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Clinical Trial Results:
A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to GSK Meningococcal group B vaccine, in Healthy Adolescents

Summary
EudraCT number	2013-002451-15
Trial protocol	FI PL
Global end of trial date	03 Mar 2016

Results information
Results version number	v3(current)
This version publication date	07 Apr 2019
First version publication date	18 May 2017
Other versions	v1 , v2
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

205215

ISRCTN number

US NCT number

NCT02212457

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

Rue de l'Institut 89, Rixensart, Belgium, B-1330

Public contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

10 Mar 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

21 May 2015

Global end of trial reached?

Yes

Global end of trial date

03 Mar 2016

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the non-inferiority of the Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant (MenABCWY) vaccine to that of the Meningococcal (group B) multicomponent recombinant adsorbed (rMenB +OMV) vaccine administered according to 0, 2 month schedule, as measured by hSBA GMTs against N. meningitidis serogroup B test strains1 at 1 month after the last meningococcal vaccination.

Protection of trial subjects

Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine is not injected into a blood vessel. The measures of safety used in this study are routine clinical procedures. They include a close vigilance for, and stringent reporting of, selected local and systemic adverse events routinely monitored in vaccine clinical studies as indicators of reactogenicity. The period of observation for AEs extended from the time a subject signed an informed consent until he or she completed the final study visit (Visit Month 13) or terminated the study early (whichever came first).

Background therapy

Evidence for comparator

Actual start date of recruitment

21 Aug 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Finland: 495

Country: Number of subjects enrolled

Poland: 433

Country: Number of subjects enrolled

United States: 135

Worldwide total number of subjects

1063

EEA total number of subjects

928

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

289

Adolescents (12-17 years)

448

Adults (18-64 years)

326

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Subjects were recruited from 32 centers from Finland, Poland and United States.

Screening details

All subjects were included in the trial.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Blinding implementation details

The trial was designed as an observer-blind study. Observer-blind means that during the course of study, the subject, the parents/guardians of the subjects and the study personnel responsible for the evaluation of any study endpoint (e.g. safety and reactogenicity) were unaware which vaccine was administered.

Are arms mutually exclusive

Yes

rMenB_0_2 Group

Arm description

Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.

Arm type

Active comparator

Investigational medicinal product name

Havrix Vaccine

Investigational medicinal product code

Other name

Hepatitis A vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects between 1 and 15 years of age received one pediatric dose (0.5 mL) of Havrix Junior Monodose Vaccine (Hepatitis A virus antigen, 720 ELISA units/0.5 mL dose), administered in the deltoid muscle. Subjects 16 years of age or older received one adult dose (1.0 mL) of Havrix Monodose Vaccine (Hepatitis A virus antigen, 1440 ELISA units/1 mL dose of hepatitis A virus antigen), administered in the deltoid muscle.

Investigational medicinal product name

Bexsero

Investigational medicinal product code

rMenB+OMV

Other name

Pharmaceutical forms

Suspension for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

0.5 milliliters (mL) dose of injectable suspension administered into the deltoid area of the non-dominant arm

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Saline Solution

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL dose of injectable saline solution administered into the deltoid area of the non-dominant arm

ABCWY_ 0_2 Group

Arm description

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.

Arm type

Experimental

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

GSK Meningococcal ABCWY Vaccine

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL dose of injectable suspension administered into the deltoid area of the non-dominant arm

Investigational medicinal product name

Havrix Vaccine

Investigational medicinal product code

Other name

Hepatitis A vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Saline solution

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL dose of injectable saline solution administered into the deltoid area of the non-dominant arm

ABCWY_0_1 Group

Arm description

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.

Arm type

Experimental

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

GSK Meningococcal ABCWY Vaccine

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL dose of injectable suspension administered into the deltoid area of the non-dominant arm

Investigational medicinal product name

Havrix Vaccine

Investigational medicinal product code

Other name

Hepatitis A vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Saline Solution

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL dose of injectable saline solution administered into the deltoid area of the non-dominant arm

ABCWY_0_6 Group

Arm description

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.

Arm type

Experimental

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

GSK Meningococcal ABCWY Vaccine

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL dose of injectable suspension administered into the deltoid area of the non-dominant arm

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Saline Solution

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL dose of injectable saline solution administered into the deltoid area of the non-dominant arm

Investigational medicinal product name

Havrix Vaccine

Investigational medicinal product code

Other name

Hepatitis A Vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

ABCWY_0_11 Group

Arm description

Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.

Arm type

Experimental

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

GSK Meningococcal ABCWY Vaccine

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL dose of injectable suspension administered into the deltoid area of the non-dominant arm

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Saline Solution

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL dose of injectable saline solution administered into the deltoid area of the non-dominant arm

Investigational medicinal product name

Havrix Vaccine

Investigational medicinal product code

Other name

Hepatitis A Vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

ABCWY_0_2_6 Group

Arm description

Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.

Arm type

Experimental

Investigational medicinal product name

MenABCWY

Investigational medicinal product code

Other name

GSK Meningococcal ABCWY Vaccine

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL dose of injectable suspension administered into the deltoid area of the non-dominant arm

Investigational medicinal product name

Havrix Vaccine

Investigational medicinal product code

Other name

Hepatitis A Vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Number of subjects in period 1	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Started	228	232	157	134	152	160
Completed	209	211	141	123	137	147
Not completed	19	21	16	11	15	13
Consent withdrawn by subject	8	10	8	6	5	4
Adverse event, non-fatal	1	2	2	2	-	1
Unspecified	2	1	2	1	-	1
Lost to follow-up	6	7	4	1	8	4
Protocol deviation	2	1	-	1	2	3

Baseline characteristics

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Reporting group title

rMenB_0_2 Group

Reporting group description

Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.

Reporting group title

ABCWY_ 0_2 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.

Reporting group title

ABCWY_0_1 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.

Reporting group title

ABCWY_0_6 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.

Reporting group title

ABCWY_0_11 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.

Reporting group title

ABCWY_0_2_6 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.

Reporting group values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group	Total
Number of subjects	228	232	157	134	152	160	1063
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0
Children (2-11 years)	56	73	39	35	39	47	289
Adolescents (12-17 years)	96	93	72	59	64	64	448
Adults (18-64 years)	76	66	46	40	49	49	326
From 65-84 years	0	0	0	0	0	0	0
85 years and over	0	0	0	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	14.5 ± 3.09	14.2 ± 3.17	14.4 ± 3.01	14.4 ± 3.06	14.5 ± 3.1	14.3 ± 3.16	-
Sex: Female, Male
Units: Subjects
Female	130	119	101	76	89	96	611
Male	98	113	56	58	63	64	452

End points

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Reporting group title

rMenB_0_2 Group

Reporting group description

Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.

Reporting group title

ABCWY_ 0_2 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.

Reporting group title

ABCWY_0_1 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.

Reporting group title

ABCWY_0_6 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.

Reporting group title

ABCWY_0_11 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.

Reporting group title

ABCWY_0_2_6 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.

Primary: Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) against N. meningitidis serogroup B test strains when administered according to 0_2 month schedule.

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End point title

Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) against N. meningitidis serogroup B test strains when administered according to 0_2 month schedule. ^[1]

End point description

The non-inferiority of the Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant (MenABCWY) vaccine to Meningococcal (group B) multicomponent recombinant adsorbed (Bexsero) vaccine, administered according to 0, 2 month schedule, as measured by hSBA GMTs against N.meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, is reported. The test strains assessed were NZ98/254, M14459, M07-0241084 and 96217. This outcome measure was evaluated in the rMenB_0_2 and ABCWY_ 0_2 Groups. Analysis was done on Per Protocol Set (PPS)–Month 3, which included all screened subjects who received a study vaccination, provided evaluable serum samples at pre- & post-vaccination, with results available for at least 1 serogroup B test strain & who was not excluded due to protocol deviations/other reasons defined before unblinding/analysis

End point type

Primary

End point timeframe

At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group
Number of subjects analysed	150	158
Units: Titers
geometric mean (confidence interval 95%)
M14459 strain (Month 0) (N-155, 147)	1.31 (1.09 to 1.57)	1.28 (1.07 to 1.53)
M14459 strain (Month 3)	15.78 (12 to 22)	11.64 (8.61 to 16)
M07-0241084 strain (Month 0)(N-151,148)	2.16 (1.61 to 2.89)	2.12 (1.60 to 2.82)
M07-0241084 strain (Month 3)(N-154,150)	11.56 (8.86 to 15)	8.19 (6.31 to 11)
96217 strain (Month 0)(N-152,143)	2.36 (1.70 to 3.28)	2.93 (2.13 to 4.03)
96217 strain (Month 3)(N-156,149)	229.29 (179 to 294)	150.82 (118 to 192)
NZ98/254 strain (Month 0)(N-154,147)	1.15 (0.95 to 1.39)	1.27 (1.06 to 1.53)
NZ98/254 strain (Month 3)(N-157,150)	24.31 (18 to 32)	11.95 (9.10 to 16)

Statistical Analysis 1

Statistical analysis description

Non-inferiority response against N. meningitidis serogroup B test strain M14459 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.

Comparison groups

ABCWY_ 0_2 Group v rMenB_0_2 Group

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[2]

Method

ANCOVA

Parameter type

Geometric Mean Ratio

Point estimate

0.74

Confidence interval

level

95%

sides

2-sided

lower limit

0.53

upper limit

1.02

Notes
[2] - Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY_0_2 versus rMenB_0_2) was greater than 0.5 for each of the four serogroup B test strains.

Staistical analysis 2

Statistical analysis description

Non-inferiority response against N. meningitidis serogroup B test strain M07-0241084 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.

Comparison groups

ABCWY_ 0_2 Group v rMenB_0_2 Group

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[3]

Method

ANCOVA

Parameter type

Geometric Mean Ratio

Point estimate

0.71

Confidence interval

level

95%

sides

2-sided

lower limit

0.54

upper limit

0.94

Notes
[3] - Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY_0_2 versus rMenB_0_2) was greater than 0.5 for each of the four serogroup B test strains.

Statistical analysis 3

Statistical analysis description

Non-inferiority response against N. meningitidis serogroup B test strain 96217 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.

Comparison groups

ABCWY_ 0_2 Group v rMenB_0_2 Group

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[4]

Method

ANCOVA

Parameter type

Geometric Mean Ratio

Point estimate

0.66

Confidence interval

level

95%

sides

2-sided

lower limit

0.51

upper limit

0.85

Notes
[4] - Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY_0_2 versus rMenB_0_2) was greater than 0.5 for each of the four serogroup B test strains.

Statistical analysis 4

Statistical analysis description

Non-inferiority response against N. meningitidis serogroup B test strain NZ98/254 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.

Comparison groups

ABCWY_ 0_2 Group v rMenB_0_2 Group

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[5]

Method

ANCOVA

Parameter type

Geometric Mean Ratio

Point estimate

0.49

Confidence interval

level

95%

sides

2-sided

lower limit

0.37

upper limit

0.66

Notes
[5] - Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY_0_2 versus rMenB_0_2) was greater than 0.5 for each of the four serogroup B test strains.

Secondary: hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_2 month schedule.

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End point title

hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_2 month schedule. ^[6]

End point description

The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule was compared with those administered according to 0, 2 months schedule, as measured by hSBA GMTs against N. meningitidis serogroup B test strains and serogroups A,C, W and Y at 1 month after the last meningococcal vaccination. The B test strains assessed were NZ98/254,M14459, M07-0241084 and 96217. This outcome measure was evaluated in the ABCWY_ 0_2 and ABCWY_0_2_6 Groups. 1 month post last meningococcal vaccination corresponds to Month 3 for ABCWY_0_2 Group and Month 7 for ABCWY_0_2_6 Group.Analysis was done on the FAS-1 month after the last meningococcal vaccination.All subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at pre- & at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.

End point type

Secondary

End point timeframe

At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group)

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	ABCWY_ 0_2 Group	ABCWY_0_2_6 Group
Number of subjects analysed	213	151
Units: Titers
geometric mean (confidence interval 95%)
M14459 (M-0)(N-207,151)	1.21 (1.07 to 1.37)	1.12 (0.98 to 1.28)
M14459 (M-3/M-7)(N-211,151)	12.17 (9.60 to 15)	27.09 (21 to 35)
M07-0241084(M-0)(N-201,145)	2.36 (1.85 to 3.01)	2.05 (1.58 to 2.67)
M07-0241084(M-3/M-7)(N-206,148)	8.91 (7.10 to 11)	18.03 (14 to 23)
96217(M-0)(N-205,146)	2.31 (1.75 to 3.06)	2.28 (1.68 to 3.07)
96217(M-3/M-7)(N-210,150)	174.27 (142 to 215)	298.76 (239 to 374)
NZ98/254(M-0)(N-208,151)	1.24 (1.09 to 1.41)	1.07 (0.93 to 1.23)
NZ98/254(M-3/M-7)(N-212,151)	12.57 (9.81 to 16)	17.55 (13 to 23)
A serogroup(M-0)(N-206,146)	1.19 (1.04 to 1.36)	1.10 (0.95 to 1.27)
A serogroup(M-3/M-7)(N-211,147)	66.73 (54 to 83)	125.45 (99 to 159)
C serogroup(M-0)(N-206,145)	3.59 (2.85 to 4.53)	3.19 (2.48 to 4.10)
C serogroup(M-3/M-7)(N-212,149)	158.8 (127 to 199)	376.44 (295 to 481)
W serogroup(M-0)(N-198,138)	5.20 (3.56 to 7.59)	4.64 (3.05 to 7.05)
W serogroup(M-3/M-7)(N-208,140)	206.62 (175 to 244)	295.9 (246 to 356)
Y serogroup(M-0)(N-202,150)	1.33 (1.10 to 1.60)	1.26 (1.03 to 1.55)
Y serogroup(M-3/M-7)(N-213,150)	79.84 (62 to 103)	163.69 (124 to 216)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥LLQ against N. meningitidis serogroups A, C, W and y and serogroup B test strains when administered according to 0_2_6 month and 0_2 month schedule.

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End point title

Percentages of subjects with hSBA titers ≥LLQ against N. meningitidis serogroups A, C, W and y and serogroup B test strains when administered according to 0_2_6 month and 0_2 month schedule. ^[7]

End point description

The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 month schedule, was compared with those, administered according to 0, 2 month schedule, as measured by the percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination.Analysis was done on the FAS-1 month after the last meningococcal vaccination.All subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at pre- & at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.

End point type

Secondary

End point timeframe

At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group)

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	ABCWY_ 0_2 Group	ABCWY_0_2_6 Group
Number of subjects analysed	213	151
Units: Percentages of subjects
number (confidence interval 95%)
NZ98/254(M-0)(N-208,151)	6 (3.37 to 10.45)	2 (0.41 to 5.70)
NZ98/254(M-3/7)(N-212,151)	63 (55.85 to 69.26)	74 (65.72 to 80.35)
M14459(M-0)(N-207,151)	5 (2.68 to 9.31)	2 (0.41 to 5.70)
M14459(M-3/M-7)(N-211,151)	70 (63.48 to 76.23)	89 (83.36 to 93.82)
M07-0241084(M-0)(N-201,145)	18 (13.30 to 24.47)	18 (12.06 to 25.16)
M07-0241084(M-3/7)(N-206,148)	49 (41.54 to 55.59)	72 (64.35 to 79.33)
96217(M-0)(N-205,144)	28 (22.24 to 34.99)	27 (20.02 to 35.11)
96217(M-3/7)(N-210,150)	97 (93.25 to 98.65)	99 (96.34 to 99.98)
Serogroup A(M-0)(N-206,146)	3 (1.08 to 6.23)	1 (0.02 to 3.76)
Serogroup A(M-3/7)(N-211,147)	88 (83.01 to 92.18)	95 (89.56 to 97.62)
Serogroup C(M-0)(N-206,145)	44 (37.28 to 51.24)	41 (32.62 to 49.15)
Serogroup C(M-3/7)(N-212,149)	99 (96.63 to 99.89)	100 (97.55 to 100)
Serogroup W(M-0)(N-198,138)	27 (21.20 to 34.04)	22 (15.17 to 29.56)
Serogroup W(M-3/7)(N-208,140)	97 (93.19 to 98.64)	99 (96.08 to 99.98)
Serogroup Y(M-0)(N-202,150)	9 (5.37 to 13.72)	6 (2.78 to 11.08)
Serogroup Y(M-3/7)(N-213,150)	92 (86.97 to 94.91)	97 (93.31 to 99.27)

No statistical analyses for this end point

Secondary: hSBA GMTs against each of N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_1 month, 0_2 month, 0_6 month and 0, 11 month schedule.

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End point title

hSBA GMTs against each of N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_1 month, 0_2 month, 0_6 month and 0, 11 month schedule. ^[8]

End point description

The immunogenicity of MenABCWY vaccine, administered according to 0, 2 months schedule, was compared with those, administered according to 0, 1 month, 0, 6 month and 0, 11 month schedules as measured by hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the second meningococcal vaccination.Analysis was done on the FAS-1 month after the last meningococcal vaccination.All subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at pre- & at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.

End point type

Secondary

End point timeframe

At 1 Month after the last vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group, Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group)

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group
Number of subjects analysed	213	143	123	133
Units: Titers
geometric mean (confidence interval 95%)
NZ98/254(N-212,142,121,131)	12.32 (9.82 to 15)	6.33 (4.86 to 8.23)	13.64 (10 to 18)	15.87 (12 to 21)
M14459(N-211,140,122,133)	12.72 (10 to 16)	9.19 (7.11 to 12)	26.48 (20 to 35)	29.57 (23 to 39)
M07-0241084(N-206,140,123,131)	9.15 (7.52 to 11)	6.59 (5.25 to 8.27)	15.04 (12 to 19)	16.22 (13 to 21)
96217(N-210,143,121,133)	165.47 (133 to 206)	117.28 (91 to 151)	237.89 (182 to 310)	244.97 (189 to 317)
A serogroup(N-211,142,123,133)	69.61 (56 to 87)	79.87 (62 to 103)	140.76 (108 to 184)	162.76 (126 to 211)
C serogroup(N-212,142,123,131)	162.57 (132 to 201)	145.73 (114 to 186)	225.00 (174 to 290)	292.61 (227 to 376)
W serogroup(N-208,143,123,131)	215.72 (182 to 256)	197.69 (162 to 241)	376.03 (306 to 462)	531.79 (434 to 652)
Y serogroup(N-213,142,123,132)	71.66 (55 to 93)	57.45 (42 to 78)	120.76 (88 to 166)	209.53 (153 to 286)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains when administered according to 0_2 month schedule.

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End point title

Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains when administered according to 0_2 month schedule. ^[9]

End point description

A sufficient immune response following Bexsero vaccine, administered according to 0, 2 month schedule, as measured by the percentage of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, was to be demonstrated. Criterion: the immune response was to be considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titers ≥ LLQ was greater than 75% for each of the four serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.

End point type

Secondary

End point timeframe

At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group
Number of subjects analysed	188	185
Units: Percentages of subjects
number (confidence interval 95%)
NZ98/254(M-0)(LLQ=8.2)(N-188,185)	7 (3.73 to 11.53)	6 (3.40 to 11.06)
NZ98/254(M-3)(LLQ=8.2)(N-188,185)	88 (82.82 to 92.52)	61 (53.65 to 68.15)
M14459(M-0)(LLQ=8.0)(N-184,179)	7 (3.41 to 11.11)	5 (2.32 to 9.33)
M14459(M-3)(LLQ=8.0)(N-184,179)	82 (75.75 to 87.32)	68 (60.21 to 74.39)
M07-0241084(M-0)(LLQ=8.9)(N-188,176)	21 (15.19 to 27.25)	18 (12.78 to 24.69)
M07-0241084(M-3)LLQ=8.9)(N-188,176)	66 (59.26 to 73.19)	47 (39.60 to 54.81)
96217(M-0)(LLQ=8.6)(N-186,178)	23 (17.26 to 29.85)	29 (22.14 to 35.89)
96217(M-3)(LLQ=8.6)(N-186,178)	99 (97.04 to 99.99)	97 (92.81 to 98.75)

No statistical analyses for this end point

Secondary: hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_6 month schedule.

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End point title

hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_6 month schedule. ^[10]

End point description

The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule was compared with those administered according to 0, 6 months schedule, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the last meningococcal vaccination.

End point type

Secondary

End point timeframe

At 1 month after last vaccination (Month 7)

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	ABCWY_0_6 Group	ABCWY_0_2_6 Group
Number of subjects analysed	123	151
Units: Titers
geometric mean (confidence interval 95%)
NZ98/254(N-121,151)	13.62 (9.98 to 19)	17.13 (13 to 23)
M14459(N-122,151)	27.82 (21 to 36)	29.27 (23 to 37)
M07-0241084(N-123,148)	17.43 (13 to 23)	20.92 (16 to 27)
96217(N-121,150)	240.13 (186 to 310)	291.63 (232 to 367)
Serogroup A(N-123,147)	140.14 (107 to 184)	128.75 (101 to 164)
Serogroup C(N-123,149)	246.48 (191 to 318)	413.60 (328 to 522)
Serogroup W(N-123,140)	341.90 (283 to 413)	282.74 (237 to 338)
Serogroup Y(N-123,150)	123.96 (91 to 169)	151.36 (115 to 200)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_6 month schedule.

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End point title

Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_6 month schedule. ^[11]

End point description

The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 month schedule, was compared with those, administered according to 0, 6 month schedule, as measured by the percentages of subjects with hSBA titers ≥ LLQ against serogroups A, C, W and Y and serogroup B test strains at 1 month after the last meningococcal vaccination.Analysis was done on the FAS- 1 month after last meningococcal vaccination, which included all screened subjects who provided informed consent, received a study vaccination & provided evaluable serum samples at 1 month after last vaccination whose results were available for atleast 1 serogroup or B strains

End point type

Secondary

End point timeframe

At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 7)

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	ABCWY_0_6 Group	ABCWY_0_2_6 Group
Number of subjects analysed	123	151
Units: Percentages of subjects
number (confidence interval 95%)
NZ98/254(M-0)(LLQ=8.2)(N-120,151)	5 (1.86 to 10.57)	2 (0.41 to 5.70)
NZ98/254(M-7)(LLQ=8.2)(N-121,151)	64 (55.25 to 72.95)	74 (65.72 to 80.35)
M14459(M-0)(LLQ=8.0)(N-121,151)	5 (1.84 to 10.48)	2 (0.41 to 5.70)
M14459(M-7)(LLQ=8.0)(N-122,151)	87 (79.58 to 92.31)	89 (83.36 to 93.82)
M07-0241084(M-0)(LLQ=8.9)(N-122,145)	14 (8.33 to 21.37)	18 (12.06 to 25.16)
M07-0241084(M-7)(LLQ=8.9)(N-123,148)	66 (56.76 to 74.16)	72 (64.35 to 79.33)
96217(M-0)(LLQ=8.6)(N-119,144)	27 (19.18 to 35.79)	27 (20.02 to 35.11)
996217(M-7)(LLQ=8.6)(N-121,150)	98 (92.93 to 99.49)	99 (96.34 to 99.98)
A serogroup(M-0)(LLQ=22.7)(N-118,146)	2 (0.21 to 5.99)	1 (0.02 to 3.76)
A serogroup(M-7)(LLQ=22.7)(N-123,147)	94 (88.63 to 97.68)	95 (89.56 to 97.62)
C serogroup(M-0)(LLQ=5.2)(N-122,145)	42 (32.94 to 51.07)	41 (32.62 to 49.15)
C serogroup(M-7)(LLQ=5.2)(N-123,149)	99 (95.55 to 99.98)	100 (97.55 to 100)
W serogroup(M-0)(LLQ=39.6)(N-119,138)	20 (13.37 to 28.51)	22 (15.17 to 29.56)
W serogroup(M-7)(LLQ=39.6)(N-123,140)	99 (95.55 to 99.98)	99 (96.08 to 99.98)
Y serogroup(M-0)(LLQ=14.7)(N-120,150)	7 (2.92 to 12.71)	6 (2.78 to 11.08)
Y serogroup(M-7)(LLQ=14.7)(N-123,150)	94 (88.63 to 97.68)	97 (93.31 to 99.27)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_1 month, 0_2 month, 0_6 month and 0_11 month schedule.

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End point title

Percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_1 month, 0_2 month, 0_6 month and 0_11 month schedule. ^[12]

End point description

The immunogenicity of MenABCWY vaccine, administered according to 0, 2 month schedule, was compared with those, administered according to 0, 1 month, 0, 6 month and 0, 11 month schedules, as measured by the percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the second meningococcal vaccination.Analysis was done on the FAS- 1 month after last meningococcal vaccination, which included all screened subjects who provided informed consent, received a study vaccination & provided evaluable serum samples at 1 month after last vaccination whose results were available for atleast 1 serogroup or B strains

End point type

Secondary

End point timeframe

At 1 month after second vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group , Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group)

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group
Number of subjects analysed	213	143	123	133
Units: Percentages of subjects
number (confidence interval 95%)
NZ98/254(LLQ=8.2)(N-212,142,121,131)	63 (55.85 to 69.26)	44 (35.36 to 52.23)	64 (55.25 to 72.95)	73 (64.85 to 80.63)
M14459(LLQ=8.0)(N-211,140,122,133)	70 (63.48 to 76.23)	62 (53.56 to 70.20)	87 (79.58 to 92.31)	89 (82.08 to 93.55)
M07-0241084(LLQ=8.9)(N-206,140,123,131)	49 (41.54 to 55.59)	40 (31.82 to 48.61)	66 (56.76 to 74.16)	69 (60.82 to 77.21)
96217(LLQ=8.6)(N-210,143,121,133)	97 (93.25 to 98.65)	97 (92.99 to 99.23)	98 (92.93 to 99.49)	98 (93.55 to 99.53)
Serogroup A (LLQ=22.7)(N-211,142,123,133)	88 (83.01 to 92.18)	92 (85.70 to 95.56)	94 (88.63 to 97.68)	94 (88.49 to 97.37)
Serogroup C (LLQ=5.2)(N-212,142,123,131)	99 (96.63 to 99.89)	100 (97.44 to 100)	99 (95.55 to 99.99)	100 (97.22 to 100)
Serogroup W (LLQ=39.6)(N-208,143,123,131)	97 (93.19 to 98.64)	96 (91.09 to 98.44)	99 (95.55 to 99.98)	98 (93.45 to 99.53)
Serogroup Y (LLQ=14.7)(N-213,142,123,132)	92 (86.97 to 94.91)	85 (78.29 to 90.61)	94 (88.63 to 97.68)	97 (92.42 to 99.17)

No statistical analyses for this end point

Secondary: hSBA GMTs against serogroups A, C, W and Y and serogroup B test strains at all the relevant time points for all schedules.

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End point title

hSBA GMTs against serogroups A, C, W and Y and serogroup B test strains at all the relevant time points for all schedules.

End point description

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the adjusted hSBA GMTs against serogroups A,C, W and Y and serogroup B test strains was assessed.

End point type

Secondary

End point timeframe

At Month 0, Month 2, Month 3, Month 7 and Month 13

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	188	185	122	114	128	137
Units: Titers
geometric mean (confidence interval 95%)
NZ98/254(M-0)(N-188,185,120,112126,134)	1.22 (1.08 to 1.38)	1.22 (1.08 to 1.38)	1.21 (1.04 to 1.40)	1.13 (0.97 to 1.31)	1.12 (0.97 to 1.29)	1.06 (0.93 to 1.22)
NZ98/254(M-2)(N-188,185,120,112,126,134)	2.67 (2.14 to 3.34)	2.27 (1.82 to 2.84)	6.50 (4.98 to 8.48)	1.92 (1.46 to 2.51)	3.87 (2.98 to 5.01)	2.20 (1.71 to 2.82)
NZ98/254(M-3)(N-188,185,120,112,126,134)	27.17 (22 to 34)	11.46 (9.28 to 14)	3.15 (2.44 to 4.05)	1.69 (1.31 to 2.19)	2.38 (1.86 to 3.05)	12.80 (10 to 16)
NZ98/254 (M-7)(N-188,185,120,112,126,134)	3.00 (2.44 to 3.67)	2.41 (1.97 to 2.95)	1.88 (1.47 to 2.40)	14.30 (11 to 18)	1.75 (1.38 to 2.22)	18.24 (14 to 23)
NZ98/254(M-13)(N-188,185,120,112,126,134)	2.33 (1.92 to 2.83)	1.93 (1.59 to 2.33)	1.81 (1.44 to 2.27)	2.57 (2.04 to 3.25)	17.08 (14 to 21)	2.82 (2.28 to 3.51)
M14459(M-0)(N-184,179,112,108,123,134)	1.37 (1.21 to 1.56)	1.22 (1.08 to 1.39)	1.22 (1.04 to 1.42)	1.21 (1.04 to 1.41)	1.34 (1.15 to 1.55)	1.17 (1.02 to 1.35)
M14459(M-2)(N-184,179,112,108,123,134)	2.83 (2.31 to 3.46)	2.55 (2.08 to 3.13)	9.23 (7.21 to 12)	2.34 (1.82 to 2.99)	3.94 (3.11 to 4.98)	2.40 (1.92 to 3.01)
M14459(M-3)(N-184,179,112,108,123,134)	18.29 (15 to 23)	12.85 (10 to 16)	5.30 (4.04 to 6.93)	2.15 (1.64 to 2.82)	3.11 (2.40 to 4.02)	15.24 (12 to 20)
M14459(M-7)(N-184,179,112,108,123,134)	3.52 (2.91 to 4.26)	3.24 (2.68 to 3.93)	2.19 (1.74 to 2.77)	27.47 (22 to 35)	1.95 (1.56 to 2.43)	28.56 (23 to 35)
M14459(M-13)(N-184,179,112,108,123,134)	2.46 (2.03 to 2.97)	2.29 (1.89 to 2.78)	1.95 (1.54 to 2.45)	3.22 (2.55 to 4.06)	29.01 (23 to 36)	3.17 (2.57 to 3.92)
M07-0241084 (M-0)(N-188,176,117,113,121,128)	2.26 (1.81 to 2.82)	2.07 (1.65 to 2.59)	2.01 (1.53 to 2.63)	2.06 (1.57 to 2.71)	2.59 (1.99 to 3.37)	1.83 (1.42 to 2.36)
M07-0241084(M-2)(N-188,176,117,113,121,128)	5.09 (4.26 to 6.07)	4.30 (3.59 to 5.14)	6.73 (5.44 to 8.34)	3.51 (2.83 to 4.35)	4.90 (3.97 to 6.04)	4.20 (3.43 to 5.15)
M07-0241084 (M-3)(N-188,176,117,113,121,128)	13.91 (12 to 17)	8.82 (7.29 to 11)	4.39 (3.49 to 5.50)	3.30 (2.62 to 4.15)	3.55 (2.84 to 4.43)	9.29 (7.49 to 12)
M07-0241084 (M-7)(N-188,176,117,113,121,128)	5.42 (4.51 to 6.51)	4.68 (3.88 to 5.63)	3.36 (2.69 to 4.20)	15.70 (13 to 20)	2.96 (2.38 to 3.67)	19.18 (16 to 24)
M07-0241084(M-13)(N-188,176,117,113,121,128)	4.45 (3.71 to 5.35)	4.01 (3.34 to 4.83)	3.07 (2.46 to 3.83)	5.42 (4.33 to 6.77)	15.68 (13 to 19)	5.80 (4.70 to 7.16)
96217(M-0)(N-186,178,120,112,128,121)	2.32 (1.82 to 2.95)	2.84 (2.23 to 3.62)	2.88 (2.16 to 3.83)	2.39 (1.78 to 3.21)	2.78 (2.11 to 3.68)	2.57 (1.94 to 3.40)
96217 (M-2)(N-186,178,120,112,128,121)	16.48 (13 to 21)	11.62 (8.96 to 15)	124.75 (92 to 169)	11.61 (8.49 to 16)	11.94 (8.87 to 16)	8.54 (6.33 to 12)
96217(M-3)(N-186,178,120,112,128,121)	263.56 (211 to 329)	169.65 (136 to 212)	82.23 (63 to 107)	8.61 (6.57 to 11)	7.72 (5.97 to 9.99)	162.27 (125 to 210)
96217(M-7)(N-186,178,120,112,128,121)	61.46 (50 to 75)	43.01 (35 to 53)	37.26 (29 to 47)	264.85 (207 to 340)	5.19 (4.10 to 6.58)	306.14 (242 to 388)
96217(M-13)(N-186,178,120,112,128,121)	33.07 (27 to 41)	22.48 (18 to 28)	24.00 (18 to 31)	42.27 (32 to 55)	264.32 (205 to 341)	47.22 (37 to 61)
Serogroup A (M-0)(N-172,178,107,105,120,127)	1.37 (1.18 to 1.59)	1.17 (1.02 to 1.36)	1.38 (1.15 to 1.65)	1.08 (0.90 to 1.30)	1.19 (1.00 to 1.41)	1.06 (0.90 to 1.25)
Serogroup A (M-2)(N-172,178,107,105,120,127)	4.05 (2.97 to 5.54)	8.35 (6.14 to 11)	85.49 (59 to 125)	7.64 (5.22 to 11)	22.54 (16 to 32)	5.18 (3.65 to 7.34)
Serogroup A (M-3)(N-172,178,107,105,120,127)	106.70 (82 to 139)	68.85 (53 to 89)	52.42 (38 to 72)	5.31 (3.86 to 7.31)	8.77 (6.49 to 12)	78.30 (58 to 105)
Serogroup A (M-7)(N-172,178,107,105,120,127)	14.15 (11 to 19)	11.49 (8.71 to 15)	9.88 (7.04 to 14)	165.14 (117 to 233)	3.25 (2.35 to 4.49)	140.73 (103 to 193)
Serogroup A (M-13)(N-172,178,107,105,120,127)	5.80 (4.30 to 7.82)	4.64 (3.45 to 6.23)	5.90 (4.11 to 8.46)	15.20 (11 to 22)	168.23 (119 to 238)	13.32 (9.52 to 19)
Serogroup C (M-0)(N-186,185,122,114,123,130)	3.46 (2.76 to 4.33)	3.38 (2.71 to 4.23)	3.87 (2.96 to 5.04)	3.36 (2.56 to 4.40)	3.80 (2.92 to 4.94)	2.99 (2.32 to 3.87)
Serogroup C (M-2)(N-186,185,122,114,123,130)	9.47 (7.18 to 13)	31.56 (24 to 42)	163.28 (118 to 227)	37.24 (27 to 52)	54.75 (40 to 76)	40.29 (29 to 55)
Serogroup C(M-3)(N-186,185,122,114,123,130)	41.25 (32 to 52)	184.05 (145 to 234)	119.71 (90 to 159)	31.50 (24 to 42)	41.15 (31 to 54)	236.97 (180 to 312)
Serogroup C(M-7)(N-186,185,122,114,123,130)	11.03 (8.81 to 14)	80.70 (65 to 101)	76.97 (59 to 100)	260.57 (199 to 342)	24.59 (19 to 32)	476.44 (369 to 615)
Serogroup C(M-13)(N-186,185,122,114,123,130)	8.45 (6.79 to 11)	37.45 (30 to 47)	38.42 (30 to 50)	57.48 (44 to 75)	303.63 (235 to 392)	113.72 (89 to 146)
Serogroup W (M-0)(N-162,180,119,108,123,123)	6.43 (4.46 to 9.27)	4.75 (3.35 to 6.73)	4.54 (2.98 to 6.90)	4.29 (2.80 to 6.58)	4.95 (3.30 to 7.44)	4.46 (2.97 to 6.69)
Serogroup W (M-2)(N-162,180,119,108,123,123)	17.43 (13 to 23)	50.71 (39 to 66)	175.57 (128 to 241)	59.37 (43 to 82)	94.34 (69 to 128)	47.54 (35 to 65)
Serogroup W (M-3)(N-162,180,119,108,123,123)	138.43 (111 to 173)	214.70 (173 to 266)	125.70 (97 to 162)	59.26 (46 to 77)	86.66 (68 to 111)	200.91 (157 to 258)
Serogroup W (M-7)(N-162,180,119,108,123,123)	22.53 (18 to 29)	79.96 (63 to 101)	74.84 (57 to 99)	340.85 (256 to 453)	58.19 (44 to 76)	270.12 (206 to 354)
Serogroup W (M-13)(N-162,180,119,108,123,123)	12.63 (9.86 to 16)	45.63 (36 to 58)	46.83 (35 to 62)	96.43 (72 to 129)	478.73 (363 to 631)	95.90 (73 to 126)
Serogroup Y (M-0)(N-188,180,120,110,127,137)	1.72 (1.41 to 2.10)	1.40 (1.14 to 1.71)	1.68 (1.32 to 2.13)	1.24 (0.97 to 1.59)	1.79 (1.42 to 2.25)	1.34 (1.07 to 1.67)
Serogroup Y (M-2)(N-188,180,120,110,127,137)	2.36 (1.72 to 3.23)	19.43 (14 to 27)	63.45 (44 to 93)	16.41 (11 to 24)	27.00 (19 to 39)	19.82 (14 to 28)
Serogroup Y (M-3)(N-188,180,120,110,127,137)	3.12 (2.34 to 4.17)	90.61 (68 to 121)	42.97 (30 to 61)	15.95 (11 to 23)	18.76 (13 to 26)	97.12 (70 to 134)
Serogroup Y (M-7)(N-188,180,120,110,127,137)	2.44 (1.87 to 3.17)	34.27 (26 to 45)	27.86 (20 to 38)	152.73 (111 to 211)	14.29 (11 to 19)	180.33 (135 to 242)
Serogroup Y (M-13)(N-188,180,120,110,127,137)	2.28 (1.75 to 2.96)	18.13 (14 to 24)	15.19 (11 to 21)	42.14 (31 to 58)	231.39 (171 to 313)	53.78 (40 to 72)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against NZ98/254 B strain for all schedules.

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End point title

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against NZ98/254 B strain for all schedules.

End point description

The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against NZ98/254 B strain was assessed.

End point type

Secondary

End point timeframe

At Month 0, Month 2, Month 3, Month 7 and Month 13.

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	188	185	120	112	126	134
Units: Percentages of subjects
number (confidence interval 95%)
NZ98/254 strain (At Month 0) ≥LLQ (8.2)	7 (3.73 to 11.53)	6 (3.40 to 11.06)	6 (2.38 to 11.65)	5 (1.99 to 11.30)	4 (1.30 to 9.02)	2 (0.46 to 6.40)
NZ98/254 Strain (At Month 0) ≥ 5	9 (4.94 to 13.45)	7 (3.79 to 11.72)	7 (2.92 to 12.71)	5 (1.99 to 11.30)	6 (2.26 to 11.11)	3 (0.82 to 7.47)
NZ98/254 Strain (At Month 0) ≥ 8	7 (4.13 to 12.18)	6 (3.40 to 11.06)	6 (2.38 to 11.65)	5 (1.99 to 11.30)	4 (1.30 to 9.02)	2 (0.46 to 6.40)
NZ98/254 Strain (At Month 0) ≥ 16	4 (1.85 to 8.21)	5 (2.62 to 9.72)	4 (1.37 to 9.46)	4 (0.98 to 8.89)	2 (0.19 to 5.62)	1 (0.02 to 4.09)
NZ98/254 Strain (At Month 0) ≥ 32	2 (0.33 to 4.59)	3 (0.88 to 6.19)	3 (0.52 to 7.13)	1 (0.02 to 4.87)	0 (0 to 2.89)	0 (0 to 2.72)
NZ98/254 Strain (At Month 0) ≥ 64	0 (0 to 1.94)	3 (0.34 to 4.67)	0 (0 to 3.03)	1 (0.02 to 4.87)	0 (0 to 2.89)	0 (0 to 2.72)
NZ98/254 Strain (At Month 0) ≥ 128	0 (0 to 1.94)	0 (0 to 1.97)	0 (0 to 3.03)	0 (0 to 3.24)	0 (0 to 2.89)	0 (0 to 2.72)
NZ98/254 Strain (At Month 2) ≥ LLQ (8.2)	23 (17.55 to 30.12)	20 (14.49 to 26.50)	43 (33.53 to 51.85)	17 (10.53 to 25.22)	27 (19.47 to 35.62)	18 (11.83 to 25.47)
NZ98/254 Strain (At Month 2) ≥ 5	29 (22.86 to 36.32)	24 (18.33 to 31.16)	58 (48.98 to 67.26)	18 (11.26 to 26.22)	36 (27.38 to 44.74)	20 (13.72 to 27.95)
NZ98/254 Strain (At Month 2) ≥ 8	23 (17.55 to 30.12)	20 (14.49 to 26.50)	43 (33.53 to 51.85)	17 (10.53 to 25.22)	28 (20.17 to 36.46)	18 (11.83 to 25.47)
NZ98/254 Strain (At Month 2) ≥ 16	19 (13.79 to 25.51)	15 (10.30 to 21.13)	28 (20.49 to 37.28)	11 (5.66 to 17.97)	23 (15.99 to 31.35)	13 (7.57 to 19.53)
NZ98/254 Strain (At Month 2) ≥ 32	15 (10.13 to 20.80)	10 (5.87 to 14.94)	20 (13.25 to 28.28)	9 (4.36 to 15.81)	17 (10.62 to 24.34)	7 (3.64 to 13.30)
NZ98/254 Strain (At Month 2) ≥ 64	9 (4.94 to 13.45)	7 (3.79 to 11.72)	12 (6.53 to 18.80)	4 (0.98 to 8.89)	13 (7.44 to 19.80)	2 (0.46 to 6.40)
NZ98/254 Strain (At Month 2) ≥ 128	2 (0.33 to 4.59)	5 (2.25 to 9.03)	5 (1.86 to 10.57)	3 (0.56 to 7.63)	6 (2.78 to 12.13)	1 (0.18 to 5.29)
NZ98/254 Strain (At Month 3) ≥ LLQ (8.2)	88 (82.82 to 92.52)	61 (53.65 to 68.15)	30 (21.98 to 39.04)	14 (8.39 to 22.16)	20 (13.27 to 27.88)	68 (59.30 to 75.71)
NZ98/254 Strain (At Month 3) ≥ 5	94 (89.12 to 96.66)	76 (68.84 to 81.67)	38 (29.61 to 47.65)	17 (10.53 to 25.22)	27 (19.47 to 35.62)	78 (70.42 to 85.00)
NZ98/254 Strain (At Month 3) ≥ 8	88 (82.82 to 92.52)	63 (55.30 to 69.69)	30 (21.98 to 39.04)	14 (8.39 to 22.16)	21 (13.94 to 28.75)	69 (60.86 to 77.07)
NZ98/254 Strain (At Month 3) ≥ 16	74 (67.05 to 80.05)	44 (37.04 to 51.79)	18 (11.86 to 26.43)	11 (5.66 to 17.97)	14 (8.69 to 21.63)	46 (37.62 to 55.08)
NZ98/254 Strain (At Month 3) ≥ 32	50 (42.64 to 57.36)	23 (17.36 to 30.00)	13 (7.17 to 19.78)	5 (1.99 to 11.30)	10 (5.02 to 16.05)	19 (12.45 to 26.30)
NZ98/254 Strain (At Month 3) ≥ 64	29 (22.86 to 36.32)	12 (7.60 to 17.45)	6 (2.38 to 11.65)	4 (0.98 to 8.89)	6 (2.26 to 11.11)	14 (8.76 to 21.25)
NZ98/254 Strain (At Month 3) ≥ 128	12 (7.48 to 17.18)	6 (3.40 to 11.06)	4 (1.37 to 9.46)	2 (0.22 to 6.30)	4 (1.30 to 9.02)	4 (1.66 to 9.49)
NZ98/254 Strain (At Month 7) ≥ LLQ (8.2)	27 (20.43 to 33.52)	19 (14.02 to 25.91)	14 (8.47 to 21.71)	63 (53.76 to 72.29)	13 (7.44 to 19.80)	72 (64.00 to 79.76)
NZ98/254 Strain (At Month 7) ≥ 5	33 (26.31 to 40.19)	27 (20.77 to 34.03)	18 (11.86 to 26.43)	80 (71.78 to 87.26)	17 (11.28 to 25.23)	82 (74.53 to 88.17)
NZ98/254 Strain (At Month 7) ≥ 8	27 (20.43 to 33.52)	20 (14.49 to 26.50)	14 (8.47 to 21.71)	69 (59.30 to 77.17)	13 (7.44 to 19.80)	74 (65.59 to 81.08)
NZ98/254 Strain (At Month 7) ≥ 16	21 (15.19 to 27.25)	14 (9.39 to 19.91)	12 (6.53 to 18.80)	46 (36.10 to 55.22)	10 (5.02 to 16.05)	55 (46.40 to 63.82)
NZ98/254 Strain (At Month 7) ≥ 32	12 (7.92 to 17.79)	10 (6.30 to 15.57)	9 (4.67 to 15.81)	26 (18.08 to 35.03)	4 (1.30 to 9.02)	34 (25.66 to 42.25)
NZ98/254 Strain (At Month 7) ≥ 64	6 (3.34 to 10.88)	6 (3.40 to 11.06)	6 (2.38 to 11.65)	13 (7.69 to 21.13)	2 (0.19 to 5.62)	16 (10.58 to 23.80)
NZ98/254 Strain (At Month 7) ≥ 128	2 (0.33 to 4.59)	4 (1.53 to 7.64)	5 (1.86 to 10.57)	7 (3.13 to 13.59)	1 (0.02 to 4.34)	5 (2.13 to 10.47)
NZ98/254 Strain (At Month 13) ≥ LLQ (8.2)	21 (15.19 to 27.25)	16 (11.22 to 22.33)	15 (9.14 to 22.67)	18 (11.26 to 26.22)	73 (64.38 to 80.53)	19 (13.08 to 27.12)
NZ98/254 Strain (At Month 13) ≥ 5	27 (20.43 to 33.52)	19 (14.02 to 25.91)	16 (9.81 to 23.62)	28 (19.64 to 36.93)	85 (77.46 to 90.67)	25 (17.60 to 32.81)
NZ98/254 Strain (At Month 13) ≥ 8	21 (15.19 to 27.25)	16 (11.22 to 22.33)	15 (9.14 to 22.67)	18 (11.26 to 26.22)	74 (65.23 to 81.24)	19 (13.08 to 27.12)
NZ98/254 Strain (At Month 13) ≥ 16	15 (10.13 to 20.80)	12 (8.05 to 18.07)	8 (4.07 to 14.79)	12 (6.33 to 19.03)	49 (40.19 to 58.26)	14 (8.76 to 21.25)
NZ98/254 Strain (At Month 13) ≥ 32	7 (4.13 to 12.18)	7 (3.79 to 11.72)	8 (3.49 to 13.76)	8 (3.74 to 14.71)	30 (22.31 to 38.97)	4 (1.66 to 9.49)
NZ98/254 Strain (At Month 13) ≥ 64	3 (0.87 to 6.10)	5 (2.25 to 9.03)	5 (1.86 to 10.57)	5 (1.99 to 11.30)	13 (8.06 to 20.72)	3 (0.82 to 7.47)
NZ98/254 Strain (At Month 13) ≥ 128	2 (0.33 to 4.59)	3 (0.88 to 6.19)	3 (0.92 to 8.31)	3 (0.56 to 7.63)	6 (2.78 to 12.13)	2 (0.46 to 6.40)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M14459 B strain for all schedules.

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End point title

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M14459 B strain for all schedules.

End point description

End point type

Secondary

End point timeframe

At Month 0, Month 2, Month 3, Month 7 and Month 13.

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	184	179	112	108	123	134
Units: Percentages of subjects
number (confidence interval 95%)
M14459 Strain (At Month 0) ≥ LLQ (8.0)	7 (3.41 to 11.11)	5 (2.32 to 9.33)	6 (2.55 to 12.45)	4 (1.02 to 9.21)	7 (2.85 to 12.41)	2 (0.46 to 6.40)
M14459 Strain (At Month 0) ≥ 5	12 (7.65 to 17.54)	7 (3.92 to 12.10)	6 (2.55 to 12.45)	6 (2.65 to 12.90)	11 (6.36 to 18.36)	4 (1.22 to 8.49)
M14459 Strain (At Month 0) ≥ 8	7 (3.41 to 11.11)	5 (2.32 to 9.33)	6 (2.55 to 12.45)	4 (1.02 to 9.21)	7 (2.85 to 12.41)	2 (0.46 to 6.40)
M14459 Strain (At Month 0) ≥ 16	3 (0.89 to 6.23)	2 (0.35 to 4.82)	2 (0.22 to 6.30)	3 (0.58 to 7.90)	2 (0.51 to 6.96)	1 (0.18 to 5.29)
M14459 Strain (At Month 0) ≥ 32	2 (0.34 to 4.69)	0 (0 to 2.04)	1 (0.02 to 4.87)	1 (0.02 to 5.05)	0 (0 to 2.95)	1 (0.02 to 4.09)
M14459 Strain (At Month 0) ≥ 64	1 (0.13 to 3.87)	0 (0 to 2.04)	0 (0 to 3.24)	0 (0 to 3.36)	0 (0 to 2.95)	1 (0.02 to 4.09)
M14459 Strain (At Month 0) ≥ 128	0 (0 to 1.98)	0 (0 to 2.04)	0 (0 to 3.24)	0 (0 to 3.36)	0 (0 to 2.95)	0 (0 to 2.72)
M14459 Strain (At Month 2) ≥ LLQ (8.0)	28 (21.88 to 35.35)	24 (17.96 to 30.96)	61 (51.04 to 69.81)	17 (10.19 to 25.06)	34 (25.84 to 43.24)	17 (11.20 to 24.63)
M14459 Strain (At Month 2) ≥ 5	38 (30.49 to 44.92)	30 (23.03 to 36.88)	75 (65.93 to 82.70)	26 (17.97 to 35.25)	42 (33.42 to 51.51)	22 (15.64 to 30.39)
M14459 Strain (At Month 2) ≥ 8	28 (21.88 to 35.35)	24 (17.96 to 30.96)	61 (51.04 to 69.81)	17 (10.19 to 25.06)	34 (25.84 to 43.24)	17 (11.20 to 24.63)
M14459 Strain (At Month 2) ≥ 16	17 (11.74 to 23.05)	13 (8.32 to 18.65)	34 (25.25 to 43.48)	11 (5.87 to 18.06)	25 (17.81 to 33.83)	12 (6.98 to 18.67)
M14459 Strain (At Month 2) ≥ 32	9 (5.05 to 13.74)	6 (3.11 to 10.73)	19 (12.00 to 27.22)	6 (2.07 to 11.70)	13 (7.62 to 20.26)	5 (2.13 to 10.47)
M14459 Strain (At Month 2) ≥ 64	4 (1.90 to 8.39)	2 (0.61 to 5.62)	4 (0.98 to 8.89)	2 (0.23 to 6.53)	8 (3.97 to 14.44)	2 (0.46 to 6.40)
M14459 Strain (At Month 2) ≥ 128	1 (0.01 to 2.99)	2 (0.35 to 4.82)	2 (0.22 to 6.30)	1 (0.02 to 5.05)	5 (1.81 to 10.32)	1 (0.18 to 5.29)
M14459 Strain (At Month 3) ≥ LLQ (8.0)	82 (75.75 to 87.32)	68 (60.21 to 74.39)	44 (34.39 to 53.44)	16 (9.45 to 24.00)	28 (20.69 to 37.29)	73 (64.80 to 80.42)
M14459 Strain (At Month 3) ≥ 5	84 (78.16 to 89.18)	74 (66.66 to 80.03)	54 (44.78 to 63.90)	20 (13.23 to 29.20)	35 (26.58 to 44.08)	80 (72.05 to 86.28)
M14459 Strain (At Month 3) ≥ 8	82 (75.75 to 87.32)	68 (60.21 to 74.39)	44 (34.39 to 53.44)	16 (9.45 to 24.00)	28 (20.69 to 37.29)	73 (64.80 to 80.42)
M14459 Strain (At Month 3) ≥ 16	66 (58.98 to 73.09)	51 (43.83 to 58.92)	24 (16.53 to 33.10)	9 (4.53 to 16.37)	18 (11.56 to 25.82)	51 (41.98 to 59.48)
M14459 Strain (At Month 3) ≥ 32	39 (32.03 to 46.58)	30 (23.54 to 37.46)	6 (2.55 to 12.45)	4 (1.02 to 9.21)	9 (4.55 to 15.44)	28 (20.91 to 36.79)
M14459 Strain (At Month 3) ≥ 64	18 (12.68 to 24.25)	11 (6.51 to 16.08)	3 (0.56 to 7.63)	1 (0.02 to 5.05)	4 (1.33 to 9.23)	10 (5.83 to 16.91)
M14459 Strain (At Month 3) ≥ 128	7 (3.41 to 11.11)	2 (0.61 to 5.62)	2 (0.22 to 6.30)	1 (0.02 to 5.05)	3 (0.89 to 8.12)	3 (0.82 to 7.47)
M14459 Strain (At Month 7) ≥ LLQ (8.0)	34 (26.91 to 41.02)	30 (23.03 to 36.88)	17 (10.53 to 25.22)	86 (78.13 to 92.01)	15 (9.56 to 23.07)	89 (82.21 to 93.60)
M14459 Strain (At Month 7) ≥ 5	44 (36.73 to 51.51)	35 (28.22 to 42.67)	21 (14.24 to 30.19)	92 (84.77 to 96.12)	20 (12.92 to 27.63)	93 (87.63 to 96.88)
M14459 Strain (At Month 7) ≥ 8	34 (26.91 to 41.02)	30 (23.03 to 36.88)	17 (10.53 to 25.22)	86 (78.13 to 92.01)	15 (9.56 to 23.07)	89 (82.21 to 93.60)
M14459 Strain (At Month 7) ≥ 16	19 (13.62 to 25.45)	14 (9.25 to 19.92)	10 (5.01 to 16.89)	69 (59.84 to 77.95)	8 (3.97 to 14.44)	72 (63.21 to 79.09)
M14459 Strain (At Month 7) ≥ 32	11 (7.21 to 16.92)	7 (3.51 to 11.42)	5 (1.99 to 11.30)	50 (40.22 to 59.78)	6 (2.32 to 11.37)	49 (40.52 to 58.02)
M14459 Strain (At Month 7) ≥ 64	3 (1.21 to 6.96)	4 (1.59 to 7.89)	3 (0.56 to 7.63)	23 (15.57 to 32.25)	4 (1.33 to 9.23)	22 (15.64 to 30.39)
M14459 Strain (At Month 7) ≥ 128	0 (0 to 1.98)	1 (0.01 to 3.07)	1 (0.02 to 4.87)	10 (5.20 to 17.49)	2 (0.20 to 5.75)	7 (3.12 to 12.37)
M14459 Strain (At Month 13) ≥ LLQ (8.0)	23 (17.46 to 30.16)	20 (14.01 to 26.13)	13 (7.01 to 20.08)	23 (15.57 to 32.25)	89 (81.64 to 93.64)	27 (19.58 to 35.20)
M14459 Strain (At Month 13) ≥ 5	30 (23.88 to 37.63)	26 (19.47 to 32.75)	20 (12.74 to 28.22)	37 (27.94 to 46.86)	93 (86.56 to 96.60)	38 (29.82 to 46.84)
M14459 Strain (At Month 13) ≥ 8	23 (17.46 to 30.16)	20 (14.01 to 26.13)	13 (7.01 to 20.08)	23 (15.57 to 32.25)	89 (81.64 to 93.64)	27 (19.58 to 35.20)
M14459 Strain (At Month 13) ≥ 16	15 (9.90 to 20.63)	9 (5.63 to 14.77)	7 (3.13 to 13.59)	13 (7.27 to 20.79)	76 (67.05 to 82.90)	13 (7.57 to 19.53)
M14459 Strain (At Month 13) ≥ 32	5 (2.64 to 9.77)	4 (1.95 to 8.62)	4 (0.98 to 8.89)	7 (3.25 to 14.07)	54 (45.25 to 63.47)	6 (2.61 to 11.42)
M14459 Strain (At Month 13) ≥ 64	2 (0.34 to 4.69)	2 (0.61 to 5.62)	3 (0.56 to 7.63)	1 (0.02 to 5.05)	29 (21.41 to 38.15)	1 (0.18 to 5.29)
M14459 Strain (At Month 13) ≥ 128	0 (0 to 1.98)	1 (0.01 to 3.07)	2 (0.22 to 6.30)	1 (0.02 to 5.05)	11 (5.75 to 17.40)	1 (0.02 to 4.09)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M07-0241084 B strain for all schedules.

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End point title

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M07-0241084 B strain for all schedules.

End point description

End point type

Secondary

End point timeframe

At Month 0, Month 2, Month 3, Month 7 and Month 13.

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	188	176	117	113	121	128
Units: Percentages of subjects
number (confidence interval 95%)
M07-0241084 Strain (At Month 0) ≥ LLQ (8.9)	21 (15.19 to 27.25)	18 (12.78 to 24.69)	17 (10.77 to 25.16)	14 (8.32 to 21.97)	21 (14.54 to 29.88)	19 (12.40 to 26.60)
M07-0241084 Strain (At Month 0) ≥ 5	30 (23.35 to 36.87)	28 (21.36 to 35.08)	25 (17.27 to 33.62)	27 (19.46 to 36.63)	30 (21.79 to 38.74)	21 (14.38 to 29.19)
M07-0241084 Strain (At Month 0) ≥ 8	22 (16.13 to 28.40)	20 (14.26 to 26.56)	18 (11.47 to 26.12)	19 (12.62 to 27.98)	24 (16.68 to 32.57)	20 (13.72 to 28.33)
M07-0241084 Strain (At Month 0) ≥ 16	13 (8.79 to 19.00)	14 (9.41 to 20.25)	12 (6.70 to 19.26)	6 (2.53 to 12.35)	16 (9.73 to 23.43)	15 (9.18 to 22.21)
M07-0241084 Strain (At Month 0) ≥ 32	8 (4.53 to 12.82)	6 (3.16 to 10.91)	7 (3.00 to 13.03)	4 (0.97 to 8.82)	9 (4.63 to 15.68)	6 (2.74 to 11.94)
M07-0241084 Strain (At Month 0) ≥ 64	3 (1.18 to 6.82)	2 (0.35 to 4.90)	3 (0.53 to 7.31)	2 (0.22 to 6.25)	3 (0.91 to 8.25)	3 (0.86 to 7.81)
M07-0241084 Strain (At Month 0) ≥ 128	0 (0 to 1.94)	0 (0 to 2.07)	0 (0 to 3.10)	2 (0.22 to 6.25)	1 (0.02 to 4.52)	1 (0.02 to 4.28)
M07-0241084 Strain (At Month 2) ≥ LLQ (8.9)	38 (30.81 to 45.11)	29 (22.40 to 36.28)	37 (28.03 to 46.16)	28 (20.24 to 37.57)	39 (30.12 to 48.13)	30 (22.65 to 39.22)
M07-0241084 Strain (At Month 2) ≥ 5	47 (40.03 to 54.74)	43 (35.75 to 50.85)	54 (44.39 to 63.10)	40 (30.73 to 49.46)	54 (44.43 to 62.83)	41 (32.04 to 49.66)
M07-0241084 Strain (At Month 2) ≥ 8	42 (34.88 to 49.42)	32 (25.54 to 39.84)	43 (33.63 to 52.21)	31 (22.61 to 40.36)	43 (34.01 to 52.29)	35 (26.93 to 44.09)
M07-0241084 Strain (At Month 2) ≥ 16	31 (24.33 to 37.98)	22 (16.26 to 29.02)	29 (21.04 to 38.17)	16 (9.72 to 24.00)	30 (21.79 to 38.74)	19 (12.40 to 26.60)
M07-0241084 Strain (At Month 2) ≥ 32	20 (14.72 to 26.67)	15 (10.36 to 21.53)	17 (10.77 to 25.16)	7 (3.11 to 13.47)	19 (12.45 to 27.14)	9 (4.37 to 14.86)
M07-0241084 Strain (At Month 2) ≥ 64	10 (5.77 to 14.71)	7 (3.99 to 12.30)	9 (4.17 to 15.16)	2 (0.22 to 6.25)	9 (4.63 to 15.68)	5 (1.74 to 9.92)
M07-0241084 Strain (At Month 2) ≥ 128	3 (1.18 to 6.82)	2 (0.35 to 4.90)	3 (0.53 to 7.31)	1 (0.02 to 4.83)	5 (1.84 to 10.48)	0 (0 to 2.84)
M07-0241084 Strain (At Month 3) ≥ LLQ (8.9)	66 (59.26 to 73.19)	47 (39.60 to 54.81)	28 (20.28 to 37.27)	28 (20.24 to 37.57)	30 (21.79 to 38.74)	53 (44.11 to 62.00)
M07-0241084 Strain (At Month 3) ≥ 5	79 (72.75 to 84.81)	69 (61.94 to 76.04)	43 (33.63 to 52.21)	40 (30.73 to 49.46)	43 (34.01 to 52.29)	62 (52.72 to 70.17)
M07-0241084 Strain (At Month 3) ≥ 8	69 (62.02 to 75.67)	55 (47.45 to 62.60)	34 (25.67 to 43.53)	31 (22.61 to 40.36)	34 (25.53 to 43.05)	56 (47.21 to 65.00)
M07-0241084 Strain (At Month 3) ≥ 16	52 (44.74 to 59.45)	33 (26.07 to 40.43)	21 (14.33 to 29.91)	12 (6.27 to 18.87)	21 (14.54 to 29.88)	40 (31.30 to 48.87)
M07-0241084 Strain (At Month 3) ≥ 32	33 (26.31 to 40.19)	18 (12.78 to 24.69)	15 (9.38 to 23.22)	5 (1.97 to 11.20)	15 (9.06 to 22.49)	23 (15.73 to 30.89)
M07-0241084 Strain (At Month 3) ≥ 64	18 (12.40 to 23.76)	11 (7.08 to 17.00)	5 (1.90 to 10.83)	1 (0.02 to 4.83)	4 (1.36 to 9.38)	13 (7.32 to 19.50)
M07-0241084 Strain (At Month 3) ≥ 128	5 (2.21 to 8.89)	3 (0.93 to 6.50)	3 (0.53 to 7.31)	1 (0.02 to 4.83)	2 (0.51 to 7.07)	2 (0.49 to 6.70)
M07-0241084 Strain (At Month 7) ≥ LLQ (8.9)	40 (32.84 to 47.27)	30 (22.92 to 36.88)	26 (18.02 to 34.54)	66 (56.88 to 74.99)	26 (18.12 to 34.35)	70 (61.60 to 78.06)
M07-0241084 Strain (At Month 7) ≥ 5	50 (42.64 to 57.36)	44 (36.30 to 51.42)	32 (24.11 to 41.76)	83 (74.99 to 89.56)	36 (27.81 to 45.60)	80 (72.53 to 86.94)
M07-0241084 Strain (At Month 7) ≥ 8	42 (34.88 to 49.42)	32 (25.54 to 39.84)	27 (19.52 to 36.36)	70 (60.57 to 78.18)	28 (20.31 to 36.99)	77 (68.26 to 83.59)
M07-0241084 Strain (At Month 7) ≥ 16	29 (22.37 to 35.76)	24 (18.28 to 31.47)	19 (12.18 to 27.07)	53 (43.48 to 62.55)	18 (11.76 to 26.22)	58 (48.77 to 66.49)
M07-0241084 Strain (At Month 7) ≥ 32	21 (15.19 to 27.25)	14 (8.94 to 19.61)	9 (4.79 to 16.20)	28 (20.24 to 37.57)	8 (4.03 to 14.67)	34 (25.49 to 42.48)
M07-0241084 Strain (At Month 7) ≥ 64	6 (2.96 to 10.23)	8 (4.42 to 12.99)	6 (2.44 to 11.94)	10 (4.96 to 16.75)	4 (1.36 to 9.38)	17 (11.10 to 24.86)
M07-0241084 Strain (At Month 7) ≥ 128	1 (0.01 to 2.93)	2 (0.35 to 4.90)	1 (0.02 to 4.67)	3 (0.55 to 7.56)	1 (0.02 to 4.52)	4 (1.28 to 8.88)
M07-0241084 Strain (At Month 13) ≥ LLQ (8.9)	34 (26.81 to 40.74)	27 (20.84 to 34.48)	23 (15.79 to 31.77)	34 (25.01 to 43.12)	69 (59.53 to 76.73)	37 (28.38 to 45.69)
M07-0241084 Strain (At Month 13) ≥ 5	46 (38.48 to 53.15)	39 (31.95 to 46.83)	36 (27.24 to 45.29)	57 (46.99 to 65.93)	82 (73.78 to 88.24)	51 (41.80 to 59.72)
M07-0241084 Strain (At Month 13) ≥ 8	37 (29.81 to 44.02)	34 (26.60 to 41.01)	27 (19.52 to 36.36)	39 (29.91 to 48.56)	74 (64.76 to 81.16)	42 (33.51 to 51.23)
M07-0241084 Strain (At Month 13) ≥ 16	26 (19.46 to 32.39)	23 (16.76 to 29.64)	17 (10.77 to 25.16)	19 (12.62 to 27.98)	55 (45.24 to 63.62)	26 (18.46 to 34.26)
M07-0241084 Strain (At Month 13) ≥ 32	16 (11.03 to 21.99)	13 (8.47 to 18.96)	11 (6.05 to 18.25)	12 (6.27 to 18.87)	35 (26.29 to 43.90)	12 (6.71 to 18.59)
M07-0241084 Strain (At Month 13) ≥ 64	6 (3.34 to 10.88)	3 (1.26 to 7.27)	4 (1.40 to 9.69)	5 (1.97 to 11.20)	20 (13.14 to 28.06)	5 (1.74 to 9.92)
M07-0241084 Strain (At Month 13) ≥ 128	2 (0.58 to 5.36)	1 (0.01 to 3.12)	2 (0.21 to 6.04)	1 (0.02 to 4.83)	9 (4.63 to 15.68)	1 (0.02 to 4.28)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against 96217 B strain for all schedules.

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End point title

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against 96217 B strain for all schedules.

End point description

End point type

Secondary

End point timeframe

At Month 0, Month 2, Month 3, Month 7 and Month 13.

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	186	178	120	112	128	121
Units: Percentages of subjects
number (confidence interval 95%)
96217 Strain (At Month 0) ≥ LLQ (8.6)	23 (17.26 to 29.85)	29 (22.14 to 35.89)	29 (21.23 to 38.16)	28 (19.64 to 36.93)	25 (17.77 to 33.42)	27 (19.57 to 36.12)
96217 Strain (At Month 0) ≥ 5	26 (19.68 to 32.72)	35 (28.38 to 42.90)	35 (26.52 to 44.24)	29 (21.23 to 38.82)	35 (26.93 to 44.09)	29 (21.05 to 37.87)
96217 Strain (At Month 0) ≥ 8	24 (18.23 to 31.00)	30 (23.68 to 37.66)	31 (22.73 to 39.91)	28 (19.64 to 36.93)	25 (17.77 to 33.42)	27 (19.57 to 36.12)
96217 Strain (At Month 0) ≥ 16	16 (11.15 to 22.22)	17 (11.67 to 23.18)	22 (14.67 to 30.11)	19 (12.00 to 27.22)	18 (11.74 to 25.73)	16 (9.73 to 23.43)
96217 Strain (At Month 0) ≥ 32	6 (3.38 to 11.00)	8 (4.37 to 12.84)	8 (4.07 to 14.79)	4 (1.47 to 10.11)	8 (3.81 to 13.90)	7 (2.90 to 12.61)
96217 Strain (At Month 0) ≥ 64	2 (0.33 to 4.64)	2 (0.62 to 5.65)	3 (0.52 to 7.13)	0 (0 to 3.24)	2 (0.49 to 6.70)	5 (1.84 to 10.48)
96217 Strain (At Month 0) ≥ 128	1 (0.01 to 2.96)	1 (0.14 to 4.00)	0 (0 to 3.03)	0 (0 to 3.24)	1 (0.02 to 4.28)	2 (0.20 to 5.84)
96217 Strain (At Month 2) ≥ LLQ (8.6)	69 (61.63 to 75.39)	64 (56.53 to 71.09)	97 (91.69 to 99.08)	62 (51.94 to 70.64)	58 (48.77 to 66.49)	50 (40.37 to 58.82)
96217 Strain (At Month 2) ≥ 5	75 (68.42 to 81.29)	67 (60.00 to 74.24)	97 (91.69 to 99.08)	66 (56.52 to 74.75)	66 (56.72 to 73.79)	53 (43.61 to 62.03)
96217 Strain (At Month 2) ≥ 8	70 (63.31 to 76.88)	64 (56.53 to 71.09)	97 (91.69 to 99.08)	63 (53.76 to 72.29)	59 (50.34 to 67.96)	51 (41.99 to 60.43)
96217 Strain (At Month 2) ≥ 16	48 (41.01 to 55.81)	48 (40.78 to 55.91)	94 (88.35 to 97.62)	48 (38.67 to 57.85)	42 (33.51 to 51.23)	39 (30.12 to 48.13)
96217 Strain (At Month 2) ≥ 32	27 (21.15 to 34.43)	21 (15.57 to 28.10)	84 (76.38 to 90.19)	20 (12.74 to 28.22)	26 (18.46 to 34.26)	24 (16.68 to 32.57)
96217 Strain (At Month 2) ≥ 64	11 (6.69 to 16.12)	15 (9.77 to 20.67)	73 (63.60 to 80.25)	9 (4.36 to 15.81)	14 (8.55 to 21.31)	12 (6.47 to 18.65)
96217 Strain (At Month 2) ≥ 128	7 (3.77 to 11.66)	4 (1.96 to 8.66)	45 (35.91 to 54.35)	4 (1.47 to 10.11)	9 (4.94 to 15.80)	7 (3.46 to 13.65)
96217 Strain (At Month 3) ≥ LLQ (8.6)	99 (97.04 to 99.99)	97 (92.81 to 98.75)	94 (88.35 to 97.62)	58 (48.34 to 67.30)	47 (38.00 to 55.89)	97 (91.75 to 99.09)
96217 Strain (At Month 3) ≥ 5	99 (97.04 to 99.99)	97 (93.57 to 99.08)	96 (90.54 to 98.53)	61 (51.04 to 69.81)	56 (47.21 to 65.00)	98 (92.93 to 99.49)
96217 Strain (At Month 3) ≥ 8	99 (97.04 to 99.99)	97 (92.81 to 98.75)	95 (89.43 to 98.14)	58 (48.34 to 67.30)	52 (43.34 to 61.24)	97 (91.75 to 99.09)
96217 Strain (At Month 3) ≥ 16	99 (97.04 to 99.99)	95 (90.62 to 97.66)	91 (84.19 to 95.33)	40 (31.03 to 49.86)	36 (27.65 to 44.89)	95 (89.52 to 98.16)
96217 Strain (At Month 3) ≥ 32	98 (95.36 to 99.67)	89 (83.83 to 93.45)	83 (75.44 to 89.51)	21 (13.49 to 29.20)	23 (15.73 to 30.89)	92 (85.33 to 95.97)
96217 Strain (At Month 3) ≥ 64	90 (84.51 to 93.74)	81 (74.34 to 86.39)	62 (52.35 to 70.39)	6 (2.55 to 12.45)	11 (6.11 to 17.67)	84 (76.57 to 90.27)
96217 Strain (At Month 3) ≥ 128	74 (67.28 to 80.32)	63 (55.38 to 70.03)	34 (25.76 to 43.38)	4 (1.47 to 10.11)	4 (1.28 to 8.88)	60 (51.04 to 69.11)
96217 Strain (At Month 7) ≥ LLQ (8.6)	95 (91.01 to 97.76)	91 (85.81 to 94.77)	88 (80.22 to 92.83)	97 (92.37 to 99.44)	39 (30.56 to 48.08)	99 (95.48 to 99.98)
96217 Strain (At Month 7) ≥ 5	96 (92.40 to 98.47)	93 (87.83 to 96.05)	91 (84.19 to 95.33)	97 (92.37 to 99.44)	44 (35.00 to 52.79)	99 (95.48 to 99.98)
96217 Strain (At Month 7) ≥ 8	95 (91.01 to 97.76)	91 (85.81 to 94.77)	88 (80.22 to 92.83)	97 (92.37 to 99.44)	40 (31.30 to 48.87)	99 (95.48 to 99.98)
96217 Strain (At Month 7) ≥ 16	93 (88.34 to 96.23)	85 (79.33 to 90.23)	76 (67.17 to 83.18)	96 (91.11 to 99.02)	30 (22.65 to 39.22)	99 (95.48 to 99.98)
96217 Strain (At Month 7) ≥ 32	75 (67.85 to 80.80)	65 (57.68 to 72.14)	57 (47.31 to 65.68)	96 (89.89 to 98.53)	18 (11.74 to 25.73)	98 (94.16 to 99.80)
96217 Strain (At Month 7) ≥ 64	43 (35.79 to 50.46)	34 (26.81 to 41.16)	32 (23.48 to 40.78)	87 (78.87 to 92.31)	7 (3.27 to 12.93)	98 (92.93 to 99.49)
96217 Strain (At Month 7) ≥ 128	11 (7.13 to 16.74)	7 (3.53 to 11.48)	12 (6.53 to 18.80)	73 (64.02 to 81.14)	2 (0.49 to 6.70)	85 (77.51 to 90.94)
96217 Strain (At Month 13) ≥ LLQ (8.6)	87 (81.41 to 91.55)	83 (76.20 to 87.85)	81 (72.64 to 87.44)	90 (83.11 to 94.99)	98 (93.30 to 99.51)	93 (87.39 to 97.10)
96217 Strain (At Month 13) ≥ 5	90 (85.14 to 94.16)	85 (78.70 to 89.76)	83 (75.44 to 89.51)	92 (85.29 to 96.26)	98 (94.47 to 99.81)	93 (87.39 to 97.10)
96217 Strain (At Month 13) ≥ 8	88 (82.03 to 92.00)	83 (76.82 to 88.33)	81 (72.64 to 87.44)	90 (83.11 to 94.99)	98 (94.47 to 99.81)	93 (87.39 to 97.10)
96217 Strain (At Month 13) ≥ 16	76 (69.00 to 81.77)	69 (61.75 to 75.80)	66 (56.62 to 74.24)	79 (70.80 to 86.51)	98 (93.30 to 99.51)	88 (80.38 to 92.89)
96217 Strain (At Month 13) ≥ 32	52 (44.72 to 59.51)	40 (32.64 to 47.48)	41 (31.95 to 50.18)	57 (47.45 to 66.45)	96 (91.12 to 98.72)	64 (55.25 to 72.95)
96217 Strain (At Month 13) ≥ 64	23 (17.26 to 29.85)	13 (8.37 to 18.76)	23 (15.38 to 31.02)	30 (22.02 to 39.76)	85 (77.79 to 90.82)	36 (27.81 to 45.60)
96217 Strain (At Month 13) ≥ 128	4 (1.87 to 8.30)	3 (0.92 to 6.43)	8 (3.49 to 13.76)	13 (7.69 to 21.13)	73 (64.08 to 80.16)	12 (7.11 to 19.62)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against A human serogroup for all schedules.

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End point title

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against A human serogroup for all schedules.

End point description

End point type

Secondary

End point timeframe

At Month 0, Month 2, Month 3, Month 7 and Month 13.

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	172	178	107	105	120	127
Units: Percentages of subjects
number (confidence interval 95%)
A human Serogroup (At Month 0) ≥ LLQ (22.7)	6 (2.82 to 10.43)	3 (1.25 to 7.19)	5 (1.53 to 10.57)	2 (0.23 to 6.71)	3 (0.52 to 7.13)	1 (0.02 to 4.31)
A human Serogroup (At Month 0) ≥ 5	10 (6.32 to 16.03)	6 (3.12 to 10.79)	10 (5.24 to 17.65)	4 (1.05 to 9.47)	8 (3.49 to 13.76)	3 (0.86 to 7.87)
A human Serogroup (At Month 0) ≥ 8	10 (5.86 to 15.35)	6 (2.73 to 10.09)	10 (5.24 to 17.65)	3 (0.59 to 8.12)	5 (1.86 to 10.57)	2 (0.49 to 6.75)
A human Serogroup (At Month 0) ≥ 16	7 (3.66 to 11.87)	4 (1.96 to 8.66)	7 (3.28 to 14.20)	2 (0.23 to 6.71)	4 (1.37 to 9.46)	2 (0.19 to 5.57)
A human Serogroup (At Month 0) ≥ 32	4 (1.65 to 8.21)	2 (0.62 to 5.65)	3 (0.58 to 7.98)	1 (0.02 to 5.19)	2 (0.20 to 5.89)	1 (0.02 to 4.31)
A human Serogroup (At Month 0) ≥ 64	1 (0.14 to 4.14)	1 (0.14 to 4.00)	2 (0.23 to 6.59)	1 (0.02 to 5.19)	0 (0 to 3.03)	1 (0.02 to 4.31)
A human Serogroup (At Month 0) ≥ 128	1 (0.01 to 3.20)	1 (0.01 to 3.09)	1 (0.02 to 5.10)	0 (0 to 3.45)	0 (0 to 3.03)	1 (0.02 to 4.31)
A human Serogroup (At Month 2) ≥ LLQ (22.7)	22 (16.13 to 29.04)	35 (27.86 to 42.32)	93 (85.80 to 96.72)	33 (24.43 to 43.20)	54 (44.83 to 63.29)	28 (20.01 to 36.19)
A human Serogroup (At Month 2) ≥ 5	37 (29.97 to 44.89)	53 (45.76 to 60.87)	95 (89.43 to 98.47)	48 (37.78 to 57.59)	75 (66.27 to 82.45)	39 (30.08 to 47.63)
A human Serogroup (At Month 2) ≥ 8	37 (29.43 to 44.30)	51 (42.98 to 58.12)	94 (88.19 to 97.91)	46 (35.96 to 55.72)	74 (65.38 to 81.72)	38 (29.35 to 46.83)
A human Serogroup (At Month 2) ≥ 16	28 (21.35 to 35.24)	44 (36.41 to 51.44)	93 (86.98 to 97.33)	41 (31.45 to 50.98)	67 (57.48 to 75.01)	31 (22.83 to 39.51)
A human Serogroup (At Month 2) ≥ 32	19 (13.09 to 25.24)	33 (26.28 to 40.58)	88 (80.12 to 93.37)	30 (21.02 to 39.22)	42 (32.74 to 51.02)	22 (15.18 to 30.26)
A human Serogroup (At Month 2) ≥ 64	12 (7.72 to 18.06)	19 (13.12 to 25.04)	69 (59.50 to 77.73)	18 (11.26 to 26.81)	33 (24.23 to 41.65)	14 (8.62 to 21.47)
A human Serogroup (At Month 2) ≥ 128	4 (1.65 to 8.21)	10 (5.66 to 14.85)	34 (24.80 to 43.42)	9 (3.99 to 15.65)	14 (8.47 to 21.71)	6 (2.76 to 12.03)
A human Serogroup (At Month 3) ≥ LLQ (22.7)	94 (89.57 to 97.18)	87 (80.61 to 91.17)	80 (71.58 to 87.42)	30 (21.02 to 39.22)	38 (28.83 to 46.80)	92 (86.00 to 96.16)
A human Serogroup (At Month 3) ≥ 5	97 (93.35 to 99.05)	94 (89.21 to 96.88)	92 (84.63 to 96.08)	40 (30.56 to 50.02)	55 (45.65 to 64.09)	94 (88.97 to 97.76)
A human Serogroup (At Month 3) ≥ 8	97 (93.35 to 99.05)	93 (87.83 to 96.05)	91 (83.48 to 95.43)	39 (29.67 to 49.06)	53 (43.18 to 61.69)	94 (87.97 to 97.24)
A human Serogroup (At Month 3) ≥ 16	95 (90.30 to 97.58)	91 (85.81 to 94.77)	86 (77.93 to 91.94)	33 (24.43 to 43.20)	42 (32.74 to 51.02)	92 (86.00 to 96.16)
A human Serogroup (At Month 3) ≥ 32	91 (85.33 to 94.59)	83 (76.20 to 87.85)	74 (64.45 to 81.85)	27 (18.51 to 36.19)	31 (22.73 to 39.91)	90 (83.13 to 94.44)
A human Serogroup (At Month 3) ≥ 64	71 (63.53 to 77.59)	57 (49.69 to 64.67)	46 (36.12 to 55.70)	12 (6.76 to 20.24)	19 (12.56 to 27.36)	61 (51.57 to 69.18)
A human Serogroup (At Month 3) ≥ 128	45 (37.76 to 53.10)	30 (23.17 to 37.07)	21 (14.14 to 30.49)	6 (2.13 to 12.02)	10 (5.27 to 16.82)	29 (21.41 to 37.85)
A human Serogroup (At Month 7) ≥ LLQ (22.7)	53 (45.74 to 61.12)	46 (38.04 to 53.12)	41 (31.70 to 51.05)	95 (89.24 to 98.44)	21 (13.96 to 29.20)	94 (87.97 to 97.24)
A human Serogroup (At Month 7) ≥ 5	70 (62.31 to 76.53)	62 (54.80 to 69.50)	60 (49.89 to 69.18)	97 (91.88 to 99.41)	29 (21.23 to 38.16)	98 (93.25 to 99.51)
A human Serogroup (At Month 7) ≥ 8	68 (60.50 to 74.92)	58 (50.82 to 65.75)	58 (48.01 to 67.42)	97 (91.88 to 99.41)	28 (19.75 to 36.40)	98 (93.25 to 99.51)
A human Serogroup (At Month 7) ≥ 16	61 (53.33 to 68.38)	51 (43.53 to 58.67)	49 (38.82 to 58.46)	97 (91.88 to 99.41)	22 (14.67 to 30.11)	97 (92.13 to 99.14)
A human Serogroup (At Month 7) ≥ 32	42 (34.95 to 50.20)	37 (29.44 to 44.05)	35 (25.65 to 44.39)	91 (84.35 to 96.01)	14 (8.47 to 21.71)	93 (86.97 to 96.71)
A human Serogroup (At Month 7) ≥ 64	19 (13.59 to 25.88)	19 (13.61 to 25.66)	18 (11.04 to 26.33)	76 (66.89 to 83.96)	7 (2.92 to 12.71)	80 (72.33 to 86.84)
A human Serogroup (At Month 7) ≥ 128	5 (2.42 to 9.70)	6 (2.73 to 10.09)	10 (5.24 to 17.65)	63 (52.88 to 72.09)	3 (0.52 to 7.13)	54 (44.48 to 62.44)
A human Serogroup (At Month 13) ≥ LLQ (22.7)	33 (26.16 to 40.71)	26 (20.09 to 33.52)	34 (24.80 to 43.42)	51 (41.47 to 61.30)	93 (87.29 to 97.08)	54 (45.26 to 63.19)
A human Serogroup (At Month 13) ≥ 5	51 (42.87 to 58.28)	42 (34.25 to 49.18)	48 (37.92 to 57.54)	68 (57.79 to 76.43)	98 (92.87 to 99.48)	65 (55.59 to 72.85)
A human Serogroup (At Month 13) ≥ 8	48 (40.59 to 55.99)	39 (31.57 to 46.34)	47 (37.02 to 56.62)	66 (55.81 to 74.70)	98 (92.87 to 99.48)	64 (54.78 to 72.12)
A human Serogroup (At Month 13) ≥ 16	38 (30.52 to 45.49)	30 (23.68 to 37.66)	41 (31.70 to 51.05)	59 (49.02 to 68.55)	95 (89.43 to 98.14)	60 (50.78 to 68.44)
A human Serogroup (At Month 13) ≥ 32	24 (17.68 to 30.92)	20 (14.09 to 26.27)	27 (18.96 to 36.55)	44 (34.14 to 53.83)	88 (81.20 to 93.47)	41 (32.30 to 50.02)
A human Serogroup (At Month 13) ≥ 64	13 (8.67 to 19.39)	8 (4.79 to 13.52)	13 (7.34 to 20.98)	27 (18.51 to 36.19)	81 (72.64 to 87.44)	16 (9.89 to 23.27)
A human Serogroup (At Month 13) ≥ 128	4 (1.65 to 8.21)	2 (0.35 to 4.85)	6 (2.09 to 11.81)	8 (3.35 to 14.46)	61 (51.50 to 69.61)	6 (2.24 to 11.03)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against C human serogroup for all schedules.

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End point title

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against C human serogroup for all schedules.

End point description

End point type

Secondary

End point timeframe

At Month 0, Month 2, Month 3, Month 7 and Month 13.

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	186	185	122	114	123	130
Units: Percentages of subjects
number (confidence interval 95%)
C human Serogroup (At Month 0) ≥ LLQ (5.2)	43 (35.79 to 50.46)	45 (38.09 to 52.87)	48 (38.43 to 56.78)	41 (32.09 to 50.83)	48 (38.88 to 57.16)	41 (32.24 to 49.73)
C human Serogroup (At Month 0) ≥ 5	46 (38.91 to 53.68)	45 (38.09 to 52.87)	49 (40.02 to 58.38)	43 (33.75 to 52.59)	49 (39.67 to 57.95)	42 (32.97 to 50.51)
C human Serogroup (At Month 0) ≥ 8	34 (27.61 to 41.71)	30 (23.75 to 37.44)	36 (27.57 to 45.25)	30 (21.62 to 39.11)	36 (27.33 to 44.91)	30 (22.28 to 38.66)
C human Serogroup (At Month 0) ≥ 16	19 (13.47 to 25.19)	14 (8.94 to 19.30)	20 (13.03 to 27.84)	14 (8.24 to 21.79)	24 (17.10 to 32.95)	8 (3.75 to 13.69)
C human Serogroup (At Month 0) ≥ 32	5 (2.61 to 9.66)	6 (3.40 to 11.06)	9 (4.59 to 15.56)	4 (0.96 to 8.74)	7 (3.40 to 13.44)	3 (0.84 to 7.69)
C human Serogroup (At Month 0) ≥ 64	2 (0.59 to 5.41)	2 (0.34 to 4.67)	2 (0.20 to 5.80)	3 (0.55 to 7.50)	3 (0.89 to 8.12)	1 (0.02 to 4.21)
C human Serogroup (At Month 0) ≥ 128	1 (0.01 to 2.96)	2 (0.34 to 4.67)	0 (0 to 2.98)	1 (0.02 to 4.79)	1 (0.02 to 4.45)	0 (0 to 2.80)
C human Serogroup (At Month 2) ≥ LLQ (5.2)	61 (53.89 to 68.33)	84 (78.27 to 89.24)	100 (97.02 to 100)	84 (76.20 to 90.37)	89 (82.60 to 94.25)	88 (80.78 to 92.80)
C human Serogroup (At Month 2) ≥ 5	62 (54.98 to 69.35)	84 (78.27 to 89.24)	100 (97.02 to 100)	84 (76.20 to 90.37)	89 (82.60 to 94.25)	88 (80.78 to 92.80)
C human Serogroup (At Month 2) ≥ 8	53 (45.25 to 60.04)	78 (71.16 to 83.60)	98 (94.20 to 99.80)	80 (71.28 to 86.76)	86 (78.80 to 91.74)	78 (69.56 to 84.52)
C human Serogroup (At Month 2) ≥ 16	35 (28.62 to 42.82)	65 (57.52 to 71.73)	95 (89.60 to 98.17)	64 (54.51 to 72.81)	72 (62.71 to 79.31)	61 (51.82 to 69.21)
C human Serogroup (At Month 2) ≥ 32	18 (13.00 to 24.60)	40 (32.88 to 47.44)	89 (81.50 to 93.58)	44 (34.58 to 53.46)	55 (46.06 to 64.25)	44 (35.16 to 52.82)
C human Serogroup (At Month 2) ≥ 64	8 (4.58 to 12.95)	23 (17.36 to 30.00)	79 (70.35 to 85.58)	29 (20.84 to 38.19)	39 (30.36 to 48.23)	25 (17.49 to 32.94)
C human Serogroup (At Month 2) ≥ 128	3 (0.88 to 6.16)	16 (10.76 to 21.73)	53 (44.03 to 62.36)	17 (10.34 to 24.80)	26 (18.52 to 34.70)	19 (12.85 to 27.07)
C human Serogroup (At Month 3) ≥ LLQ (5.2)	97 (93.84 to 99.12)	99 (96.15 to 99.87)	98 (94.20 to 99.80)	81 (72.25 to 87.49)	88 (80.68 to 93.01)	99 (95.79 to 99.98)
C human Serogroup (At Month 3) ≥ 5	97 (93.84 to 99.12)	99 (96.15 to 99.87)	98 (94.20 to 99.80)	81 (72.25 to 87.49)	88 (80.68 to 93.01)	100 (97.20 to 100)
C human Serogroup (At Month 3) ≥ 8	94 (89.00 to 96.62)	98 (94.56 to 99.41)	98 (92.98 to 99.49)	77 (68.40 to 84.53)	84 (76.01 to 89.78)	99 (95.79 to 99.98)
C human Serogroup (At Month 3) ≥ 16	78 (71.89 to 84.17)	96 (92.36 to 98.47)	95 (89.60 to 98.17)	62 (52.72 to 71.19)	63 (54.25 to 71.91)	98 (93.40 to 99.52)
C human Serogroup (At Month 3) ≥ 32	56 (48.46 to 63.17)	90 (84.43 to 93.70)	86 (78.63 to 91.67)	43 (33.75 to 52.59)	46 (36.53 to 54.75)	94 (88.23 to 97.31)
C human Serogroup (At Month 3) ≥ 64	26 (19.68 to 32.72)	78 (71.16 to 83.60)	67 (58.13 to 75.44)	25 (17.75 to 34.45)	30 (22.14 to 39.00)	85 (77.24 to 90.34)
C human Serogroup (At Month 3) ≥ 128	11 (6.69 to 16.12)	58 (50.92 to 65.57)	40 (31.39 to 49.42)	18 (11.06 to 25.79)	21 (14.30 to 29.42)	60 (51.05 to 68.49)
C human Serogroup (At Month 7) ≥ LLQ (5.2)	69 (61.63 to 75.39)	96 (92.36 to 98.47)	97 (91.82 to 99.10)	99 (95.21 to 99.98)	82 (74.18 to 88.44)	100 (97.20 to 100)
C human Serogroup (At Month 7) ≥ 5	69 (62.19 to 75.89)	96 (92.36 to 98.47)	97 (91.82 to 99.10)	99 (95.21 to 99.98)	82 (74.18 to 88.44)	100 (97.20 to 100)
C human Serogroup (At Month 7) ≥ 8	58 (50.62 to 65.24)	96 (92.36 to 98.47)	96 (90.69 to 98.66)	99 (95.21 to 99.98)	73 (64.43 to 80.76)	99 (95.79 to 99.98)
C human Serogroup (At Month 7) ≥ 16	38 (30.65 to 45.02)	90 (85.06 to 94.13)	91 (84.44 to 95.41)	98 (93.81 to 99.79)	55 (46.06 to 64.25)	99 (95.79 to 99.98)
C human Serogroup (At Month 7) ≥ 32	23 (16.79 to 29.27)	74 (66.54 to 79.72)	77 (68.57 to 84.18)	95 (88.90 to 98.04)	35 (26.58 to 44.08)	98 (94.55 to 99.81)
C human Serogroup (At Month 7) ≥ 64	9 (5.00 to 13.59)	53 (45.51 to 60.34)	53 (44.03 to 62.36)	86 (78.21 to 91.76)	26 (18.52 to 34.70)	96 (91.25 to 98.74)
C human Serogroup (At Month 7) ≥ 128	3 (0.88 to 6.16)	30 (23.75 to 37.44)	25 (17.96 to 34.09)	74 (64.61 to 81.49)	16 (10.22 to 23.99)	85 (78.12 to 90.97)
C human Serogroup (At Month 13) ≥ LLQ (5.2)	60 (52.25 to 66.79)	92 (87.63 to 95.80)	94 (88.54 to 97.66)	97 (92.50 to 99.45)	100 (97.05 to 100)	99 (95.79 to 99.98)
C human Serogroup (At Month 13) ≥ 5	61 (53.34 to 67.82)	92 (87.63 to 95.80)	94 (88.54 to 97.66)	98 (93.81 to 99.79)	100 (97.05 to 100)	99 (95.79 to 99.98)
C human Serogroup (At Month 13) ≥ 8	48 (41.01 to 55.81)	88 (82.55 to 92.40)	89 (82.47 to 94.20)	91 (84.46 to 95.71)	98 (94.25 to 99.80)	98 (93.40 to 99.52)
C human Serogroup (At Month 13) ≥ 16	30 (23.61 to 37.25)	78 (71.26 to 83.60)	79 (70.35 to 85.58)	83 (75.20 to 89.66)	98 (93.04 to 99.49)	94 (88.23 to 97.31)
C human Serogroup (At Month 13) ≥ 32	15 (10.24 to 21.02)	51 (43.37 to 58.22)	57 (48.10 to 66.28)	61 (51.83 to 70.37)	97 (91.88 to 99.11)	81 (72.93 to 87.15)
C human Serogroup (At Month 13) ≥ 64	9 (5.00 to 13.59)	28 (21.76 to 35.17)	25 (17.25 to 33.21)	38 (28.81 to 47.28)	93 (87.59 to 97.15)	58 (49.49 to 67.03)
C human Serogroup (At Month 13) ≥ 128	2 (0.59 to 5.41)	16 (10.76 to 21.73)	16 (10.31 to 24.18)	25 (16.98 to 33.51)	85 (76.93 to 90.44)	40 (31.51 to 48.95)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against W human serogroup for all schedules.

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End point title

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against W human serogroup for all schedules.

End point description

End point type

Secondary

End point timeframe

At Month 0, Month 2, Month 3, Month 7 and Month 13.

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	162	180	119	108	123	123
Units: Percentages of subjects
number (confidence interval 95%)
W human Serogroup (At Month 0) ≥ LLQ (39.6)	30 (23.29 to 37.95)	26 (19.86 to 33.17)	29 (21.42 to 38.46)	20 (13.23 to 29.20)	29 (21.41 to 38.15)	22 (14.99 to 30.31)
W human Serogroup (At Month 0) ≥ 5	51 (43.27 to 59.15)	43 (35.98 to 50.91)	41 (32.24 to 50.57)	42 (32.25 to 51.55)	45 (35.75 to 53.94)	45 (35.75 to 53.94)
W human Serogroup (At Month 0) ≥ 8	49 (41.45 to 57.34)	41 (33.85 to 48.67)	40 (31.45 to 49.72)	41 (31.38 to 50.62)	45 (35.75 to 53.94)	43 (34.20 to 52.32)
W human Serogroup (At Month 0) ≥ 16	44 (36.05 to 51.83)	39 (31.73 to 46.42)	39 (30.66 to 48.87)	34 (25.40 to 44.01)	41 (31.89 to 49.88)	38 (29.60 to 47.41)
W human Serogroup (At Month 0) ≥ 32	35 (27.86 to 43.07)	31 (24.43 to 38.42)	31 (22.93 to 40.23)	24 (16.37 to 33.25)	33 (25.09 to 42.40)	26 (18.52 to 34.70)
W human Serogroup (At Month 0) ≥ 64	21 (14.99 to 28.07)	19 (13.45 to 25.38)	20 (13.37 to 28.51)	13 (7.27 to 20.79)	21 (14.30 to 29.42)	12 (6.99 to 19.32)
W human Serogroup (At Month 0) ≥ 128	8 (4.34 to 13.33)	9 (5.17 to 14.03)	10 (5.32 to 16.95)	10 (5.20 to 17.49)	7 (2.85 to 12.41)	4 (1.33 to 9.23)
W human Serogroup (At Month 2) ≥ LLQ (39.6)	48 (40.24 to 56.12)	65 (57.55 to 71.95)	96 (90.47 to 98.62)	67 (56.95 to 75.45)	77 (68.81 to 84.31)	60 (50.95 to 68.88)
W human Serogroup (At Month 2) ≥ 5	66 (58.21 to 73.29)	90 (84.66 to 93.96)	99 (95.41 to 99.98)	92 (84.77 to 96.12)	93 (86.56 to 96.60)	93 (86.56 to 96.60)
W human Serogroup (At Month 2) ≥ 8	64 (56.30 to 71.57)	86 (80.18 to 90.81)	99 (95.41 to 99.98)	92 (84.77 to 96.12)	93 (86.56 to 96.60)	89 (81.64 to 93.64)
W human Serogroup (At Month 2) ≥ 16	60 (52.52 to 68.07)	82 (75.84 to 87.51)	99 (95.41 to 99.98)	81 (72.86 to 88.31)	89 (82.60 to 94.25)	80 (72.37 to 87.08)
W human Serogroup (At Month 2) ≥ 32	52 (44.49 to 60.36)	69 (62.16 to 76.08)	98 (94.06 to 99.80)	72 (62.78 to 80.41)	78 (69.69 to 85.01)	65 (55.92 to 73.42)
W human Serogroup (At Month 2) ≥ 64	44 (36.05 to 51.83)	50 (42.47 to 57.53)	84 (76.19 to 90.10)	52 (42.03 to 61.57)	67 (58.45 to 75.65)	44 (34.97 to 53.13)
W human Serogroup (At Month 2) ≥ 128	29 (22.16 to 36.65)	31 (23.92 to 37.84)	62 (52.84 to 70.91)	33 (24.55 to 43.05)	49 (39.67 to 57.95)	27 (19.24 to 35.57)
W human Serogroup (At Month 3) ≥ LLQ (39.6)	89 (83.01 to 93.28)	97 (92.89 to 98.77)	85 (77.15 to 90.78)	68 (57.91 to 76.28)	77 (68.81 to 84.31)	97 (91.88 to 99.11)
W human Serogroup (At Month 3) ≥ 5	96 (92.11 to 98.63)	99 (96.04 to 99.87)	98 (94.06 to 99.80)	94 (87.10 to 97.35)	92 (85.56 to 96.03)	100 (97.05 to 100)
W human Serogroup (At Month 3) ≥ 8	96 (92.11 to 98.63)	99 (96.04 to 99.87)	97 (92.81 to 99.48)	90 (82.51 to 94.80)	90 (83.58 to 94.86)	100 (97.05 to 100)
W human Serogroup (At Month 3) ≥ 16	96 (91.30 to 98.25)	99 (96.04 to 99.87)	96 (90.47 to 98.62)	81 (71.83 to 87.54)	86 (78.80 to 91.74)	99 (95.55 to 99.98)
W human Serogroup (At Month 3) ≥ 32	91 (85.19 to 94.72)	98 (94.41 to 99.39)	91 (84.06 to 95.29)	73 (63.76 to 81.22)	78 (69.69 to 85.01)	98 (93.04 to 99.49)
W human Serogroup (At Month 3) ≥ 64	80 (73.27 to 86.08)	93 (88.64 to 96.51)	77 (68.73 to 84.48)	50 (40.22 to 59.78)	64 (55.09 to 72.67)	91 (84.56 to 95.45)
W human Serogroup (At Month 3) ≥ 128	61 (53.15 to 68.66)	74 (66.83 to 80.14)	50 (41.11 to 59.71)	33 (24.55 to 43.05)	44 (34.97 to 53.13)	70 (61.00 to 77.86)
W human Serogroup (At Month 7) ≥ LLQ (39.6)	60 (51.90 to 67.49)	82 (75.23 to 87.03)	79 (70.57 to 85.92)	99 (94.95 to 99.98)	74 (65.30 to 81.48)	99 (95.55 to 99.98)
W human Serogroup (At Month 7) ≥ 5	71 (63.35 to 77.84)	97 (92.89 to 98.77)	96 (90.47 to 98.62)	100 (96.64 to 100)	93 (86.56 to 96.60)	100 (97.05 to 100)
W human Serogroup (At Month 7) ≥ 8	70 (62.70 to 77.28)	95 (90.72 to 97.69)	95 (89.35 to 98.13)	100 (96.64 to 100)	91 (84.56 to 95.45)	100 (97.05 to 100)
W human Serogroup (At Month 7) ≥ 16	69 (61.41 to 76.15)	92 (87.29 to 95.68)	91 (84.06 to 95.29)	100 (96.64 to 100)	87 (79.74 to 92.38)	100 (97.05 to 100)
W human Serogroup (At Month 7) ≥ 32	63 (55.03 to 70.41)	84 (78.31 to 89.41)	84 (76.19 to 90.10)	100 (96.64 to 100)	76 (67.93 to 83.61)	99 (95.55 to 99.98)
W human Serogroup (At Month 7) ≥ 64	49 (40.85 to 56.73)	68 (60.42 to 74.54)	67 (58.02 to 75.55)	97 (92.10 to 99.42)	59 (49.31 to 67.35)	98 (93.04 to 99.49)
W human Serogroup (At Month 7) ≥ 128	31 (23.85 to 38.59)	41 (33.31 to 48.11)	34 (25.98 to 43.72)	87 (79.21 to 92.73)	34 (25.84 to 43.24)	82 (74.18 to 88.44)
W human Serogroup (At Month 13) ≥ LLQ (39.6)	47 (39.04 to 54.90)	64 (56.41 to 70.90)	66 (56.28 to 74.02)	82 (73.90 to 89.06)	98 (93.04 to 99.49)	84 (76.01 to 89.78)
W human Serogroup (At Month 13) ≥ 5	62 (54.40 to 69.83)	93 (87.97 to 96.10)	90 (83.05 to 94.68)	99 (94.95 to 99.98)	99 (95.55 to 99.98)	98 (94.25 to 99.80)
W human Serogroup (At Month 13) ≥ 8	60 (52.52 to 68.07)	90 (84.66 to 93.96)	90 (83.05 to 94.68)	98 (93.47 to 99.77)	99 (95.55 to 99.98)	98 (94.25 to 99.80)
W human Serogroup (At Month 13) ≥ 16	57 (48.79 to 64.54)	84 (77.69 to 88.94)	81 (72.42 to 87.34)	94 (87.10 to 97.35)	99 (95.55 to 99.98)	96 (90.77 to 98.67)
W human Serogroup (At Month 13) ≥ 32	50 (42.05 to 57.95)	71 (63.90 to 77.61)	72 (63.32 to 80.08)	85 (77.06 to 91.29)	98 (94.25 to 99.80)	89 (82.60 to 94.25)
W human Serogroup (At Month 13) ≥ 64	35 (27.28 to 42.43)	44 (36.52 to 51.47)	48 (38.66 to 57.25)	73 (63.76 to 81.22)	98 (93.04 to 99.49)	68 (59.29 to 76.39)
W human Serogroup (At Month 13) ≥ 128	21 (14.99 to 28.07)	22 (16.38 to 29.01)	28 (19.92 to 36.68)	43 (33.13 to 52.47)	94 (88.63 to 97.68)	45 (35.75 to 53.94)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against Y human serogroup for all schedules.

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End point title

Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against Y human serogroup for all schedules.

End point description

End point type

Secondary

End point timeframe

At Month 0, Month 2, Month 3, Month 7 and Month 13.

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	188	180	120	110	127	137
Units: Percentages of subjects
number (confidence interval 95%)
Y human Serogroup (At Month 0) ≥ LLQ (14.7)	15 (10.13 to 20.80)	10 (6.04 to 15.34)	13 (7.82 to 20.75)	6 (2.60 to 12.67)	13 (7.38 to 19.65)	7 (3.05 to 12.10)
Y human Serogroup (At Month 0) ≥ 5	16 (11.03 to 21.99)	11 (6.92 to 16.64)	15 (9.14 to 22.67)	7 (3.19 to 13.83)	17 (10.54 to 24.16)	9 (4.61 to 14.80)
Y human Serogroup (At Month 0) ≥ 8	16 (11.03 to 21.99)	11 (6.92 to 16.64)	14 (8.47 to 21.71)	7 (3.19 to 13.83)	16 (9.89 to 23.27)	9 (4.61 to 14.80)
Y human Serogroup (At Month 0) ≥ 16	15 (10.13 to 20.80)	10 (6.04 to 15.34)	13 (7.17 to 19.78)	6 (2.60 to 12.67)	12 (6.76 to 18.73)	6 (2.55 to 11.18)
Y human Serogroup (At Month 0) ≥ 32	9 (5.36 to 14.08)	3 (0.91 to 6.36)	8 (4.07 to 14.79)	3 (0.57 to 7.76)	8 (3.84 to 14.00)	4 (1.62 to 9.29)
Y human Serogroup (At Month 0) ≥ 64	2 (0.58 to 5.36)	2 (0.35 to 4.79)	4 (1.37 to 9.46)	0 (0 to 3.30)	5 (1.75 to 10.00)	3 (0.80 to 7.31)
Y human Serogroup (At Month 0) ≥ 128	0 (0 to 1.94)	1 (0.01 to 3.06)	1 (0.02 to 4.56)	0 (0 to 3.30)	1 (0.02 to 4.31)	1 (0.02 to 4.00)
Y human Serogroup (At Month 2) ≥ LLQ (14.7)	21 (15.19 to 27.25)	66 (58.70 to 72.99)	85 (77.33 to 90.86)	60 (50.22 to 69.22)	72 (62.98 to 79.29)	61 (52.62 to 69.51)
Y human Serogroup (At Month 2) ≥ 5	27 (20.91 to 34.08)	72 (64.48 to 78.12)	90 (83.18 to 94.73)	65 (55.79 to 74.26)	78 (69.74 to 84.82)	65 (56.35 to 72.91)
Y human Serogroup (At Month 2) ≥ 8	26 (19.95 to 32.95)	70 (62.74 to 76.59)	89 (82.19 to 94.10)	62 (52.07 to 70.92)	76 (68.03 to 83.46)	64 (54.85 to 71.56)
Y human Serogroup (At Month 2) ≥ 16	20 (14.72 to 26.67)	64 (56.41 to 70.90)	85 (77.33 to 90.86)	58 (48.39 to 67.52)	69 (60.49 to 77.17)	60 (51.14 to 68.13)
Y human Serogroup (At Month 2) ≥ 32	13 (8.35 to 18.40)	47 (39.75 to 54.79)	75 (66.27 to 82.45)	47 (37.68 to 57.02)	54 (44.48 to 62.44)	50 (41.70 to 59.01)
Y human Serogroup (At Month 2) ≥ 64	5 (2.21 to 8.89)	31 (23.92 to 37.84)	59 (49.82 to 68.05)	30 (21.63 to 39.48)	39 (30.08 to 47.63)	39 (31.18 to 48.12)
Y human Serogroup (At Month 2) ≥ 128	1 (0.13 to 3.79)	14 (9.19 to 19.82)	39 (30.39 to 48.50)	12 (6.45 to 19.36)	23 (15.86 to 31.12)	23 (16.56 to 31.34)
Y human Serogroup (At Month 3) ≥ LLQ (14.7)	27 (20.43 to 33.52)	92 (87.29 to 95.68)	80 (71.72 to 86.75)	58 (48.39 to 67.52)	62 (53.17 to 70.65)	90 (83.45 to 94.30)
Y human Serogroup (At Month 3) ≥ 5	33 (26.31 to 40.19)	94 (89.33 to 96.91)	84 (76.38 to 90.19)	65 (54.85 to 73.43)	70 (61.32 to 77.88)	93 (86.99 to 96.44)
Y human Serogroup (At Month 3) ≥ 8	30 (23.84 to 37.43)	93 (88.64 to 96.51)	83 (75.44 to 89.51)	60 (50.22 to 69.22)	67 (58.03 to 75.02)	93 (86.99 to 96.44)
Y human Serogroup (At Month 3) ≥ 16	26 (19.95 to 32.95)	92 (86.63 to 95.26)	79 (70.80 to 86.04)	57 (47.48 to 66.66)	59 (49.98 to 67.70)	90 (83.45 to 94.30)
Y human Serogroup (At Month 3) ≥ 32	18 (12.86 to 24.34)	84 (77.69 to 88.94)	68 (58.35 to 75.77)	44 (34.20 to 53.42)	44 (35.30 to 53.17)	83 (75.88 to 89.05)
Y human Serogroup (At Month 3) ≥ 64	9 (4.94 to 13.45)	68 (61.00 to 75.05)	47 (37.51 to 55.99)	24 (16.06 to 32.68)	31 (23.55 to 40.33)	65 (56.35 to 72.91)
Y human Serogroup (At Month 3) ≥ 128	2 (0.58 to 5.36)	39 (32.25 to 46.99)	28 (19.75 to 36.40)	16 (10.00 to 24.62)	23 (15.86 to 31.12)	47 (38.15 to 55.43)
Y human Serogroup (At Month 7) ≥ LLQ (14.7)	23 (17.07 to 29.55)	78 (70.99 to 83.62)	72 (62.72 to 79.51)	95 (88.51 to 97.97)	54 (44.48 to 62.44)	97 (92.69 to 99.20)
Y human Serogroup (At Month 7) ≥ 5	26 (19.95 to 32.95)	86 (79.56 to 90.34)	80 (71.72 to 86.75)	95 (89.71 to 98.51)	69 (59.67 to 76.45)	99 (94.83 to 99.82)
Y human Serogroup (At Month 7) ≥ 8	26 (19.46 to 32.39)	84 (77.69 to 88.94)	77 (68.07 to 83.90)	95 (89.71 to 98.51)	64 (54.78 to 72.12)	98 (93.73 to 99.55)
Y human Serogroup (At Month 7) ≥ 16	22 (16.13 to 28.40)	74 (66.83 to 80.14)	69 (60.09 to 77.27)	94 (87.33 to 97.40)	52 (42.93 to 60.91)	97 (92.69 to 99.20)
Y human Serogroup (At Month 7) ≥ 32	13 (8.35 to 18.40)	63 (55.27 to 69.85)	54 (44.83 to 63.29)	87 (79.57 to 92.86)	40 (31.56 to 49.22)	91 (85.20 to 95.39)
Y human Serogroup (At Month 7) ≥ 64	3 (0.87 to 6.10)	37 (30.15 to 44.73)	35 (26.52 to 44.24)	79 (70.30 to 86.26)	27 (19.31 to 35.35)	75 (67.08 to 82.16)
Y human Serogroup (At Month 7) ≥ 128	1 (0.01 to 2.93)	14 (9.66 to 20.44)	22 (14.67 to 30.11)	57 (47.48 to 66.66)	13 (8.00 to 20.56)	57 (48.20 to 65.36)
Y human Serogroup (At Month 13) ≥ LLQ (14.7)	19 (13.32 to 24.93)	64 (56.41 to 70.90)	58 (48.15 to 66.47)	78 (69.30 to 85.49)	97 (92.13 to 99.14)	82 (75.06 to 88.44)
Y human Serogroup (At Month 13) ≥ 5	25 (18.98 to 31.82)	76 (68.61 to 81.64)	73 (64.49 to 80.99)	91 (83.92 to 95.55)	97 (92.13 to 99.14)	91 (85.20 to 95.39)
Y human Serogroup (At Month 13) ≥ 8	24 (18.03 to 30.69)	71 (63.90 to 77.61)	63 (54.05 to 71.94)	84 (75.38 to 90.00)	97 (92.13 to 99.14)	87 (80.03 to 92.02)
Y human Serogroup (At Month 13) ≥ 16	18 (12.40 to 23.76)	61 (53.58 to 68.27)	55 (45.65 to 64.09)	76 (67.32 to 83.94)	97 (92.13 to 99.14)	81 (73.44 to 87.21)
Y human Serogroup (At Month 13) ≥ 32	10 (5.77 to 14.71)	43 (35.45 to 50.35)	40 (31.17 to 49.34)	60 (50.22 to 69.22)	93 (86.97 to 96.71)	69 (60.13 to 76.27)
Y human Serogroup (At Month 13) ≥ 64	3 (1.18 to 6.82)	21 (15.39 to 27.81)	23 (15.38 to 31.02)	41 (31.63 to 50.69)	92 (86.00 to 96.16)	46 (37.44 to 54.70)
Y human Serogroup (At Month 13) ≥ 128	1 (0.13 to 3.79)	9 (5.17 to 14.03)	11 (5.90 to 17.81)	21 (13.74 to 29.70)	73 (64.65 to 80.69)	28 (21.09 to 36.80)

No statistical analyses for this end point

Secondary: Percentages of subjects with two-, three- and four-fold titer rise against serogroups A, C, W and Y and serogroup B test Strains for all schedules.

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End point title

Percentages of subjects with two-, three- and four-fold titer rise against serogroups A, C, W and Y and serogroup B test Strains for all schedules.

End point description

The kinetic of immune response (at Months 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with two-, three- and four-fold titer rise against serogroups A, C, W and Y and serogroup B test strains was assessed. The two/three/four fold titer rise is defined as: a) for subjects with prevaccination hSBA titers ≤ LLQ, a postvaccination hSBA ≥ 2/3/4 LLQ; b) for subjects with a prevaccination hSBA titers ≥ LLQ, an increase of at least 2/3/4 times of the prevaccination hSBA titer.

End point type

Secondary

End point timeframe

At Month 2, Month 3, Month 7 and Month 13

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	188	185	122	114	128	137
Units: Percentages of subjects
number (confidence interval 95%)
NZ98/254≥2-fold(M-2) N-188,185,122,114,128,137	18 (12.86 to 24.34)	13 (8.49 to 18.69)	28 (19.75 to 36.40)	9 (4.36 to 15.81)	21 (14.62 to 29.62)	12 (6.98 to 18.67)
NZ98/254≥3-fold(M-2)N-188,185,122,114,128,137	14 (9.24 to 19.60)	9 (5.44 to 14.30)	19 (12.56 to 27.36)	9 (4.36 to 15.81)	17 (11.28 to 25.23)	7 (3.64 to 13.30)
NZ98/254≥4-fold(M-2)N-188,185,122,114,128,137	11 (7.05 to 16.57)	8 (4.61 to 13.02)	17 (10.49 to 24.56)	7 (3.13 to 13.59)	17 (10.62 to 24.34)	7 (3.12 to 12.37)
NZ98/254≥2-fold(M-3)N-188,185,122,114,128,137	73 (66.48 to 79.57)	42 (34.43 to 49.08)	18 (11.17 to 25.50)	9 (4.36 to 15.81)	13 (8.06 to 20.72)	43 (34.76 to 52.11)
NZ98/254≥3-fold (M-3)N-188,185,122,114,128,137	61 (53.81 to 68.18)	32 (25.25 to 39.13)	13 (7.17 to 19.78)	5 (1.99 to 11.30)	10 (5.61 to 17.00)	28 (20.91 to 36.79)
NZ98/254≥4-fold (M-3)N-188,185,122,114,128,137	47 (39.51 to 54.21)	22 (15.92 to 28.26)	9 (4.67 to 15.81)	4 (0.98 to 8.89)	9 (4.44 to 15.08)	19 (12.45 to 26.30)
NZ98/254≥2-fold (M-7)N-188,185,122,114,128,137	19 (13.32 to 24.93)	12 (8.05 to 18.07)	11 (5.90 to 17.81)	45 (35.24 to 54.33)	7 (3.32 to 13.13)	54 (44.92 to 62.38)
NZ98/254≥3-fold (M-7)N-188,185,122,114,128,137	11 (7.05 to 16.57)	10 (6.30 to 15.57)	7 (2.92 to 12.71)	33 (24.44 to 42.56)	6 (2.78 to 12.13)	43 (34.76 to 52.11)
NZ98/254≥4-fold (M-7)N-188,185,122,114,128,137	9 (5.36 to 14.08)	8 (4.61 to 13.02)	6 (2.38 to 11.65)	24 (16.53 to 33.10)	4 (1.30 to 9.02)	33 (24.97 to 41.47)
NZ98/254≥2-fold (M-13)N-188,185,122,114,128,137	11 (6.62 to 15.95)	9 (5.44 to 14.30)	7 (2.92 to 12.71)	10 (5.01 to 16.89)	49 (40.19 to 58.26)	14 (8.76 to 21.25)
NZ98/254≥3-fold (M-13)N-188,185,122,114,128,137	5 (2.58 to 9.56)	7 (3.79 to 11.72)	6 (2.38 to 11.65)	9 (4.36 to 15.81)	37 (28.12 to 45.55)	7 (3.64 to 13.30)
NZ98/254≥4-fold (M-13)N-188,185,122,114,128,137	4 (1.85 to 8.21)	5 (2.62 to 9.72)	5 (1.86 to 10.57)	6 (2.55 to 12.45)	26 (18.76 to 34.77)	4 (1.66 to 9.49)
M14459≥2-fold (M-2)N-184,179,112,108,123,137	14 (9.44 to 20.02)	13 (8.32 to 18.65)	34 (25.25 to 43.48)	8 (3.88 to 15.23)	23 (15.69 to 31.19)	11 (6.40 to 17.79)
M14459≥3-fold (M-2)N-184,179,112,108,123,137	10 (5.90 to 15.02)	10 (6.07 to 15.43)	23 (15.76 to 32.14)	6 (2.07 to 11.70)	15 (9.56 to 23.07)	6 (2.61 to 11.42)
M14459≥4-fold (M-2)N-184,179,112,108,123,137	7 (3.82 to 11.78)	6 (2.71 to 10.03)	15 (9.10 to 23.19)	4 (1.02 to 9.21)	12 (6.99 to 19.32)	4 (1.22 to 8.49)
M14459≥2-fold (M-3)N-184,179,112,108,123,137	65 (57.86 to 72.07)	50 (42.72 to 57.82)	24 (16.53 to 33.10)	6 (2.65 to 12.90)	14 (8.26 to 21.20)	50 (41.25 to 58.75)
M14459≥3-fold (M-3)N-184,179,112,108,123,137	49 (41.49 to 56.37)	39 (31.38 to 46.10)	10 (5.01 to 16.89)	3 (0.58 to 7.90)	11 (5.75 to 17.40)	39 (30.52 to 47.60)
M14459≥4-fold (M-3)N-184,179,112,108,123,137	38 (30.49 to 44.92)	28 (22.01 to 35.70)	4 (1.47 to 10.11)	3 (0.58 to 7.90)	7 (3.40 to 13.44)	28 (20.24 to 36.00)
M14459≥2-fold (M-7)N-184,179,112,108,123,137	16 (11.28 to 22.45)	14 (9.25 to 19.92)	9 (4.36 to 15.81)	69 (58.88 to 77.12)	7 (2.85 to 12.41)	72 (63.21 to 79.09)
M14459≥3-fold (M-7)N-184,179,112,108,123,137	12 (7.65 to 17.54)	7 (3.92 to 12.10)	6 (2.55 to 12.45)	55 (44.76 to 64.24)	6 (2.32 to 11.37)	54 (45.65 to 63.10)
M14459≥4-fold (M-7)N-184,179,112,108,123,137	8 (4.22 to 12.44)	6 (3.11 to 10.73)	4 (0.98 to 8.89)	48 (38.43 to 57.97)	5 (1.81 to 10.32)	49 (39.79 to 57.29)
M14459≥2-fold(M-13)N-184,179,112,108,123,137	11 (7.21 to 16.92)	9 (5.63 to 14.77)	6 (2.55 to 12.45)	10 (5.20 to 17.49)	74 (65.30 to 81.48)	12 (6.98 to 18.67)
M14459≥3-fold (M-13)N-184,179,112,108,123,137	8 (4.22 to 12.44)	4 (1.95 to 8.62)	4 (1.47 to 10.11)	7 (3.25 to 14.07)	59 (50.12 to 68.11)	6 (2.61 to 11.42)
M14459≥4-fold (M-13)N-184,179,112,108,123,137	3 (1.21 to 6.96)	4 (1.59 to 7.89)	3 (0.56 to 7.63)	6 (2.07 to 11.70)	51 (42.05 to 60.33)	4 (1.66 to 9.49)
M07-0241084≥2-fold (M-2)N-188,176,117,113,121,128	16 (11.49 to 22.58)	11 (6.63 to 16.34)	20 (12.89 to 28.02)	5 (1.97 to 11.20)	19 (12.45 to 27.14)	8 (3.81 to 13.90)
M07-0241084≥3-fold (M-2)N-188,176,117,113,121,128	12 (7.92 to 17.79)	7 (3.57 to 11.61)	9 (4.79 to 16.20)	2 (0.22 to 6.25)	12 (6.47 to 18.65)	4 (1.28 to 8.88)
M07-0241084≥4-fold (M-2)N-188,176,117,113,121,128	8 (4.53 to 12.82)	5 (1.98 to 8.76)	7 (3.00 to 13.03)	2 (0.22 to 6.25)	9 (4.63 to 15.68)	1 (0.02 to 4.28)
M07-0241084≥2-fold (M-3)N-188,176,117,113,121,128	37 (29.81 to 44.02)	22 (16.26 to 29.02)	11 (6.05 to 18.25)	2 (0.22 to 6.25)	8 (4.03 to 14.67)	21 (14.38 to 29.19)
M07-0241084≥3-fold (M-3)N-188,176,117,113,121,128	28 (21.40 to 34.64)	12 (7.54 to 17.66)	7 (3.00 to 13.03)	1 (0.02 to 4.83)	5 (1.84 to 10.48)	17 (11.10 to 24.86)
M07-0241084≥4-fold (M-3)N-188,176,117,113,121,128	19 (13.32 to 24.93)	9 (5.29 to 14.34)	4 (1.40 to 9.69)	0 (0 to 3.21)	4 (1.36 to 9.38)	13 (7.93 to 20.41)
M07-0241084≥2-fold (M-7)N-188,176,117,113,121,128	19 (13.32 to 24.93)	13 (8.00 to 18.31)	8 (3.58 to 14.10)	43 (34.07 to 53.01)	4 (1.36 to 9.38)	42 (33.51 to 51.23)
M07-0241084≥3-fold (M-7)N-188,176,117,113,121,128	11 (7.05 to 16.57)	7 (3.99 to 12.30)	6 (2.44 to 11.94)	31 (22.61 to 40.36)	1 (0.02 to 4.52)	32 (24.06 to 40.85)
M07-0241084≥4-fold (M-7)N-188,176,117,113,121,128	7 (4.13 to 12.18)	6 (2.76 to 10.20)	3 (0.94 to 8.52)	19 (12.62 to 27.98)	1 (0.02 to 4.52)	22 (15.05 to 30.04)
M07-0241084≥2-fold (M-13)N-188,176,117,113,121,128	13 (8.35 to 18.40)	11 (7.08 to 17.00)	8 (3.58 to 14.10)	13 (7.62 to 20.95)	41 (32.45 to 50.63)	15 (9.18 to 22.21)
M07-0241084≥3-fold (M-13)N-188,176,117,113,121,128	9 (4.94 to 13.45)	7 (3.99 to 12.30)	5 (1.90 to 10.83)	9 (4.33 to 15.67)	34 (25.53 to 43.05)	10 (5.52 to 16.74)
M07-0241084≥4-fold (M-13)N-188,176,117,113,121,128	5 (2.58 to 9.56)	6 (2.76 to 10.20)	4 (1.40 to 9.69)	6 (2.53 to 12.35)	21 (13.84 to 28.97)	6 (2.74 to 11.94)
96217≥ 2-fold (M-2)(N-186,178,120,112,128,121)	34 (27.61 to 41.71)	29 (22.65 to 36.48)	88 (81.20 to 93.47)	32 (23.63 to 41.63)	31 (23.35 to 40.04)	26 (18.84 to 35.24)
96217≥ 3-fold (M-2)(N-186,178,120,112,128,121)	26 (19.68 to 32.72)	20 (14.09 to 26.27)	81 (72.64 to 87.44)	19 (12.00 to 27.22)	18 (11.74 to 25.73)	19 (12.45 to 27.14)
96217≥ 4-fold (M-2)(N-186,178,120,112,128,121)	18 (12.54 to 24.00)	13 (8.37 to 18.76)	76 (67.17 to 83.18)	12 (6.33 to 19.03)	14 (8.55 to 21.31)	16 (9.73 to 23.43)
96217≥ 2-fold (M-3)(N-186,178,120,112,128,121)	97 (93.84 to 99.12)	92 (87.16 to 95.63)	85 (77.33 to 90.86)	28 (19.64 to 36.93)	23 (16.41 to 31.74)	91 (84.32 to 95.37)
96217≥ 3-fold (M-3)(N-186,178,120,112,128,121)	96 (92.40 to 98.47)	89 (83.18 to 93.00)	76 (67.17 to 83.18)	14 (8.39 to 22.16)	17 (11.10 to 24.86)	88 (81.35 to 93.53)
96217≥ 4-fold (M-3)(N-186,178,120,112,128,121)	94 (89.66 to 97.01)	83 (76.20 to 87.85)	69 (60.09 to 77.27)	11 (5.66 to 17.97)	13 (7.93 to 20.41)	83 (75.63 to 89.60)
96217≥ 2-fold (M-7)(N-186,178,120,112,128,121)	81 (74.81 to 86.53)	74 (66.48 to 79.91)	64 (54.90 to 72.71)	96 (91.11 to 99.02)	16 (10.45 to 23.98)	97 (91.75 to 99.09)
96217≥ 3-fold (M-7)(N-186,178,120,112,128,121)	73 (65.57 to 78.85)	63 (55.38 to 70.03)	52 (42.37 to 60.88)	96 (91.11 to 99.02)	9 (4.94 to 15.80)	96 (90.62 to 98.64)
96217≥ 4-fold (M-7)(N-186,178,120,112,128,121)	61 (53.89 to 68.33)	50 (42.43 to 57.57)	42 (32.74 to 51.02)	95 (88.70 to 98.01)	7 (3.27 to 12.93)	94 (88.44 to 97.64)
96217≥ 2-fold (M-13)(N-186,178,120,112,128,121)	65 (57.73 to 71.88)	54 (46.32 to 61.42)	52 (42.37 to 60.88)	72 (63.07 to 80.36)	96 (91.12 to 98.72)	77 (68.32 to 84.04)
96217≥ 3-fold (M-13)(N-186,178,120,112,128,121)	53 (45.78 to 60.56)	39 (32.10 to 46.91)	34 (25.76 to 43.38)	54 (44.78 to 63.90)	95 (89.06 to 97.77)	62 (52.71 to 70.65)
96217 ≥ 4-fold (M-13)(N-186,178,120,112,128,121)	35 (28.62 to 42.82)	22 (16.57 to 29.32)	28 (19.75 to 36.40)	45 (35.24 to 54.33)	93 (87.07 to 96.73)	51 (41.99 to 60.43)
A Serogroup≥2-fold(M-2)N-172,178,107,105,120,127	12 (7.72 to 18.06)	23 (17.07 to 29.92)	78 (68.49 to 85.07)	21 (13.62 to 29.99)	38 (28.83 to 46.80)	17 (10.54 to 24.16)
A Serogroup≥3-fold(M-2)N-172,178,107,105,120,127	9 (5.41 to 14.67)	16 (11.19 to 22.55)	64 (53.69 to 72.64)	14 (8.22 to 22.47)	30 (21.98 to 39.04)	13 (7.38 to 19.65)
A Serogroup≥4-fold(M-2)N-172,178,107,105,120,127	6 (2.82 to 10.43)	11 (6.55 to 16.17)	50 (39.72 to 59.37)	11 (6.05 to 19.11)	20 (13.25 to 28.28)	7 (3.29 to 13.03)
A Serogroup≥2-fold(M-3)N-172,178,107,105,120,127	80 (72.85 to 85.40)	71 (63.52 to 77.35)	61 (50.84 to 70.05)	20 (12.83 to 28.93)	24 (16.82 to 32.83)	74 (65.49 to 81.39)
A Serogroup≥3-fold (M-3)N-172,178,107,105,120,127	66 (58.09 to 72.76)	52 (44.64 to 59.77)	41 (31.70 to 51.05)	12 (6.76 to 20.24)	18 (11.86 to 26.43)	56 (46.83 to 64.70)
A Serogroup≥4-fold (M-3)N-172,178,107,105,120,127	56 (48.64 to 63.93)	42 (34.79 to 49.75)	31 (22.27 to 40.50)	7 (2.72 to 13.25)	14 (8.47 to 21.71)	40 (31.56 to 49.22)
A Serogroup≥2-fold (M-7)N-172,178,107,105,120,127	27 (20.82 to 34.63)	28 (21.11 to 34.71)	25 (17.33 to 34.55)	87 (78.64 to 92.51)	8 (3.49 to 13.76)	88 (81.27 to 93.24)
A Serogroup≥3-fold (M-7)N-172,178,107,105,120,127	17 (11.59 to 23.31)	16 (11.19 to 22.55)	16 (9.54 to 24.21)	76 (66.89 to 83.96)	6 (2.38 to 11.65)	77 (68.88 to 84.14)
A Serogroup≥4-fold (M-7)N-172,178,107,105,120,127	11 (6.78 to 16.71)	10 (5.66 to 14.85)	13 (7.34 to 20.98)	70 (60.78 to 78.98)	5 (1.86 to 10.57)	70 (61.32 to 77.88)
A Serogroup≥2-fold(M-13)N-172,178,107,105,120,127	16 (10.61 to 22.01)	12 (7.91 to 18.11)	18 (11.04 to 26.33)	31 (22.72 to 41.22)	85 (77.33 to 90.86)	28 (20.71 to 37.02)
A Serogroup≥3-fold (M-13)N-172,178,107,105,120,127	9 (5.41 to 14.67)	8 (4.37 to 12.84)	11 (5.93 to 18.77)	25 (16.86 to 34.14)	80 (71.72 to 86.75)	15 (9.25 to 22.37)
A Serogroup≥4-fold (M-13)N-172,178,107,105,120,127	5 (2.42 to 9.70)	4 (1.60 to 7.93)	9 (4.57 to 16.52)	15 (8.97 to 23.56)	78 (68.98 to 84.62)	7 (3.29 to 13.03)
C Serogroup≥2-fold(M-2)N-186,185,122,114,123,130	24 (18.23 to 31.00)	64 (56.41 to 70.71)	95 (89.60 to 98.17)	55 (45.66 to 64.58)	73 (64.43 to 80.76)	62 (52.61 to 69.93)
C Serogroup≥3-fold (M-2)N-186,185,122,114,123,130	15 (10.24 to 21.02)	50 (42.84 to 57.69)	91 (84.44 to 95.41)	48 (38.79 to 57.80)	59 (49.31 to 67.35)	54 (44.89 to 62.62)
C Serogroup≥4-fold (M-2)N-186,185,122,114,123,130	9 (5.00 to 13.59)	42 (34.43 to 49.08)	88 (80.53 to 92.95)	44 (34.58 to 53.46)	50 (40.46 to 58.75)	42 (32.97 to 50.51)
C Serogroup≥2-fold (M-3)N-186,185,122,114,123,130	80 (73.05 to 85.12)	94 (89.61 to 96.99)	93 (86.46 to 96.57)	58 (48.29 to 67.08)	65 (55.92 to 73.42)	98 (93.40 to 99.52)
C Serogroup≥3-fold (M-3)N-186,185,122,114,123,130	64 (56.63 to 70.87)	90 (85.06 to 94.13)	90 (83.45 to 94.81)	47 (37.94 to 56.94)	50 (40.46 to 58.75)	96 (91.25 to 98.74)
C Serogroup≥4-fold (M-3)N-186,185,122,114,123,130	49 (41.54 to 56.34)	87 (81.31 to 91.51)	83 (74.90 to 89.02)	41 (32.09 to 50.83)	42 (33.42 to 51.51)	92 (85.36 to 95.70)
C Serogroup≥2-fold (M-7)N-186,185,122,114,123,130	29 (22.62 to 36.12)	86 (80.70 to 91.06)	89 (81.50 to 93.58)	97 (92.50 to 99.45)	50 (40.46 to 58.75)	98 (94.55 to 99.81)
C Serogroup≥3-fold (M-7)N-186,185,122,114,123,130	16 (10.70 to 21.62)	80 (73.50 to 85.51)	79 (70.35 to 85.58)	94 (87.76 to 97.50)	37 (28.09 to 45.75)	98 (94.55 to 99.81)
C Serogroup≥4-fold (M-7)N-186,185,122,114,123,130	10 (6.26 to 15.49)	71 (64.26 to 77.75)	72 (63.29 to 79.87)	92 (85.54 to 96.33)	28 (19.96 to 36.43)	98 (93.40 to 99.52)
C Serogroup≥2-fold (M-13)N-186,185,122,114,123,130	19 (13.94 to 25.77)	73 (65.97 to 79.23)	74 (65.04 to 81.32)	82 (73.23 to 88.22)	97 (91.88 to 99.11)	92 (86.31 to 96.25)
C Serogroup≥3-fold (M-13)N-186,185,122,114,123,130	13 (8.89 to 19.20)	64 (56.41 to 70.71)	61 (52.24 to 70.14)	70 (60.89 to 78.38)	96 (90.77 to 98.67)	89 (82.59 to 93.99)
C Serogroup≥4-fold (M-13)N-186,185,122,114,123,130	10 (5.84 to 14.86)	51 (43.91 to 58.75)	53 (44.03 to 62.36)	56 (46.54 to 65.42)	93 (87.59 to 97.15)	85 (77.24 to 90.34)
W Serogroup≥2-fold (M-2)N-162,180,119,108,123,123	24 (17.71 to 31.41)	32 (24.95 to 39.00)	65 (55.42 to 73.24)	35 (26.24 to 44.96)	50 (41.25 to 59.54)	33 (25.09 to 42.40)
W Serogroup≥3-fold (M-2)N-162,180,119,108,123,123	17 (11.28 to 23.31)	19 (13.93 to 25.99)	52 (42.75 to 61.34)	25 (17.17 to 34.25)	40 (31.12 to 49.05)	22 (14.99 to 30.31)
W Serogroup≥4-fold (M-2)N-162,180,119,108,123,123	11 (6.72 to 16.99)	16 (11.06 to 22.31)	42 (33.03 to 51.41)	18 (10.94 to 26.10)	34 (25.84 to 43.24)	18 (11.56 to 25.82)
W Serogroup≥2-fold (M-3)N-162,180,119,108,123,123	67 (59.48 to 74.44)	78 (71.59 to 84.12)	55 (46.07 to 64.57)	34 (25.40 to 44.01)	46 (37.31 to 55.56)	76 (67.93 to 83.61)
W Serogroup≥3-fold (M-3)N-162,180,119,108,123,123	54 (46.32 to 62.16)	65 (57.55 to 71.95)	39 (29.87 to 48.02)	23 (15.57 to 32.25)	34 (25.84 to 43.24)	67 (58.45 to 75.65)
W Serogroup≥4-fold (M-3)N-162,180,119,108,123,123	43 (34.87 to 50.59)	57 (49.09 to 64.02)	30 (22.17 to 39.35)	19 (12.46 to 28.17)	28 (20.69 to 37.29)	56 (46.87 to 65.03)
W Serogroup≥2-fold (M-7)N-162,180,119,108,123,123	31 (24.42 to 39.23)	51 (43.57 to 58.62)	43 (33.83 to 52.25)	90 (82.51 to 94.80)	41 (31.89 to 49.88)	89 (81.64 to 93.64)
W Serogroup≥3-fold (M-7)N-162,180,119,108,123,123	22 (15.53 to 28.74)	30 (23.41 to 37.26)	29 (20.67 to 37.57)	81 (71.83 to 87.54)	28 (19.96 to 36.43)	80 (72.37 to 87.08)
W Serogroup≥4-fold (M-7)N-162,180,119,108,123,123	13 (8.21 to 19.13)	21 (14.91 to 27.20)	17 (10.58 to 24.76)	73 (63.76 to 81.22)	20 (13.61 to 28.52)	73 (64.43 to 80.76)
W Serogroup≥2-fold (M-13)N-162,180,119,108,123,123	20 (13.92 to 26.73)	26 (19.36 to 32.58)	32 (23.69 to 41.10)	56 (46.60 to 66.00)	94 (88.63 to 97.68)	61 (51.77 to 69.64)
W Serogroup≥3-fold (M-13)N-162,180,119,108,123,123	9 (4.81 to 14.07)	13 (8.28 to 18.55)	17 (10.58 to 24.76)	38 (28.80 to 47.81)	92 (85.56 to 96.03)	46 (36.53 to 54.75)
W Serogroup≥4-fold (M-13)N-162,180,119,108,123,123	7 (3.44 to 11.82)	11 (6.48 to 15.99)	13 (7.88 to 20.91)	27 (18.78 to 36.24)	89 (82.60 to 94.25)	29 (21.41 to 38.15)
Y Serogroup≥2-fold (M-2) N-188,180,120,110,127,137	6 (2.96 to 10.23)	49 (41.38 to 56.43)	74 (65.38 to 81.72)	47 (37.68 to 57.02)	53 (43.70 to 61.68)	51 (42.42 to 59.73)
Y Serogroup≥3-fold (M-2)N-188,180,120,110,127,137	4 (1.51 to 7.52)	39 (32.25 to 46.99)	64 (54.90 to 72.71)	40 (30.78 to 49.78)	41 (32.30 to 50.02)	43 (34.64 to 51.80)
Y Serogroup≥4-fold (M-2)N-188,180,120,110,127,137	2 (0.58 to 5.36)	32 (25.46 to 39.58)	58 (48.15 to 66.47)	33 (24.08 to 42.33)	36 (27.88 to 45.22)	37 (29.13 to 45.89)
Y Serogroup≥2-fold (M-3)N-188,180,120,110,127,137	10 (5.77 to 14.71)	84 (78.31 to 89.41)	66 (56.62 to 74.24)	45 (35.93 to 55.23)	46 (36.81 to 54.74)	83 (75.88 to 89.05)
Y Serogroup≥3-fold (M-3)N-188,180,120,110,127,137	7 (3.73 to 11.53)	80 (73.40 to 85.58)	55 (45.65 to 64.09)	35 (25.74 to 44.21)	35 (26.43 to 43.60)	75 (67.08 to 82.16)
Y Serogroup≥4-fold (M-3)N-188,180,120,110,127,137	4 (1.85 to 8.21)	68 (61.00 to 75.05)	48 (39.12 to 57.63)	29 (20.82 to 38.52)	31 (23.55 to 40.33)	66 (57.86 to 74.26)
Y Serogroup≥2-fold (M-7)N-188,180,120,110,127,137	5 (2.21 to 8.89)	60 (52.45 to 67.22)	51 (41.55 to 60.07)	90 (82.81 to 94.90)	39 (30.08 to 47.63)	92 (86.09 to 95.92)
Y Serogroup≥3-fold (M-7)N-188,180,120,110,127,137	3 (1.18 to 6.82)	48 (40.29 to 55.34)	44 (35.11 to 53.52)	83 (74.35 to 89.27)	28 (20.71 to 37.02)	87 (80.03 to 92.02)
Y Serogroup≥4-fold (M-7)N-188,180,120,110,127,137	3 (0.87 to 6.10)	41 (33.31 to 48.11)	38 (29.61 to 47.65)	79 (70.30 to 86.26)	23 (15.86 to 31.12)	76 (67.87 to 82.80)
Y Serogroup≥2-fold (M-13)N-188,180,120,110,127,137	5 (2.21 to 8.89)	43 (35.45 to 50.35)	38 (29.61 to 47.65)	60 (50.22 to 69.22)	94 (88.97 to 97.76)	72 (63.20 to 78.91)
Y Serogroup≥3-fold (M-13)N-188,180,120,110,127,137	3 (1.18 to 6.82)	34 (27.01 to 41.30)	28 (20.49 to 37.28)	48 (38.55 to 57.91)	91 (84.08 to 95.02)	54 (45.30 to 62.56)
Y Serogroup≥4-fold (M-13)N-188,180,120,110,127,137	2 (0.58 to 5.36)	25 (18.86 to 31.99)	23 (16.10 to 31.93)	45 (35.93 to 55.23)	89 (82.20 to 93.84)	47 (38.15 to 55.43)

No statistical analyses for this end point

Secondary: The area under the curve (AUC) for percentage of subjects with hSBA titers ≥LLQ for all serogroups and strains.

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End point title

The area under the curve (AUC) for percentage of subjects with hSBA titers ≥LLQ for all serogroups and strains.

End point description

The area under the curve for percentage of subjects with hSBA titers ≥ LLQ for all serogroups (A, C, W and Y) and for all serogroup B test strains (M14459, 96217, NZ98/254 and M07-0241084) was summarized overall (from Month 0 to Month 13) and by period (from Month 0 to Month 2, Month 2 to Month 3, Month 3 to Month 7 and Month 7 to Month 13) by vaccine groups. It was computed as the sum of the trapezoidal areas and the time unit used was the month. AUC 0_13 = (r0+r2)(2-0)/2 + (r2+r3)(3-2)/2 + (r3+r7)(7-3)/2 + (r7+r13)(13-7)/2 with ri = percentages of subjects with both hSBA titers >= LLQ against N. meningitis for all serogroups A, C, W and Y and for all serogroup B test strains at Month 1. The LLQ for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively. The LLQ for strains M14459,96217,NZ98/254 and M07-0241084 were 8.0,8.6,8.2 and 8.9 respectively.

End point type

Secondary

End point timeframe

From Month 0 to Month 13

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	200	196	131	118	132	140
Units: Area Under Curve
number (not applicable)
Serogroup A(M- 0-2)N-191,189,129,113,126,140	26.52	38.01	98.62	38.05	57.12	27.86
Serogroup A(M-2-3)N-197,193,125,118,130,135	57.69	60.98	86.91	33.40	47.00	59.13
Serogroup A(M-3-7)N-191,194,124,118,127,136	292.53	264.81	243.86	252.54	119.41	370.46
Serogroup A(M-7-13)N-194,191,127,113,132,136	256.04	214.62	217.88	446.58	343.24	436.76
M14459(M-0-2)N-196,194,127,113,130,140	35.10	27.81	67.02	21.09	40.10	18.57
M14459(M-2-3)N-198,193,127,117,129,139	55.45	46.06	52.36	16.53	30.88	44.90
M14459(M-3-7)N-197,192,129,117,132,140	228.61	196.15	117.62	206.84	84.60	325.33
M14459(M-7-13)N-197,188,125,115,132,135	162.94	141.79	82.51	329.36	309.09	347.86
96217(M-0-2)N-197,190,130,117,130,134	93.52	91.00	124.70	88.27	83.08	79.10
96217(M2-3)N-197,192,130,117,132,134	85.03	80.02	95.77	58.55	52.33	74.25
96217(M-3-7)N-199,193,131,116,132,139	388.93	373.02	361.75	307.65	172.73	392.59
96217(M-7-13)N-200,191,127,117,132,139	545.92	515.49	495.00	561.47	411.36	578.42
NZ98/254(M-0-2)N-198,194,129,116,131,139	30.27	25.84	48.92	22.37	31.33	20.13
NZ98/254(M-2-3)N-198,194,129,117,131,137	55.56	40.77	37.21	15.89	24.05	42.93
NZ98/254(M-3-7)N-196,194,130,116,132,140	227.81	162.89	92.78	156.65	65.46	282.91
NZ98/254(M-7-13)N-200,193,129,117,130,138	142.59	105.40	90.34	242.66	257.90	277.24
M07-0241084(M-0-2)N-196,191,127,117,130,140	57.74	43.20	53.67	42.74	58.93	47.53
M07-0241084(M-2-3)N-198,189,129,116,128,137	52.46	37.16	34.01	28.33	34.47	41.65
M07-0241084(M-3-7)N-197,193,129,118,132,137	213.53	151.20	111.63	190.79	110.94	251.09
M07-0241084(M-7-13)N-198,190,130,116,130,136	217.26	159.73	145.97	301.71	282.69	320.48
Serogroup C(M-0-2)N-198,193,129,118,131,140	102.82	129.30	148.03	126.63	135.79	128.34
Serogroup C(M-2-3)N-197,194,129,117,132,136	78.78	91.97	99.22	82.97	88.21	92.85
Serogroup C(M-3-7)N-199,196,131,118,131,138	331.60	390.80	390.79	360.70	339.12	398.53
Serogroup C(M-7-13)N-196,192,130,116,130,139	382.55	567.41	574.69	589.70	545.04	595.68
Serogroup W(M-0-2)N-199,195,130,116,131,138	75.66	93.12	124.89	85.71	103.94	84.23
Serogroup W(M-2-3)N-186,190,129,114,131,137	68.51	81.75	90.33	65.66	75.19	78.97
Serogroup W(M-3-7)N-195,195,131,118,131,129	293.42	359.84	327.79	331.64	297.71	392.61
Serogroup W(M-7-13)N-194,192,130,117,130,139	305.31	444.54	434.34	543.61	512.92	550.19
Serogroup Y(M-0-2)N-199,193,129,115,131,139	36.25	76.31	99.44	67.83	84.92	67.58
Serogroup Y(M-2-3)N-197,195,128,116,132,138	24.51	79.32	83.26	58.88	67.70	75.50
Serogroup Y(M-3-7)N-199,194,131,118,132,139	100.05	339.26	339.26	303.62	234.85	373.95
Serogroup Y(M-7-13)N-199,191,129,117,131,139	125.13	425.13	389.69	520.64	454.48	537.41

No statistical analyses for this end point

Secondary: Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after vaccination.

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End point title

Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after vaccination.

End point description

Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after each vaccination. Assessed solicited symptoms were Pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C).

End point type

Secondary

End point timeframe

Within 30 minutes after vaccination

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	228	232	155	134	151	159
Units: Participants
Any Induration(1st vacc)N-217,219,146,128,143,151	0	0	0	0	0	0
Grade3Induration(1stvacc)N-217,219,146,128,143,151	0	0	0	0	0	0
Any Induration(2nd vacc)N-215,217,150,125,144,151	0	0	0	0	0	0
Grade 3 Induration(2nd vaccination)	0	0	0	0	0	0
Any Induration(3rd vaccination)	0	0	0	0	0	0
Grade 3 Induration(3rd vaccination)	0	0	0	0	0	0
Any Induration(4th vaccination)	0	0	0	0	0	0
Grade 3 Induration(4th vaccination)	0	0	0	0	0	0
Any Induration(5th vaccination)	0	0	0	0	0	0
Grade 3 Induration(5th vaccination)	0	0	0	0	0	0
Any Erythema(1st vaccination)	1	0	0	0	1	0
Grade 3 Erythema(1st vaccination)	0	0	0	0	0	0
Any Erythema(2nd vaccination)	2	0	0	1	0	0
Grade 3 Erythema(2nd vaccination)	0	0	0	0	0	0
Any Erythema(3rd vaccination)	0	1	0	1	0	0
Grade 3 Erythema(3rd vaccination)	0	0	0	0	0	0
Any Erythema(4th vaccination)	0	1	0	0	0	1
Grade 3 Erythema(4th vaccination)	0	0	0	0	0	0
Any Erythema(5th vaccination)	0	0	0	0	0	0
Grade 3 Erythema(5th vaccination)	0	0	0	0	0	0
Any Pain(1st vaccination)	19	4	12	8	17	13
Grade 3 Pain(1st vaccination)	0	0	0	0	0	0
Any Pain(2nd vaccination)	10	12	11	9	14	9
Grade 3 Pain(2nd vaccination)	0	0	0	0	0	0
Any Pain(3rd vaccination)	10	11	8	7	5	13
Grade 3 Pain(3rd vaccination)	0	0	0	0	0	0
Any Pain(4th vaccination)	28	22	7	14	8	17
Grade 3 Pain(4th vaccination)	0	0	0	0	0	0
Any Pain(5th vaccination)	19	16	12	15	13	12
Grade 3 Pain(5th vaccination)	0	0	0	0	0	0
Any Nausea(1st vaccination)	0	0	2	1	2	2
Grade 3 Nausea(1st vaccination)	0	0	0	0	0	0
Any Nausea(2nd vaccination)	2	0	1	1	0	0
Grade 3 Nausea(2nd vaccination)	0	0	0	0	0	0
Any Nausea(3rd vaccination)	2	0	2	0	0	1
Grade 3 Nausea(3rd vaccination)	0	0	0	0	0	0
Any Nausea(4th vaccination)	2	0	2	0	1	0
Grade 3 Nausea(4th vaccination)	0	0	0	0	0	0
Any Nausea(5th vaccination)	1	0	3	1	0	1
Grade 3 Nausea(5th vaccination)	0	0	0	0	0	0
Any Fatigue (1st vaccination)	4	6	6	1	2	1
Grade 3 Fatigue(1st vaccination)	0	0	0	0	0	0
Any Fatigue (2nd vaccination)	4	3	1	1	2	0
Grade 3 Fatigue(2nd vaccination)	0	0	0	0	0	0
Any Fatigue (3rd vaccination)	2	4	0	1	1	2
Grade 3 Fatigue(3rd vaccination)	0	0	0	1	0	0
Any Fatigue (4th vaccination)	2	1	1	0	1	3
Grade 3 Fatigue(4th vaccination)	0	0	0	0	0	0
Any Fatigue (5th vaccination)	1	2	1	3	1	1
Grade 3 Fatigue(5th vaccination)	0	0	0	0	0	0
Any Myalgia(1st vaccination)	0	1	0	0	0	0
Grade 3 Myalgia(1st vaccination)	0	0	0	0	0	0
Any Myalgia(2nd vaccination)	0	0	1	0	3	1
Grade 3 Myalgia(2nd vaccination)	0	0	0	0	0	0
Any Myalgia(3rd vaccination)	0	0	0	1	0	0
Grade 3 Myalgia(3rd vaccination)	0	0	0	0	0	0
Any Myalgia(4th vaccination)	0	0	0	0	1	0
Grade 3 Myalgia(4th vaccination)	0	0	0	0	0	0
Any Myalgia(5th vaccination)	0	4	1	0	1	0
Grade 3 Myalgia(5th vaccination)	0	0	0	0	0	0
Any Arthralgia(1st vaccination)	0	0	0	0	0	0
Grade 3 Arthralgia(1st vaccination)	0	0	0	0	0	0
Any Arthralgia(2nd vaccination)	0	0	0	0	0	0
Grade 3 Arthralgia(2nd vaccination)	0	0	0	0	0	0
Any Arthralgia(3rd vaccination)	0	0	0	0	0	0
Grade 3 Arthralgia(3rd vaccination)	0	0	0	0	0	0
Any Arthralgia(4th vaccination)	0	0	0	0	0	0
Grade 3 Arthralgia(4th vaccination)	0	0	0	0	0	0
Any Arthralgia(5th vaccination)	0	0	0	0	0	0
Grade 3 Arthralgia(5th vaccination)	0	0	0	0	0	0
Any Headache(1st vaccination)	2	3	1	1	1	0
Grade 3 Headache(1st vaccination)	0	0	0	0	0	0
Any Headache(2nd vaccination)	3	1	2	1	1	1
Grade 3 Headache(2nd vaccination)	0	0	0	0	0	0
Any Headache(3rd vaccination)	2	1	2	0	1	1
Grade 3 Headache(3rd vaccination)	0	0	0	0	0	0
Any Headache(4th vaccination)	3	2	0	0	1	1
Grade 3 Headache(4th vaccination)	0	0	0	0	0	0
Any Headache(5th vaccination)	2	1	0	0	0	1
Grade 3 Headache(5th vaccination)	0	0	0	0	0	0
Any Chills(1st vaccination)	0	1	1	0	2	2
Grade 3 Chills(1st vaccination)	0	0	0	0	0	0
Any Chills(2nd vaccination)	1	1	1	1	0	0
Gradec3 Chills(2nd vaccination)	0	0	0	0	0	0
Any Chills(3rd vaccination)	1	1	0	0	0	0
Grade 3 Chills(3rd vaccination)	0	0	0	0	0	0
Any Chills(4th vaccination)	1	1	0	0	0	0
Grade 3 Chills(4th vaccination)	0	0	0	0	0	0
Any Chills(5th vaccination)	1	1	0	0	0	0
Grade 3 Chills(5th vaccination)	0	0	0	0	0	0
Any Appetite Loss(1st vaccination)	0	0	0	0	0	0
Grade 3 Appetite Loss(1st vaccination)	0	0	0	0	0	0
Any Appetite Loss(2nd vaccination)	0	0	0	0	0	0
Grade 3 Appetite Loss(2nd vaccination)	0	0	0	0	0	0
Any Appetite Loss(3rd vaccination)	0	0	0	0	0	0
Grade 3 Appetite Loss(3rd vaccination)	0	0	0	0	0	0
Any Appetite Loss(4th vaccination)	0	0	0	0	0	0
Grade 3 Appetite Loss(4th vaccination)	0	0	0	0	0	0
AnyAppetiteLoss(5th vaccination)	0	0	0	0	0	0
Grade 3 Appetite Loss(5th vaccination)	0	0	0	0	0	0
Fever(1st vaccination)	0	0	0	0	0	0
Fever(2nd vaccination)	0	0	0	0	0	0
Fever(3rd vaccination)	0	0	0	0	0	0
Fever(4th vaccination)	0	0	0	0	0	0
Fever(5th vaccination)	0	0	0	0	0	0
Pain/Fever prevention(1st vaccination)	0	0	0	0	0	0
Pain/Fever prevention(2nd vaccination)	0	2	0	0	0	0
Pain/Fever prevention(3rd vaccination)	1	0	0	0	0	0
Pain/Fever prevention(4th vaccination)	0	0	0	0	0	0
Pain/Fever prevention(5th vaccination)	0	0	0	0	0	0
Pain/Fever treatment(1st vaccination)	0	0	1	0	0	0
Pain/Fever treatment(2nd vaccination)	1	0	0	0	0	1
Pain/Fever treatment(3rd vaccination)	0	0	0	0	0	0
Pain/Fever treatment(4th vaccination)	0	1	0	0	0	0
Pain/Fever treatment(5th vaccination)	0	0	0	0	1	0

No statistical analyses for this end point

Secondary: Number of participants reporting any unsolicited AEs within 30 minutes after vaccination.

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End point title

Number of participants reporting any unsolicited AEs within 30 minutes after vaccination.

End point description

An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a participant and/or parent/legal guardian who has signed the informed consent. Number of participants reporting any unsolicited AE within 30 minutes after each vaccination.

End point type

Secondary

End point timeframe

Within 30 minutes after vaccination

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	221	228	151	129	147	157
Units: Participants
Dizziness	3	0	1	2	0	1
Presyncope	2	1	0	0	0	0
Syncope	0	1	1	0	1	0
Injection site pain	1	0	0	0	0	1
Asthenia	0	0	0	0	0	1
Dyspnoea	1	0	0	0	0	0
Fatigue	0	0	0	0	1	0
Headache	0	0	0	0	1	0
Hypoaesthesia	0	0	0	0	1	0
Injection site bruising	1	0	0	0	0	0
Injection site warmth	0	1	0	0	0	0
Pain	0	0	0	0	1	0
Paraesthesia	1	0	0	0	0	0
Pruritus allergic	0	0	1	0	0	0

No statistical analyses for this end point

Secondary: Number of participants reporting unsolicited AEs from Day 1 to Day 30 after any vaccination.

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End point title

Number of participants reporting unsolicited AEs from Day 1 to Day 30 after any vaccination.

End point description

The number of participants reporting unsolicited AEs and possibly or probably related unsolicited AEs were assessed.

End point type

Secondary

End point timeframe

Day 1 through Day 30 after any vaccination

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	221	228	151	129	147	157
Units: Participants
Any AE(s)	146	148	93	76	97	104
Possibly or Probably Related AE(s)	25	31	23	16	18	27

No statistical analyses for this end point

Secondary: Number of participants reporting any solicited local or systemic adverse events (AEs) and other indicators of reactogenicity from Day 1 to Day 7.

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End point title

Number of participants reporting any solicited local or systemic adverse events (AEs) and other indicators of reactogenicity from Day 1 to Day 7.

End point description

Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported.

End point type

Secondary

End point timeframe

At Day 1 (6 hours) to Day 7 after vaccination

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	228	231	155	134	151	159
Units: Participants
Any AE	225	228	153	131	151	157
Any Local AE	224	227	148	129	148	156
Any Systemic AE	201	201	143	117	134	143
Any Pain (1st vacc)	213	223	142	126	80	146
Grade 3 Pain (1st vacc)	9	13	2	10	0	6
Any Pain (2nd vacc)	32	34	122	41	135	51
Grade 3 Pain (2nd vacc)	0	1	5	0	11	0
Any Pain (3rd vacc)	193	185	38	26	16	133
Grade 3 Pain (3rd vacc)	11	7	0	0	0	5
Any Pain (4th vacc)	79	77	19	106	44	138
Grade 3 Pain (4th vacc)	1	0	0	10	0	9
Any Pain (5th vacc)	83	80	58	48	119	64
Grade 3 Pain (5th vacc)	0	1	1	0	11	1
Any Erythema (1st vacc)	23	21	16	11	1	23
Grade 3 Erythema (1st vacc)	0	1	1	0	0	2
Any Erythema (2nd vacc)	3	5	8	1	17	2
Grade3Erythema(2ndvacc)	0	0	1	0	3	0
Any Erythema (3rd vacc)	32	27	0	2	0	19
Grade3Erythema(3rdvacc)	2	6	0	0	0	1
Any Erythema (4th vacc)	1	1	0	10	0	13
Grade3Erythema(4thvacc)	0	0	0	1	0	4
Any Erythema (5th vacc)	1	1	1	0	11	0
Grade3Erythema(5thvacc)	0	0	0	0	1	0
AnyInduration(1st vacc)	21	20	12	13	3	19
Grade3Induration(1vacc)	0	0	0	1	0	1
AnyInduration(2nd vacc)	2	2	10	0	11	2
Grade3Induration(2vacc)	0	0	0	0	0	0
AnyInduration(3rd vacc)	24	17	0	0	1	20
Grade3Induration(3vacc)	2	0	0	0	0	0
AnyInduration(4th vacc)	2	3	0	10	0	14
Grade3Induration(4vacc)	0	0	0	1	0	1
AnyInduration(5th vacc)	2	3	1	2	16	1
Grade 3 Induration(5th vacc)	0	0	0	1	1	0
Any Fatigue (1st vacc)	126	121	84	68	68	76
Grade 3 Fatigue(1st vacc)	7	7	4	3	3	4
Any Fatigue (2nd vacc)	61	64	64	40	64	49
Grade 3 Fatigue(2nd vacc)	0	3	4	2	1	0
Any Fatigue (3rd vacc)	106	96	44	32	32	55
Garde 3 Fatigue(3rd vacc)	4	5	1	0	1	1
Any Fatigue (4th vacc)	50	56	37	51	35	73
Grade 3 Fatigue(4th vacc)	2	3	0	5	2	3
Any Fatigue (5th vacc)	62	59	37	41	51	46
Grade3Fatigue(5th vacc)	1	2	4	0	6	3
Any Headache (1st vacc)	103	92	65	52	63	64
Grade3Headache(1stvacc)	4	3	5	2	2	3
Any Headache (2nd vacc)	67	47	70	36	63	41
Grade3Headache(2ndvacc)	1	2	3	2	4	2
Any Headache (3rd vacc)	90	76	42	28	30	53
Grade3Headache(3rdvacc)	3	4	1	0	3	0
Any Headache (4th vacc)	49	35	26	44	26	52
Grade3Headache(4thvacc)	3	3	0	2	0	4
Any Headache (5th vacc)	64	40	33	33	52	37
Grade3Headache(5thvacc)	1	1	2	1	2	2
Any Myalgia (1st vacc)	62	53	39	34	33	40
Grade3Myalgia(1st vacc)	2	4	2	2	0	3
Any Myalgia (2nd vacc)	15	20	27	15	37	18
Grade3Myalgia(2nd vacc)	0	3	1	1	1	0
Any Myalgia (3rd vacc)	52	40	13	10	13	34
Grade3Myalgia(3rd vacc)	2	2	0	0	2	2
Any Myalgia (4th vacc)	17	20	11	26	13	39
Grade3Myalgia(4th vacc)	1	1	1	2	0	2
Any Myalgia (5th vacc)	16	26	19	12	21	19
Grade3Myalgia(5th vacc)	0	1	0	0	1	1
AnyAppetite Loss(1vacc)	41	33	28	22	14	18
Grade3AppetiteLoss(1vacc)	2	3	0	0	0	0
AnyAppetiteLoss(2vacc)	17	11	15	12	19	9
Grade3AppetiteLoss(2vacc)	0	1	0	0	2	0
AnyAppetiteLoss(3vacc)	28	28	7	7	11	17
Grade3AppetiteLoss(3vacc)	1	0	1	0	1	0
AnyAppetiteLoss(4vacc)	11	10	4	13	11	23
Grade3AppetiteLoss(4vacc)	0	0	0	0	0	0
AnyAppetiteLoss(5vacc)	18	14	9	9	22	7
Grade3AppetiteLoss(5vacc)	0	0	1	0	0	0
Any Nausea (1st vacc)	42	36	28	17	26	21
Grade 3 Nausea(1stvacc)	1	0	0	0	0	1
Any Nausea (2nd vacc)	17	15	20	10	26	15
Grade 3 Nausea(2nd vacc)	0	0	0	0	0	0
Any Nausea (3rd vacc)	35	24	10	8	4	21
Grade 3 Nausea(3rd vacc)	0	0	0	0	0	0
Any Nausea (4th vacc)	21	13	9	11	14	23
Grade 3 Nausea(4th vacc)	1	0	0	0	0	0
Any Nausea (5th vacc)	16	15	8	11	21	12
Grade 3 Nausea(5th vacc)	0	0	0	0	0	0
Any Chills (1st vacc)	45	36	41	24	27	40
Grade 3 Chills(1stvacc)	1	0	1	1	2	1
Any Chills (2nd vacc)	17	26	26	12	32	15
Grade 3 Chills(2ndvacc)	0	1	1	0	0	0
Any Chills(3rd vacc)	33	33	9	7	12	22
Grade 3 Chills(3rdvacc)	1	1	0	0	1	0
Any Chills(4thvacc)	11	11	10	12	9	31
Grade 3 Chills(4thvacc)	2	0	0	0	0	1
Any Chills (5th vacc)	19	23	17	11	22	13
Grade 3 Chills(5vacc)	0	0	0	1	0	0
Fever (1st vacc)	5	4	5	1	2	3
Fever (2nd vacc)	2	6	4	2	9	3
Fever (3rd vacc)	6	3	2	0	4	4
Fever (4th vacc)	0	2	0	3	0	7
Fever (5th vacc)	5	1	2	0	3	1
Pain/Fever prevention(1)	28	34	21	26	5	34
Pain/Fever prevention(2)	5	7	18	5	24	7
Pain/Fever prevention(3)	32	34	3	2	3	21
Pain/Fever prevention(4)	6	5	3	19	3	25
Pain/Fever prevention(5)	5	9	4	1	26	3
Pain/Fever treatment(1)	31	45	27	32	6	31
Pain/Fever treatment(2)	3	4	20	3	29	4
Pain/Fever treatment(3)	38	37	2	4	2	23
Pain/Fever treatment(4)	7	4	2	22	2	27
Pain/Fever treatment(5)	3	8	2	3	29	2
Any Arthralgia(1st vacc)	25	14	13	17	12	14
Grade3Arthralgia(1stvacc)	0	1	0	0	1	2
Any Arthralgia (2nd vacc)	7	11	10	9	8	7
Grade3Arthralgia(2ndvacc)	0	0	0	1	0	1
Any Arthralgia(3rd vacc)	16	7	4	3	6	11
Grade3Arthralgia(3rdvacc)	0	1	0	0	0	0
Any Arthralgia(4th vacc)	8	10	5	10	7	18
Grade3Arthralgia(4thvacc)	1	0	0	0	0	2
Any Arthralgia(5th vacc)	8	9	8	6	11	11
Grade3Arthralgia(5thvacc)	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of participants reporting any serious AE (SAE), medically attended AEs (MAAEs), AEs leading to premature withdrawal

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End point title

Number of participants reporting any serious AE (SAE), medically attended AEs (MAAEs), AEs leading to premature withdrawal

End point description

The number of participants reporting any SAE, possibly or probably related SAE(s), medically-attended AEs, AEs leading to premature withdrawal, AEs leading to death, AEs leading to hospitalization and AEs leading to dose reduction, interruption and delay in study vaccination during the entire study period is reported.

End point type

Secondary

End point timeframe

During the entire study period (Month 0 to Month 13)

End point values	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Number of subjects analysed	221	228	151	129	147	157
Units: Participants
Any SAE(s)	9	3	8	7	2	6
Possibly or Probably Related SAE(s)	0	1	1	0	0	0
Medically Attended AE(s)	103	97	68	57	67	79
AE(s) leading to premature withdrawal	2	6	4	2	1	3
AE(s) leading to Death	0	0	0	0	0	0
AE(s) leading to Hospitalization	9	1	7	6	1	6
AE(s)leadingtodosereduction,interruption,vaccdelay	8	8	7	2	4	5

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period.

Adverse event reporting additional description

Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

rMenB_0_2 Group

Reporting group description

Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.

Reporting group title

ABCWY_ 0_2 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1.

Reporting group title

ABCWY_0_1 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6.

Reporting group title

ABCWY_0_6 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2.

Reporting group title

ABCWY_0_11 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2.

Reporting group title

ABCWY_0_2_6 Group

Reporting group description

Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12.

Serious adverse events	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Total subjects affected by serious adverse events
subjects affected / exposed	9 / 228 (3.95%)	3 / 231 (1.30%)	8 / 155 (5.16%)	7 / 134 (5.22%)	2 / 151 (1.32%)	6 / 159 (3.77%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	1 / 155 (0.65%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Tooth extraction
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	1 / 134 (0.75%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fatigue
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	1 / 134 (0.75%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Testicular torsion
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	1 / 159 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mental disorder
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	1 / 134 (0.75%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	0 / 228 (0.00%)	1 / 231 (0.43%)	1 / 155 (0.65%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Carbon monoxide poisoning
subjects affected / exposed	0 / 228 (0.00%)	1 / 231 (0.43%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	1 / 159 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	1 / 159 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrioventricular block second degree
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Partial seizures
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	1 / 151 (0.66%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	0 / 228 (0.00%)	1 / 231 (0.43%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	1 / 151 (0.66%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Iron deficiency anaemia
subjects affected / exposed	2 / 228 (0.88%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal migraine
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	1 / 155 (0.65%)	1 / 134 (0.75%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	1 / 134 (0.75%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Tubulointerstitial nephritis
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	1 / 159 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	1 / 155 (0.65%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Connective tissue disorder
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	1 / 155 (0.65%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Torticollis
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	1 / 159 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	2 / 155 (1.29%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	1 / 134 (0.75%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infectious mononucleosis
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nasopharyngitis
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pelvic inflammatory disease
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	1 / 159 (0.63%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	1 / 155 (0.65%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	1 / 134 (0.75%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 228 (0.44%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Failure to thrive
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	1 / 155 (0.65%)	0 / 134 (0.00%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Obesity
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	0 / 134 (0.00%)	0 / 151 (0.00%)	1 / 159 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Type 1 diabetes mellitus
subjects affected / exposed	0 / 228 (0.00%)	0 / 231 (0.00%)	0 / 155 (0.00%)	1 / 134 (0.75%)	0 / 151 (0.00%)	0 / 159 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	rMenB_0_2 Group	ABCWY_ 0_2 Group	ABCWY_0_1 Group	ABCWY_0_6 Group	ABCWY_0_11 Group	ABCWY_0_2_6 Group
Total subjects affected by non serious adverse events
subjects affected / exposed	226 / 228 (99.12%)	229 / 231 (99.13%)	153 / 155 (98.71%)	131 / 134 (97.76%)	151 / 151 (100.00%)	158 / 159 (99.37%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Arthralgia
subjects affected / exposed	48 / 228 (21.05%)	48 / 231 (20.78%)	28 / 155 (18.06%)	31 / 134 (23.13%)	27 / 151 (17.88%)	38 / 159 (23.90%)
occurrences all number	109	125	57	96	68	101
Injury, poisoning and procedural complications
Respiratory tract infection
subjects affected / exposed	15 / 228 (6.58%)	12 / 231 (5.19%)	10 / 155 (6.45%)	5 / 134 (3.73%)	6 / 151 (3.97%)	10 / 159 (6.29%)
occurrences all number	24	15	16	12	12	13
Nervous system disorders
Headache
subjects affected / exposed	165 / 228 (72.37%)	149 / 231 (64.50%)	114 / 155 (73.55%)	93 / 134 (69.40%)	110 / 151 (72.85%)	117 / 159 (73.58%)
occurrences all number	830	593	496	450	478	530
General disorders and administration site conditions
Chills
subjects affected / exposed	80 / 228 (35.09%)	76 / 231 (32.90%)	61 / 155 (39.35%)	40 / 134 (29.85%)	62 / 151 (41.06%)	70 / 159 (44.03%)
occurrences all number	236	216	172	136	173	208
Fatigue
subjects affected / exposed	169 / 228 (74.12%)	165 / 231 (71.43%)	119 / 155 (76.77%)	98 / 134 (73.13%)	105 / 151 (69.54%)	120 / 159 (75.47%)
occurrences all number	956	891	534	533	559	633
Injection site erythema
subjects affected / exposed	131 / 228 (57.46%)	131 / 231 (56.71%)	80 / 155 (51.61%)	80 / 134 (59.70%)	89 / 151 (58.94%)	97 / 159 (61.01%)
occurrences all number	465	367	271	268	284	398
Injection site induration
subjects affected / exposed	110 / 228 (48.25%)	98 / 231 (42.42%)	67 / 155 (43.23%)	53 / 134 (39.55%)	70 / 151 (46.36%)	85 / 159 (53.46%)
occurrences all number	437	359	260	176	248	458
Injection site pain
subjects affected / exposed	221 / 228 (96.93%)	225 / 231 (97.40%)	148 / 155 (95.48%)	129 / 134 (96.27%)	148 / 151 (98.01%)	154 / 159 (96.86%)
occurrences all number	1870	1598	1003	1065	1087	1592
Pyrexia
subjects affected / exposed	27 / 228 (11.84%)	27 / 231 (11.69%)	20 / 155 (12.90%)	13 / 134 (9.70%)	25 / 151 (16.56%)	26 / 159 (16.35%)
occurrences all number	37	34	26	16	33	32
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	16 / 228 (7.02%)	9 / 231 (3.90%)	6 / 155 (3.87%)	5 / 134 (3.73%)	9 / 151 (5.96%)	9 / 159 (5.66%)
occurrences all number	22	9	6	6	12	12
Nausea
subjects affected / exposed	74 / 228 (32.46%)	68 / 231 (29.44%)	51 / 155 (32.90%)	47 / 134 (35.07%)	56 / 151 (37.09%)	62 / 159 (38.99%)
occurrences all number	232	145	136	85	167	149
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	12 / 228 (5.26%)	5 / 231 (2.16%)	6 / 155 (3.87%)	1 / 134 (0.75%)	1 / 151 (0.66%)	3 / 159 (1.89%)
occurrences all number	14	6	7	1	1	3
Oropharyngeal pain
subjects affected / exposed	12 / 228 (5.26%)	13 / 231 (5.63%)	9 / 155 (5.81%)	7 / 134 (5.22%)	5 / 151 (3.31%)	7 / 159 (4.40%)
occurrences all number	14	13	13	9	6	8
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	103 / 228 (45.18%)	99 / 231 (42.86%)	69 / 155 (44.52%)	54 / 134 (40.30%)	65 / 151 (43.05%)	81 / 159 (50.94%)
occurrences all number	271	315	169	178	213	244
Infections and infestations
Gastroenteritis
subjects affected / exposed	15 / 228 (6.58%)	11 / 231 (4.76%)	13 / 155 (8.39%)	9 / 134 (6.72%)	10 / 151 (6.62%)	10 / 159 (6.29%)
occurrences all number	16	11	13	11	12	10
Nasopharyngitis
subjects affected / exposed	37 / 228 (16.23%)	30 / 231 (12.99%)	28 / 155 (18.06%)	21 / 134 (15.67%)	24 / 151 (15.89%)	25 / 159 (15.72%)
occurrences all number	53	50	40	38	34	44
Pharyngitis
subjects affected / exposed	16 / 228 (7.02%)	21 / 231 (9.09%)	7 / 155 (4.52%)	8 / 134 (5.97%)	11 / 151 (7.28%)	15 / 159 (9.43%)
occurrences all number	16	21	9	8	14	15
Rhinitis
subjects affected / exposed	15 / 228 (6.58%)	18 / 231 (7.79%)	7 / 155 (4.52%)	6 / 134 (4.48%)	5 / 151 (3.31%)	11 / 159 (6.92%)
occurrences all number	18	21	10	6	5	14
Tonsillitis
subjects affected / exposed	7 / 228 (3.07%)	10 / 231 (4.33%)	3 / 155 (1.94%)	6 / 134 (4.48%)	9 / 151 (5.96%)	5 / 159 (3.14%)
occurrences all number	9	11	4	8	10	5
Upper respiratory tract infection
subjects affected / exposed	53 / 228 (23.25%)	58 / 231 (25.11%)	37 / 155 (23.87%)	31 / 134 (23.13%)	35 / 151 (23.18%)	37 / 159 (23.27%)
occurrences all number	74	92	52	46	51	51
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	69 / 228 (30.26%)	64 / 231 (27.71%)	45 / 155 (29.03%)	43 / 134 (32.09%)	45 / 151 (29.80%)	52 / 159 (32.70%)
occurrences all number	208	164	107	91	131	121

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Were there any global substantial amendments to the protocol? Yes

22 Apr 2014

The protocol was amended primarily to address comments from CBER on the previous version of the protocol, relating to addition of secondary immunogenicity objective and inclusion of detail on safety data collection and randomization procedures. Additional changes were made to ensure that the subjects/parents/legal guardians were encouraged to contact sites during the entire study in case medically-attended AEs or any AEs which was perceived as being of concern. Additionally the placebo was provided as ampoules instead of the vials and the protocol text was amended accordingly.

03 Feb 2015

The protocol was amended to further clarify certain sections and to correct the content errors/typographical errors which were recognized in the protocol version 3.0.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) against N. meningitidis serogroup B test strains when administered according to 0_2 month schedule.

Primary: Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) against N. meningitidis serogroup B test strains when administered according to 0_2 month schedule.

Secondary: hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_2 month schedule.

Secondary: hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_2 month schedule.

Secondary: Percentages of subjects with hSBA titers ≥LLQ against N. meningitidis serogroups A, C, W and y and serogroup B test strains when administered according to 0_2_6 month and 0_2 month schedule.

Secondary: Percentages of subjects with hSBA titers ≥LLQ against N. meningitidis serogroups A, C, W and y and serogroup B test strains when administered according to 0_2_6 month and 0_2 month schedule.

Secondary: hSBA GMTs against each of N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_1 month, 0_2 month, 0_6 month and 0, 11 month schedule.

Secondary: hSBA GMTs against each of N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_1 month, 0_2 month, 0_6 month and 0, 11 month schedule.

Secondary: Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains when administered according to 0_2 month schedule.

Secondary: Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains when administered according to 0_2 month schedule.

Secondary: hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_6 month schedule.

Secondary: hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_6 month schedule.

Secondary: Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_6 month schedule.

Secondary: Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against serogroups A, C, W and Y and serogroup B test strains when administered according to 0_2_6 month and 0_6 month schedule.

Secondary: Percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_1 month, 0_2 month, 0_6 month and 0_11 month schedule.

Secondary: Percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains when administered according to 0_1 month, 0_2 month, 0_6 month and 0_11 month schedule.

Secondary: hSBA GMTs against serogroups A, C, W and Y and serogroup B test strains at all the relevant time points for all schedules.

Secondary: hSBA GMTs against serogroups A, C, W and Y and serogroup B test strains at all the relevant time points for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against NZ98/254 B strain for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against NZ98/254 B strain for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M14459 B strain for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M14459 B strain for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M07-0241084 B strain for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M07-0241084 B strain for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against 96217 B strain for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against 96217 B strain for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against A human serogroup for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against A human serogroup for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against C human serogroup for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against C human serogroup for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against W human serogroup for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against W human serogroup for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against Y human serogroup for all schedules.

Secondary: Percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against Y human serogroup for all schedules.

Secondary: Percentages of subjects with two-, three- and four-fold titer rise against serogroups A, C, W and Y and serogroup B test Strains for all schedules.

Secondary: Percentages of subjects with two-, three- and four-fold titer rise against serogroups A, C, W and Y and serogroup B test Strains for all schedules.

Secondary: The area under the curve (AUC) for percentage of subjects with hSBA titers ≥LLQ for all serogroups and strains.

Secondary: The area under the curve (AUC) for percentage of subjects with hSBA titers ≥LLQ for all serogroups and strains.

Secondary: Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after vaccination.

Secondary: Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after vaccination.

Secondary: Number of participants reporting any unsolicited AEs within 30 minutes after vaccination.

Secondary: Number of participants reporting any unsolicited AEs within 30 minutes after vaccination.

Secondary: Number of participants reporting unsolicited AEs from Day 1 to Day 30 after any vaccination.

Secondary: Number of participants reporting unsolicited AEs from Day 1 to Day 30 after any vaccination.

Secondary: Number of participants reporting any solicited local or systemic adverse events (AEs) and other indicators of reactogenicity from Day 1 to Day 7.

Secondary: Number of participants reporting any solicited local or systemic adverse events (AEs) and other indicators of reactogenicity from Day 1 to Day 7.

Secondary: Number of participants reporting any serious AE (SAE), medically attended AEs (MAAEs), AEs leading to premature withdrawal

Secondary: Number of participants reporting any serious AE (SAE), medically attended AEs (MAAEs), AEs leading to premature withdrawal

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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