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

A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1 to Assess Antibody Persistence at One Year After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting at 12 Months of Age and to Evaluate the Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01139021

Enrollment

508

Registered

2010-06-08

Start date

2010-06-30

Completion date

2011-09-30

Last updated

2015-04-10

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

Conditions

Meningococcal Disease

Keywords

Children, Meningococcal disease, Prevention, Vaccination

Brief summary

One year antibody persistence after the fourth dose boost or two catch-up doses administered starting from 12 months of age and to evaluate the response to a a third dose boost or two catch-up dose starting at 24 months of age.

Interventions

BIOLOGICALrMenB+OMV NZ

Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

23 Months to 27 Months

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female children, 23 to 27 months of age (naïve children) * Available for all the visits scheduled in the study; * For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained; * Available for all the visits scheduled in the study; * In good health as determined by medical history, physical examination, clinical judgment of the investigator. * Healthy children who participated in the immunogenicity part of V72P13E1 and have received their last vaccination 12 months (-30/+60 days) before enrolment in V72P13E2; * Who received all vaccinations with rMenB+OMV NZ in V72P13 and V72P13E1 according to the protocols; * Who provided at least the blood sample one month after their fourth dose of rMenB+OMV NZ (groups B246\_12M12/B246\_12M13) or after their second dose of rMenB+OMV NZ (groups B13\_15\_27/B12\_14\_26) in V72P13E1 according to the protocol; * For whom parent(s)/legal guardian(s) had given written informed consent after the nature of the study has been explained; * In good health as determined by medical history, physical examination, clinical judgment of the investigator.

Exclusion criteria

* Subjects whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study; * History of any meningococcal B vaccine administration; * Previous ascertained or suspected disease caused by N. meningitidis; * For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained; * History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; * Antibiotics treatment within 6 days prior to enrolment; * Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; * Any serious chronic or progressive disease * Known or suspected impairment/ alteration of the immune system, * Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines) * Significant acute or chronic infection within the previous 7 days or axillary temperature ≥38C within the previous day; * Family members and household members of research staff; * Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); * Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to enrolment (use of low or moderate doses of inhaled steroids is not an exclusion); * Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrolment; * Participation in another clinical trial within 90 days prior to enrolment or planned for during study; * Receipt of, or intent to immunize with any other vaccine(s) within 30 days prior to enrolment (exception: flu-vaccines should not be administered within 14 days prior to enrolment); * Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Design outcomes

Primary

Measure	Time frame	Description
Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.	12 months post booster (fourth) vaccination.	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).
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.	12 months post booster (fourth) vaccination.	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).
Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.	12 months post booster (fourth) vaccination.	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).

Secondary

Measure	Time frame	Description
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.	12 months post two catch-up dose vaccination and 6 months post booster dose.	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.
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.	1 month and 6 months post two catch-up doses.	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.
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.	1 month and 6 months post two catch-up doses.	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.
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.	1 month post two catch-up doses versus prevaccination	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).
GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.	12 months post two catch-up dose vaccination and 6 months post booster dose.	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.
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.	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.
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.	Up to 7 days after any vaccination.	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.
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.	Up to 7 days after any vaccination.	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.
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.	Up to 7 days after any vaccination	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.
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.	1 month and 6 months post two catch-up doses.	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).
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.	6month post booster dose and 12 months post two catch-up dose vaccination.	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.
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.	1 month post booster dose versus prebooster.	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.

Countries

Czechia, Finland

Participant flow

Recruitment details

Participants were enrolled from Finland and Czech Republic study center.

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	152
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.	153
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.	67
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.	19
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.	116
B12M13 Subject was randomized in group B13\_15\_27 but treated as group B12\_M13.	1
Total	508

Withdrawals & dropouts

Period	Reason	FG000	FG003	FG004
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

Characteristic	B246_12M12	B246_12M13	B13_15_27	B12_14_26	B_24_26	B12M13	Total
Age, Continuous	25 months STANDARD_DEVIATION 1	25.3 months STANDARD_DEVIATION 0.9	27.3 months STANDARD_DEVIATION 0.9	26.6 months STANDARD_DEVIATION 1.2	24.7 months STANDARD_DEVIATION 1.4	26 months STANDARD_DEVIATION 0	25.4 months STANDARD_DEVIATION 1.3
Region of Enrollment Czech Republic	105 Number of Subjects	113 Number of Subjects	47 Number of Subjects	14 Number of Subjects	66 Number of Subjects	0 Number of Subjects	345 Number of Subjects
Region of Enrollment Finland	47 Number of Subjects	40 Number of Subjects	20 Number of Subjects	5 Number of Subjects	50 Number of Subjects	1 Number of Subjects	163 Number of Subjects
Sex: Female, Male Female	87 Participants	68 Participants	37 Participants	9 Participants	61 Participants	0 Participants	262 Participants
Sex: Female, Male Male	65 Participants	85 Participants	30 Participants	10 Participants	55 Participants	1 Participants	246 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	67 / 67	18 / 18	110 / 112
serious Total, serious adverse events	2 / 67	1 / 18	6 / 112

Outcome results

Primary

Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.

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).

Time frame: 12 months post booster (fourth) vaccination.

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

Arm	Measure	Value (GEOMETRIC_MEAN)
B246_12M12	Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.	360 Concentration IU/mL
B246_12M13	Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.	389 Concentration IU/mL
B246_12Tot	Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.	352 Concentration IU/mL

Primary

Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.

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).

Time frame: 12 months post booster (fourth) vaccination.

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M13	Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.	NZ98/254	1.79 Titers
B246_12M13	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)	8.3 Titers
B246_12M13	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)	90 Titers
B246_12M13	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)	3.62 Titers
B246_12Tot	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)	81 Titers
B246_12Tot	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)	3.35 Titers
B246_12Tot	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)	6.5 Titers
B246_12Tot	Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.	NZ98/254	1.91 Titers

Primary

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.

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).

Time frame: 12 months post booster (fourth) vaccination.

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

Arm	Measure	Group	Value (NUMBER)
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M13	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)	17 Percentage of subjects
B246_12M13	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)	64 Percentage of subjects
B246_12M13	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)	99 Percentage of subjects
B246_12M13	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)	32 Percentage of subjects
B246_12M13	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)	47 Percentage of subjects
B246_12M13	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)	98 Percentage of subjects
B246_12M13	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)	14 Percentage of subjects
B246_12M13	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)	24 Percentage of subjects
B246_12Tot	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)	62 Percentage of subjects
B246_12Tot	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)	97 Percentage of subjects
B246_12Tot	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)	97 Percentage of subjects
B246_12Tot	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)	27 Percentage of subjects
B246_12Tot	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)	36 Percentage of subjects
B246_12Tot	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)	13 Percentage of subjects
B246_12Tot	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)	45 Percentage of subjects
B246_12Tot	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)	17 Percentage of subjects

Secondary

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.

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.

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B246_12M12	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
B246_12M12	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
B246_12M13	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)	3259 Concentration IU/mL
B246_12M13	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)	246 Concentration IU/mL
B246_12Tot	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)	2597 Concentration IU/mL
B246_12Tot	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)	227 Concentration IU/mL

Secondary

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.

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).

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B246_12M12	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
B246_12M12	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

Secondary

GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.

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.

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M13	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)	1.2 Titers
B246_12M13	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)	16 Titers
B246_12M13	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)	3.29 Titers
B246_12M13	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)	70 Titers
B246_12M13	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)	525 Titers
B246_12M13	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)	8.4 Titers
B246_12M13	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)	71 Titers
B246_12M13	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)	36 Titers
B246_12Tot	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)	1.75 Titers
B246_12Tot	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)	65 Titers
B246_12Tot	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)	10 Titers
B246_12Tot	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)	3.4 Titers
B246_12Tot	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)	8.8 Titers
B246_12Tot	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)	518 Titers
B246_12Tot	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)	51 Titers
B246_12Tot	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)	26 Titers

Secondary

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.

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.

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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

Secondary

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.

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.

Time frame: Up to 7 days after any vaccination.

Arm	Measure	Group	Value (NUMBER)
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M13	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	0 Number of subjects
B246_12M13	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	16 Number of subjects
B246_12M13	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)	16 Number of subjects
B246_12M13	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=)	13 Number of subjects
B246_12M13	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	9 Number of subjects
B246_12M13	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	9 Number of subjects
B246_12M13	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	15 Number of subjects
B246_12M13	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)	9 Number of subjects
B246_12M13	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	7 Number of subjects
B246_12M13	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	11 Number of subjects
B246_12M13	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	1 Number of subjects
B246_12M13	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	14 Number of subjects
B246_12M13	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	5 Number of subjects
B246_12M13	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	0 Number of subjects
B246_12M13	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 )	6 Number of subjects
B246_12M13	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
B246_12M13	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
B246_12M13	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	12 Number of subjects

Secondary

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.

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.

Time frame: Up to 7 days after any vaccination.

Population: The analysis was done on safety subset.

Arm	Measure	Group	Value (NUMBER)
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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

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.

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.

Time frame: Up to 7 days after any vaccination.

Population: The analysis was done on safety subset.

Arm	Measure	Group	Value (NUMBER)
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M13	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
B246_12M13	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	10 Number of Subjects
B246_12M13	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
B246_12M13	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	1 Number of Subjects

Secondary

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.

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.

Time frame: Up to 7 days after any vaccination

Population: The analysis was done on safety subset.

Arm	Measure	Group	Value (NUMBER)
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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

Secondary

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.

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.

Time frame: 1 month post booster dose versus prebooster.

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

Arm	Measure	Group	Value (NUMBER)
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M13	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)	88 Percentage of Subjects
B246_12M13	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
B246_12M13	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)	94 Percentage of Subjects
B246_12M13	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)	100 Percentage of Subjects
B246_12Tot	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)	83 Percentage of Subjects
B246_12Tot	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
B246_12Tot	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)	96 Percentage of Subjects
B246_12Tot	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

Secondary

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.

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).

Time frame: 1 month post two catch-up doses versus prevaccination

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

Arm	Measure	Group	Value (NUMBER)
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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

Secondary

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.

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.

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

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

Arm	Measure	Group	Value (NUMBER)
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M13	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
B246_12M13	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)	82 Percentage of subjects
B246_12M13	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)	94 Percentage of subjects
B246_12M13	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)	94 Percentage of subjects
B246_12M13	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)	56 Percentage of subjects
B246_12M13	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)	94 Percentage of subjects
B246_12M13	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)	81 Percentage of subjects
B246_12M13	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)	6 Percentage of subjects
B246_12M13	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)	56 Percentage of subjects
B246_12M13	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)	65 Percentage of subjects
B246_12M13	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)	94 Percentage of subjects
B246_12M13	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)	22 Percentage of subjects
B246_12M13	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)	6 Percentage of subjects
B246_12M13	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)	28 Percentage of subjects
B246_12M13	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)	100 Percentage of subjects
B246_12M13	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)	100 Percentage of subjects
B246_12Tot	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)	13 Percentage of subjects
B246_12Tot	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
B246_12Tot	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)	93 Percentage of subjects
B246_12Tot	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)	15 Percentage of subjects
B246_12Tot	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)	75 Percentage of subjects
B246_12Tot	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)	85 Percentage of subjects
B246_12Tot	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)	71 Percentage of subjects
B246_12Tot	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)	93 Percentage of subjects
B246_12Tot	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)	26 Percentage of subjects
B246_12Tot	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
B246_12Tot	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)	61 Percentage of subjects
B246_12Tot	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)	99 Percentage of subjects
B246_12Tot	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)	96 Percentage of subjects
B246_12Tot	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)	95 Percentage of subjects
B246_12Tot	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)	37 Percentage of subjects
B246_12Tot	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)	55 Percentage of subjects

Secondary

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.

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.

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

Population: Analysis was done on MITT population (Secondary)

Arm	Measure	Group	Value (NUMBER)
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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
B246_12M12	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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

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Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.

Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.

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.

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.

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.

GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.

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.

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.

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.

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.

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.

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.

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.

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.

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.