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Clinical Trial Results:
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03.

Summary
EudraCT number	2012-003937-41
Trial protocol	PL
Global end of trial date	17 Apr 2015

Results information
Results version number	v2(current)
This version publication date	23 Oct 2016
First version publication date	30 Apr 2016
Other versions	v1
Version creation reason	Correction of full data set Correction of data required. Moreover, a back-up user needs to be assigned as the sponsorship is now changed for the study.

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

V102_03E1

ISRCTN number

US NCT number

NCT01992536

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)

Yes

EMA paediatric investigation plan number(s)

EMEA-001260-PIP01-11

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

17 Apr 2015

Is this the analysis of the primary completion data?

Yes

Primary completion date

30 May 2014

Global end of trial reached?

Yes

Global end of trial date

17 Apr 2015

Was the trial ended prematurely?

Main objective of the trial

1. To evaluate the immune response against meningococcal serogroups A, C, W and Y as measured by percentage of subjects having seroresponse at Day 30 following administration of a booster dose of MenABCWY in subjects who previously received the same vaccine formulation in study V102_03. 2. To evaluate the immune response against strains of serogroup B as measured by percentage of subjects having human serum bactericidal activity (hSBA) titers ≥ 1:5 at Day 30 following administration of a booster dose of MenABCWY in subjects who previously received the same vaccine formulation in study V102_03. Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: ▫ For subjects with a pre-vaccination hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8. ▫ For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.

Protection of trial subjects

This clinical study was designed and shall be implemented and reported in accordance with the International Conference on Harmonisation of Technical requirements (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations including European Directive 2001/20/EC and US Code of Federal Regulations (CFR) Title 21 and with the ethical principles laid down in the Declaration of Helsinki (European Council 2001, US CFR, ICH 1997).

Background therapy

Evidence for comparator

Actual start date of recruitment

16 Dec 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 117

Country: Number of subjects enrolled

Poland: 77

Worldwide total number of subjects

194

EEA total number of subjects

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)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Subjects were recruited from 5 study sites in Poland and from 8 study sites in US.

Screening details

All enrolled subjects were included in the study.

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, Monitor, Data analyst, Assessor

Blinding implementation details

Observer blind

Are arms mutually exclusive

Yes

2OMV_OMV

Arm description

Subjects who previously received two doses of MenABCWY + outer membrane vesicle (OMV) in the parent study, received one booster dose of same vaccine in this study.

Arm type

Experimental

Investigational medicinal product name

Combined MenABCWY vaccine (MenACWY lyophilized) + (rMenB + OMV NZ) liquid suspension

Investigational medicinal product code

MenACWY + rMenB + OMV NZ

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL

2OMV_Pbo

Arm description

Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.

Arm type

Placebo

Investigational medicinal product name

Saline solution

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL

2qOMV_qOMV

Arm description

Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.

Arm type

Experimental

Investigational medicinal product name

Combined MenABCWY vaccine (MenACWY lyophilized) + (rMenB + ¼ OMV NZ) liquid suspension

Investigational medicinal product code

MenACWY + rMenB + ¼ OMV NZ

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL

2qOMV_Pbo

Arm description

Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.

Arm type

Placebo

Investigational medicinal product name

Saline solution

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL

2B_OMV

Arm description

Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.

Arm type

Experimental

Investigational medicinal product name

Combined MenABCWY vaccine (MenACWY lyophilized) + (rMenB + OMV NZ) liquid suspension

Investigational medicinal product code

MenACWY + rMenB + OMV NZ

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL

2B_qOMV

Arm description

Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.

Arm type

Experimental

Investigational medicinal product name

Combined MenABCWY vaccine (MenACWY lyophilized) + (rMenB + ¼ OMV NZ) liquid suspension

Investigational medicinal product code

MenACWY + rMenB + ¼ OMV NZ

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL

1M_OMV

Arm description

Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.

Arm type

Experimental

Investigational medicinal product name

Combined MenABCWY vaccine (MenACWY lyophilized) + (rMenB + OMV NZ) liquid suspension

Investigational medicinal product code

MenACWY + rMenB + OMV NZ

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL

1M_qOMV

Arm description

Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.

Arm type

Experimental

Investigational medicinal product name

Combined MenABCWY vaccine (MenACWY lyophilized) + (rMenB + ¼ OMV NZ) liquid suspension

Investigational medicinal product code

MenACWY + rMenB + ¼ OMV NZ

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL

1M_Pbo

Arm description

Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.

Arm type

Placebo

Investigational medicinal product name

Saline solution

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL

2B_Pbo

Arm description

Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.

Arm type

Placebo

Investigational medicinal product name

Saline solution

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL

Number of subjects in period 1 ^[1]	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo	2B_Pbo
Started	26	25	17	24	11	21	21	19	19	7
Completed	22	22	16	22	11	20	21	18	18	0
Not completed	4	3	1	2	0	1	0	1	1	7
Consent withdrawn by subject	-	1	-	2	-	-	-	-	-	-
Lost to follow-up	4	2	1	-	-	1	-	1	1	-
Administrative reason	-	-	-	-	-	-	-	-	-	7

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Four subjects in the 194 enrolled were not assigned to any treatment and therefore were not included in any group.

Baseline characteristics

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Reporting group title

2OMV_OMV

Reporting group description

Subjects who previously received two doses of MenABCWY + outer membrane vesicle (OMV) in the parent study, received one booster dose of same vaccine in this study.

Reporting group title

2OMV_Pbo

Reporting group description

Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.

Reporting group title

2qOMV_qOMV

Reporting group description

Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.

Reporting group title

2qOMV_Pbo

Reporting group description

Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.

Reporting group title

2B_OMV

Reporting group description

Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.

Reporting group title

2B_qOMV

Reporting group description

Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.

Reporting group title

1M_OMV

Reporting group description

Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.

Reporting group title

1M_qOMV

Reporting group description

Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.

Reporting group title

1M_Pbo

Reporting group description

Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.

Reporting group title

2B_Pbo

Reporting group description

Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.

Reporting group values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo	2B_Pbo	Total
Number of subjects	26	25	17	24	11	21	21	19	19	7	190
Age categorical
Units: Subjects
Age continuous
Units: months
arithmetic mean (standard deviation)	18.8 ± 5.19	17.1 ± 4.31	18 ± 5.05	19 ± 5.4	20.9 ± 3.99	19.7 ± 5.36	16.8 ± 4.65	19.2 ± 6.1	17.6 ± 5.19	17.9 ± 4.67	-
Gender categorical
Units: Subjects
Female	8	13	9	14	2	15	12	12	11	3	99
Male	18	12	8	10	9	6	9	7	8	4	91

End points

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Reporting group title

2OMV_OMV

Reporting group description

Subjects who previously received two doses of MenABCWY + outer membrane vesicle (OMV) in the parent study, received one booster dose of same vaccine in this study.

Reporting group title

2OMV_Pbo

Reporting group description

Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.

Reporting group title

2qOMV_qOMV

Reporting group description

Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.

Reporting group title

2qOMV_Pbo

Reporting group description

Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.

Reporting group title

2B_OMV

Reporting group description

Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.

Reporting group title

2B_qOMV

Reporting group description

Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.

Reporting group title

1M_OMV

Reporting group description

Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.

Reporting group title

1M_qOMV

Reporting group description

Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.

Reporting group title

1M_Pbo

Reporting group description

Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.

Reporting group title

2B_Pbo

Reporting group description

Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.

Subject analysis set title

All Enrolled

Subject analysis set type

Intention-to-treat

Subject analysis set description

All screened subjects who have been enrolled (i.e., attended the first clinic visit and received a subject ID).

Subject analysis set title

Exposed

Subject analysis set type

Intention-to-treat

Subject analysis set description

All subjects in the Enrolled Population, who received a study vaccination.

Subject analysis set title

Full Analysis Set (FAS) Day 1 (Persistence)

Subject analysis set type

Full analysis

Subject analysis set description

All subjects in the enrolled population who provided an evaluable serum sample at Visit Day 1.

Subject analysis set title

Full Analysis Set (FAS) Day 30 (Booster)

Subject analysis set type

Full analysis

Subject analysis set description

All subjects in the enrolled population who were randomised, received the study vaccination in the current study and provided an evaluable serum sample at Visit Day 30 (for Seroresponse, Day 1 and Day 30 samples).

Subject analysis set title

Full Analysis Set (FAS) Day 365 (Persistence of Booster)

Subject analysis set type

Full analysis

Subject analysis set description

All subjects in the enrolled population who were randomised, received the study vaccination in the current study and provided an evaluable serum sample at Visit Day 365.

Subject analysis set title

Safety set (Solicited AEs)

Subject analysis set type

Safety analysis

Subject analysis set description

All subjects in the Exposed Set with any solicited adverse event (AE) data.

Subject analysis set title

Safety set (Unsolicited AEs)

Subject analysis set type

Safety analysis

Subject analysis set description

All subjects in the Exposed Set with unsolicited AE data.

Subject analysis set title

Safety set (overall)

Subject analysis set type

Safety analysis

Subject analysis set description

All subjects in the exposed population who have either post-vaccination adverse event or safety records.

Subject analysis set title

ABCWY+OMV

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects received two doses of MenABCWY+OMV administered two months apart in parent study.

Subject analysis set title

ABCWY+qOMV

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects received two doses of MenABCWY+qOMV administered two months apart in parent study.

Subject analysis set title

rMenB+OMV

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects received two doses of rMenB + OMV, administered two months apart in parent study.

Subject analysis set title

Menveo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects received one dose of placebo followed by one dose of MenACWY administered two months apart in parent study.

Primary: 1. Percentages of subjects with HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y.

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End point title

1. Percentages of subjects with HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y. ^[1] ^[2]

End point description

Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03. Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer. Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at day 30 (for seroresponse, day 1 and day 30 samples were required).

End point type

Primary

End point timeframe

Day 30

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this endpoint was descriptive, no statistical analyses were conducted.
[2] - 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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2qOMV_qOMV
Number of subjects analysed	25	16
Units: Percentage
number (confidence interval 95%)
Men A	96 (79.6 to 99.9)	94 (69.8 to 99.84)
Men C	85 (62.1 to 96.8)	100 (69.2 to 100)
Men W	85 (62.1 to 96.8)	85 (54.6 to 98.1)
Men Y	96 (79.6 to 99.9)	100 (76.8 to 100)

No statistical analyses for this end point

Primary: 2. Percentage of subjects with HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroup B.

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End point title

2. Percentage of subjects with HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroup B. ^[3] ^[4]

End point description

Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroup B at Day 1 (24 months after the last vaccination in the primary series of study V102_03) and one month (Day 30) following administration of a booster dose of MenABCWY in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03. Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at day 30 (for seroresponse, Day 1 and Day 30 samples were required).

End point type

Primary

End point timeframe

Day 1 and Day 30

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this endpoint was descriptive, no statistical analyses were conducted.
[4] - 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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2qOMV_qOMV
Number of subjects analysed	25	17
Units: Percentage
number (confidence interval 95%)
M14459 (fHBP) (Day 1)	24 (9.4 to 45.1)	7 (0.17 to 31.9)
M14459 (fHBP) (Day 30)	92 (74 to 99)	88 (63.6 to 98.5)
M01-0240364 (NadA) (Day 1)	25 (9.8 to 46.7)	20 (4.3 to 48.1)
M01-0240364 (NadA) (Day 30)	100 (86.3 to 100)	100 (80.5 to 100)
NZ98/254 (PorA) (Day 1)	16 (4.5 to 36.1)	7 (0.17 to 31.9)
NZ98/254 (PorA) (Day 30)	92 (74 to 99)	71 (44 to 89.7)
M07-0241084 (NHBA) (Day 1)	36 (18 to 57.5)	27 (7.8 to 55.1)
M07-0241084 (NHBA) (Day 30)	100 (86.3 to 100)	88 (63.6 to 98.5)
H44/76 (fHBP) (Day 1)	16 (4.5 to 36.1)	13 (1.6 to 38.3)
H44/76 (fHBP) (Day 30)	96 (79.6 to 99.9)	100 (80.5 to 100)
5/99 (NadA) (Day 1)	76 (54.9 to 90.6)	87 (59.5 to 98.3)
5/99 (NadA) (Day 30)	100 (86.3 to 100)	100 (80.5 to 100)

No statistical analyses for this end point

Secondary: 3. Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y.

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End point title

3. Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y.

End point description

Percentage of subjects with HT-hSBA titer ≥ 1:8 in serogroups A, C, W, Y against N. meningitidis assessed prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03. Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.

End point type

Secondary

End point timeframe

Day 1 (Pre vaccination)

End point values	ABCWY+OMV	ABCWY+qOMV	rMenB+OMV	Menveo
Number of subjects analysed	51	40	38	59
Units: Percentage
number (confidence interval 95%)
Men A (Day 1)	27 (15.9 to 41.7)	28 (14.6 to 43.9)	29 (15.4 to 45.9)	31 (19.5 to 44.5)
Men C (Day 1)	67 (51.6 to 79.6)	68 (51.3 to 82.5)	45 (28.6 to 61.7)	57 (43.2 to 69.8)
Men W (Day 1)	92 (80.8 to 97.8)	75 (57.8 to 87.9)	76 (59.8 to 88.6)	68 (54 to 79.7)
Men Y (Day 1)	65 (50.1 to 77.6)	50 (33.4 to 66.6)	16 (6 to 31.3)	46 (32.7 to 59.2)

No statistical analyses for this end point

Secondary: 4. Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis strains of serogroup B.

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End point title

4. Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis strains of serogroup B.

End point description

Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B assessed prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03. Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.

End point type

Secondary

End point timeframe

Day 1 (Pre vaccination)

End point values	ABCWY+OMV	ABCWY+qOMV	rMenB+OMV	Menveo
Number of subjects analysed	51	39	38	59
Units: Percentage
number (confidence interval 95%)
M14459 (fHBP) (Day 1)	29 (17.5 to 43.8)	13 (4.3 to 27.4)	26 (13.4 to 43.1)	14 (6 to 25)
M01-0240364 (NadA) (Day 1)	24 (13.1 to 38.2)	16 (6.2 to 32)	35 (20.2 to 52.5)	7 (1.9 to 16.7)
NZ98/254 (PorA) (Day 1)	24 (12.8 to 37.5)	8 (1.6 to 20.9)	16 (6 to 31.3)	3 (0.41 to 11.7)
M07-0241084 (NHBA) (Day 1)	37 (24.1 to 51.9)	29 (15.4 to 45.9)	50 (33.4 to 66.6)	22 (12.3 to 34.7)
H44/76 (fHBP) (Day 1)	22 (11.3 to 35.3)	18 (7.5 to 33.5)	34 (19.6 to 51.4)	3 (0.41 to 11.7)
5/99 (NadA) (Day 1)	76 (62.5 to 87.2)	87 (71.9 to 95.6)	94 (81.3 to 99.3)	19 (9.7 to 30.9)

No statistical analyses for this end point

Secondary: 5. The HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, Y.

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End point title

5. The HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, Y.

End point description

The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03. Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.

End point type

Secondary

End point timeframe

Day 1 (Pre vaccination)

End point values	ABCWY+OMV	ABCWY+qOMV	rMenB+OMV	Menveo
Number of subjects analysed	51	40	38	59
Units: Titers
geometric mean (confidence interval 95%)
Men A (Day 1)	3.34 (2.19 to 5.08)	3.3 (1.95 to 5.6)	2.96 (1.7 to 5.17)	4.14 (2.75 to 6.23)
Men C (Day 1)	18 (11 to 30)	13 (8 to 20)	6.05 (4.28 to 8.55)	10 (6.36 to 17)
Men W (Day 1)	35 (24 to 52)	23 (12 to 45)	20 (11 to 34)	17 (9.65 to 29)
Men Y (Day 1)	13 (7.01 to 23)	8.85 (4.24 to 18)	1.8 (1.25 to 2.6)	6.49 (3.72 to 11)

No statistical analyses for this end point

Secondary: 6. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

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End point title

6. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

End point description

The HT-hSBA GMTs against N. meningitidis strains of serogroup B prior the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03. Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.

End point type

Secondary

End point timeframe

Day 1 (Pre vaccination)

End point values	ABCWY+OMV	ABCWY+qOMV	rMenB+OMV	Menveo
Number of subjects analysed	51	39	38	59
Units: Titers
geometric mean (confidence interval 95%)
M14459 (fHBP)	2.67 (1.92 to 3.7)	1.94 (1.48 to 2.56)	2.82 (2 to 3.96)	1.87 (1.43 to 2.43)
M01-0240364 (NadA)	2.67 (1.7 to 4.2)	2.1 (1.21 to 3.65)	4.72 (2.44 to 9.13)	1.37 (1.06 to 1.78)
NZ98/254 (PorA)	2.03 (1.43 to 2.89)	1.46 (1.15 to 1.85)	1.75 (1.24 to 2.47)	1.16 (1 to 1.34)
M07-0241084 (NHBA)	3.76 (2.55 to 5.56)	2.42 (1.7 to 3.45)	4.56 (2.97 to 7.01)	2.35 (1.68 to 3.28)
H44/76 (fHBP)	2.54 (1.69 to 3.82)	1.78 (1.26 to 2.53)	3.22 (2.18 to 4.76)	1.32 (1.06 to 1.65)
5/99 (NadA)	16 (11 to 24)	33 (19 to 54)	39 (25 to 62)	2.46 (1.73 to 3.51)

No statistical analyses for this end point

Secondary: 7. The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y.

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End point title

7. The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y. ^[5]

End point description

The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y at Day 1 and one month after the administration of MenABCWY booster vaccination or placebo. Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at day 30 (for seroresponse, Day 1 and Day 30 samples were required).

End point type

Secondary

End point timeframe

Day 1 and Day 30

Notes
[5] - 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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Number of subjects analysed	25	25	16	23	11	21	21	18	18
Units: Titers
geometric mean (confidence interval 95%)
Men A (Day 1)	3.41 (1.87 to 6.22)	2.92 (1.59 to 5.36)	2.86 (1.23 to 6.63)	2.73 (1.41 to 5.27)	2.26 (0.96 to 5.31)	3.94 (1.58 to 9.85)	6.62 (2.85 to 15)	2.09 (1.28 to 3.41)	5.02 (2.06 to 12)
Men A (Day 30)	259 (174 to 383)	4.28 (2.03 to 9.03)	333 (199 to 559)	3.07 (1.51 to 6.25)	438 (287 to 670)	416 (198 to 871)	138 (84 to 229)	46 (24 to 87)	4.91 (2 to 12)
Men C (Day 1)	23 (9.45 to 57)	16 (7.06 to 36)	17 (5.98 to 51)	11 (6.24 to 19)	5.45 (2.41 to 12)	9.02 (5.24 to 16)	7.75 (4.19 to 14)	7.53 (2.38 to 24)	17 (6.6 to 44)
Men C (Day 30)	660 (401 to 1084)	17 (7.6 to 38)	612 (245 to 1524)	11 (5.51 to 22)	292 (75 to 1142)	135 (69 to 261)	338 (205 to 558)	304 (124 to 742)	20 (7.2 to 56)
Men W (Day 1)	34 (20 to 59)	33 (17 to 65)	30 (8.9 to 101)	18 (7.3 to 46)	25 (7.98 to 79)	29 (13 to 64)	28 (12 to 66)	9.37 (2.85 to 31)	9.42 (3.03 to 29)
Men W (Day 30)	792 (516 to 1216)	34 (16 to 71)	880 (671 to 1154)	26 (11 to 59)	392 (252 to 610)	363 (278 to 473)	629 (384 to 1032)	364 (180 to 736)	16 (4.87 to 53)
Men Y (Day 1)	10 (4.89 to 21)	15 (5.5 to 43)	15 (4.33 to 53)	5.66 (2.25 to 14)	2.4 (1.05 to 5.47)	1.84 (1.07 to 3.14)	6.43 (2.86 to 14)	5.79 (1.77 to 19)	5.32 (1.81 to 16)
Men Y (Day 30)	464 (294 to 734)	16 (5.65 to 48)	697 (435 to 1116)	5.17 (2.16 to 12)	48 (14 to 157)	39 (13 to 120)	658 (431 to 1003)	419 (217 to 809)	6.36 (1.91 to 21)

No statistical analyses for this end point

Secondary: 8. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

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End point title

8. The HT-hSBA GMTs against N. meningitidis strains of serogroup B. ^[6]

End point description

The HT-hSBA GMTs against N. meningitidis strains of serogroup B at Day 1 and one month after the administration of MenABCWY booster vaccination or placebo. Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at day 30 (for seroresponse, Day 1 and Day 30 samples were required).

End point type

Secondary

End point timeframe

Day 1 and Day 30

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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Number of subjects analysed	25	25	17	23	11	21	21	19	18
Units: Titers
geometric mean (confidence interval 95%)
M14459 (fHBP) (Day 1)	2.57 (1.57 to 4.22)	2.58 (1.62 to 4.12)	1.6 (0.97 to 2.65)	2.27 (1.61 to 3.2)	3.11 (1.74 to 5.56)	3.18 (1.87 to 5.41)	1.91 (1.14 to 3.2)	1.45 (1.03 to 2.05)	2.37 (1.31 to 4.29)
M14459 (fHBP) (Day 30)	31 (18 to 54)	2.18 (1.39 to 3.42)	20 (11 to 37)	2.33 (1.62 to 3.35)	56 (27 to 117)	35 (21 to 58)	3.44 (2.05 to 5.75)	2.57 (1.51 to 4.37)	2.93 (1.14 to 7.53)
M01-0240364 (NadA) (Day 1)	2.28 (1.3 to 3.98)	3.11 (1.44 to 6.68)	2.67 (0.87 to 8.24)	1.36 (0.83 to 2.23)	2.46 (0.72 to 8.4)	6.81 (2.47 to 19)	1.34 (0.84 to 2.13)	1.23 (0.88 to 1.71)	1.63 (0.86 to 3.11)
M01-0240364 (NadA) (Day 30)	685 (397 to 1182)	3.21 (1.4 to 7.37)	856 (454 to 1614)	1.94 (1.02 to 3.69)	1336 (810 to 2202)	1275 (794 to 2048)	3.5 (1.32 to 9.3)	3.42 (1.19 to 9.8)	1.76 (0.75 to 4.09)
NZ98/254 (PorA) (Day 1)	1.65 (1.09 to 2.48)	2.11 (1.28 to 3.49)	1.32 (0.94 to 1.84)	1.58 (1.11 to 2.27)	1.72 (0.99 to 2.98)	2.07 (1.17 to 3.66)	1.18 (0.84 to 1.66)	1.18 (0.9 to 1.54)	1.12 (0.94 to 1.34)
NZ98/254 (PorA) (Day 30)	29 (18 to 47)	2.03 (1.21 to 3.4)	12 (5.04 to 31)	1.87 (1.11 to 3.16)	17 (6.22 to 45)	28 (17 to 44)	2.48 (1.31 to 4.69)	1.58 (0.96 to 2.59)	1.71 (0.84 to 3.5)
M07-0241084 (NHBA) (Day 1)	3.53 (2.09 to 5.95)	3.54 (1.98 to 6.31)	2.16 (1.15 to 4.08)	2.52 (1.58 to 4.03)	4.1 (1.89 to 8.9)	6.08 (3.18 to 12)	2.08 (1.26 to 3.42)	2.06 (1.13 to 3.77)	3.01 (1.38 to 6.56)
M07-0241084 (NHBA) (Day 30)	50 (31 to 79)	3.66 (2.02 to 6.64)	29 (14 to 58)	2.48 (1.55 to 3.96)	68 (33 to 142)	69 (36 to 129)	3.26 (1.75 to 6.06)	2.15 (1.13 to 4.07)	3.86 (1.4 to 11)
H44/76 (fHBP) (Day 1)	2.92 (1.5 to 5.67)	2.03 (1.23 to 3.34)	1.46 (0.96 to 2.21)	1.92 (1.11 to 3.32)	3.45 (1.81 to 6.57)	3.24 (1.76 to 5.94)	1.09 (0.96 to 1.22)	1.47 (0.92 to 2.36)	1.18 (0.97 to 1.44)
H44/76 (fHBP) (Day 30)	97 (60 to 157)	2.36 (1.39 to 4.01)	56 (32 to 97)	2.54 (1.42 to 4.53)	132 (64 to 271)	79 (42 to 149)	5.27 (2.54 to 11)	3.85 (1.85 to 8.02)	1.63 (0.75 to 3.52)
5/99 (NadA) (Day 1)	17 (9.56 to 29)	16 (8.32 to 30)	35 (14 to 92)	30 (15 to 60)	27 (8.61 to 86)	43 (24 to 77)	2.97 (1.58 to 5.59)	1.74 (1.01 to 3.03)	2.81 (1.3 to 6.06)
5/99 (NadA) (Day 30)	1131 (716 to 1787)	20 (10 to 42)	1598 (900 to 2840)	34 (20 to 59)	2205 (1560 to 3117)	2576 (1716 to 3867)	28 (11 to 67)	30 (11 to 78)	3.41 (1.2 to 9.73)

No statistical analyses for this end point

Secondary: 9. Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains.

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End point title

9. Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains. ^[7]

End point description

Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, from baseline to one month after the administration of MenABCWY booster vaccination or placebo. Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase. Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at day 30 (for seroresponse, Day 1 and Day 30 samples were required).

End point type

Secondary

End point timeframe

Day 30

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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Number of subjects analysed	25	25	16	23	11	21	21	19	18
Units: Percentage
number (confidence interval 95%)
M14459 (fHBP)	72 (50.6 to 87.9)	0 (0 to 13.7)	87 (59.5 to 98.3)	0 (0 to 14.8)	100 (71.5 to 100)	76 (52.8 to 91.8)	15 (3.2 to 37.9)	5 (0.13 to 26)	6 (0.14 to 27.3)
M01-0240364 (NadA)	100 (85.8 to 100)	4 (0.1 to 20.4)	93 (68.1 to 99.83)	5 (0.13 to 24.9)	100 (69.2 to 100)	90 (69.6 to 98.8)	20 (5.7 to 43.7)	22 (6.4 to 47.6)	6 (0.14 to 27.3)
NZ98/254 (PorA)	76 (54.9 to 90.6)	0 (0 to 13.7)	67 (38.4 to 88.2)	4 (0.11 to 21.9)	82 (48.2 to 97.7)	67 (43 to 85.4)	19 (5.4 to 41.9)	5 (0.13 to 26)	6 (0.14 to 27.3)
M07-0241084 (NHBA)	76 (54.9 to 90.6)	0 (0 to 13.7)	87 (59.5 to 98.3)	0 (0 to 15.4)	82 (48.2 to 97.7)	62 (38.4 to 81.9)	14 (3 to 36.3)	0 (0 to 17.6)	6 (0.14 to 27.3)
H44/76 (fHBP)	84 (63.9 to 95.5)	4 (0.1 to 20.4)	94 (69.8 to 99.84)	0 (0 to 15.4)	100 (71.5 to 100)	76 (52.8 to 91.8)	37 (16.3 to 61.6)	26 (9.1 to 51.2)	6 (0.14 to 27.3)
5/99 (NadA)	100 (86.3 to 100)	4 (0.1 to 20.4)	93 (68.1 to 99.83)	0 (0 to 15.4)	100 (66.4 to 100)	95 (76.2 to 99.88)	57 (34 to 78.2)	79 (54.4 to 93.9)	6 (0.14 to 27.3)

No statistical analyses for this end point

Secondary: 10. Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A ,C, W, Y.

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End point title

10. Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A ,C, W, Y. ^[8]

End point description

Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y at Day 1 and 30 Days after the administration of a booster dose of MenABCWY vaccine or placebo in this study. Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at day 30 (for seroresponse, Day 1 and Day 30 samples were required).

End point type

Secondary

End point timeframe

Day 1 and Day 30

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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Number of subjects analysed	25	25	16	23	11	21	21	18	18
Units: Percentage
number (confidence interval 95%)
Men A (Day 1)	32 (14.9 to 53.5)	20 (6.8 to 40.7)	19 (4 to 45.6)	27 (10.7 to 50.2)	27 (6 to 61)	33 (14.6 to 57)	47 (24.4 to 71.1)	6 (0.16 to 30.2)	39 (17.3 to 64.3)
Men A (Day 30)	100 (86.3 to 100)	36 (18 to 57.5)	100 (79.4 to 100)	27 (10.7 to 50.2)	100 (71.5 to 100)	95 (76.2 to 99.88)	100 (82.4 to 100)	94 (71.3 to 99.85)	39 (17.3 to 64.3)
Men C (Day 1)	70 (45.7 to 88.1)	65 (42.7 to 83.6)	70 (34.8 to 93.3)	68 (45.1 to 86.1)	43 (9.9 to 81.6)	63 (35.4 to 84.8)	57 (34 to 78.2)	44 (21.5 to 69.2)	65 (38.3 to 85.8)
Men C (Day 30)	100 (83.9 to 100)	63 (40.6 to 81.2)	100 (71.5 to 100)	61 (38.5 to 80.3)	100 (59 to 100)	100 (79.4 to 100)	100 (83.9 to 100)	89 (65.3 to 98.6)	61 (35.7 to 82.7)
Men W (Day 1)	95 (75.1 to 99.87)	88 (67.6 to 97.3)	77 (46.2 to 95)	71 (47.8 to 88.7)	82 (48.2 to 97.7)	79 (54.4 to 93.9)	83 (58.6 to 96.4)	53 (27.8 to 77)	53 (26.6 to 78.7)
Men W (Day 30)	100 (83.2 to 100)	79 (57.8 to 92.9)	100 (79.4 to 100)	77 (54.6 to 92.2)	100 (71.5 to 100)	100 (82.4 to 100)	100 (82.4 to 100)	100 (80.5 to 100)	63 (35.4 to 84.8)
Men Y (Day 1)	64 (42.5 to 82)	64 (42.5 to 82)	64 (35.1 to 87.2)	41 (20.7 to 63.6)	36 (10.9 to 69.2)	10 (1.2 to 30.4)	52 (29.8 to 74.3)	39 (17.3 to 64.3)	39 (17.3 to 64.3)
Men Y (Day 30)	100 (86.3 to 100)	60 (38.7 to 78.9)	100 (79.4 to 100)	39 (19.7 to 61.5)	82 (48.2 to 97.7)	76 (52.8 to 91.8)	100 (83.9 to 100)	100 (81.5 to 100)	39 (17.3 to 64.3)

No statistical analyses for this end point

Secondary: 11. Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis serogroup B strains.

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End point title

11. Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis serogroup B strains. ^[9]

End point description

Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains at Day 1 and 30 Days after the administration of a booster dose of MenABCWY vaccine or placebo in this study. Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at day 30 (for seroresponse, Day 1 and Day 30 samples were required).

End point type

Secondary

End point timeframe

Day 1 and Day 30

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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Number of subjects analysed	25	25	17	23	11	21	21	19	18
Units: Percentage
number (confidence interval 95%)
M14459 (fHBP) (Day 1)	24 (9.4 to 45.1)	32 (14.9 to 53.5)	7 (0.17 to 31.9)	17 (5 to 38.8)	36 (10.9 to 69.2)	29 (11.3 to 52.2)	10 (1.2 to 31.7)	11 (1.3 to 33.1)	22 (6.4 to 47.6)
M14459 (fHBP) (Day 30)	92 (74 to 99)	28 (12.1 to 49.4)	88 (63.6 to 98.5)	30 (13.2 to 52.9)	100 (71.5 to 100)	95 (76.2 to 99.88)	35 (15.4 to 59.2)	32 (12.6 to 56.6)	22 (6.4 to 47.6)
M01-0240364 (NadA) (Day 1)	25 (9.8 to 46.7)	24 (9.4 to 45.1)	20 (4.3 to 48.1)	5 (0.13 to 24.9)	20 (2.5 to 55.6)	43 (21.8 to 66)	5 (0.13 to 24.9)	6 (0.14 to 27.3)	11 (1.4 to 34.7)
M01-0240364 (NadA) (Day 30)	100 (86.3 to 100)	24 (9.4 to 45.1)	100 (80.5 to 100)	18 (5.2 to 40.3)	100 (71.5 to 100)	100 (83.9 to 100)	25 (8.7 to 49.1)	26 (9.1 to 51.2)	11 (1.4 to 34.7)
NZ98/254 (PorA) (Day 1)	16 (4.5 to 36.1)	28 (12.1 to 49.4)	7 (0.17 to 31.9)	9 (1.1 to 28)	9 (0.23 to 41.3)	24 (8.2 to 47.2)	5 (0.12 to 23.8)	5 (0.13 to 26)	0 (0 to 18.5)
NZ98/254 (PorA) (Day 30)	92 (74 to 99)	20 (6.8 to 40.7)	71 (44 to 89.7)	13 (2.8 to 33.6)	82 (48.2 to 97.7)	95 (76.2 to 99.88)	19 (5.4 to 41.9)	16 (3.4 to 39.6)	6 (0.14 to 27.3)
M07-0241084 (NHBA) (Day 1)	36 (18 to 57.5)	36 (18 to 57.5)	27 (7.8 to 55.1)	27 (10.7 to 50.2)	64 (30.8 to 89.1)	52 (29.8 to 74.3)	19 (5.4 to 41.9)	16 (3.4 to 39.6)	33 (13.3 to 59)
M07-0241084 (NHBA) (Day 30)	100 (86.3 to 100)	40 (21.1 to 61.3)	88 (63.6 to 98.5)	30 (13.2 to 52.9)	91 (58.7 to 99.77)	95 (76.2 to 99.88)	33 (14.6 to 57)	21 (6.1 to 45.6)	33 (13.3 to 59)
H44/76 (fHBP) (Day 1)	16 (4.5 to 36.1)	24 (9.4 to 45.1)	13 (1.6 to 38.3)	18 (5.2 to 40.3)	45 (16.7 to 76.6)	29 (11.3 to 52.2)	0 (0 to 17.6)	5 (0.13 to 26)	0 (0 to 18.5)
H44/76 (fHBP) (Day 30)	96 (79.6 to 99.9)	24 (9.4 to 45.1)	100 (80.5 to 100)	26 (10.2 to 48.4)	100 (71.5 to 100)	100 (83.9 to 100)	58 (33.5 to 79.7)	32 (12.6 to 56.6)	6 (0.14 to 27.3)
5/99 (NadA) (Day 1)	76 (54.9 to 90.6)	76 (54.9 to 90.6)	87 (59.5 to 98.3)	86 (65.1 to 97.1)	89 (51.8 to 99.72)	95 (76.2 to 99.88)	19 (5.4 to 41.9)	16 (3.4 to 39.6)	22 (6.4 to 47.6)
5/99 (NadA) (Day 30)	100 (86.3 to 100)	84 (63.9 to 95.5)	100 (80.5 to 100)	91 (72 to 98.9)	100 (71.5 to 100)	100 (83.9 to 100)	76 (52.8 to 91.8)	84 (60.4 to 96.6)	22 (6.4 to 47.6)

No statistical analyses for this end point

Secondary: 12. Percentage of subjects with seroresponse to N. meningitidis serogroups A, C, W and Y, at Day 30 after booster vaccination.

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End point title

12. Percentage of subjects with seroresponse to N. meningitidis serogroups A, C, W and Y, at Day 30 after booster vaccination. ^[10]

End point description

Percentage of subjects with seroresponse to N. meningitidis serogroups A, C, W and Y at Day 30 after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline. Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at day 30 (for seroresponse, Day 1 and Day 30 samples were required).

End point type

Secondary

End point timeframe

Day 30

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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Number of subjects analysed	25	25	16	23	11	21	21	18	18
Units: Percentage
number (confidence interval 95%)
Men A overall	96 (79.6 to 99.9)	12 (2.5 to 31.2)	94 (69.8 to 99.84)	0 (0 to 15.4)	100 (71.5 to 100)	86 (63.7 to 97)	84 (60.4 to 96.6)	94 (69.8 to 99.84)	0 (0 to 18.5)
Men C overall	85 (62.1 to 96.8)	4 (0.11 to 21.9)	100 (69.2 to 100)	0 (0 to 15.4)	100 (59 to 100)	81 (54.4 to 96)	95 (76.2 to 99.88)	78 (52.4 to 93.6)	6 (0.15 to 28.7)
Men W overall	85 (62.1 to 96.8)	4 (0.11 to 21.1)	85 (54.6 to 98.1)	5 (0.12 to 23.8)	82 (48.2 to 97.7)	68 (43.4 to 87.4)	83 (58.6 to 96.4)	76 (50.1 to 93.2)	20 (4.3 to 48.1)
Men Y overall	96 (79.6 to 99.9)	4 (0.1 to 20.4)	100 (76.8 to 100)	0 (0 to 15.4)	73 (39 to 94)	62 (38.4 to 81.9)	95 (76.2 to 99.88)	89 (65.3 to 98.6)	6 (0.14 to 27.3)

No statistical analyses for this end point

Secondary: 13. Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y.

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End point title

13. Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y. ^[11]

End point description

Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at 24 and 36 months after the primary vaccination. Analysis was done on the FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.

End point type

Secondary

End point timeframe

Day 1 and Day 365

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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Number of subjects analysed	21	22	16	20	11	20	20	18	17
Units: Percentage
number (confidence interval 95%)
Men A (Day 1)	38 (18.1 to 61.6)	18 (5.2 to 40.3)	20 (4.3 to 48.1)	30 (11.9 to 54.3)	30 (6.7 to 65.2)	35 (15.4 to 59.2)	45 (23.1 to 68.5)	12 (1.5 to 36.4)	41 (18.4 to 67.1)
Men A (Day 365)	67 (43 to 85.4)	23 (7.8 to 45.4)	88 (61.7 to 98.4)	25 (8.7 to 49.1)	90 (55.5 to 99.75)	85 (62.1 to 96.8)	85 (62.1 to 96.8)	50 (26 to 74)	35 (14.2 to 61.7)
Men C (Day 1)	65 (40.8 to 84.6)	68 (43.4 to 87.4)	71 (41.9 to 91.6)	65 (40.8 to 84.6)	36 (10.9 to 69.2)	58 (33.5 to 79.7)	58 (33.5 to 79.7)	50 (26 to 74)	75 (47.6 to 92.7)
Men C (Day 365)	100 (83.9 to 100)	62 (38.4 to 81.9)	100 (79.4 to 100)	50 (27.2 to 72.8)	82 (48.2 to 97.7)	95 (74 to 99.87)	100 (82.4 to 100)	89 (65.3 to 98.6)	65 (38.3 to 85.8)
Men W (Day 1)	95 (75.1 to 99.87)	95 (77.2 to 99.88)	75 (42.8 to 94.5)	70 (45.7 to 88.1)	82 (48.2 to 97.7)	75 (50.9 to 91.3)	82 (56.6 to 96.2)	61 (35.7 to 82.7)	56 (29.9 to 80.2)
Men W (Day 365)	100 (83.9 to 100)	82 (59.7 to 94.8)	100 (79.4 to 100)	65 (40.8 to 84.6)	91 (58.7 to 99.77)	100 (83.2 to 100)	100 (82.4 to 100)	100 (81.5 to 100)	65 (38.3 to 85.8)
Men Y (Day 1)	62 (38.4 to 81.9)	62 (38.4 to 81.9)	71 (41.9 to 91.6)	40 (19.1 to 63.9)	36 (10.9 to 69.2)	11 (1.4 to 34.7)	55 (31.5 to 76.9)	44 (21.5 to 69.2)	41 (18.4 to 67.1)
Men Y (Day 365)	95 (76.2 to 99.88)	52 (29.8 to 74.3)	100 (79.4 to 100)	40 (19.1 to 63.9)	45 (16.7 to 76.6)	72 (46.5 to 90.3)	100 (83.2 to 100)	89 (65.3 to 98.6)	47 (23 to 72.2)

No statistical analyses for this end point

Secondary: 14. Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis strains of serogroup B.

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End point title

14. Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis strains of serogroup B. ^[12]

End point description

Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B at 24 and 36 months after the primary vaccination. Analysis was done on FAS Day 30 (Booster) and FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 and Day 365.

End point type

Secondary

End point timeframe

Day 1, Day 30 and Day 365

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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Number of subjects analysed	21	22	16	20	11	20	21	18	17
Units: Percentage
number (confidence interval 95%)
M14459 (fHBP) (Day 1)	24 (8.2 to 47.2)	36 (17.2 to 59.3)	7 (0.18 to 33.9)	15 (3.2 to 37.9)	36 (10.9 to 69.2)	30 (11.9 to 54.3)	10 (1.2 to 30.4)	11 (1.4 to 34.7)	24 (6.8 to 49.9)
M14459 (fHBP) (Day 30)	95 (76.2 to 99.88)	32 (13.9 to 54.9)	88 (61.7 to 98.4)	20 (5.7 to 43.7)	100 (71.5 to 100)	95 (75.1 to 99.87)	35 (15.4 to 59.2)	33 (13.3 to 59)	25 (7.3 to 52.4)
M14459 (fHBP) (Day 365)	57 (34 to 78.2)	18 (5.2 to 40.3)	38 (15.2 to 64.6)	5 (0.13 to 24.9)	82 (48.2 to 97.7)	60 (36.1 to 80.9)	14 (3 to 36.3)	11 (1.4 to 34.7)	24 (6.8 to 49.9)
M01-0240364 (NadA) (Day 1)	24 (8.2 to 47.2)	27 (10.7 to 50.2)	21 (4.7 to 50.8)	6 (0.14 to 27.3)	20 (2.5 to 55.6)	42 (20.3 to 66.5)	5 (0.13 to 24.9)	6 (0.15 to 28.7)	12 (1.5 to 36.4)
M01-0240364 (NadA) (Day 30)	100 (83.9 to 100)	27 (10.7 to 50.2)	100 (79.4 to 100)	6 (0.15 to 28.7)	100 (71.5 to 100)	100 (82.4 to 100)	21 (6.1 to 45.6)	28 (9.7 to 53.5)	13 (1.6 to 38.3)
M01-0240364 (NadA) (Day 365)	71 (47.8 to 88.7)	32 (13.9 to 54.9)	75 (47.6 to 92.7)	6 (0.14 to 27.3)	100 (71.5 to 100)	95 (74 to 99.87)	15 (3.2 to 37.9)	11 (1.4 to 34.7)	18 (3.8 to 43.4)
NZ98/254 (PorA) (Day 1)	19 (5.4 to 41.9)	32 (13.9 to 54.9)	7 (0.18 to 33.9)	5 (0.13 to 24.9)	9 (0.23 to 41.3)	26 (9.1 to 51.2)	5 (0.12 to 23.8)	6 (0.14 to 27.3)	0 (0 to 19.5)
NZ98/254 (PorA) (Day 30)	95 (76.2 to 99.88)	23 (7.8 to 45.4)	75 (47.6 to 92.7)	10 (1.2 to 31.7)	82 (48.2 to 97.7)	95 (74 to 99.87)	19 (5.4 to 41.9)	17 (3.6 to 41.4)	6 (0.16 to 30.2)
NZ98/254 (PorA) (Day 365)	29 (11.3 to 52.2)	14 (2.9 to 34.9)	31 (11 to 58.7)	5 (0.13 to 24.9)	45 (16.7 to 76.6)	42 (20.3 to 66.5)	19 (5.4 to 41.9)	6 (0.14 to 27.3)	6 (0.15 to 28.7)
M07-0241084 (NHBA) (Day 1)	38 (18.1 to 61.6)	41 (20.7 to 63.6)	29 (8.4 to 58.1)	25 (8.7 to 49.1)	64 (30.8 to 89.1)	58 (33.5 to 79.7)	19 (5.4 to 41.9)	17 (3.6 to 41.4)	35 (14.2 to 61.7)
M07-0241084 (NHBA) (Day 30)	100 (83.9 to 100)	45 (24.4 to 67.8)	94 (69.8 to 99.84)	25 (8.7 to 49.1)	91 (58.7 to 99.77)	95 (74 to 99.87)	33 (14.6 to 57)	22 (6.4 to 47.6)	38 (15.2 to 64.6)
M07-0241084 (NHBA) (Day 365)	62 (38.4 to 81.9)	32 (13.9 to 54.9)	50 (24.7 to 75.3)	20 (5.7 to 43.7)	82 (48.2 to 97.7)	74 (48.8 to 90.9)	29 (11.3 to 52.2)	17 (3.6 to 41.4)	35 (14.2 to 61.7)
H44/76 (fHBP) (Day 1)	19 (5.4 to 41.9)	27 (10.7 to 50.2)	13 (1.7 to 40.5)	15 (3.2 to 37.9)	45 (16.7 to 76.6)	30 (11.9 to 54.3)	5 (0.12 to 23.8)	6 (0.14 to 27.3)	0 (0 to 19.5)
H44/76 (fHBP) (Day 30)	95 (76.2 to 99.88)	27 (10.7 to 50.2)	100 (79.4 to 100)	15 (3.2 to 37.9)	100 (71.5 to 100)	100 (83.2 to 100)	58 (33.5 to 79.7)	33 (13.3 to 59)	6 (0.16 to 30.2)
H44/76 (fHBP) (Day 365)	76 (52.8 to 91.8)	18 (5.2 to 40.3)	44 (19.8 to 70.1)	10 (1.2 to 31.7)	82 (48.2 to 97.7)	65 (40.8 to 84.6)	19 (5.4 to 41.9)	11 (1.4 to 34.7)	6 (0.15 to 28.7)
5/99 (NadA) (Day 1)	76 (52.8 to 91.8)	82 (59.7 to 94.8)	86 (57.2 to 98.2)	85 (62.1 to 96.8)	89 (51.8 to 99.72)	95 (74 to 99.87)	19 (5.4 to 41.9)	17 (3.6 to 41.4)	24 (6.8 to 49.9)
5/99 (NadA) (Day 30)	100 (83.9 to 100)	86 (65.1 to 97.1)	100 (79.4 to 100)	90 (68.3 to 98.8)	100 (71.5 to 100)	100 (82.4 to 100)	76 (52.8 to 91.8)	83 (58.6 to 96.4)	25 (7.3 to 52.4)
5/99 (NadA) (Day 365)	95 (76.2 to 99.88)	77 (54.6 to 92.2)	100 (79.4 to 100)	80 (56.3 to 94.3)	100 (71.5 to 100)	100 (82.4 to 100)	43 (21.8 to 66)	33 (13.3 to 59)	18 (3.8 to 43.4)

No statistical analyses for this end point

Secondary: 15. Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains.

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End point title

15. Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains. ^[13]

End point description

Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains at 36 months after the primary vaccination. Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase. Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.

End point type

Secondary

End point timeframe

Day 30 and Day 365

Notes
[13] - 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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Number of subjects analysed	21	22	15	20	11	20	21	18	17
Units: Percentage
number (confidence interval 95%)
M14459 (fHBP) (Day 30)	76 (52.8 to 91.8)	0 (0 to 15.4)	86 (57.2 to 98.2)	0 (0 to 16.8)	100 (71.5 to 100)	75 (50.9 to 91.3)	15 (3.2 to 37.9)	6 (0.14 to 27.3)	6 (0.16 to 30.2)
M14459 (fHBP) (Day 365)	24 (8.2 to 47.2)	0 (0 to 15.4)	0 (0 to 23.2)	0 (0 to 16.8)	36 (10.9 to 69.2)	25 (8.7 to 49.1)	10 (1.2 to 30.4)	0 (0 to 18.5)	6 (0.15 to 28.7)
M01-0240364 (NadA) (Day 30)	100 (83.9 to 100)	5 (0.12 to 22.8)	93 (66.1 to 99.82)	6 (0.15 to 28.7)	100 (69.2 to 100)	89 (66.9 to 98.7)	16 (3.4 to 39.6)	24 (6.8 to 49.9)	6 (0.16 to 30.2)
M01-0240364 (NadA) (Day 365)	62 (38.4 to 81.9)	5 (0.12 to 22.8)	64 (35.1 to 87.2)	6 (0.14 to 27.3)	90 (55.5 to 99.75)	79 (54.4 to 93.9)	15 (3.2 to 37.9)	6 (0.15 to 28.7)	6 (0.15 to 28.7)
NZ98/254 (PorA) (Day 30)	81 (58.1 to 94.6)	0 (0 to 15.4)	71 (41.9 to 91.6)	5 (0.13 to 24.9)	82 (48.2 to 97.7)	63 (38.4 to 83.7)	19 (5.4 to 41.9)	6 (0.14 to 27.3)	6 (0.16 to 30.2)
NZ98/254 (PorA) (Day 365)	10 (1.2 to 30.4)	0 (0 to 15.4)	14 (1.8 to 42.8)	0 (0 to 16.8)	9 (0.23 to 41.3)	5 (0.13 to 26)	10 (1.2 to 30.4)	0 (0 to 18.5)	6 (0.15 to 28.7)
M07-0241084 (NHBA) (Day 30)	81 (58.1 to 94.6)	0 (0 to 15.4)	93 (66.1 to 99.82)	0 (0 to 16.8)	82 (48.2 to 97.7)	58 (33.5 to 79.7)	14 (3 to 36.3)	0 (0 to 18.5)	6 (0.16 to 30.2)
M07-0241084 (NHBA) (Day 365)	19 (5.4 to 41.9)	0 (0 to 15.4)	0 (0 to 23.2)	0 (0 to 16.8)	27 (6 to 61)	5 (0.13 to 26)	0 (0 to 16.1)	0 (0 to 18.5)	6 (0.15 to 28.7)
H44/76 (fHBP) (Day 30)	81 (58.1 to 94.6)	5 (0.12 to 22.8)	93 (68.1 to 99.83)	0 (0 to 16.8)	100 (71.5 to 100)	75 (50.9 to 91.3)	37 (16.3 to 61.6)	28 (9.7 to 53.5)	6 (0.16 to 30.2)
H44/76 (fHBP) (Day 365)	38 (18.1 to 61.6)	0 (0 to 15.4)	20 (4.3 to 48.1)	0 (0 to 16.8)	64 (30.8 to 89.1)	30 (11.9 to 54.3)	10 (1.2 to 30.4)	0 (0 to 18.5)	6 (0.15 to 28.7)
5/99 (NadA) (Day 30)	100 (83.9 to 100)	5 (0.12 to 22.8)	93 (66.1 to 99.82)	0 (0 to 16.8)	100 (66.4 to 100)	100 (82.4 to 100)	57 (34 to 78.2)	78 (52.4 to 93.6)	6 (0.16 to 30.2)
5/99 (NadA) (Day 365)	67 (43 to 85.4)	5 (0.12 to 22.8)	86 (57.2 to 98.2)	0 (0 to 16.8)	89 (51.8 to 99.72)	74 (48.8 to 90.9)	29 (11.3 to 52.2)	28 (9.7 to 53.5)	6 (0.15 to 28.7)

No statistical analyses for this end point

Secondary: 16. The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y.

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End point title

16. The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y. ^[14]

End point description

The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y at 24 and 36 months after the primary vaccination. Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.

End point type

Secondary

End point timeframe

Day 1 and Day 365

Notes
[14] - 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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Number of subjects analysed	21	22	16	20	11	20	20	18	17
Units: Titers
geometric mean (confidence interval 95%)
Men A (Day 1)	3.98 (1.98 to 8)	2.73 (1.44 to 5.15)	3.07 (1.26 to 7.47)	2.98 (1.38 to 6.42)	2.27 (0.87 to 5.94)	4.22 (1.63 to 11)	6.31 (2.82 to 14)	2.49 (1.52 to 4.09)	5.48 (2.18 to 14)
Men A (Day 365)	25 (11 to 59)	2.62 (1.39 to 4.94)	44 (18 to 105)	3.03 (1.3 to 7.06)	54 (17 to 174)	53 (22 to 130)	34 (16 to 69)	6.52 (2.71 to 16)	3.54 (1.4 to 8.92)
Men C (Day 1)	18 (8.21 to 39)	19 (7.54 to 49)	19 (8.13 to 44)	10 (5.52 to 19)	5.2 (2.8 to 9.65)	7.83 (4.51 to 14)	7.89 (4.26 to 15)	8.45 (2.64 to 27)	24 (9.34 to 61)
Men C (Day 365)	128 (75 to 217)	15 (5.82 to 39)	177 (102 to 305)	9.14 (4.07 to 21)	29 (10 to 82)	32 (16 to 67)	81 (46 to 141)	72 (27 to 191)	24 (8.98 to 66)
Men W (Day 1)	36 (21 to 62)	43 (24 to 79)	30 (7.82 to 112)	17 (6.88 to 43)	25 (7.98 to 79)	23 (9.81 to 52)	28 (11 to 70)	15 (4.54 to 47)	10 (3.53 to 30)
Men W (Day 365)	190 (133 to 272)	28 (13 to 59)	213 (135 to 337)	16 (5.58 to 47)	80 (26 to 246)	96 (72 to 127)	172 (97 to 306)	104 (49 to 221)	16 (5.27 to 49)
Men Y (Day 1)	10 (4.39 to 24)	16 (4.85 to 54)	24 (6.62 to 90)	5.39 (2.06 to 14)	2.4 (1.05 to 5.47)	1.9 (1.02 to 3.55)	7.05 (3.08 to 16)	6.83 (2.11 to 22)	7.03 (1.99 to 25)
Men Y (Day 365)	116 (58 to 231)	18 (5.05 to 62)	235 (147 to 376)	5.93 (1.97 to 18)	7.17 (1.91 to 27)	20 (6.92 to 58)	193 (123 to 301)	101 (36 to 280)	9.56 (2.44 to 37)

No statistical analyses for this end point

Secondary: 17. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

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End point title

17. The HT-hSBA GMTs against N. meningitidis strains of serogroup B. ^[15]

End point description

The HT-hSBA GMTs against N. meningitidis strains of serogroup B at 24 and 36 months after the primary vaccination. Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.

End point type

Secondary

End point timeframe

Day 1 and Day 365

Notes
[15] - 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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Number of subjects analysed	21	22	16	20	11	20	21	18	17
Units: Titers
geometric mean (confidence interval 95%)
M14459 (fHBP) (Day 1)	2.69 (1.51 to 4.78)	2.94 (1.77 to 4.89)	1.54 (0.9 to 2.63)	2.01 (1.4 to 2.88)	3.11 (1.74 to 5.56)	3.37 (1.95 to 5.81)	1.85 (1.13 to 3.04)	1.48 (1.03 to 2.13)	2.55 (1.37 to 4.77)
M14459 (fHBP) (Day 365)	7.19 (3.89 to 13)	1.67 (1.07 to 2.6)	2.94 (1.49 to 5.8)	1.47 (1.07 to 2.03)	11 (4.41 to 28)	7.12 (3.59 to 14)	2.09 (1.33 to 3.29)	1.38 (0.98 to 1.93)	2.17 (1.07 to 4.41)
M01-0240364 (NadA) (Day 1)	2.33 (1.25 to 4.36)	3.39 (1.43 to 8.05)	2.87 (0.86 to 9.59)	1.26 (0.89 to 1.8)	2.46 (0.72 to 8.4)	6.29 (2.22 to 18)	1.24 (0.79 to 1.94)	1.24 (0.88 to 1.77)	1.68 (0.85 to 3.33)
M01-0240364 (NadA) (Day 365)	30 (9.54 to 93)	3.55 (1.56 to 8.07)	74 (18 to 300)	1.23 (0.91 to 1.68)	303 (174 to 527)	155 (69 to 350)	1.61 (0.99 to 2.63)	1.71 (0.86 to 3.42)	2.03 (0.9 to 4.58)
NZ98/254 (PorA) (Day 1)	1.73 (1.06 to 2.81)	2.34 (1.33 to 4.1)	1.34 (0.94 to 1.93)	1.48 (1.01 to 2.17)	1.72 (0.99 to 2.98)	2.24 (1.2 to 4.17)	1.18 (0.84 to 1.66)	1.19 (0.9 to 1.58)	1.13 (0.94 to 1.37)
NZ98/254 (PorA) (Day 365)	3.49 (2.12 to 5.74)	1.71 (1.14 to 2.57)	2.67 (1.27 to 5.61)	1.23 (0.9 to 1.69)	3.28 (1.66 to 6.49)	3.77 (1.98 to 7.18)	1.65 (1.04 to 2.61)	1.19 (0.91 to 1.54)	1.28 (0.85 to 1.92)
M07-0241084 (NHBA) (Day 1)	3.68 (2.07 to 6.54)	4.2 (2.25 to 7.85)	2.28 (1.16 to 4.48)	2.36 (1.51 to 3.7)	4.1 (1.89 to 8.9)	7.35 (3.82 to 14)	2.08 (1.26 to 3.42)	2.15 (1.14 to 4.05)	3.5 (1.57 to 7.8)
M07-0241084 (NHBA) (Day 365)	7.96 (4.6 to 14)	3.28 (2.16 to 4.97)	4.09 (2.3 to 7.25)	2.04 (1.43 to 2.92)	10 (4.51 to 24)	11 (6.35 to 18)	2.45 (1.59 to 3.79)	1.91 (1.14 to 3.23)	3.92 (1.9 to 8.07)
H44/76 (fHBP) (Day 1)	3.58 (1.66 to 7.71)	2.23 (1.28 to 3.9)	1.49 (0.96 to 2.33)	1.73 (0.97 to 3.1)	3.45 (1.81 to 6.57)	3.43 (1.83 to 6.43)	1.34 (0.85 to 2.13)	1.51 (0.91 to 2.48)	1.19 (0.97 to 1.47)
H44/76 (fHBP) (Day 365)	12 (5.18 to 26)	1.93 (1.2 to 3.1)	4.19 (1.93 to 9.11)	1.83 (1.07 to 3.15)	21 (6 to 71)	11 (4.68 to 25)	1.96 (1.21 to 3.19)	1.92 (1.17 to 3.17)	1.49 (0.9 to 2.48)
5/99 (NadA) (Day 1)	18 (9.47 to 34)	18 (9.5 to 34)	31 (12 to 85)	31 (15 to 65)	27 (8.61 to 86)	39 (21 to 74)	2.97 (1.58 to 5.59)	1.8 (1.01 to 3.22)	3.2 (1.44 to 7.09)
5/99 (NadA) (Day 365)	175 (79 to 385)	13 (6.07 to 29)	305 (149 to 625)	23 (11 to 47)	587 (351 to 983)	491 (258 to 936)	6.05 (3.1 to 12)	4.23 (1.48 to 12)	2.45 (1 to 5.99)

No statistical analyses for this end point

Secondary: 18. Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y.

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End point title

18. Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y. ^[16]

End point description

Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination. Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.

End point type

Secondary

End point timeframe

Day 1, Day 30 and Day 365

Notes
[16] - 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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2qOMV_qOMV	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV
Number of subjects analysed	21	16	11	20	20	18
Units: Percentage
number (confidence interval 95%)
Men A (Day 1)	38 (18.1 to 61.6)	20 (4.3 to 48.1)	30 (6.7 to 65.2)	35 (15.4 to 59.2)	45 (23.1 to 68.5)	12 (1.5 to 36.4)
Men C (Day 1)	65 (40.8 to 84.6)	71 (41.9 to 91.6)	36 (10.9 to 69.2)	58 (33.5 to 79.7)	58 (33.5 to 79.7)	50 (26 to 74)
Men W (Day 1)	95 (75.1 to 99.87)	75 (42.8 to 94.5)	82 (48.2 to 97.7)	75 (50.9 to 91.3)	82 (56.6 to 96.2)	61 (35.7 to 82.7)
Men Y (Day 1)	62 (38.4 to 81.9)	71 (41.9 to 91.6)	36 (10.9 to 69.2)	11 (1.4 to 34.7)	55 (31.5 to 76.9)	44 (21.5 to 69.2)
Men A (Day 30)	100 (83.9 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	95 (75.1 to 99.87)	100 (81.5 to 100)	94 (69.8 to 99.84)
Men C (Day 30)	100 (80.5 to 100)	100 (69.2 to 100)	100 (59 to 100)	100 (76.8 to 100)	100 (82.4 to 100)	88 (63.6 to 98.5)
Men W (Day 30)	100 (81.5 to 100)	100 (78.2 to 100)	100 (71.5 to 100)	100 (81.5 to 100)	100 (80.5 to 100)	100 (79.4 to 100)
Men Y (Day 30)	100 (83.9 to 100)	100 (78.2 to 100)	82 (48.2 to 97.7)	83 (58.6 to 96.4)	100 (83.2 to 100)	100 (80.5 to 100)
Men A (Day 365)	67 (43 to 85.4)	88 (61.7 to 98.4)	90 (55.5 to 99.75)	85 (62.1 to 96.8)	85 (62.1 to 96.8)	50 (26 to 74)
Men C (Day 365)	100 (83.9 to 100)	100 (79.4 to 100)	82 (48.2 to 97.7)	95 (74 to 99.87)	100 (82.4 to 100)	89 (65.3 to 98.6)
Men W(Day 365)	100 (83.9 to 100)	100 (79.4 to 100)	91 (58.7 to 99.77)	100 (83.2 to 100)	100 (82.4 to 100)	100 (81.5 to 100)
Men Y (Day 365)	95 (76.2 to 99.88)	100 (79.4 to 100)	45 (16.7 to 76.6)	72 (46.5 to 90.3)	100 (83.2 to 100)	89 (65.3 to 98.6)

No statistical analyses for this end point

Secondary: 19. Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis in strains of serogroup B.

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End point title

19. Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis in strains of serogroup B. ^[17]

End point description

Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis in strains of serogroup B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination. Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.

End point type

Secondary

End point timeframe

Day 1, Day 30 and Day 365

Notes
[17] - 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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2qOMV_qOMV	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV
Number of subjects analysed	21	16	11	20	21	18
Units: Percentage
number (confidence interval 95%)
M14459 (fHBP) (Day 1)	24 (8.2 to 47.2)	7 (0.18 to 33.9)	36 (10.9 to 69.2)	30 (11.9 to 54.3)	10 (1.2 to 30.4)	11 (1.4 to 34.7)
M01-0240364 (NadA) (Day 1)	24 (8.2 to 47.2)	21 (4.7 to 50.8)	20 (2.5 to 55.6)	42 (20.3 to 66.5)	5 (0.13 to 24.9)	6 (0.15 to 28.7)
NZ98/254 (PorA) (Day 1)	19 (5.4 to 41.9)	7 (0.18 to 33.9)	9 (0.23 to 41.3)	26 (9.1 to 51.2)	5 (0.12 to 23.8)	6 (0.14 to 27.3)
M07-0241084 (NHBA) (Day 1)	38 (18.1 to 61.6)	29 (8.4 to 58.1)	64 (30.8 to 89.1)	58 (33.5 to 79.7)	19 (5.4 to 41.9)	17 (3.6 to 41.4)
H44/76 (fHBP) (Day 1)	19 (5.4 to 41.9)	13 (1.7 to 40.5)	45 (16.7 to 76.6)	30 (11.9 to 54.3)	5 (0.12 to 23.8)	6 (0.14 to 27.3)
5/99 (NadA) (Day 1)	76 (52.8 to 91.8)	86 (57.2 to 98.2)	89 (51.8 to 99.72)	95 (74 to 99.87)	19 (5.4 to 41.9)	17 (3.6 to 41.4)
M14459 (fHBP) (Day 30)	95 (76.2 to 99.88)	88 (61.7 to 98.4)	100 (71.5 to 100)	95 (75.1 to 99.87)	35 (15.4 to 59.2)	33 (13.3 to 59)
M01-0240364 (NadA) (Day 30)	100 (83.9 to 100)	100 (79.4 to 100)	100 (71.5 to 100)	100 (82.4 to 100)	21 (6.1 to 45.6)	28 (9.7 to 53.5)
NZ98/254 (PorA) (Day 30)	95 (76.2 to 99.88)	75 (47.6 to 92.7)	82 (48.2 to 97.7)	95 (74 to 99.87)	19 (5.4 to 41.9)	17 (3.6 to 41.4)
M07-0241084 (NHBA) (Day 30)	100 (83.9 to 100)	94 (69.8 to 99.84)	91 (58.7 to 99.77)	95 (74 to 99.87)	33 (14.6 to 57)	22 (6.4 to 47.6)
H44/76 (fHBP) (Day 30)	95 (76.2 to 99.88)	100 (79.4 to 100)	100 (71.5 to 100)	100 (83.2 to 100)	58 (33.5 to 79.7)	33 (13.3 to 59)
5/99 (NadA) (Day 30)	100 (83.9 to 100)	100 (79.4 to 100)	100 (71.5 to 100)	100 (82.4 to 100)	76 (52.8 to 91.8)	83 (58.6 to 96.4)
M14459 (fHBP) (Day 365)	57 (34 to 78.2)	38 (15.2 to 64.6)	82 (48.2 to 97.7)	60 (36.1 to 80.9)	14 (3 to 36.3)	11 (1.4 to 34.7)
M01-0240364 (NadA) (Day 365)	71 (47.8 to 88.7)	75 (47.6 to 92.7)	100 (71.5 to 100)	95 (74 to 99.87)	15 (3.2 to 37.9)	11 (1.4 to 34.7)
NZ98/254 (PorA) (Day 365)	29 (11.3 to 52.2)	31 (11 to 58.7)	45 (16.7 to 76.6)	42 (20.3 to 66.5)	19 (5.4 to 41.9)	6 (0.14 to 27.3)
M07-0241084 (NHBA) (Day 365)	62 (38.4 to 81.9)	50 (24.7 to 75.3)	82 (48.2 to 97.7)	74 (48.8 to 90.9)	29 (11.3 to 52.2)	17 (3.6 to 41.4)
H44/76 (fHBP) (Day 365)	76 (52.8 to 91.8)	44 (19.8 to 70.1)	82 (48.2 to 97.7)	65 (40.8 to 84.6)	19 (5.4 to 41.9)	11 (1.4 to 34.7)
5/99 (NadA) (Day 365)	95 (76.2 to 99.88)	100 (79.4 to 100)	100 (71.5 to 100)	100 (82.4 to 100)	43 (21.8 to 66)	33 (13.3 to 59)

No statistical analyses for this end point

Secondary: 20. The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y.

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End point title

20. The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y. ^[18]

End point description

The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination. Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.

End point type

Secondary

End point timeframe

Day 1, Day 30 and Day 365

Notes
[18] - 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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2qOMV_qOMV	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV
Number of subjects analysed	21	16	11	20	20	18
Units: Titers
geometric mean (confidence interval 95%)
Men A (Day 1)	3.98 (1.98 to 8)	3.07 (1.26 to 7.47)	2.27 (0.87 to 5.94)	4.22 (1.63 to 11)	6.31 (2.82 to 14)	2.49 (1.52 to 4.09)
Men C (Day 1)	18 (8.21 to 39)	19 (8.13 to 44)	5.2 (2.8 to 9.65)	7.83 (4.51 to 14)	7.89 (4.26 to 15)	8.45 (2.64 to 27)
Men W (Day 1)	36 (21 to 62)	30 (7.82 to 112)	25 (7.98 to 79)	23 (9.81 to 52)	28 (11 to 70)	15 (4.54 to 47)
Men Y (Day 1)	10 (4.39 to 24)	24 (6.62 to 90)	2.4 (1.05 to 5.47)	1.9 (1.02 to 3.55)	7.05 (3.08 to 16)	6.83 (2.11 to 22)
Men A (Day 30)	275 (174 to 435)	348 (202 to 601)	445 (277 to 715)	428 (196 to 931)	140 (82 to 239)	46 (23 to 91)
Men C (Day 30)	737 (459 to 1183)	766 (325 to 1804)	292 (75 to 1142)	102 (57 to 181)	322 (186 to 556)	307 (118 to 795)
Men W (Day 30)	844 (535 to 1333)	890 (665 to 1190)	392 (252 to 610)	395 (321 to 487)	620 (354 to 1085)	360 (169 to 765)
Men Y (Day 30)	444 (257 to 768)	748 (463 to 1208)	48 (14 to 157)	54 (17 to 171)	662 (424 to 1032)	404 (201 to 811)
Men A (Day 365)	25 (11 to 59)	44 (18 to 105)	54 (17 to 174)	53 (22 to 130)	34 (16 to 69)	6.52 (2.71 to 16)
Men C (Day 365)	128 (75 to 217)	177 (102 to 305)	29 (10 to 82)	32 (16 to 67)	81 (46 to 141)	72 (27 to 191)
Men W (Day 365)	190 (133 to 272)	213 (135 to 337)	80 (26 to 246)	96 (72 to 127)	172 (96 to 306)	104 (49 to 221)
Men Y (Day 365)	116 (58 to 231)	235 (147 to 376)	7.17 (1.91 to 27)	20 (6.92 to 58)	193 (123 to 301)	101 (36 to 280)

No statistical analyses for this end point

Secondary: 21. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

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End point title

21. The HT-hSBA GMTs against N. meningitidis strains of serogroup B. ^[19]

End point description

The HT-hSBA GMTs against N. meningitidis strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.

End point type

Secondary

End point timeframe

Day 1, Day 30 and Day 365

Notes
[19] - 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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2qOMV_qOMV	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV
Number of subjects analysed	21	16	11	20	21	18
Units: Titers
geometric mean (confidence interval 95%)
M14459 (fHBP) (Day 1)	2.69 (1.51 to 4.78)	1.54 (0.9 to 2.63)	3.11 (1.74 to 5.56)	3.37 (1.95 to 5.81)	1.85 (1.13 to 3.04)	1.48 (1.03 to 2.13)
M01-0240364 (NadA) (Day 1)	2.33 (1.25 to 4.36)	2.87 (0.86 to 9.59)	2.46 (0.72 to 8.4)	6.29 (2.22 to 18)	1.24 (0.79 to 1.94)	1.24 (0.88 to 1.77)
NZ98/254 (PorA) (Day 1)	1.73 (1.06 to 2.81)	1.34 (0.94 to 1.93)	1.72 (0.99 to 2.98)	2.24 (1.2 to 4.17)	1.18 (0.84 to 1.66)	1.19 (0.9 to 1.58)
M07-0241084 (NHBA) (Day 1)	3.68 (2.07 to 6.54)	2.28 (1.16 to 4.48)	4.1 (1.89 to 8.9)	7.35 (3.82 to 14)	2.08 (1.26 to 3.42)	2.15 (1.14 to 4.05)
H44/76 (fHBP) (Day 1)	3.58 (1.66 to 7.71)	1.49 (0.96 to 2.33)	3.45 (1.81 to 6.57)	3.43 (1.83 to 6.43)	1.34 (0.85 to 2.13)	1.51 (0.91 to 2.48)
5/99 (NadA) (Day 1)	18 (9.47 to 34)	31 (12 to 85)	27 (8.61 to 86)	39 (21 to 74)	2.97 (1.58 to 5.59)	1.8 (1.01 to 3.22)
M14459 (fHBP) (Day 30)	39 (21 to 70)	20 (10 to 39)	56 (27 to 117)	35 (21 to 60)	3.44 (2.05 to 5.75)	2.71 (1.56 to 4.7)
M01-0240364 (NadA) (Day 30)	679 (352 to 1310)	903 (463 to 1761)	1336 (810 to 2202)	1261 (746 to 2131)	2.68 (1.15 to 6.25)	3.66 (1.21 to 11)
NZ98/254 (PorA) (Day 30)	32 (19 to 52)	15 (5.93 to 36)	17 (6.22 to 45)	28 (17 to 47)	2.48 (1.31 to 4.69)	1.62 (0.96 to 2.74)
M07-0241084 (NHBA) (Day 30)	59 (36 to 98)	36 (20 to 64)	68 (33 to 142)	66 (35 to 124)	3.26 (1.75 to 6.06)	2.24 (1.14 to 4.38)
H44/76 (fHBP) (Day 30)	104 (59 to 184)	57 (32 to 102)	132 (64 to 271)	79 (40 to 153)	5.27 (2.54 to 11)	3.89 (1.79 to 8.47)
5/99 (NadA) (Day 30)	1147 (665 to 1980)	1598 (864 to 2956)	2205 (1560 to 3117)	2816 (1856 to 4273)	28 (11 to 67)	29 (10 to 80)
M14459 (fHBP) (Day 365)	7.19 (3.89 to 13)	2.94 (1.49 to 5.8)	11 (4.41 to 28)	7.12 (3.59 to 14)	2.09 (1.33 to 3.29)	1.38 (0.98 to 1.93)
M01-0240364 (NadA) (Day 365)	30 (9.54 to 93)	74 (18 to 300)	303 (174 to 527)	155 (69 to 350)	1.61 (0.99 to 2.63)	1.71 (0.86 to 3.42)
NZ98/254 (PorA) (Day 365)	3.49 (2.12 to 5.74)	2.67 (1.27 to 5.61)	3.28 (1.66 to 6.49)	3.77 (1.98 to 7.18)	1.65 (1.04 to 2.61)	1.19 (0.91 to 1.54)
M07-0241084 (NHBA) (Day 365)	7.96 (4.6 to 14)	4.09 (2.3 to 7.25)	10 (4.51 to 24)	11 (6.35 to 18)	2.45 (1.59 to 3.79)	1.91 (1.14 to 3.23)
H44/76 (fHBP) (Day 365)	12 (5.18 to 26)	4.19 (1.93 to 9.11)	21 (6 to 71)	11 (4.68 to 25)	1.96 (1.21 to 3.19)	1.92 (1.17 to 3.17)
5/99 (NadA) (Day 365)	175 (79 to 385)	305 (149 to 625)	587 (351 to 983)	491 (258 to 936)	6.05 (3.1 to 12)	4.23 (1.48 to 12)

No statistical analyses for this end point

Secondary: 22. Percentage of subjects with Ht-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y at 12 months after booster vaccination.

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End point title

22. Percentage of subjects with Ht-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y at 12 months after booster vaccination. ^[20]

End point description

Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination in this study. Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.

End point type

Secondary

End point timeframe

Day 1, Day 30 and Day 365

Notes
[20] - 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 scope of this endpoint was descriptive, no statistical analyses were conducted.

End point values	2OMV_OMV	2qOMV_qOMV	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV
Number of subjects analysed	21	16	11	20	20	18
Units: Percentage
number (confidence interval 95%)
Men A (Day 1)	38 (18.1 to 61.6)	20 (4.3 to 48.1)	30 (6.7 to 65.2)	35 (15.4 to 59.2)	45 (23.1 to 68.5)	12 (1.5 to 36.4)
Men C (Day 1)	65 (40.8 to 84.6)	71 (41.9 to 91.6)	36 (10.9 to 69.2)	58 (33.5 to 79.7)	58 (33.5 to 79.7)	50 (26 to 74)
Men W (Day 1)	95 (75.1 to 99.87)	75 (42.8 to 94.5)	82 (48.2 to 97.7)	75 (50.9 to 91.3)	82 (56.6 to 96.2)	61 (35.7 to 82.7)
Men Y (Day 1)	62 (38.4 to 81.9)	71 (41.9 to 91.6)	36 (10.9 to 69.2)	11 (1.4 to 34.7)	55 (31.5 to 76.9)	44 (21.5 to 69.2)
Men A (Day 30)	100 (83.9 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	95 (75.1 to 99.87)	100 (81.5 to 100)	94 (69.8 to 99.84)
Men C (Day 30)	100 (80.5 to 100)	100 (69.2 to 100)	100 (59 to 100)	100 (76.8 to 100)	100 (82.4 to 100)	88 (63.6 to 98.5)
Men W (Day 30)	100 (81.5 to 100)	100 (78.2 to 100)	100 (71.5 to 100)	100 (81.5 to 100)	100 (80.5 to 100)	100 (79.4 to 100)
Men Y (Day 30)	100 (83.9 to 100)	100 (78.2 to 100)	82 (48.2 to 97.7)	83 (58.6 to 96.4)	100 (83.2 to 100)	100 (80.5 to 100)
Men A (Day 365)	67 (43 to 85.4)	88 (61.7 to 98.4)	90 (55.5 to 99.75)	85 (62.1 to 96.8)	85 (62.1 to 96.8)	50 (26 to 74)
Men C (Day 365)	100 (83.9 to 100)	100 (79.4 to 100)	82 (48.2 to 97.7)	95 (74 to 99.87)	100 (82.4 to 100)	89 (65.3 to 98.6)
Men W (Day 365)	100 (83.9 to 100)	100 (79.4 to 100)	91 (58.7 to 99.77)	100 (83.2 to 100)	100 (82.4 to 100)	100 (81.5 to 100)
Men Y (Day 365)	95 (76.2 to 99.88)	100 (79.4 to 100)	45 (16.7 to 76.6)	72 (46.5 to 90.3)	100 (83.2 to 100)	89 (65.3 to 98.6)

No statistical analyses for this end point

Secondary: 23. Number of subjects with solicited local and systemic AEs following booster vaccination in this study.

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End point title

23. Number of subjects with solicited local and systemic AEs following booster vaccination in this study.

End point description

Number of subjects reporting solicited local and systemic AEs after receiving a booster dose of MenABCWY vaccine or placebo. Analysis was done on the Solicited Safety Set, i.e. all exposed subjects who provide post vaccination solicited adverse event data.

End point type

Secondary

End point timeframe

From Day 1 (6 hours) through Day 7 after any vaccination.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo	2B_Pbo
Number of subjects analysed	26	24	17	23	11	21	21	19	19	6
Units: Subjects
Any local	23	7	15	8	11	18	19	17	5	1
Injection site pain	20	6	14	7	11	17	19	17	4	1
Injection site induration	7	2	5	2	9	6	7	4	1	0
Injection site erythema	11	2	7	3	6	7	6	9	2	0
Any systemic	12	9	12	6	5	10	15	10	5	1
Chills	3	1	0	0	1	2	5	1	1	0
Nausea	0	2	3	1	3	5	4	5	1	0
Fatigue	9	6	8	2	5	8	11	6	5	0
Myalgia	6	2	5	0	1	4	8	4	1	0
Arthralgia	3	2	3	1	0	2	4	2	3	0
Loss of appetite	2	1	4	2	1	3	8	3	2	0
Headache	7	6	8	3	5	4	12	5	2	1
Rash	0	0	1	0	0	1	1	2	0	0
Body temperature (> 38 °C)	2	0	0	1	0	0	0	0	0	0
Use of analgesics/antipyretics	0	0	1	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: 24. Number of subjects with unsolicited (any AEs and possibly related AEs) following booster vaccination in this study.

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End point title

24. Number of subjects with unsolicited (any AEs and possibly related AEs) following booster vaccination in this study.

End point description

Number of subjects reporting unsolicited AEs (any AEs and at least possibly related AEs) after receiving a booster dose of MenABCWY vaccine or placebo from Day 1 to Day 30. Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.

End point type

Secondary

End point timeframe

Day 1 through Day 30

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo	2B_Pbo
Number of subjects analysed	26	24	17	23	11	21	21	19	19	6
Units: Subjects
Any AEs	6	4	5	2	3	7	6	5	4	1
At least possibly related	3	1	3	0	2	3	2	3	0	0

No statistical analyses for this end point

Secondary: 25. Number of subjects with unsolicited AEs following booster vaccination in this study.

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End point title

25. Number of subjects with unsolicited AEs following booster vaccination in this study.

End point description

Number of subjects reporting any serious unsolicited AEs (SAEs), possibly related SAEs, medically attended AEs, unsolicited AEs leading to withdrawal and deaths after receiving a booster dose of MenABCWY vaccine or placebo, are reported for the entire study period. Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 365.

End point type

Secondary

End point timeframe

Day 1 through Day 365

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo	2B_Pbo
Number of subjects analysed	26	24	17	23	11	21	21	19	19	6
Units: Subjects
Any SAEs	0	0	1	1	0	1	0	1	1	0
At Least Possibly related SAEs	0	0	0	0	0	0	0	0	0	0
NOCD	0	3	2	0	0	1	1	1	1	0
Medically attended AEs	12	10	12	9	6	9	13	11	11	1
AEs leading to withdrawal	0	0	0	0	0	0	0	0	0	0
Deaths	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: 26. Number of subjects with unsolicited AEs leading to New Onset Chronic Disease (NOCD) before study vaccination.

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End point title

26. Number of subjects with unsolicited AEs leading to New Onset Chronic Disease (NOCD) before study vaccination.

End point description

Number of subjects reporting New Onset Chronic Disease (NOCD),from the end of the primary parental study V102_03 up to Day 1 visit in V102_03E1 study, is reported. (Any NOCD AEs: NOCD V102_03 vs. NOCD- Day 1, Pre vaccination, V102_03E1). Analysis was done on the all enrolled set population. All screened subjects who have been enrolled (ie, attended the first clinic visit and received a subject ID).

End point type

Secondary

End point timeframe

From primary parent study completion up to Day 1 in this study.

End point values	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo	2B_Pbo
Number of subjects analysed	26	25	17	24	11	21	21	19	19	7
Units: Subjects
NOCD (SOC/PT) Day 1, V102_03E1)	2	4	0	1	0	2	2	2	1	1

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited AEs between Day 1 (from 30 minutes) to Day 7; any unsolicited AEs from Day 1 (from 30 minutes) to Day 30, and SAEs, medically attended AEs, AEs leading to withdrawal, death and NOCD from Day 1 to Day 365.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.1

Reporting group title

2B_Pbo

Reporting group description

Reporting group title

2OMV_OMV

Reporting group description

Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.

Reporting group title

2OMV_Pbo

Reporting group description

Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.

Reporting group title

2qOMV_qOMV

Reporting group description

Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.

Reporting group title

2qOMV_Pbo

Reporting group description

Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.

Reporting group title

2B_OMV

Reporting group description

Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.

Reporting group title

2B_qOMV

Reporting group description

Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.

Reporting group title

1M_OMV

Reporting group description

Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.

Reporting group title

1M_qOMV

Reporting group description

Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.

Reporting group title

1M_Pbo

Reporting group description

Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.

Serious adverse events	2B_Pbo	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	1 / 24 (4.17%)	0 / 11 (0.00%)	1 / 21 (4.76%)	0 / 21 (0.00%)	1 / 19 (5.26%)	1 / 19 (5.26%)
number of deaths (all causes)	0	0	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Facial bones fracture
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	1 / 24 (4.17%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	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	0 / 0	0 / 0	0 / 0	0 / 0
Limb injury
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	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	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Syncope
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	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	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	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	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	1 / 21 (4.76%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	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	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	2B_Pbo	2OMV_OMV	2OMV_Pbo	2qOMV_qOMV	2qOMV_Pbo	2B_OMV	2B_qOMV	1M_OMV	1M_qOMV	1M_Pbo
Total subjects affected by non serious adverse events
subjects affected / exposed	4 / 6 (66.67%)	25 / 27 (92.59%)	16 / 24 (66.67%)	16 / 17 (94.12%)	14 / 24 (58.33%)	11 / 11 (100.00%)	19 / 21 (90.48%)	20 / 21 (95.24%)	17 / 19 (89.47%)	15 / 19 (78.95%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Vascular disorders
Essential hypertension
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
General disorders and administration site conditions
Chills
subjects affected / exposed	0 / 6 (0.00%)	3 / 27 (11.11%)	1 / 24 (4.17%)	0 / 17 (0.00%)	0 / 24 (0.00%)	1 / 11 (9.09%)	2 / 21 (9.52%)	6 / 21 (28.57%)	1 / 19 (5.26%)	1 / 19 (5.26%)
occurrences all number	0	3	2	0	0	3	2	6	1	1
Fatigue
subjects affected / exposed	0 / 6 (0.00%)	9 / 27 (33.33%)	8 / 24 (33.33%)	8 / 17 (47.06%)	2 / 24 (8.33%)	5 / 11 (45.45%)	8 / 21 (38.10%)	11 / 21 (52.38%)	6 / 19 (31.58%)	5 / 19 (26.32%)
occurrences all number	0	9	11	9	2	5	9	11	7	7
Induration
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	1 / 11 (9.09%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0
Injection site erythema
subjects affected / exposed	0 / 6 (0.00%)	11 / 27 (40.74%)	2 / 24 (8.33%)	7 / 17 (41.18%)	3 / 24 (12.50%)	7 / 11 (63.64%)	7 / 21 (33.33%)	7 / 21 (33.33%)	9 / 19 (47.37%)	2 / 19 (10.53%)
occurrences all number	0	12	2	8	3	7	7	8	9	2
Injection site induration
subjects affected / exposed	0 / 6 (0.00%)	7 / 27 (25.93%)	2 / 24 (8.33%)	6 / 17 (35.29%)	3 / 24 (12.50%)	10 / 11 (90.91%)	7 / 21 (33.33%)	11 / 21 (52.38%)	9 / 19 (47.37%)	1 / 19 (5.26%)
occurrences all number	0	7	2	6	3	11	9	13	9	1
Injection site pain
subjects affected / exposed	1 / 6 (16.67%)	21 / 27 (77.78%)	7 / 24 (29.17%)	14 / 17 (82.35%)	7 / 24 (29.17%)	11 / 11 (100.00%)	18 / 21 (85.71%)	19 / 21 (90.48%)	17 / 19 (89.47%)	6 / 19 (31.58%)
occurrences all number	1	23	7	14	7	11	19	19	19	6
Pyrexia
subjects affected / exposed	0 / 6 (0.00%)	2 / 27 (7.41%)	1 / 24 (4.17%)	0 / 17 (0.00%)	1 / 24 (4.17%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	2	1	0	1	0	0	0	0	0
Vaccination site erythema
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Injection site pruritus
subjects affected / exposed	0 / 6 (0.00%)	1 / 27 (3.70%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	1	0
Vaccination site pain
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	1 / 11 (9.09%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0
Immune system disorders
Hypersensitivity
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Reproductive system and breast disorders
Breast mass
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Dysmenorrhoea
subjects affected / exposed	1 / 6 (16.67%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	1 / 21 (4.76%)	1 / 21 (4.76%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	1	0	0	0	0	0	1	1	0	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	1 / 6 (16.67%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	1	0	0	2	0	0	0	0	0	0
Cough
subjects affected / exposed	0 / 6 (0.00%)	2 / 27 (7.41%)	0 / 24 (0.00%)	1 / 17 (5.88%)	1 / 24 (4.17%)	0 / 11 (0.00%)	0 / 21 (0.00%)	1 / 21 (4.76%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	3	0	1	1	0	0	1	0	0
Rhinitis allergic
subjects affected / exposed	1 / 6 (16.67%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	1 / 21 (4.76%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	1	0	0	0	0	0	1	0	0	0
Investigations
Blood iron decreased
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Body temperature increased
subjects affected / exposed	1 / 6 (16.67%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Limb injury
subjects affected / exposed	0 / 6 (0.00%)	2 / 27 (7.41%)	1 / 24 (4.17%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	1 / 21 (4.76%)	1 / 21 (4.76%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	2	1	0	0	0	1	1	0	1
Post vaccination syndrome
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Concussion
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	1 / 21 (4.76%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	0
Head injury
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Joint dislocation
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Nervous system disorders
Dizziness postural
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Headache
subjects affected / exposed	1 / 6 (16.67%)	8 / 27 (29.63%)	6 / 24 (25.00%)	8 / 17 (47.06%)	3 / 24 (12.50%)	5 / 11 (45.45%)	4 / 21 (19.05%)	14 / 21 (66.67%)	5 / 19 (26.32%)	2 / 19 (10.53%)
occurrences all number	2	8	6	9	3	7	5	15	5	2
Syncope
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	1 / 11 (9.09%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Eye disorders
Photophobia
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Myopia
subjects affected / exposed	0 / 6 (0.00%)	1 / 27 (3.70%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	1	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	2 / 24 (8.33%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0
Nausea
subjects affected / exposed	0 / 6 (0.00%)	1 / 27 (3.70%)	2 / 24 (8.33%)	3 / 17 (17.65%)	1 / 24 (4.17%)	3 / 11 (27.27%)	5 / 21 (23.81%)	4 / 21 (19.05%)	5 / 19 (26.32%)	1 / 19 (5.26%)
occurrences all number	0	1	2	4	1	3	5	4	6	1
Tooth impacted
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Abdominal pain
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 6 (0.00%)	2 / 27 (7.41%)	1 / 24 (4.17%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	1 / 21 (4.76%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	2	1	0	0	0	0	1	0	1
Dermatitis contact
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1	0	0	0	0	0	1
Rash
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	1 / 21 (4.76%)	3 / 21 (14.29%)	2 / 19 (10.53%)	0 / 19 (0.00%)
occurrences all number	0	0	0	2	0	0	1	3	2	0
Dermatitis
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	1 / 11 (9.09%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0
Erythema
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	1 / 11 (9.09%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	1	0
Urticaria
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	2 / 11 (18.18%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	0
Renal and urinary disorders
Proteinuria
subjects affected / exposed	0 / 6 (0.00%)	1 / 27 (3.70%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	1	0	0	0	0	0	0	0	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 6 (0.00%)	4 / 27 (14.81%)	2 / 24 (8.33%)	3 / 17 (17.65%)	1 / 24 (4.17%)	0 / 11 (0.00%)	2 / 21 (9.52%)	4 / 21 (19.05%)	2 / 19 (10.53%)	3 / 19 (15.79%)
occurrences all number	0	4	2	3	1	0	2	4	2	4
Myalgia
subjects affected / exposed	0 / 6 (0.00%)	6 / 27 (22.22%)	2 / 24 (8.33%)	5 / 17 (29.41%)	0 / 24 (0.00%)	1 / 11 (9.09%)	4 / 21 (19.05%)	8 / 21 (38.10%)	4 / 19 (21.05%)	1 / 19 (5.26%)
occurrences all number	0	6	2	5	0	1	4	8	4	1
Myositis
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Scoliosis
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	2 / 17 (11.76%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0
Back pain
subjects affected / exposed	0 / 6 (0.00%)	1 / 27 (3.70%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	1	0
Costochondritis
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	0	0	0	0	0	0	2
Joint effusion
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Temporomandibular joint syndrome
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Infections and infestations
Bronchitis
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	2 / 24 (8.33%)	2 / 17 (11.76%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	2	2	0	0	0	0	0	1
Influenza
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	2 / 21 (9.52%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	1	0	0	2	0	0	0
Laryngitis
subjects affected / exposed	0 / 6 (0.00%)	1 / 27 (3.70%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0
Lice infestation
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	1	0	0	0	0	0	1
Nasopharyngitis
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	2 / 24 (8.33%)	0 / 17 (0.00%)	1 / 24 (4.17%)	1 / 11 (9.09%)	2 / 21 (9.52%)	1 / 21 (4.76%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	2	0	1	3	2	1	0	1
Pharyngitis
subjects affected / exposed	0 / 6 (0.00%)	1 / 27 (3.70%)	2 / 24 (8.33%)	2 / 17 (11.76%)	0 / 24 (0.00%)	1 / 11 (9.09%)	1 / 21 (4.76%)	2 / 21 (9.52%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	1	2	2	0	1	1	2	0	2
Pneumonia
subjects affected / exposed	0 / 6 (0.00%)	2 / 27 (7.41%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	1 / 21 (4.76%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	3	0	0	0	0	0	1	0	0
Pneumonia mycoplasmal
subjects affected / exposed	0 / 6 (0.00%)	1 / 27 (3.70%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	2	0	1	0	0	0	0	0	0
Sinusitis
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	1 / 24 (4.17%)	0 / 11 (0.00%)	0 / 21 (0.00%)	1 / 21 (4.76%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	2	1	0	0	1	0	0
Tonsillitis
subjects affected / exposed	0 / 6 (0.00%)	2 / 27 (7.41%)	0 / 24 (0.00%)	1 / 17 (5.88%)	1 / 24 (4.17%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	2	0	1	2	0	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	2 / 17 (11.76%)	1 / 24 (4.17%)	1 / 11 (9.09%)	1 / 21 (4.76%)	2 / 21 (9.52%)	2 / 19 (10.53%)	1 / 19 (5.26%)
occurrences all number	0	0	0	2	1	1	1	2	2	2
Viral infection
subjects affected / exposed	0 / 6 (0.00%)	2 / 27 (7.41%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0
Acute sinusitis
subjects affected / exposed	0 / 6 (0.00%)	1 / 27 (3.70%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	1	0	0	0	0	0	0	0	1
Conjunctivitis
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	2 / 21 (9.52%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	0	0	2	0	1
Croup infectious
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Herpes virus infection
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	1 / 24 (4.17%)	1 / 11 (9.09%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0
Onychomycosis
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	0	0	0	0	1
Otitis media
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0
Pharyngitis streptococcal
subjects affected / exposed	0 / 6 (0.00%)	1 / 27 (3.70%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	2 / 21 (9.52%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	1	0	0	0	0	0	2	0	1
Respiratory tract infection
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	1 / 11 (9.09%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0
Tooth abscess
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 19 (5.26%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	0	0	0	1	1
Viral pharyngitis
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	1 / 21 (4.76%)	1 / 19 (5.26%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	0	0	3	2	1
Metabolism and nutrition disorders
Abnormal weight gain
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0
Decreased appetite
subjects affected / exposed	1 / 6 (16.67%)	2 / 27 (7.41%)	1 / 24 (4.17%)	4 / 17 (23.53%)	2 / 24 (8.33%)	1 / 11 (9.09%)	3 / 21 (14.29%)	8 / 21 (38.10%)	4 / 19 (21.05%)	2 / 19 (10.53%)
occurrences all number	1	3	2	5	2	1	3	9	4	3
Obesity
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	2 / 24 (8.33%)	0 / 17 (0.00%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0
Vitamin D deficiency
subjects affected / exposed	0 / 6 (0.00%)	0 / 27 (0.00%)	0 / 24 (0.00%)	1 / 17 (5.88%)	0 / 24 (0.00%)	0 / 11 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0

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Were there any global substantial amendments to the protocol? Yes

09 May 2013

• Modified schedule for booster dose administration. • To ensure an adequate number of subjects in each treatment group, the sample size and randomisation ratios per group have been adjusted. • Collection of data related to NOCD at the time of study entry and during the trial was added. • Updated Protocol to new Protocol Template. All Novartis approved language on topics relating to Diary Cards, safety data collection, visit procedures, protocol deviations, withdrawal from study criteria, and AE reporting are incorporated into the current protocol amendment 1.0, version 2.0 dated 09 May 13.

19 Nov 2013

Increased window time for Day 1 visit (for U.S. study sites).

06 May 2014

• Increased window time for Day 1 visit (extended to all study sites). • Added approach for interim and final analyses. Added administration of Bexsero for Group IVc outside the scope of study per request of Polish Ethics Committee. • Defined “End of Study” to align with Novartis standards. • Added public database posting and AE/SAE reporting requirements to align with Novartis standards.

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: 1. Percentages of subjects with HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y.

Primary: 1. Percentages of subjects with HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y.

Primary: 2. Percentage of subjects with HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroup B.

Primary: 2. Percentage of subjects with HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroup B.

Secondary: 3. Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y.

Secondary: 3. Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y.

Secondary: 4. Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis strains of serogroup B.

Secondary: 4. Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis strains of serogroup B.

Secondary: 5. The HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, Y.

Secondary: 5. The HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, Y.

Secondary: 6. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

Secondary: 6. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

Secondary: 7. The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y.

Secondary: 7. The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y.

Secondary: 8. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

Secondary: 8. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

Secondary: 9. Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains.

Secondary: 9. Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains.

Secondary: 10. Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A ,C, W, Y.

Secondary: 10. Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A ,C, W, Y.

Secondary: 11. Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis serogroup B strains.

Secondary: 11. Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis serogroup B strains.

Secondary: 12. Percentage of subjects with seroresponse to N. meningitidis serogroups A, C, W and Y, at Day 30 after booster vaccination.

Secondary: 12. Percentage of subjects with seroresponse to N. meningitidis serogroups A, C, W and Y, at Day 30 after booster vaccination.

Secondary: 13. Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y.

Secondary: 13. Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y.

Secondary: 14. Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis strains of serogroup B.

Secondary: 14. Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis strains of serogroup B.

Secondary: 15. Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains.

Secondary: 15. Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains.

Secondary: 16. The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y.

Secondary: 16. The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y.

Secondary: 17. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

Secondary: 17. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

Secondary: 18. Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y.

Secondary: 18. Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y.

Secondary: 19. Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis in strains of serogroup B.

Secondary: 19. Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis in strains of serogroup B.

Secondary: 20. The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y.

Secondary: 20. The HT-hSBA GMTs against N. meningitidis serogroups A, C, W, Y.

Secondary: 21. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

Secondary: 21. The HT-hSBA GMTs against N. meningitidis strains of serogroup B.

Secondary: 22. Percentage of subjects with Ht-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y at 12 months after booster vaccination.

Secondary: 22. Percentage of subjects with Ht-hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W, Y at 12 months after booster vaccination.

Secondary: 23. Number of subjects with solicited local and systemic AEs following booster vaccination in this study.

Secondary: 23. Number of subjects with solicited local and systemic AEs following booster vaccination in this study.

Secondary: 24. Number of subjects with unsolicited (any AEs and possibly related AEs) following booster vaccination in this study.

Secondary: 24. Number of subjects with unsolicited (any AEs and possibly related AEs) following booster vaccination in this study.

Secondary: 25. Number of subjects with unsolicited AEs following booster vaccination in this study.

Secondary: 25. Number of subjects with unsolicited AEs following booster vaccination in this study.

Secondary: 26. Number of subjects with unsolicited AEs leading to New Onset Chronic Disease (NOCD) before study vaccination.

Secondary: 26. Number of subjects with unsolicited AEs leading to New Onset Chronic Disease (NOCD) before study vaccination.

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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