on FAS, Immunogenicity.

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	92 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	96 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	81 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	38 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	94 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	100 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	47 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	61 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	94 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	81 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	31 Percentages of subjects
B246_12_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	100 Percentages of subjects
B246_12_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	100 Percentages of subjects
B246_12_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	69 Percentages of subjects
B246_12_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	33 Percentages of subjects
B246_18_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	88 Percentages of subjects
B246_18_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	92 Percentages of subjects
B246_18_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	39 Percentages of subjects
B246_18_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	96 Percentages of subjects
B246_24_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	73 Percentages of subjects
B246_24_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	100 Percentages of subjects
B246_24_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	93 Percentages of subjects
B246_24_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	40 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	97 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	88 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	49 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	97 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	96 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	46 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	96 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	72 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	32 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	96 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	85 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	85 Percentages of subjects
B48 50	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173	17 Percentages of subjects
B48 50	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 strain; N=26,18,16,16,26,15,39,25,26,175	63 Percentages of subjects
B48 50	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 strain; N=24,17,16,12,23,15,35,24,25,158	21 Percentages of subjects
B48 50	Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 strain; N=26,18,16,15,25,15,38,25,26,168	86 Percentages of subjects

Secondary

Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.

The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age. Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains. Immune sufficiency was not applicable for M10713 strain.

Time frame: Day 91 (1 month post second vaccination)

Population: Analysis was done on FAS (Immunogenicity).

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.	hSBA≥ 1:5 (H44/76 strain)	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.	hSBA≥ 1:5 (5/99 strain)	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.	hSBA≥ 1:5 (NZ 98/254 strain; N=174)	91 Percentages of subjects
B+R246_12_48	Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.	hSBA≥ 1:8 (H44/76 strain)	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.	hSBA≥ 1:8 (5/99 strain)	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.	hSBA≥ 1:8 (NZ 98/254 strain; N=174)	80 Percentages of subjects

Secondary

Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules

The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.

Time frame: Day 31 (1 month post vaccination)

Population: Analysis was done on FAS (Immunogenicity).

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (H44/76 strain)	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (5/99 strain; N=95,10,12,171)	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (NZ 98/254 strain; N=95,10,12,173)	96 Percentages of subjects
B+R246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (M10713 strain; N=90,9,10,167)	93 Percentages of subjects
B+R246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (H44/76 strain)	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (5/99 strain; N=94,10,12,171)	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (NZ 98/254 strain; N=95,10,12,173)	95 Percentages of subjects
B+R246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (M10713 strain; N=90,9,10,167)	92 Percentages of subjects
B+R246_18_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (5/99 strain; N=94,10,12,171)	100 Percentages of subjects
B+R246_18_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (H44/76 strain)	100 Percentages of subjects
B+R246_18_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (5/99 strain; N=95,10,12,171)	100 Percentages of subjects
B+R246_18_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (M10713 strain; N=90,9,10,167)	100 Percentages of subjects
B+R246_18_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (NZ 98/254 strain; N=95,10,12,173)	60 Percentages of subjects
B+R246_18_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (M10713 strain; N=90,9,10,167)	100 Percentages of subjects
B+R246_18_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (NZ 98/254 strain; N=95,10,12,173)	70 Percentages of subjects
B+R246_18_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (H44/76 strain)	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (NZ 98/254 strain; N=95,10,12,173)	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (NZ 98/254 strain; N=95,10,12,173)	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (M10713 strain; N=90,9,10,167)	90 Percentages of subjects
B+R246_24_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (H44/76 strain)	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (5/99 strain; N=94,10,12,171)	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (M10713 strain; N=90,9,10,167)	90 Percentages of subjects
B+R246_24_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (H44/76 strain)	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (5/99 strain; N=95,10,12,171)	100 Percentages of subjects
B246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (NZ 98/254 strain; N=95,10,12,173)	24 Percentages of subjects
B246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (M10713 strain; N=90,9,10,167)	77 Percentages of subjects
B246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (5/99 strain; N=95,10,12,171)	90 Percentages of subjects
B246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:5 (H44/76 strain)	71 Percentages of subjects
B246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (H44/76 strain)	63 Percentages of subjects
B246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (M10713 strain; N=90,9,10,167)	74 Percentages of subjects
B246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (NZ 98/254 strain; N=95,10,12,173)	17 Percentages of subjects
B246_12_48	Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules	hSBA≥ 1:8 (5/99 strain; N=94,10,12,171)	87 Percentages of subjects

Secondary

Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules

The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.

Time frame: Day 1 (22-34 months post last MenB vaccine)

Population: FAS, Persistency. Note: Reporting groups in this endpoint and in endpoints 5 and 6 received vaccination according to different schedules with respect to the groups reported in endpoints 1, 2 and 3.

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (H44/76 strain)	8 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (NZ 98/254 strain)	3 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (5/99 strain; N=96,11,11,200)	81 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (M10713 strain; N=96,10,10,192)	49 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (NZ 98/254 strain)	2 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (M10713 strain; N=96,10,10,192)	59 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (H44/76 strain)	11 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (5/99 strain; N=96,11,11,200)	84 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (M10713 strain; N=96,10,10,192)	40 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (H44/76 strain)	9 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (5/99 strain; N=96,11,11,200)	100 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (5/99 strain; N=96,11,11,200)	100 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (NZ 98/254 strain)	18 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (NZ 98/254 strain)	18 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (H44/76 strain)	9 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (M10713 strain; N=96,10,10,192)	60 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (5/99 strain; N=96,11,11,200)	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (NZ 98/254 strain)	0 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (M10713 strain; N=96,10,10,192)	60 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (H44/76 strain)	9 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (NZ 98/254 strain)	0 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (M10713 strain; N=96,10,10,192)	60 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (H44/76 strain)	0 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (5/99 strain; N=96,11,11,200)	100 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (M10713 strain; N=96,10,10,192)	56 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (H44/76 strain)	0 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (5/99 strain; N=96,11,11,200)	5 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (NZ 98/254 strain)	0 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:5 (M10713 strain; N=96,10,10,192)	60 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (H44/76 strain)	0 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (5/99 strain; N=96,11,11,200)	3 Percentages of subjects
B246_12_48	Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	hSBA≥ 1:8 (NZ 98/254 strain)	0 Percentages of subjects

Secondary

Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.

Time frame: Day 31 (1 month post vaccination)

Population: Analysis was done on FAS, Immunogenicity, ie, all subjects in the enrolled population who actually received a study vaccination, and provided at least one evaluable serum sample at post baseline.

Arm	Measure	Group	Value (NUMBER)
B+R246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,173	92 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,167	84 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,175	96 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,173	85 Percentages of subjects
B+R246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,167	76 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,167	89 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,173	83 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,173	61 Percentages of subjects
B+R246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,167	89 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,167	88 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,173	81 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,167	88 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,173	94 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B+R246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,173	75 Percentages of subjects
B246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,167	93 Percentages of subjects
B246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,167	93 Percentages of subjects
B246_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,173	81 Percentages of subjects
B246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,167	96 Percentages of subjects
B246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,173	88 Percentages of subjects
B246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,173	88 Percentages of subjects
B246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,167	96 Percentages of subjects
B246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,175	96 Percentages of subjects
B246_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,167	93 Percentages of subjects
B246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,167	93 Percentages of subjects
B246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,173	80 Percentages of subjects
B246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B246_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,173	80 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,167	97 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,173	88 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,173	95 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175	97 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,167	97 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,175	97 Percentages of subjects
B+R234_12_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,173	92 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,167	100 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,167	100 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B+R234_18_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,173	81 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,173	88 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,167	100 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,173	92 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175	100 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171	100 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,175	96 Percentages of subjects
B+R234_24_48	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,167	96 Percentages of subjects
B48 50	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,167	77 Percentages of subjects
B48 50	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,175	63 Percentages of subjects
B48 50	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,173	17 Percentages of subjects
B48 50	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,167	74 Percentages of subjects
B48 50	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171	87 Percentages of subjects
B48 50	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,173	24 Percentages of subjects
B48 50	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171	90 Percentages of subjects
B48 50	Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules	H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175	71 Percentages of subjects

Secondary

Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules

The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.

Time frame: Day 1 (22-36 months post last MenB vaccine; baseline for naive)

Population: FAS, Persistency.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B+R246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 strain	1.61 Titers
B+R246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 strain; N=96, 11, 11, 200	23 Titers
B+R246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 strain	1.15 Titers
B+R246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 strain; N=96, 10, 10, 192	7.83 Titers
B+R246_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 strain; N=96, 11, 11, 200	47 Titers
B+R246_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 strain	2.68 Titers
B+R246_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 strain; N=96, 10, 10, 192	9.67 Titers
B+R246_18_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 strain	2.03 Titers
B+R246_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 strain	1.06 Titers
B+R246_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 strain; N=96, 11, 11, 200	69 Titers
B+R246_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 strain; N=96, 10, 10, 192	8.4 Titers
B+R246_24_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 strain	1.69 Titers
B246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	M10713 strain; N=96, 10, 10, 192	8.75 Titers
B246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	5/99 strain; N=96, 11, 11, 200	1.15 Titers
B246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	H44/76 strain	1.04 Titers
B246_12_48	Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules	NZ 98/254 strain	1.01 Titers

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026

Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1

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Outcome results

Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules

Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules

Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules

Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules

GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.

GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules

GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

Number of Subjects Reporting Unsolicited AEs After Any Vaccination.

Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine

Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.

Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules

Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules

Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules

Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules