Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.

A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Immunocompromised Patients From 2 to 17 Years of Age Who Are at Increased Risk of Meningococcal Disease Because of Complement Deficiency or Asplenia Compared to Matched Healthy Controls.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02141516

Enrollment

239

Registered

2014-05-19

Start date

2014-05-31

Completion date

2015-03-31

Last updated

2017-02-15

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

Conditions

Meningococcal Disease

Keywords

Meningitis, vaccination, complement deficiency, asplenia, splenic dysfunction

Brief summary

The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction. A group of healthy age-matched subjects will be enrolled to serve as a descriptive control for immunogenicity and safety.

Interventions

BIOLOGICALrMenB+OMV

2 doses of vaccine 2 months apart

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

Inclusion criterion applicable to All Groups * Subjects aged 2 to 17 years (inclusive) at enrollment * weighing at least 13 Kg at the time of enrollment Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies Inclusion criterion applicable to Group B \- Subjects at risk of meningococcal disease because of functional or anatomic asplenia Inclusion criterion applicable to Group C - healthy subjects

Design outcomes

Primary

Measure	Time frame	Description
Number Of Subjects With Unsolicited Adverse Events (AEs).	At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)	Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).
Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	Day 1 and Day 91 (one month after the second dose of the study vaccine)	Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	Day 1 and Day 91 (one month after the second dose of the study vaccine).	Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	Day 1 and Day 91 (one month after the second dose of the study vaccine).	Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	Day 1 and Day 91 (one month after the second dose of the study vaccine).	Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	Day 91 (one month after the second dose of the study vaccine).	Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	Day 1 and Day 91 (one month after the second dose of the study vaccine).	Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	Day 1 and Day 91 (one month after the second dose of the study vaccine).	Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.	Day 91 (one month after the second dose of the study vaccine).	Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.

Secondary

Measure	Time frame	Description
Number of Subjects Reporting Solicited Local and Systemic AEs.	From Day 1 until Day 7 after any vaccination.	Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.

Countries

Italy, Poland, Russia, Spain, United Kingdom

Participant flow

Recruitment details

Subjects were enrolled at 4 centers in Italy, 3 centers in Poland, 3 centers in the Russian Federation, 4 centers in Spain and 4 centers in the United Kingdom.

Pre-assignment details

All the enrolled subjects were included in the trial. One subject did not complete the study because he/she did not meet criteria for re-vaccination; two subjects met enrollment delay criteria since they required regular blood transfusions and they were unable to commit to visit windows (screen failure).

Participants by arm

Arm	Count
CompDef Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.	40
Asplenia Subjects aged ≥ 2 to ≤17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.	112
Healthy Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.	87
Total	239

Withdrawals & dropouts

Period	Reason	FG001
Overall Study	Adverse Event	1
Overall Study	Lost to Follow-up	1
Overall Study	Other	3

Baseline characteristics

Characteristic	CompDef	Asplenia	Healthy	Total
Age, Continuous	8.5 Years STANDARD_DEVIATION 4.35	11.1 Years STANDARD_DEVIATION 3.7	10.2 Years STANDARD_DEVIATION 4.14	10.3 Years STANDARD_DEVIATION 4.07
Sex/Gender, Customized Female	17 participants	46 participants	44 participants	107 participants
Sex/Gender, Customized Male	23 participants	66 participants	43 participants	132 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	39 / 40	106 / 110	145 / 150	87 / 87	232 / 237
serious Total, serious adverse events	1 / 40	5 / 110	6 / 150	0 / 87	6 / 237

Outcome results

Primary

ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.

Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.

Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set

Arm	Measure	Value (GEOMETRIC_MEAN)
CompDef	ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	62 Ratios
Asplenia	ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	138 Ratios
CompDef + Asplenia	ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	112 Ratios
Healthy	ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	111 Ratios

Primary

Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.

Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.

Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
CompDef	Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	287-953 - Day 1 (N=39,106,145,84)	33 IU/mL
CompDef	Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	287-953 - Day 91 (N=40,106,146,84)	2039 IU/mL
Asplenia	Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	287-953 - Day 91 (N=40,106,146,84)	3418 IU/mL
Asplenia	Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	287-953 - Day 1 (N=39,106,145,84)	25 IU/mL
CompDef + Asplenia	Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	287-953 - Day 1 (N=39,106,145,84)	27 IU/mL
CompDef + Asplenia	Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	287-953 - Day 91 (N=40,106,146,84)	2973 IU/mL
Healthy	Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	287-953 - Day 1 (N=39,106,145,84)	27 IU/mL
Healthy	Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.	287-953 - Day 91 (N=40,106,146,84)	2957 IU/mL

Primary

Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.

Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.

Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
CompDef	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	5/99 - Day 91 (N=38,106,144,83)	263 Titers
CompDef	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	H44/76 - Day 1 (N=39,104,143,84)	1.08 Titers
CompDef	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	M10713 - Day 91 (N=37,103,140,83)	20 Titers
CompDef	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	NZ98/254 - Day 91 (N=38,106,144,84)	8.46 Titers
CompDef	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	M10713 - Day 1 (N=36,102,138,82)	8.57 Titers
CompDef	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	H44/76 - Day 91 (N=39,104,143,85)	48 Titers
CompDef	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	NZ98/254 - Day 1 (N=36,105,141,83)	0.95 Titers
CompDef	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	5/99 - Day 1 (N=37,103,140,82)	0.87 Titers
Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	NZ98/254 - Day 1 (N=36,105,141,83)	1.1 Titers
Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	M10713 - Day 1 (N=36,102,138,82)	15 Titers
Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	5/99 - Day 91 (N=38,106,144,83)	300 Titers
Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	M10713 - Day 91 (N=37,103,140,83)	45 Titers
Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	5/99 - Day 1 (N=37,103,140,82)	1.43 Titers
Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	H44/76 - Day 1 (N=39,104,143,84)	1.17 Titers
Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	NZ98/254 - Day 91 (N=38,106,144,84)	18 Titers
Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	H44/76 - Day 91 (N=39,104,143,85)	65 Titers
CompDef + Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	M10713 - Day 91 (N=37,103,140,83)	36 Titers
CompDef + Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	NZ98/254 - Day 1 (N=36,105,141,83)	1.06 Titers
CompDef + Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	NZ98/254 - Day 91 (N=38,106,144,84)	14 Titers
CompDef + Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	5/99 - Day 91 (N=38,106,144,83)	290 Titers
CompDef + Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	H44/76 - Day 1 (N=39,104,143,84)	1.14 Titers
CompDef + Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	5/99 - Day 1 (N=37,103,140,82)	1.26 Titers
CompDef + Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	H44/76 - Day 91 (N=39,104,143,85)	60 Titers
CompDef + Asplenia	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	M10713 - Day 1 (N=36,102,138,82)	13 Titers
Healthy	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	NZ98/254 - Day 91 (N=38,106,144,84)	14 Titers
Healthy	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	5/99 - Day 1 (N=37,103,140,82)	1.24 Titers
Healthy	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	5/99 - Day 91 (N=38,106,144,83)	307 Titers
Healthy	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	H44/76 - Day 1 (N=39,104,143,84)	1.15 Titers
Healthy	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	H44/76 - Day 91 (N=39,104,143,85)	76 Titers
Healthy	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	M10713 - Day 1 (N=36,102,138,82)	16 Titers
Healthy	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	NZ98/254 - Day 1 (N=36,105,141,83)	1.05 Titers
Healthy	Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	M10713 - Day 91 (N=37,103,140,83)	42 Titers

Primary

Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.

Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.

Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
CompDef	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	5/99 - Day 91/Day 1 (N=37,103,140,82)	299 Ratios
CompDef	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	H44/76 - Day 91/Day 1 (N=39,104,143,84)	44 Ratios
CompDef	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	M10713 - Day 91/Day 1 (N=36,102,138,82)	2.25 Ratios
CompDef	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	NZ98/254 - Day 91/Day 1 (N=36,105,141,83)	8.58 Ratios
Asplenia	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	NZ98/254 - Day 91/Day 1 (N=36,105,141,83)	16 Ratios
Asplenia	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	M10713 - Day 91/Day 1 (N=36,102,138,82)	2.95 Ratios
Asplenia	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	H44/76 - Day 91/Day 1 (N=39,104,143,84)	56 Ratios
Asplenia	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	5/99 - Day 91/Day 1 (N=37,103,140,82)	207 Ratios
CompDef + Asplenia	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	M10713 - Day 91/Day 1 (N=36,102,138,82)	2.75 Ratios
CompDef + Asplenia	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	NZ98/254 - Day 91/Day 1 (N=36,105,141,83)	14 Ratios
CompDef + Asplenia	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	H44/76 - Day 91/Day 1 (N=39,104,143,84)	52 Ratios
CompDef + Asplenia	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	5/99 - Day 91/Day 1 (N=37,103,140,82)	228 Ratios
Healthy	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	H44/76 - Day 91/Day 1 (N=39,104,143,84)	66 Ratios
Healthy	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	5/99 - Day 91/Day 1 (N=37,103,140,82)	245 Ratios
Healthy	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	NZ98/254 - Day 91/Day 1 (N=36,105,141,83)	13 Ratios
Healthy	Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.	M10713 - Day 91/Day 1 (N=36,102,138,82)	2.71 Ratios

Primary

Number Of Subjects With Unsolicited Adverse Events (AEs).

Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).

Time frame: At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)

Population: Analysis was done on the Unsolicited Safety Set (all subjects in the exposed set with postvaccination unsolicited AE records).

Arm	Measure	Group	Value (NUMBER)
CompDef	Number Of Subjects With Unsolicited Adverse Events (AEs).	AEs Leading to Death	0 participants
CompDef	Number Of Subjects With Unsolicited Adverse Events (AEs).	Any AE	17 participants
CompDef	Number Of Subjects With Unsolicited Adverse Events (AEs).	Any SAEs	1 participants
CompDef	Number Of Subjects With Unsolicited Adverse Events (AEs).	AEs Leading to Withdrawal	0 participants
CompDef	Number Of Subjects With Unsolicited Adverse Events (AEs).	At least Possibly Related SAEs	0 participants
CompDef	Number Of Subjects With Unsolicited Adverse Events (AEs).	At least possibly related AEs	9 participants
CompDef	Number Of Subjects With Unsolicited Adverse Events (AEs).	Medically Attended AEs	13 participants
Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	At least Possibly Related SAEs	0 participants
Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	AEs Leading to Death	0 participants
Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	Any AE	38 participants
Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	At least possibly related AEs	19 participants
Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	Any SAEs	5 participants
Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	AEs Leading to Withdrawal	1 participants
Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	Medically Attended AEs	26 participants
CompDef + Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	Any SAEs	6 participants
CompDef + Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	At least Possibly Related SAEs	0 participants
CompDef + Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	At least possibly related AEs	28 participants
CompDef + Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	AEs Leading to Death	0 participants
CompDef + Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	Medically Attended AEs	39 participants
CompDef + Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	AEs Leading to Withdrawal	1 participants
CompDef + Asplenia	Number Of Subjects With Unsolicited Adverse Events (AEs).	Any AE	55 participants
Healthy	Number Of Subjects With Unsolicited Adverse Events (AEs).	Medically Attended AEs	18 participants
Healthy	Number Of Subjects With Unsolicited Adverse Events (AEs).	Any SAEs	0 participants
Healthy	Number Of Subjects With Unsolicited Adverse Events (AEs).	At least Possibly Related SAEs	0 participants
Healthy	Number Of Subjects With Unsolicited Adverse Events (AEs).	AEs Leading to Withdrawal	0 participants
Healthy	Number Of Subjects With Unsolicited Adverse Events (AEs).	At least possibly related AEs	18 participants
Healthy	Number Of Subjects With Unsolicited Adverse Events (AEs).	AEs Leading to Death	0 participants
Healthy	Number Of Subjects With Unsolicited Adverse Events (AEs).	Any AE	34 participants

Primary

Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.

Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.

Time frame: Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set

Arm	Measure	Value (NUMBER)
CompDef	Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.	97 Percentage of Subjects
Asplenia	Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.	98 Percentage of Subjects
CompDef + Asplenia	Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.	98 Percentage of Subjects
Healthy	Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.	98 Percentage of Subjects

Primary

Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.

Time frame: Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set

Arm	Measure	Group	Value (NUMBER)
CompDef	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 91 (N=36,102,138,82)	25 Percentage of Subjects
CompDef	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 91 (N=39,104,143,84)	87 Percentage of Subjects
CompDef	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 91 (N=37,103,140,82)	92 Percentage of Subjects
CompDef	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 91 (N=36,105,141,83)	61 Percentage of Subjects
Asplenia	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 91 (N=39,104,143,84)	94 Percentage of Subjects
Asplenia	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 91 (N=37,103,140,82)	100 Percentage of Subjects
Asplenia	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 91 (N=36,102,138,82)	33 Percentage of Subjects
Asplenia	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 91 (N=36,105,141,83)	80 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 91 (N=37,103,140,82)	98 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 91 (N=36,105,141,83)	75 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 91 (N=36,102,138,82)	31 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 91 (N=39,104,143,84)	92 Percentage of Subjects
Healthy	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 91 (N=39,104,143,84)	98 Percentage of Subjects
Healthy	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 91 (N=36,105,141,83)	73 Percentage of Subjects
Healthy	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 91 (N=37,103,140,82)	98 Percentage of Subjects
Healthy	Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 91 (N=36,102,138,82)	33 Percentage of Subjects

Primary

Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.

Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.

Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).

Population: Analysis was done on Full Analysis Set

Arm	Measure	Group	Value (NUMBER)
CompDef	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 1 (N=39,104,143,84)	0 Percentage of Subjects
CompDef	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 91 (N=39,104,143,85)	87 Percentage of Subjects
CompDef	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 1 (N=36,102,138,82)	47 Percentage of Subjects
CompDef	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 91 (N=37,103,140,83)	70 Percentage of Subjects
CompDef	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 1 (N=36,105,141,83)	0 Percentage of Subjects
CompDef	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 91 (N=38,106,144,84)	63 Percentage of Subjects
CompDef	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 1 (N=37,103,140,82)	0 Percentage of Subjects
CompDef	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 91 (N=38,106,144,83)	92 Percentage of Subjects
Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 91 (N=38,106,144,84)	79 Percentage of Subjects
Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 1 (N=36,105,141,83)	4 Percentage of Subjects
Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 91 (N=39,104,143,85)	95 Percentage of Subjects
Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 91 (N=38,106,144,83)	100 Percentage of Subjects
Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 1 (N=37,103,140,82)	11 Percentage of Subjects
Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 91 (N=37,103,140,83)	94 Percentage of Subjects
Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 1 (N=36,102,138,82)	68 Percentage of Subjects
Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 1 (N=39,104,143,84)	2 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 1 (N=37,103,140,82)	8 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 1 (N=36,102,138,82)	62 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 91 (N=37,103,140,83)	88 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 1 (N=36,105,141,83)	3 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 91 (N=38,106,144,84)	75 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 91 (N=38,106,144,83)	98 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 1 (N=39,104,143,84)	1 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 91 (N=39,104,143,85)	93 Percentage of Subjects
Healthy	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 1 (N=36,102,138,82)	68 Percentage of Subjects
Healthy	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 91 (N=37,103,140,83)	98 Percentage of Subjects
Healthy	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 91 (N=39,104,143,85)	98 Percentage of Subjects
Healthy	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 1 (N=39,104,143,84)	2 Percentage of Subjects
Healthy	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 1 (N=36,105,141,83)	0 Percentage of Subjects
Healthy	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 91 (N=38,106,144,83)	99 Percentage of Subjects
Healthy	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 1 (N=37,103,140,82)	5 Percentage of Subjects
Healthy	Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 91 (N=38,106,144,84)	73 Percentage of Subjects

Primary

Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.

Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.

Time frame: Day 1 and Day 91 (one month after the second dose of the study vaccine)

Population: Analysis was done on Full Analysis Set (all subjects in the enrolled set who: received a study vaccination and provided an evaluable serum sample at 1 month after the second dose of rMenB+OMV NZ, with assay result available for at least one of the serogroup B indicator strains or M10713 strain or ELISA).

Arm	Measure	Group	Value (NUMBER)
CompDef	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 1 (N=36,105,141,83)	0 Percentage of Subjects
CompDef	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 91 (N=38,106,144,83)	95 Percentage of Subjects
CompDef	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 91 (N=37,103,140,83)	73 Percentage of Subjects
CompDef	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 1 (N=37,103,140,82)	0 Percentage of Subjects
CompDef	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 91 (N=38,106,144,84)	68 Percentage of Subjects
CompDef	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 1 (N=39,104,143,84)	0 Percentage of Subjects
CompDef	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 91 (N=39,104,143,85)	87 Percentage of Subjects
CompDef	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 1 (N=36,102,138,82)	56 Percentage of Subjects
Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 91 (N=39,104,143,85)	97 Percentage of Subjects
Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 1 (N=36,102,138,82)	79 Percentage of Subjects
Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 1 (N=39,104,143,84)	7 Percentage of Subjects
Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 91 (N=37,103,140,83)	94 Percentage of Subjects
Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 1 (N=37,103,140,82)	12 Percentage of Subjects
Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 91 (N=38,106,144,83)	100 Percentage of Subjects
Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 1 (N=36,105,141,83)	4 Percentage of Subjects
Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 91 (N=38,106,144,84)	86 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 1 (N=37,103,140,82)	9 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 91 (N=38,106,144,83)	99 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 1 (N=39,104,143,84)	5 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 91 (N=39,104,143,85)	94 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 1 (N=36,102,138,82)	73 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 91 (N=37,103,140,83)	89 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 1 (N=36,105,141,83)	3 Percentage of Subjects
CompDef + Asplenia	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 91 (N=38,106,144,84)	81 Percentage of Subjects
Healthy	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 91 (N=39,104,143,85)	98 Percentage of Subjects
Healthy	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	H44/76 - Day 1 (N=39,104,143,84)	6 Percentage of Subjects
Healthy	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 91 (N=38,106,144,84)	83 Percentage of Subjects
Healthy	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	NZ98/254 - Day 1 (N=36,105,141,83)	2 Percentage of Subjects
Healthy	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 91 (N=38,106,144,83)	99 Percentage of Subjects
Healthy	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 1 (N=36,102,138,82)	78 Percentage of Subjects
Healthy	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	5/99 - Day 1 (N=37,103,140,82)	6 Percentage of Subjects
Healthy	Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.	M10713 - Day 91 (N=37,103,140,83)	99 Percentage of Subjects

Secondary

Number of Subjects Reporting Solicited Local and Systemic AEs.

Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.

Time frame: From Day 1 until Day 7 after any vaccination.

Population: Analysis was done on Solicited Safety Set (all subjects in the exposed set with any solicited AE data).

Arm	Measure	Group	Value (NUMBER)
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Persistent Crying (< 6 years; N=12,9,21,13,34)	2 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Headache (≥ 6 years)	11 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Swelling (≥ 6 years)	8 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Induration (< 6 years; N=12,9,21,13,34)	5 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Treat. P/F (< 6 years; N=12,9,21,13,34)	5 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Irritability (< 6 years; N=12,9,21,13,34)	6 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Diarrhea (< 6 years; N=12,9,21,13,34)	5 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fever (≥ 38°C) (≥ 6 years)	6 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Swelling (< 6 years; N=12,9,21,13,34)	6 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fever (≥38°C) (< 6 years; N=12,9,21,13,34)	3 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Rash (≥ 6 years)	7 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Myalgia (≥ 6 years; N=28,100,128,73,201)	8 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Systemic (< 6 years; N=12,9,21,13,34)	11 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Tenderness (<6 years; N=12,9,21,13,34)	12 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fatigue (≥ 6 years)	11 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Change in Eating Habits (<6 years;N=12,9,21,13,34)	5 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Treat. Pain/Fever (≥ 6 years)	14 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Pain (≥ 6 years)	25 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Local (≥ 6 years)	26 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Vomiting (< 6 years; N=12,9,21,13,34)	2 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any (≥ 6 years)	27 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any (< 6 years; N=12,9,21,13,34)	12 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Arthralgia (≥ 6 years)	7 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Induration (≥ 6 years)	11 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Sleepiness (< 6 years; N=12,9,21,13,34)	7 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Prev. Pain/Fever (≥ 6 years)	5 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Systemic (≥ 6 years)	21 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Prevention Pain/Fever (<6 years; N=12,9,21,13,34)	5 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Rash (< 6 years; N=12,9,21,13,34)	3 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Local (< 6 years; N=12,9,21,13,34)	12 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Nausea (≥ 6 years)	7 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Erythema (< 6 years; N=12,9,21,13,34)	7 participants
CompDef	Number of Subjects Reporting Solicited Local and Systemic AEs.	Erythema (≥ 6 years)	7 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Treat. P/F (< 6 years; N=12,9,21,13,34)	3 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Prev. Pain/Fever (≥ 6 years)	9 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Erythema (≥ 6 years)	19 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Local (≥ 6 years)	98 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fatigue (≥ 6 years)	55 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Swelling (≥ 6 years)	24 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Pain (≥ 6 years)	97 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Treat. Pain/Fever (≥ 6 years)	39 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Arthralgia (≥ 6 years)	25 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Systemic (≥ 6 years)	75 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Erythema (< 6 years; N=12,9,21,13,34)	4 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Local (< 6 years; N=12,9,21,13,34)	6 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fever (≥ 38°C) (≥ 6 years)	6 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Induration (< 6 years; N=12,9,21,13,34)	4 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Swelling (< 6 years; N=12,9,21,13,34)	4 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any (< 6 years; N=12,9,21,13,34)	8 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Tenderness (<6 years; N=12,9,21,13,34)	6 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Rash (≥ 6 years)	9 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Change in Eating Habits (<6 years;N=12,9,21,13,34)	1 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Diarrhea (< 6 years; N=12,9,21,13,34)	3 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Systemic (< 6 years; N=12,9,21,13,34)	6 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Irritability (< 6 years; N=12,9,21,13,34)	2 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Nausea (≥ 6 years)	28 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Persistent Crying (< 6 years; N=12,9,21,13,34)	2 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Rash (< 6 years; N=12,9,21,13,34)	0 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Sleepiness (< 6 years; N=12,9,21,13,34)	3 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Myalgia (≥ 6 years; N=28,100,128,73,201)	31 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Vomiting (< 6 years; N=12,9,21,13,34)	0 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any (≥ 6 years)	98 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Induration (≥ 6 years)	27 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fever (≥38°C) (< 6 years; N=12,9,21,13,34)	1 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Prevention Pain/Fever (<6 years; N=12,9,21,13,34)	1 participants
Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Headache (≥ 6 years)	47 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Erythema (< 6 years; N=12,9,21,13,34)	11 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fever (≥38°C) (< 6 years; N=12,9,21,13,34)	4 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Persistent Crying (< 6 years; N=12,9,21,13,34)	4 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any (< 6 years; N=12,9,21,13,34)	20 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fever (≥ 38°C) (≥ 6 years)	12 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Systemic (≥ 6 years)	96 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any (≥ 6 years)	125 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Rash (< 6 years; N=12,9,21,13,34)	3 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Prev. Pain/Fever (≥ 6 years)	14 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Myalgia (≥ 6 years; N=28,100,128,73,201)	39 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Arthralgia (≥ 6 years)	32 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Headache (≥ 6 years)	58 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Sleepiness (< 6 years; N=12,9,21,13,34)	10 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Treat. Pain/Fever (≥ 6 years)	53 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Induration (≥ 6 years)	38 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Pain (≥ 6 years)	122 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Erythema (≥ 6 years)	26 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Vomiting (< 6 years; N=12,9,21,13,34)	2 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Tenderness (<6 years; N=12,9,21,13,34)	18 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Prevention Pain/Fever (<6 years; N=12,9,21,13,34)	6 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Change in Eating Habits (<6 years;N=12,9,21,13,34)	6 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Rash (≥ 6 years)	16 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Swelling (< 6 years; N=12,9,21,13,34)	10 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Local (< 6 years; N=12,9,21,13,34)	18 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Local (≥ 6 years)	124 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Diarrhea (< 6 years; N=12,9,21,13,34)	8 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Swelling (≥ 6 years)	32 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Nausea (≥ 6 years)	35 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Induration (< 6 years; N=12,9,21,13,34)	9 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fatigue (≥ 6 years)	66 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Irritability (< 6 years; N=12,9,21,13,34)	8 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Systemic (< 6 years; N=12,9,21,13,34)	17 participants
CompDef + Asplenia	Number of Subjects Reporting Solicited Local and Systemic AEs.	Treat. P/F (< 6 years; N=12,9,21,13,34)	8 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Arthralgia (≥ 6 years)	18 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any (< 6 years; N=12,9,21,13,34)	13 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Local (< 6 years; N=12,9,21,13,34)	12 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Systemic (< 6 years; N=12,9,21,13,34)	12 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any (≥ 6 years)	74 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Local (≥ 6 years)	74 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Systemic (≥ 6 years)	60 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Erythema (< 6 years; N=12,9,21,13,34)	6 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Induration (< 6 years; N=12,9,21,13,34)	5 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Swelling (< 6 years; N=12,9,21,13,34)	6 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Tenderness (<6 years; N=12,9,21,13,34)	12 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Change in Eating Habits (<6 years;N=12,9,21,13,34)	8 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Diarrhea (< 6 years; N=12,9,21,13,34)	3 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Irritability (< 6 years; N=12,9,21,13,34)	9 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Persistent Crying (< 6 years; N=12,9,21,13,34)	6 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Rash (< 6 years; N=12,9,21,13,34)	0 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Sleepiness (< 6 years; N=12,9,21,13,34)	5 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Vomiting (< 6 years; N=12,9,21,13,34)	0 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fever (≥38°C) (< 6 years; N=12,9,21,13,34)	4 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Prevention Pain/Fever (<6 years; N=12,9,21,13,34)	4 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Treat. P/F (< 6 years; N=12,9,21,13,34)	11 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Erythema (≥ 6 years)	27 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Induration (≥ 6 years)	19 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Swelling (≥ 6 years)	24 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Pain (≥ 6 years)	71 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fatigue (≥ 6 years)	46 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Headache (≥ 6 years)	35 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Myalgia (≥ 6 years; N=28,100,128,73,201)	27 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Nausea (≥ 6 years)	15 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Rash (≥ 6 years)	6 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fever (≥ 38°C) (≥ 6 years)	5 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Prev. Pain/Fever (≥ 6 years)	15 participants
Healthy	Number of Subjects Reporting Solicited Local and Systemic AEs.	Treat. Pain/Fever (≥ 6 years)	38 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Prevention Pain/Fever (<6 years; N=12,9,21,13,34)	10 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fever (≥38°C) (< 6 years; N=12,9,21,13,34)	8 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Systemic (< 6 years; N=12,9,21,13,34)	29 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Headache (≥ 6 years)	93 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Vomiting (< 6 years; N=12,9,21,13,34)	2 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Sleepiness (< 6 years; N=12,9,21,13,34)	15 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Rash (< 6 years; N=12,9,21,13,34)	3 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Treat. Pain/Fever (≥ 6 years)	91 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Myalgia (≥ 6 years; N=28,100,128,73,201)	66 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Persistent Crying (< 6 years; N=12,9,21,13,34)	10 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Irritability (< 6 years; N=12,9,21,13,34)	17 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Diarrhea (< 6 years; N=12,9,21,13,34)	11 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Prev. Pain/Fever (≥ 6 years)	29 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Nausea (≥ 6 years)	50 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Change in Eating Habits (<6 years;N=12,9,21,13,34)	14 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Tenderness (<6 years; N=12,9,21,13,34)	30 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Swelling (< 6 years; N=12,9,21,13,34)	16 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Local (< 6 years; N=12,9,21,13,34)	30 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Rash (≥ 6 years)	22 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Induration (< 6 years; N=12,9,21,13,34)	14 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Erythema (< 6 years; N=12,9,21,13,34)	17 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Systemic (≥ 6 years)	156 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any (< 6 years; N=12,9,21,13,34)	33 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fever (≥ 38°C) (≥ 6 years)	17 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any Local (≥ 6 years)	198 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Pain (≥ 6 years)	193 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Arthralgia (≥ 6 years)	50 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Swelling (≥ 6 years)	56 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Induration (≥ 6 years)	57 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Erythema (≥ 6 years)	53 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Any (≥ 6 years)	199 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Fatigue (≥ 6 years)	112 participants
Total	Number of Subjects Reporting Solicited Local and Systemic AEs.	Treat. P/F (< 6 years; N=12,9,21,13,34)	19 participants

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

Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.

Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.

Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.

Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.

Number Of Subjects With Unsolicited Adverse Events (AEs).

Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.

Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.

Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.

Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.

Number of Subjects Reporting Solicited Local and Systemic AEs.