Trial Outcomes & Findings for One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age (NCT NCT01139021)

Last Updated: 2015-04-10

Results Overview

To assess the immunogenicity in terms of human Serum Bactericidal Assay (hSBA) GMTs through antibody persistence at 12 months after a booster (fourth) dose of Novartis Meningococcal B Recombinant Vaccine (rMenB+OMV NZ) in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246\_12M12 received Measles, Mumps, Rubella, Varicella (MMRV) at 12 months of age (concomitantly) and group B246\_12M13 received MMRV at 13 months of age (separately). Analysis was done on Modified Intention-To-Treat (MITT) population- (Primary).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

508 participants

Primary outcome timeframe

12 months post booster (fourth) vaccination.

Results posted on

2015-04-10

Participant Flow

Participants were enrolled from Finland and Czech Republic study center.

The eligible subjects from V72P13E1 (NCT00847145) who originally participated in the open-label, immunogenicity subset of parent study V72P13 (NCT00657709) and a naïve group, at 24 months of age, who did not previously participate in V72P13 (or V72P13E1) were enrolled in this study.

Participant milestones

Participant milestones
Measure	B246_12M12 Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B13_15_27 Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.	B12_14_26 Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.	B_24_26 Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.	B12M13 Subject was randomized in group B13\_15\_27 but treated as group B12\_M13.
Overall Study STARTED	152	153	67	19	116	1
Overall Study COMPLETED	151	153	67	18	107	1
Overall Study NOT COMPLETED	1	0	0	1	9	0

Reasons for withdrawal

Reasons for withdrawal
Measure	B246_12M12 Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B12_14_26 Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.	B_24_26 Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
Overall Study Adverse Event	0	0	1
Overall Study Lost to Follow-up	0	0	2
Overall Study Protocol Violation	1	0	2
Overall Study Withdrawal by Subject	0	1	4

Baseline Characteristics

One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B246_12M12 n=152 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 n=153 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B13_15_27 n=67 Participants Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.	B12_14_26 n=19 Participants Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.	B_24_26 n=116 Participants Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.	B12M13 n=1 Participants Subject was randomized in group B13\_15\_27 but treated as group B12\_M13.	Total n=508 Participants Total of all reporting groups
Age, Continuous	25 months STANDARD_DEVIATION 1.0 • n=93 Participants	25.3 months STANDARD_DEVIATION 0.9 • n=4 Participants	27.3 months STANDARD_DEVIATION 0.9 • n=27 Participants	26.6 months STANDARD_DEVIATION 1.2 • n=483 Participants	24.7 months STANDARD_DEVIATION 1.4 • n=36 Participants	26 months STANDARD_DEVIATION 0 • n=10 Participants	25.4 months STANDARD_DEVIATION 1.3 • n=115 Participants
Sex: Female, Male Female	87 Participants n=93 Participants	68 Participants n=4 Participants	37 Participants n=27 Participants	9 Participants n=483 Participants	61 Participants n=36 Participants	0 Participants n=10 Participants	262 Participants n=115 Participants
Sex: Female, Male Male	65 Participants n=93 Participants	85 Participants n=4 Participants	30 Participants n=27 Participants	10 Participants n=483 Participants	55 Participants n=36 Participants	1 Participants n=10 Participants	246 Participants n=115 Participants
Region of Enrollment Czech Republic	105 Number of Subjects n=93 Participants	113 Number of Subjects n=4 Participants	47 Number of Subjects n=27 Participants	14 Number of Subjects n=483 Participants	66 Number of Subjects n=36 Participants	0 Number of Subjects n=10 Participants	345 Number of Subjects n=115 Participants
Region of Enrollment Finland	47 Number of Subjects n=93 Participants	40 Number of Subjects n=4 Participants	20 Number of Subjects n=27 Participants	5 Number of Subjects n=483 Participants	50 Number of Subjects n=36 Participants	1 Number of Subjects n=10 Participants	163 Number of Subjects n=115 Participants

PRIMARY outcome

Timeframe: 12 months post booster (fourth) vaccination.

Population: Analysis was done on Modified Intention-To-Treat (MITT) population (Primary).

Outcome measures

Outcome measures
Measure	B246_12M12 n=147 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 n=153 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot n=300 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. H44/76-SL (N=147,152,299)	7.38 Titers Interval 5.55 to 9.83	8.3 Titers Interval 6.17 to 11.0	6.5 Titers Interval 5.63 to 7.5
Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. 5/99 (N=147,151,298)	68 Titers Interval 52.0 to 91.0	90 Titers Interval 67.0 to 121.0	81 Titers Interval 71.0 to 94.0
Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. NZ98/254	1.57 Titers Interval 1.24 to 1.99	1.79 Titers Interval 1.4 to 2.29	1.91 Titers Interval 1.7 to 2.15
Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. M10713 (N=143,148,291)	4.37 Titers Interval 3.24 to 5.9	3.62 Titers Interval 2.65 to 4.94	3.35 Titers Interval 2.88 to 3.9

PRIMARY outcome

Timeframe: 12 months post booster (fourth) vaccination.

Population: Analysis was done on MITT population (Primary).

To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody persistence at 12 months after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246\_12M12 received MMRV at 12 months of age (concomitantly) and group B246\_12M13 received MMRV at 13 months of age (separately). Analysis was done on MITT population (Primary).

Outcome measures

Outcome measures
Measure	B246_12M12 n=147 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 n=153 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot n=300 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. H44/76-SL (hSBA ≥1:5) (N=147, 152, 299)	60 Percentage of subjects Interval 51.0 to 68.0	64 Percentage of subjects Interval 56.0 to 71.0	62 Percentage of subjects Interval 56.0 to 67.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. 5/99 (hSBA ≥1:5) (N=147, 151, 298)	96 Percentage of subjects Interval 91.0 to 98.0	99 Percentage of subjects Interval 95.0 to 100.0	97 Percentage of subjects Interval 95.0 to 99.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. NZ98/254 (hSBA ≥1:5)	18 Percentage of subjects Interval 12.0 to 25.0	17 Percentage of subjects Interval 11.0 to 24.0	17 Percentage of subjects Interval 13.0 to 22.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. M10713 (hSBA ≥1:5) (N=143, 148, 291)	40 Percentage of subjects Interval 32.0 to 48.0	32 Percentage of subjects Interval 25.0 to 41.0	36 Percentage of subjects Interval 31.0 to 42.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. H44/76-SL (hSBA ≥1:8) (N=147, 152, 299)	44 Percentage of subjects Interval 35.0 to 52.0	47 Percentage of subjects Interval 39.0 to 55.0	45 Percentage of subjects Interval 39.0 to 51.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. 5/99 (hSBA ≥1:8) (N=147, 151, 298)	96 Percentage of subjects Interval 91.0 to 98.0	98 Percentage of subjects Interval 94.0 to 100.0	97 Percentage of subjects Interval 94.0 to 99.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. NZ98/254 (hSBA ≥1:8) (N=147, 153, 300)	12 Percentage of subjects Interval 7.0 to 19.0	14 Percentage of subjects Interval 9.0 to 21.0	13 Percentage of subjects Interval 10.0 to 18.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination. M10713 (hSBA ≥1:8) (N=143, 148, 291)	31 Percentage of subjects Interval 23.0 to 39.0	24 Percentage of subjects Interval 17.0 to 31.0	27 Percentage of subjects Interval 22.0 to 33.0

PRIMARY outcome

Timeframe: 12 months post booster (fourth) vaccination.

Population: Analysis was done on MITT population (Primary).

To assess the immunogenicity in terms of GMCs determined by Enzyme Linked Immunosorbent Assay (ELISA) through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246\_12M12 received MMRV at 12 months of age (concomitantly) and group B246\_12M13 received MMRV at 13 months of age (separately) against vaccine antigen 287-953. Analysis was done on MITT population (Primary).

Outcome measures

Outcome measures
Measure	B246_12M12 n=148 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 n=153 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot n=301 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.	360 Concentration IU/mL Interval 293.0 to 442.0	389 Concentration IU/mL Interval 314.0 to 482.0	352 Concentration IU/mL Interval 317.0 to 391.0

SECONDARY outcome

Timeframe: 12 months post two catch-up dose vaccination and 6 months post booster dose.

Population: Analysis was done on MITT population (Secondary).

To assess the immunogenicity in terms of hSBA GMTs at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age. Both the groups received MMRV at 12 months of age.

Outcome measures

Outcome measures
Measure	B246_12M12 n=67 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 n=18 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot n=85 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination. H44/76-SL (12months)	14 Titers Interval 9.01 to 23.0	8.4 Titers Interval 4.13 to 17.0	10 Titers Interval 8.0 to 13.0
GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination. 5/99 (12months) (N= 67, 18, 85)	73 Titers Interval 43.0 to 123.0	71 Titers Interval 32.0 to 154.0	65 Titers Interval 49.0 to 85.0
GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination. NZ98/254 (12months) (N= 67, 18, 85)	1.67 Titers Interval 1.09 to 2.55	1.2 Titers Interval 0.64 to 2.27	1.75 Titers Interval 1.39 to 2.2
GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination. M10713 (12months) (N= 64, 18, 82)	3.74 Titers Interval 2.14 to 6.54	3.29 Titers Interval 1.43 to 7.56	3.4 Titers Interval 2.5 to 4.61
GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination. H44/76-SL (6months) (N= 67, 17, 84)	68 Titers Interval 41.0 to 113.0	70 Titers Interval 32.0 to 151.0	51 Titers Interval 38.0 to 68.0
GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination. 5/99 (6months) (N= 67, 17, 84)	524 Titers Interval 332.0 to 827.0	525 Titers Interval 263.0 to 1047.0	518 Titers Interval 405.0 to 664.0
GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination. NZ98/254 (6months) (N= 67, 17, 84)	8.87 Titers Interval 5.23 to 15.0	16 Titers Interval 7.13 to 35.0	8.8 Titers Interval 6.63 to 12.0
GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination. M10713 (6months) (N= 66, 16, 82)	30 Titers Interval 18.0 to 49.0	36 Titers Interval 17.0 to 78.0	26 Titers Interval 20.0 to 33.0

SECONDARY outcome

Timeframe: 6month post booster dose and 12 months post two catch-up dose vaccination.

Population: Analysis was done on MITT population (Secondary).

To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age. Both the groups received MMRV at 12 months of age.

Outcome measures

Outcome measures
Measure	B246_12M12 n=67 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 n=18 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot n=85 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. H44/76-SL (hSBA ≥1:5) (12months)	75 Percentage of subjects Interval 63.0 to 84.0	56 Percentage of subjects Interval 31.0 to 78.0	71 Percentage of subjects Interval 60.0 to 80.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. 5/99 (hSBA ≥1:5) (12months) (N= 67, 18, 85)	97 Percentage of subjects Interval 90.0 to 100.0	94 Percentage of subjects Interval 73.0 to 100.0	96 Percentage of subjects Interval 90.0 to 99.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. NZ98/254 (hSBA ≥1:5) (12months) (N= 67, 18, 85)	18 Percentage of subjects Interval 10.0 to 29.0	6 Percentage of subjects Interval 0.0 to 27.0	15 Percentage of subjects Interval 8.0 to 25.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. M10713 (hSBA ≥1:5) (12months) (N= 64, 18, 82)	39 Percentage of subjects Interval 27.0 to 52.0	28 Percentage of subjects Interval 10.0 to 53.0	37 Percentage of subjects Interval 26.0 to 48.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. H44/76-SL (hSBA ≥1:5) (6months) (N= 67, 17, 84)	99 Percentage of subjects Interval 92.0 to 100.0	100 Percentage of subjects Interval 80.0 to 100.0	99 Percentage of subjects Interval 94.0 to 100.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. 5/99 (hSBA ≥1:5) (6months) (N= 67, 18, 84)	100 Percentage of subjects Interval 95.0 to 100.0	100 Percentage of subjects Interval 80.0 to 100.0	100 Percentage of subjects Interval 96.0 to 100.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. NZ98/254 (hSBA ≥1:5) (6months) (N= 67, 18, 84)	73 Percentage of subjects Interval 61.0 to 83.0	82 Percentage of subjects Interval 57.0 to 96.0	75 Percentage of subjects Interval 64.0 to 84.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. M10713 (hSBA ≥1:5) (6months) (N= 66, 16, 82)	92 Percentage of subjects Interval 83.0 to 97.0	94 Percentage of subjects Interval 70.0 to 100.0	93 Percentage of subjects Interval 85.0 to 97.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. H44/76-SL (hSBA ≥1:8) (12months) (N= 67, 18, 85)	63 Percentage of subjects Interval 50.0 to 74.0	56 Percentage of subjects Interval 31.0 to 78.0	61 Percentage of subjects Interval 50.0 to 72.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. 5/99 (hSBA ≥1:8) (12months) (N= 67, 18, 85)	96 Percentage of subjects Interval 87.0 to 99.0	94 Percentage of subjects Interval 73.0 to 100.0	95 Percentage of subjects Interval 88.0 to 99.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. NZ98/254 (hSBA ≥1:8) (12months) (N= 67, 18, 85)	15 Percentage of subjects Interval 7.0 to 26.0	6 Percentage of subjects Interval 0.0 to 27.0	13 Percentage of subjects Interval 7.0 to 22.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. M10713 (hSBA ≥1:8) (12months) (N= 64, 18, 82)	27 Percentage of subjects Interval 16.0 to 39.0	22 Percentage of subjects Interval 6.0 to 48.0	26 Percentage of subjects Interval 17.0 to 36.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. H44/76-SL (hSBA ≥1:8) (6months) (N=67, 17, 84)	91 Percentage of subjects Interval 82.0 to 97.0	100 Percentage of subjects Interval 80.0 to 100.0	93 Percentage of subjects Interval 85.0 to 97.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. 5/99 (hSBA ≥1:8) (6months) (N= 67, 17, 84)	100 Percentage of subjects Interval 95.0 to 100.0	94 Percentage of subjects Interval 71.0 to 100.0	99 Percentage of subjects Interval 94.0 to 100.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. NZ98/254 (hSBA ≥1:8) (6months) (N= 67, 17, 84)	52 Percentage of subjects Interval 40.0 to 65.0	65 Percentage of subjects Interval 38.0 to 86.0	55 Percentage of subjects Interval 44.0 to 66.0
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination. M10713 (hSBA ≥1:8) (6months) (N= 66, 16, 82)	86 Percentage of subjects Interval 76.0 to 94.0	81 Percentage of subjects Interval 54.0 to 96.0	85 Percentage of subjects Interval 76.0 to 92.0

SECONDARY outcome

Timeframe: 1 month post booster dose versus prebooster.

Population: Analysis was done on MITT population (Secondary).

To assess the immunogenicity in terms of percentage of subjects with at least four fold increase in hSBA titers 1 month post booster dose of rMenB+OMV NZ administered at 26 or 27 months of age, in children previously administered two catch-up doses of rMenB+OMV NZ at either 12 and 14 or 13 and 15 months of age.Both the groups received MMRV at 12 months of age.

Outcome measures

Outcome measures
Measure	B246_12M12 n=67 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 n=18 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot n=85 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination. H44/76-SL (N= 66, 18, 84)	100 Percentage of Subjects Interval 95.0 to 100.0	100 Percentage of Subjects Interval 81.0 to 100.0	100 Percentage of Subjects Interval 96.0 to 100.0
Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination. 5/99 (N= 67, 18, 85)	99 Percentage of Subjects Interval 92.0 to 100.0	100 Percentage of Subjects Interval 81.0 to 100.0	99 Percentage of Subjects Interval 94.0 to 100.0
Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination. NZ98/254 (N= 65, 18, 83)	97 Percentage of Subjects Interval 89.0 to 100.0	94 Percentage of Subjects Interval 73.0 to 100.0	96 Percentage of Subjects Interval 90.0 to 99.0
Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination. M10713 (N= 62, 16, 78)	82 Percentage of Subjects Interval 70.0 to 91.0	88 Percentage of Subjects Interval 62.0 to 98.0	83 Percentage of Subjects Interval 73.0 to 91.0

SECONDARY outcome

Timeframe: 12 months post two catch-up dose vaccination and 6 months post booster dose.

Population: Analysis was done on MITT population (Secondary).

To assess the immunogenicity in terms of GMCs determined by ELISA at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age. Both the groups received MMRV at 12 months of age.

Outcome measures

Outcome measures
Measure	B246_12M12 n=67 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 n=18 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot n=85 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
GMCs to Assess Antibody Persistence at One Year After Two Catch-up Doses and 6 Months After Booster of rMenB+OMV NZ Vaccination Against 287-953 Strain. 287-953 (6months) (N=67, 17, 84)	2314 Concentration IU/mL Interval 1596.0 to 3355.0	3259 Concentration IU/mL Interval 1859.0 to 5712.0	2597 Concentration IU/mL Interval 2104.0 to 3205.0
GMCs to Assess Antibody Persistence at One Year After Two Catch-up Doses and 6 Months After Booster of rMenB+OMV NZ Vaccination Against 287-953 Strain. 287-953 (12months)	219 Concentration IU/mL Interval 149.0 to 322.0	246 Concentration IU/mL Interval 138.0 to 437.0	227 Concentration IU/mL Interval 185.0 to 278.0

SECONDARY outcome

Timeframe: 1 month and 6 months post two catch-up doses.

Population: Analysis was done on MITT population (Secondary).

To assess the immunogenicity in terms of GMTs through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Outcome measures

Outcome measures
Measure	B246_12M12 n=108 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. H44/76-SL (1months) (N= 105)	220 Titers Interval 186.0 to 261.0	—	—
GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. 5/99 (1months) (N= 103)	455 Titers Interval 372.0 to 556.0	—	—
GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. NZ98/254 (1months) (N=108 )	27 Titers Interval 23.0 to 32.0	—	—
GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. M10713 (1months) (N=100)	38 Titers Interval 32.0 to 45.0	—	—
GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. H44/76-SL (6months) (N=104)	22 Titers Interval 18.0 to 27.0	—	—
GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. 5/99 (6months) (N= 104)	71 Titers Interval 57.0 to 89.0	—	—
GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. NZ98/254 (6 months) (N= 104)	1.88 Titers Interval 1.57 to 2.26	—	—
GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. M10713 (6months) (N= 104)	8.04 Titers Interval 6.39 to 10.0	—	—

SECONDARY outcome

Timeframe: 1 month and 6 months post two catch-up doses.

Population: Analysis was done on MITT population (Secondary)

To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody response at at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Outcome measures

Outcome measures
Measure	B246_12M12 n=108 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. H44/76-SL (hSBA ≥1:5) (1months) (N=105)	100 Percentage of subjects Interval 97.0 to 100.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. 5/99 (hSBA ≥1:5) (1months) (N= 103)	99 Percentage of subjects Interval 95.0 to 100.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. NZ98/254 (hSBA ≥1:5) (1months) (N= 108)	98 Percentage of subjects Interval 93.0 to 100.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. M10713 (hSBA ≥1:5) (1months) (N= 100)	97 Percentage of subjects Interval 91.0 to 99.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. H44/76-SL (hSBA ≥1:5) (6months) (N=104)	93 Percentage of subjects Interval 87.0 to 97.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. 5/99 (hSBA ≥1:5) (6months) (N= 104 )	96 Percentage of subjects Interval 90.0 to 99.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. NZ98/254 (hSBA ≥1:5) (6months) (N= 104)	18 Percentage of subjects Interval 11.0 to 27.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. M10713 (hSBA ≥1:5) (6months) (N= 104)	70 Percentage of subjects Interval 60.0 to 79.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. H44/76-SL (hSBA ≥1:8) (1months) (N=105)	100 Percentage of subjects Interval 97.0 to 100.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. 5/99 (hSBA ≥1:8) (1months) (N= 103)	99 Percentage of subjects Interval 95.0 to 100.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. NZ98/254 (hSBA ≥1:8) (1months) (N= 108)	96 Percentage of subjects Interval 91.0 to 99.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. M10713 (hSBA ≥1:8) (1months) (N= 100)	95 Percentage of subjects Interval 89.0 to 98.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. H44/76-SL (hSBA ≥1:8) (6months) (N=104)	88 Percentage of subjects Interval 80.0 to 93.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. 5/99 (hSBA ≥1:8) (6months) (N= 104)	96 Percentage of subjects Interval 90.0 to 99.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. NZ98/254 (hSBA ≥1:8) (6months) (N= 104)	12 Percentage of subjects Interval 6.0 to 19.0	—	—
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. M10713 (hSBA ≥1:8) (6months) (N= 104)	52 Percentage of subjects Interval 42.0 to 62.0	—	—

SECONDARY outcome

Timeframe: 1 month post two catch-up doses versus prevaccination

Population: Analysis was done on MITT population (Secondary).

To assess the immunogenicity in terms of percentage of subjects with fourfold increases in hSBA titers at 1 month post two catch-up doses of rMenB+OMV NZ in children previously administered to naive children at 24 and 26 months of age against 4 strains. Analysis was done on MITT population (Secondary).

Outcome measures

Outcome measures
Measure	B246_12M12 n=108 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. H44/76-SL (N=105)	100 Percentage of subjects Interval 97.0 to 100.0	—	—
Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. 5/99 (N= 101)	99 Percentage of subjects Interval 95.0 to 100.0	—	—
Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. NZ98/254 (N=108 )	96 Percentage of subjects Interval 91.0 to 99.0	—	—
Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. M10713 (N= 99)	85 Percentage of subjects Interval 76.0 to 91.0	—	—

SECONDARY outcome

Timeframe: 1 month and 6 months post two catch-up doses.

Population: Analysis was done on MITT population (Secondary).

To assess the immunogenicity in terms of GMCs to assess through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain. Analysis was done on MITT population (Secondary).

Outcome measures

Outcome measures
Measure	B246_12M12 n=108 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
GMCs to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age Against 287-953 Strain. 287-953 strain (1months)	5448 Concentration IU/mL Interval 4630.0 to 6411.0	—	—
GMCs to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age Against 287-953 Strain. 287-953 strain (6months)	383 Concentration IU/mL Interval 319.0 to 459.0	—	—

SECONDARY outcome

Timeframe: Up to 7 days after any vaccination.

To assess the safety and tolerability by reporting solicited local and systemic AEs of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.

Outcome measures

Outcome measures
Measure	B246_12M12 n=67 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 n=18 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Change Eat. Habits (N=67,17)	25 Number of subjects	9 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Sleepiness	22 Number of subjects	7 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Swelling	35 Number of subjects	9 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Any Systemic	53 Number of subjects	15 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Any Local	64 Number of subjects	16 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Tenderness (N=67,17)	63 Number of subjects	16 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Erythema (N=)	47 Number of subjects	13 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Induration	37 Number of subjects	9 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Vomiting	4 Number of subjects	0 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Diarrhea	4 Number of subjects	1 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Irritability	40 Number of subjects	14 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Unusual Crying	16 Number of subjects	5 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Rash	1 Number of subjects	0 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Fever ( >= 38C )	22 Number of subjects	6 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Temperature (>= 40 C)	0 Number of subjects	0 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Medical Attend. Fever	0 Number of subjects	0 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Antipyr. Med. Used Prev	55 Number of subjects	12 Number of subjects	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Antipyr. Med. Used Trt	47 Number of subjects	11 Number of subjects	—

SECONDARY outcome

Timeframe: Up to 7 days after any vaccination.

Population: The analysis was done on safety subset.

To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events in yerms of serious adverse events (SAEs), atleast possibly related SAEs and AEs leading to withdrawl of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.

Outcome measures

Outcome measures
Measure	B246_12M12 n=67 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 n=18 Participants Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. Any AE	45 Number of Subjects	10 Number of Subjects	—
Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. SAEs	2 Number of Subjects	1 Number of Subjects	—
Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. At least possibly related SAEs	0 Number of Subjects	0 Number of Subjects	—
Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children. AEs leading to withdrawal	0 Number of Subjects	0 Number of Subjects	—

SECONDARY outcome

Timeframe: Up to 7 days after any vaccination.

Population: The analysis was done on safety subset.

To assess the safety and tolerability by reporting solicited local and systemic adverse events of two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Outcome measures

Outcome measures
Measure	B246_12M12 n=112 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Temperature (>= 40 C)	1 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Any Local	110 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Tenderness	109 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Erythema	103 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Induration	75 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Swelling	58 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Any Systemic	98 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Change Eat. Habits	53 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Sleepiness	70 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Vomiting	14 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Diarrhea	23 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Irritability	84 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Unusual Crying	47 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Rash	14 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Fever ( >= 38C)	44 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Medical Attend. Fever	2 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Antipyr. Med. Used Prev	33 Number of subjects	—	—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Antipyr. Med. Used Trt	38 Number of subjects	—	—

SECONDARY outcome

Timeframe: Up to 7 days after any vaccination

Population: The analysis was done on safety subset.

To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. The analysis was done on safety subset.

Outcome measures

Outcome measures
Measure	B246_12M12 n=112 Participants Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12M13 Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.	B246_12Tot Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Any AE	96 Number of Subjects	—	—
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. Serious AEs	6 Number of Subjects	—	—
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. At least possibly related SAEs	0 Number of Subjects	—	—
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age. AEs leading to withdrawal	1 Number of Subjects	—	—

Adverse Events

B13_15_27

Serious events: 2 serious events

Other events: 67 other events

Deaths: 0 deaths

B12_14_26

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

B24_26

Serious events: 6 serious events

Other events: 110 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	B13_15_27 n=67 participants at risk Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.	B12_14_26 n=18 participants at risk Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 months of age.	B24_26 n=112 participants at risk Subjects assessed for safety and tolerability after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/67 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.00% 0/18 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.89% 1/112 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoidal Hypertrophy	0.00% 0/67 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.00% 0/18 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.89% 1/112 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.
Gastrointestinal disorders Enteritis	0.00% 0/67 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.00% 0/18 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.89% 1/112 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.00% 0/67 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.00% 0/18 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.89% 1/112 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.
Infections and infestations Bronchitis	1.5% 1/67 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.00% 0/18 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.89% 1/112 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.
Infections and infestations Laryngitis	1.5% 1/67 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.00% 0/18 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.00% 0/112 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.
Infections and infestations Oral Herpes	0.00% 0/67 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	5.6% 1/18 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.00% 0/112 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.
Infections and infestations Otitis Media	0.00% 0/67 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.00% 0/18 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.89% 1/112 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.
Infections and infestations Pneumonia Respiratory Syncytial	0.00% 0/67 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.00% 0/18 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.	0.89% 1/112 • Throughout the study (solicited and unsolicited from Day 1 to Day 209). Any solicited and unsolicited adverse events, unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day. Any solicited and unsolicited adverse events were reported up to day 7 post vaccination for group B13\_15\_27, B12\_14\_26 and B\_24\_26 . Since no vaccination was administered to group B246\_12M12 and B246\_12M13 and antibody persistence was explored at 12 months after the fourth dose rMenB+OMV NZ, the two group are excluded from the reporting AEs.

Other adverse events

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER