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Clinical Trial Results:
A Phase 2, Open-label, Controlled, Multi-Center Extension Study to Evaluate 4-Year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158).

Summary
EudraCT number	2016-004420-29
Trial protocol	Outside EU/EEA
Global end of trial date	10 Dec 2015

Results information
Results version number	v3(current)
This version publication date	13 Jan 2018
First version publication date	16 Mar 2017
Other versions	v1 , v2
Version creation reason

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

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Trial information

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Sponsor protocol code

205213

ISRCTN number

US NCT number

NCT02451514

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

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

Public contact

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

Scientific contact

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

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

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

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

Yes

Analysis stage

Final

Date of interim/final analysis

07 Nov 2016

Is this the analysis of the primary completion data?

Yes

Primary completion date

14 Nov 2015

Global end of trial reached?

Yes

Global end of trial date

10 Dec 2015

Was the trial ended prematurely?

Main objective of the trial

• To assess the antibody persistence against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, as measured by the percentage of subjects with hSBA titers ≥ lower limit quantitation (LLQ) and other thresholds, hSBA Geometric Mean Titers (GMTs) and geometric mean ratios (GMRs). • To evaluate the immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in vaccine-naïve subjects (VNS) of similar age, as measured by the percentage of subjects with hSBA titers ≥LLQ and other thresholds, hSBA GMTs and GMRs.

Protection of trial subjects

The study was conducted in compliance with the protocol, Good Clinical Practices (GCPs) and applicable regulatory requirement(s). This clinical study was designed, implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations, Novartis codes on protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki (European Council 2001, US Code of Federal Regulations, ICH 1997).

Background therapy

Evidence for comparator

Actual start date of recruitment

30 Jun 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Chile: 13

Country: Number of subjects enrolled

Panama: 88

Country: Number of subjects enrolled

Colombia: 28

Worldwide total number of subjects

129

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 sites in Panama, 3 sites in Colombia and 1 site in Chile.

Screening details

Healthy adolescents & young adults, who received 2 doses of MenABCWY+OMV vaccine or 1 dose of MENACWY in parent study V102_02(NCT01210885) & only Tdap vaccination in V102_02E1(NCT01367158) study were included in the present study, along with Naive subjects of similar age.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Blinding implementation details

The study was an open-label study. Therefore, no blinding procedures were utilized.

Are arms mutually exclusive

Yes

MenABCWY+OMV Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Meningococcal (groups A, C , W , Y-135) Oligosaccharide Diphtheria CRM197 Conjugate combined with Meningococcal (group B) Multi-Component Recombinant Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses ( 0.5 ml each), 1 month apart

MenACWY Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Meningococcal (groups A, C , W , Y-135) Oligosaccharide Diphtheria CRM197 Conjugate combined with Meningococcal (group B) Multi-Component Recombinant Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses ( 0.5 ml each), 1 month apart

Naive Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Meningococcal (groups A, C , W , Y-135) Oligosaccharide Diphtheria CRM197 Conjugate combined with Meningococcal (group B) Multi-Component Recombinant Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses ( 0.5 ml each), 1 month apart

Number of subjects in period 1	MenABCWY+OMV Group	MenACWY Group	Naive Group
Started	33	46	50
Completed	33	46	50

Baseline characteristics

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Reporting group title

MenABCWY+OMV Group

Reporting group description

Reporting group title

MenACWY Group

Reporting group description

Reporting group title

Naive Group

Reporting group description

Reporting group values	MenABCWY+OMV Group	MenACWY Group	Naive Group	Total
Number of subjects	33	46	50	129
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0
Children (2-11 years)	0	0	0	0
Adolescents (12-17 years)	12	14	19	45
Adults (18-64 years)	21	32	31	84
From 65-84 years	0	0	0	0
85 years and over	0	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	18.61 ( 2.207 )	18.72 ( 1.87 )	17.96 ( 2.04 )	-
Gender categorical
Units: Subjects
Female	22	27	25	74
Male	11	19	25	55
Race/Ethnicity, Customized
Units: Subjects
Race American Indian or Alaska Native	2	4	3	9
Race Black or African American	4	2	4	10
Race White	7	6	6	19
Race Other	20	34	37	91

Subject analysis set title

MenABCWY+OMV Group (A)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 4, Day 8 and Day 31.

Subject analysis set title

MenACWY Group (B1)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects who received MenACWY vaccine in the parent study V102_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart, in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 4, Day 31 (before vaccination) and Day 61.

Subject analysis set title

MenACWY group (B2)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Naive Group (C1)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. Blood samples will be collected from subjects at Day 1 (before vaccination), Day 31 (before vaccination), Day 34 and Day 61.

Subject analysis set title

Naive Group (C2)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis sets values	MenABCWY+OMV Group (A)	MenACWY Group (B1)	MenACWY group (B2)	Naive Group (C1)	Naive Group (C2)
Number of subjects	33	23	23	26	24
Age categorical
Units: Subjects
In utero
Preterm newborn infants (gestational age < 37 wks)
Newborns (0-27 days)
Infants and toddlers (28 days-23 months)
Children (2-11 years)
Adolescents (12-17 years)
Adults (18-64 years)
From 65-84 years
85 years and over
Age continuous
Units: years
arithmetic mean (standard deviation)	18.6 ( 2.21 )	18.7 ( 1.72 )	18.7 ( 2.05 )	17.8 ( 2.15 )	18.1 ( 1.94 )
Gender categorical
Units: Subjects
Female	22	15	12	15	10
Male	11	8	11	11	14
Race/Ethnicity, Customized
Units: Subjects
Race American Indian or Alaska Native	2	2	2	1	2
Race Black or African American	4	1	1	2	2
Race White	7	3	3	3	3
Race Other	20	17	17	20	17

End points

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Reporting group title

MenABCWY+OMV Group

Reporting group description

Reporting group title

MenACWY Group

Reporting group description

Reporting group title

Naive Group

Reporting group description

Subject analysis set title

MenABCWY+OMV Group (A)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

MenACWY Group (B1)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

MenACWY group (B2)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Naive Group (C1)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Naive Group (C2)

Subject analysis set type

Full analysis

Subject analysis set description

Primary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

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End point title

Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. ^[1]

End point description

The HT-hSBA assay format was changed in 2015 in response to CBER comments & validation of this new format & determination of the LLOQ values for the same, are ongoing. However, the old assay format was used for sample testing in this extension trial, to maintain data comparability with the parent trials. The LLOQ cut-off values for the old assay format correspond to 8 for ACWY serogroups & 5 for B strains, & this data is already available & included in the submission. The ongoing validation procedure & determination of new LLOQ values are pertinent to the new assay format for HT-hSBA & are not considered relevant to the data obtained from the testing of the V102_02E2 study. Therefore, in the Company’s judgment, the results generated with pre-defined LLOQs of 8 (for ACWY) & 5 (for B strains) are final & there will be no additional data generation with new HT-hSBA LLOQ cut-offs.

End point type

Primary

End point timeframe

At Day 1 (4 years persistence)

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 primary end point was descriptive, no statistical hypothesis test was performed.

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	0 ^[2]	0 ^[3]	0 ^[4]
Units: Percentages of subjects
number (confidence interval 95%)	( to )	( to )	( to )

Notes
[2] - No additional data generation with new HT-hSBA LLOQ cut-offs
[3] - No additional data generation with new HT-hSBA LLOQ cut-offs
[4] - No additional data generation with new HT-hSBA LLOQ cut-offs

No statistical analyses for this end point

Primary: Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

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End point title

Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y. ^[5]

End point description

Antibody levels against N. meningitidis serogroups A, C, W and Y in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of subjects with hSBA ≥ 8. The analysis was performed on Full Analysis Set (FAS) immunogenicity persistence population, which included all subjects in the Enrolled population who provided at least one evaluable serum sample at baseline (Visit 1 in this study) and whose assay results were available for at least one strain.

End point type

Primary

End point timeframe

At Day 1 (4 years persistence)

Notes
[5] - 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 primary end point was descriptive, no statistical hypothesis test was performed.

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Percentages of subjects
number (confidence interval 95%)
Serogroup A (N=33;46;50)	27 (13.3 to 45.5)	41 (27.0 to 56.8)	2 (0.05 to 10.6)
Serogroup C (N=32;46;49)	69 (50.0 to 83.9)	43 (28.9 to 58.9)	45 (30.7 to 59.8)
Serogroup W (N=32;46;47)	75 (56.6 to 88.5)	78 (63.6 to 89.1)	53 (38.1 to 67.9)
Serogroup Y (N=32;44;47)	38 (21.1 to 56.3)	59 (43.2 to 73.7)	19 (9.1 to 33.3)

No statistical analyses for this end point

Primary: Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

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End point title

Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains. ^[6]

End point description

Antibody levels against N. meningitidis serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity persistence population, which included all subjects in the Enrolled population who provided at least one evaluable serum sample at baseline (Visit 1 in this study) and whose assay results were available for at least one strain.

End point type

Primary

End point timeframe

At Day 1 (4 years persistence)

Notes
[6] - 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 primary end point was descriptive, no statistical hypothesis test was performed.

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Percentages of subjects
number (confidence interval 95%)
Serogroup B, M14459 (N=33;46;50)	18 (7.0 to 35.5)	4 (0.5 to 14.8)	8 (2.2 to 19.2)
Serogroup B, M01-0240364 (N=31;44;50)	13 (3.6 to 29.8)	5 (0.6 to 15.5)	4 (0.49 to 13.7)
Serogroup B, NZ98/254 (N=33;46;50)	15 (5.1 to 31.9)	2 (0.06 to 11.5)	6 (1.3 to 16.5)
Serogroup B, M10713 (N=33;46;50)	48 (30.8 to 66.5)	33 (19.5 to 48.0)	38 (24.7 to 52.8)
Serogroup B, H44/76 (N=33;46;50)	27 (13.3 to 45.5)	4 (0.5 to 14.8)	10 (3.3 to 21.8)
Serogroup B, 5/99 (N=33;46;50)	70 (51.3 to 84.4)	17 (7.8 to 31.4)	16 (7.2 to 29.1)

No statistical analyses for this end point

Primary: Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

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End point title

Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

End point description

GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity persistence population, which included all subjects in the Enrolled population who provided at least one evaluable serum sample at baseline (Visit 1 in this study) and whose assay results were available for at least one strain.

End point type

Primary

End point timeframe

At Day 1

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Titers
geometric mean (confidence interval 95%)
Serogroup B, M14459 (N=33;46;50)	2.04 (1.46 to 2.83)	1.37 (1.12 to 1.69)	1.48 (1.18 to 1.85)
Serogroup B, M01-0240364 (N=31;44;50)	2.26 (1.26 to 4.08)	1.14 (0.97 to 1.35)	1.23 (1.02 to 1.47)
Serogroup B, NZ98/254 (N=33;46;50)	1.81 (1.30 to 2.51)	1.35 (1.15 to 1.59)	1.45 (1.18 to 1.77)
Serogroup B, M10713 (N=33;46;50)	3.66 (2.38 to 5.62)	2.56 (1.74 to 3.75)	3.10 (2.16 to 4.45)
Serogroup B, H44/76 (N=33;46;50)	2.33 (1.57 to 3.45)	1.21 (1.03 to 1.42)	1.44 (1.14 to 1.80)
Serogroup B, 5/99 (N=33;46;50)	13 (7.29 to 22)	1.78 (1.36 to 2.34)	1.90 (1.42 to 2.53)
Serogroup A (N=33;46;50)	4.06 (2.22 to 7.44)	6.64 (3.56 to 12)	1.20 (1.05 to 1.37)
Serogroup C (N=32;46;49)	17 (7.80 to 37)	6.62 (4.10 to 11)	5.11 (3.49 to 7.48)
Serogroup W (N=32;46;47)	28 (15 to 53)	25 (15 to 40)	8.37 (4.78 to 15)
Serogroup Y (N=32;44;47)	6.17 (3.00 to 13)	12 (6.29 to 22)	2.00 (1.40 to 2.85)

Statistical analysis 1

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.48

Confidence interval

level

95%

sides

2-sided

lower limit

1.03

upper limit

2.12

Statistical analysis 2

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.67

upper limit

1.28

Statistical analysis 3

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.

Comparison groups

MenABCWY+OMV Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.38

Confidence interval

level

95%

sides

2-sided

lower limit

0.97

upper limit

1.96

Statistical analysis 4

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.98

Confidence interval

level

95%

sides

2-sided

lower limit

1.27

upper limit

3.09

Statistical analysis 5

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.63

upper limit

1.37

Statistical analysis 6

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.

Comparison groups

MenABCWY+OMV Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.84

Confidence interval

level

95%

sides

2-sided

lower limit

1.2

upper limit

2.84

Statistical analysis 7

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.34

Confidence interval

level

95%

sides

2-sided

lower limit

0.96

upper limit

1.85

Statistical analysis 8

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.94

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

1.25

Statistical analysis 9

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.

Comparison groups

MenABCWY+OMV Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.25

Confidence interval

level

95%

sides

2-sided

lower limit

0.91

upper limit

1.72

Statistical analysis 10

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.43

Confidence interval

level

95%

sides

2-sided

lower limit

0.81

upper limit

2.53

Statistical analysis 11

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.82

Confidence interval

level

95%

sides

2-sided

lower limit

0.49

upper limit

1.37

Statistical analysis 12

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.

Comparison groups

MenABCWY+OMV Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.18

Confidence interval

level

95%

sides

2-sided

lower limit

0.67

upper limit

2.06

Statistical analysis 13

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.92

Confidence interval

level

95%

sides

2-sided

lower limit

1.33

upper limit

2.78

Statistical analysis 14

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.84

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

1.17

Statistical analysis 15

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.

Comparison groups

MenABCWY+OMV Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.62

Confidence interval

level

95%

sides

2-sided

lower limit

1.13

upper limit

2.32

Statistical analysis 16

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

7.15

Confidence interval

level

95%

sides

2-sided

lower limit

4.25

upper limit

Statistical analysis 17

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.94

Confidence interval

level

95%

sides

2-sided

lower limit

0.59

upper limit

1.5

Statistical analysis 18

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.

Comparison groups

MenABCWY+OMV Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

6.73

Confidence interval

level

95%

sides

2-sided

lower limit

4.03

upper limit

Statistical analysis 19

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.61

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

1.23

Statistical analysis 20

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

5.53

Confidence interval

level

95%

sides

2-sided

lower limit

2.96

upper limit

Statistical analysis 21

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.

Comparison groups

MenABCWY+OMV Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

3.38

Confidence interval

level

95%

sides

2-sided

lower limit

1.7

upper limit

6.73

Statistical analysis 22

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

2.58

Confidence interval

level

95%

sides

2-sided

lower limit

1.2

upper limit

5.54

Statistical analysis 23

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.66

upper limit

2.56

Statistical analysis 24

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.

Comparison groups

MenABCWY+OMV Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

3.34

Confidence interval

level

95%

sides

2-sided

lower limit

1.57

upper limit

7.11

Statistical analysis 25

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.14

Confidence interval

level

95%

sides

2-sided

lower limit

0.51

upper limit

2.59

Statistical analysis 26

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

2.93

Confidence interval

level

95%

sides

2-sided

lower limit

1.4

upper limit

6.12

Statistical analysis 27

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.

Comparison groups

MenABCWY+OMV Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

3.35

Confidence interval

level

95%

sides

2-sided

lower limit

1.49

upper limit

7.57

Statistical analysis 28

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.52

Confidence interval

level

95%

sides

2-sided

lower limit

0.23

upper limit

1.18

Statistical analysis 29

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

5.94

Confidence interval

level

95%

sides

2-sided

lower limit

2.84

upper limit

Statistical analysis 30

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.

Comparison groups

MenABCWY+OMV Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

3.09

Confidence interval

level

95%

sides

2-sided

lower limit

1.38

upper limit

6.92

Primary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and B test strains.

Top of page

End point title

Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and B test strains. ^[7]

End point description

End point type

Primary

End point timeframe

At Day 31

Notes
[7] - 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 primary end point was descriptive, no statistical hypothesis test was performed.

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	0 ^[8]	0 ^[9]	0 ^[10]
Units: Percentages of subjects
number (confidence interval 95%)	( to )	( to )	( to )

Notes
[8] - No additional data generation with new HT-hSBA LLOQ cut-offs
[9] - No additional data generation with new HT-hSBA LLOQ cut-offs
[10] - No additional data generation with new HT-hSBA LLOQ cut-offs

No statistical analyses for this end point

Primary: Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

Top of page

End point title

Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y. ^[11]

End point description

Immune response against N. meningitidis serogroups A, C, W and Y 30 days after a single dose of MenABCWY+OMV in subjects who previously vaccinated subjects, and in Naïve subjects of similar age, as measured by the percentages of subjects with hSBA ≥ 8. The analysis was performed on FAS immunogenicity persistence population set Day 31, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay results were available for at least one strain.

End point type

Primary

End point timeframe

At Day 31

Notes
[11] - 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 primary end point was descriptive, no statistical hypothesis test was performed.

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Percentage of Subjects
number (confidence interval 95%)
Serogroup A (N=33;46;50)	100 (89.4 to 100.0)	100 (92.3 to 100.0)	76 (61.8 to 86.9)
Serogroup C (N=30;38;48)	100 (88.4 to 100.0)	100 (90.7 to 100.0)	94 (82.8 to 98.7)
Serogroup W (N=28;38;46)	100 (87.7 to 100.0)	100 (90.7 to 100.0)	96 (85.2 to 99.5)
Serogroup Y (N=23;23;46)	100 (85.2 to 100.0)	100 (85.2 to 100.0)	85 (71.1 to 93.7)

No statistical analyses for this end point

Primary: Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

Top of page

End point title

Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains. ^[12]

End point description

Immune response against N. meningitidis serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in Naïve subjects of similar age, as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity persistence population set Day 31, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay results were available for at least one strain.

End point type

Primary

End point timeframe

At Day 31

Notes
[12] - 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 primary end point was descriptive, no statistical hypothesis test was performed.

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Percentages of Subjects
number (confidence interval 95%)
Serogroup B, M14459 (N=33;45;50)	85 (68.1 to 94.9)	31 (18.2 to 46.6)	40 (26.4 to 54.8)
Serogroup B, M01-0240364 (N=30;44;45)	97 (82.8 to 99.92)	25 (13.2 to 40.3)	29 (16.4 to 44.3)
Serogroup B, NZ98/254 (N=33;46;50)	82 (64.5 to 93.0)	37 (23.2 to 52.5)	52 (37.4 to 66.3)
Serogroup B, M10713 (N=33;46;50)	85 (68.1 to 94.9)	52 (36.9 to 67.1)	58 (43.2 to 71.8)
Serogroup B, H44/76 (N=33;46;50)	97 (84.2 to 99.92)	52 (36.9 to 67.1)	60 (45.2 to 73.6)
Serogroup B, 5/99 (N=33;46;50)	100 (89.4 to 100.0)	78 (63.6 to 89.1)	82 (68.6 to 91.4)

No statistical analyses for this end point

Primary: Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Top of page

End point title

Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

End point description

GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity persistence population set Day 31, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay results were available for at least one strain.

End point type

Primary

End point timeframe

At Day 31

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Titers
geometric mean (confidence interval 95%)
Serogroup B, M14459 (N=33;45;50)	24 (14 to 42)	2.83 (1.88 to 4.24)	4.02 (2.67 to 6.06)
Serogroup B, M01-0240364 (N=30;44;45)	601 (339 to 1064)	3.05 (1.77 to 5.26)	3.11 (1.76 to 5.51)
Serogroup B, NZ98/254 (N=33;46;50)	13 (8.50 to 18)	3.57 (2.37 to 5.38)	5.75 (3.95 to 8.37)
Serogroup B, M10713 (N=33;46;50)	20 (13 to 31)	5.51 (3.45 to 8.79)	7.70 (5.04 to 12)
Serogroup B, H44/76 (N=33;46;50)	98 (57 to 170)	5.78 (3.59 to 9.31)	7.27 (4.53 to 12)
Serogroup B, 5/99 (N=33;46;50)	1426 (940 to 2164)	19 (11 to 34)	25 (15 to 42)
Serogroup A (N=33;46;50)	396 (288 to 545)	149 (106 to 210)	22 (14 to 35)
Serogroup C (N=30;38;48)	1676 (1164 to 2414)	1199 (849 to 1692)	58 (35 to 96)
Serogroup W (N=28;38;46)	1823 (1163 to 2856)	2259 (1678 to 3041)	117 (83 to 166)
Serogroup Y (N=23;23;46)	779 (430 to 1413)	1692 (1206 to 2373)	85 (45 to 163)

Statistical analysis 1

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

8.5

Confidence interval

level

95%

sides

2-sided

lower limit

4.41

upper limit

Statistical analysis 2

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.39

upper limit

1.27

Statistical analysis 3

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.

Comparison groups

Naive Group v MenABCWY+OMV Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

5.97

Confidence interval

level

95%

sides

2-sided

lower limit

3.14

upper limit

Statistical analysis 4

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

197

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

452

Statistical analysis 5

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.98

Confidence interval

level

95%

sides

2-sided

lower limit

0.47

upper limit

2.07

Statistical analysis 6

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.

Comparison groups

Naive Group v MenABCWY+OMV Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

193

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

442

Statistical analysis 7

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

3.51

Confidence interval

level

95%

sides

2-sided

lower limit

1.96

upper limit

6.27

Statistical analysis 8

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Mixed models analysis

Parameter type

Geometric mean ratio

Point estimate

0.62

Confidence interval

level

95%

sides

2-sided

lower limit

0.37

upper limit

Statistical analysis 9

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.

Comparison groups

Naive Group v MenABCWY+OMV Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

2.17

Confidence interval

level

95%

sides

2-sided

lower limit

1.23

upper limit

3.85

Statistical analysis 10

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

3.57

Confidence interval

level

95%

sides

2-sided

lower limit

1.84

upper limit

6.92

Statistical analysis 11

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.72

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

1.29

Statistical analysis 12

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.

Comparison groups

Naive Group v MenABCWY+OMV Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

2.55

Confidence interval

level

95%

sides

2-sided

lower limit

1.33

upper limit

4.89

Statistical analysis 13

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

8.18

upper limit

Statistical analysis 14

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.41

upper limit

1.53

Statistical analysis 15

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.

Comparison groups

Naive Group v MenABCWY+OMV Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

6.59

upper limit

Statistical analysis 16

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

160

Statistical analysis 17

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.77

Confidence interval

level

95%

sides

2-sided

lower limit

0.38

upper limit

1.53

Statistical analysis 18

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.

Comparison groups

Naive Group v MenABCWY+OMV Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

121

Statistical analysis 19

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

2.66

Confidence interval

level

95%

sides

2-sided

lower limit

1.46

upper limit

4.83

Statistical analysis 20

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

6.76

Confidence interval

level

95%

sides

2-sided

lower limit

3.96

upper limit

Statistical analysis 21

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.

Comparison groups

Naive Group v MenABCWY+OMV Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Statistical analysis 22

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.72

upper limit

2.71

Statistical analysis 23

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Statistical analysis 24

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.

Comparison groups

Naive Group v MenABCWY+OMV Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Statistical analysis 25

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.81

Confidence interval

level

95%

sides

2-sided

lower limit

0.47

upper limit

1.38

Statistical analysis 26

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Statistical analysis 27

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.

Comparison groups

Naive Group v MenABCWY+OMV Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

9.27

upper limit

Statistical analysis 28

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.

Comparison groups

MenABCWY+OMV Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.46

Confidence interval

level

95%

sides

2-sided

lower limit

0.17

upper limit

1.28

Statistical analysis 29

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.

Comparison groups

Naive Group v MenACWY Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

8.2

upper limit

Statistical analysis 30

Statistical analysis description

Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.

Comparison groups

Naive Group v MenABCWY+OMV Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

9.13

Confidence interval

level

95%

sides

2-sided

lower limit

3.78

upper limit

Primary: Geometric Mean hSBA Ratio (GMRs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

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End point title

Geometric Mean hSBA Ratio (GMRs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. ^[13]

End point description

GMRs as measure of the immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity persistence population set Day 31, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay results were available for at least one strain.

End point type

Primary

End point timeframe

Day 31 versus Day 1

Notes
[13] - 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 primary end point was descriptive, no statistical hypothesis test was performed.

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Ratios
geometric mean (confidence interval 95%)
Serogroup B, M14459 (N=33;45;50)	12 (6.88 to 20)	2.11 (1.45 to 3.07)	2.72 (1.91 to 3.87)
Serogroup B, M01-0240364 (N=28;42;45)	229 (108 to 485)	2.80 (1.59 to 4.96)	2.48 (1.51 to 4.07)
Serogroup B, NZ98/254 (N=33;46;50)	6.92 (4.61 to 10)	2.64 (1.73 to 4.02)	3.98 (2.73 to 5.79)
Serogroup B, M10713 (N=33;46;50)	5.38 (3.54 to 8.17)	2.15 (1.46 to 3.17)	2.48 (1.78 to 3.45)
Serogroup B, H44/76 (N=33;46;50)	42 (25 to 72)	4.78 (2.90 to 7.89)	5.06 (3.21 to 7.97)
Serogroup B, 5/99 (N=33;46;50)	112 (68 to 185)	11 (6.09 to 19)	13 (8.14 to 22)
Serogroup A (N=33;46;50)	98 (54 to 177)	22 (13 to 38)	18 (12 to 29)
Serogroup C (N=30;38;48)	105 (49 to 222)	238 (145 to 392)	12 (6.88 to 19)
Serogroup W (N=28;38;44)	67 (34 to 132)	112 (65 to 191)	16 (8.35 to 30)
Serogroup Y (N=22;22;43)	162 (70 to 375)	216 (80 to 580)	46 (23 to 92)

No statistical analyses for this end point

Secondary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

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End point title

Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

End point description

End point type

Secondary

End point timeframe

At Days 1, 4, 8 and 31

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	0 ^[14]	0 ^[15]	0 ^[16]
Units: Percentages of subjects
number (confidence interval 95%)	( to )	( to )	( to )

Notes
[14] - No additional data generation with new HT-hSBA LLOQ cut-offs
[15] - No additional data generation with new HT-hSBA LLOQ cut-offs
[16] - No additional data generation with new HT-hSBA LLOQ cut-offs

No statistical analyses for this end point

Secondary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

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End point title

Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

End point description

End point type

Secondary

End point timeframe

At Days 1, 31, 34, 38 and 61

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	0 ^[17]	0 ^[18]	0 ^[19]
Units: Percentage of subjects
number (confidence interval 95%)	( to )	( to )	( to )

Notes
[17] - No additional data generation with new HT-hSBA LLOQ cut-offs
[18] - No additional data generation with new HT-hSBA LLOQ cut-offs
[19] - No additional data generation with new HT-hSBA LLOQ cut-offs

No statistical analyses for this end point

Secondary: Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

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End point title

Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

End point description

Kinetics of immune response following 1 dose of MenABCWY+OMV in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY, at Days 1, 4, 8, 31, 34, 38 and 61, as measured by the percentages of subjects with hSBA ≥ 8. The analysis was performed on FAS immunogenicity kinetics population set, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay results were available for at least one strain.

End point type

Secondary

End point timeframe

At Days 1, 4, 8, 31, 34, 38 and 61

End point values	MenABCWY+OMV Group (A)	MenACWY Group (B1)	MenACWY group (B2)	Naive Group (C1)	Naive Group (C2)
Number of subjects analysed	33	23	23	26	24
Units: Percentages of subjects
number (confidence interval 95%)
Serogroup A; Day 1 (N=33;23;23;26;24)	27 (13.3 to 45.5)	52 (30.6 to 73.2)	30 (13.2 to 52.9)	0 (0.0 to 13.2)	4 (0.11 to 21.1)
Serogroup A; Day 4 (N=33;23;0;0;0)	24 (11.1 to 42.3)	52 (30.6 to 73.2)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Serogroup A; Day 8 (N=33;0;22;0;0)	100 (89.4 to 100.0)	0 (0 to 0)	82 (59.7 to 94.8)	0 (0 to 0)	0 (0 to 0)
Serogroup A; Day 31 (N=33;23;23;26;24)	100 (89.4 to 100.0)	100 (85.2 to 100.0)	100 (85.2 to 100.0)	73 (52.2 to 88.4)	79 (57.8 to 92.9)
Serogroup A; Day 34 (N=0;0;0;26;0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	77 (56.4 to 91.0)	0 (0 to 0)
Serogroup A; Day 38 (N=0;0;0;0;24)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	96 (78.9 to 99.89)
Serogroup A; Day 61 (N=0;23;23;23;24)	0 (0 to 0)	100 (85.2 to 100.0)	100 (85.2 to 100.0)	100 (85.2 to 100.0)	88 (67.6 to 97.3)
Serogroup C; Day 1 (N=32;23;23;25;24)	69 (50.0 to 83.9)	61 (38.5 to 80.3)	26 (10.2 to 48.4)	40 (21.1 to 61.3)	50 (29.1 to 70.9)
Serogroup C; Day 4 (N=30;22;0;0;0)	73 (54.1 to 87.7)	64 (40.7 to 82.8)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Serogroup C; Day 8 (N=29;0;19;0;0)	100 (88.1 to 100.0)	0 (0 to 0)	100 (82.4 to 100.0)	0 (0 to 0)	0 (0 to 0)
Serogroup C; Day 31 (N=30;17;21;25;23)	100 (88.4 to 100.0)	100 (80.5 to 100.0)	100 (83.9 to 100.0)	100 (86.3 to 100.0)	87 (66.4 to 97.2)
Serogroup C; Day 34 (N=0;0;0;20;0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	100 (83.2 to 100.0)	0 (0 to 0)
Serogroup C; Day 38 (N=0;0;0;0;22)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	100 (84.6 to 100.0)
Serogroup C; Day 61 (N=0;15;19;24;23)	0 (0 to 0)	100 (78.2 to 100.0)	100 (82.4 to 100.0)	100 (85.8 to 100.0)	100 (85.2 to 100.0)
Serogroup W; Day 1 (N=32;23;23;25;22)	75 (56.6 to 88.5)	70 (47.1 to 86.8)	87 (66.4 to 97.2)	44 (24.4 to 65.1)	64 (40.7 to 82.8)
Serogroup W; Day 4 (N=25;22;0;0;0)	76 (54.9 to 90.6)	73 (49.8 to 89.3)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Serogroup W; Day 8 (N=25;0;16;0;0)	100 (86.3 to 100.0)	0 (0 to 0)	100 (79.4 to 100.0)	0 (0 to 0)	0 (0 to 0)
Serogroup W; Day 31 (N=28;17;21;22;24)	100 (87.7 to 100.0)	100 (80.5 to 100.0)	100 (83.9 to 100.0)	100 (84.6 to 100.0)	92 (73.0 to 99.0)
Serogroup W; Day 34 (N=0;0;0;19;0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	100 (82.4 to 100.0)	0 (0 to 0)
Serogroup W; Day 38 (N=0;0;0;0;20)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	100 (83.2 to 100.0)
Serogroup W; Day 61 (N=0;15;17;20;21)	0 (0 to 0)	100 (78.2 to 100.0)	100 (80.5 to 100.0)	100 (83.2 to 100.0)	100 (83.9 to 100.0)
Serogroup Y; Day 1 (N=32;22;22;23;24)	38 (21.1 to 56.3)	64 (40.7 to 82.8)	55 (32.2 to 75.6)	17 (5.0 to 38.8)	21 (7.1 to 42.2)
Serogroup Y; Day 4 (N=31;22;0;0;0)	42 (24.5 to 60.9)	50 (28.2 to 71.8)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Serogroup Y; Day 8 (N=23;0;13;0;0)	100 (85.2 to 100.0)	0 (0 to 0)	100 (75.3 to 100.0)	0 (0 to 0)	0 (0 to 0)
Serogroup Y; Day 31 (N=23;12;11;23;23)	100 (85.2 to 100.0)	100 (73.5 to 100.0)	100 (71.5 to 100.0)	91 (72.0 to 98.9)	78 (56.3 to 92.5)
Serogroup Y; Day 34 (N=0;0;0;23;0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	96 (78.1 to 99.89)	0 (0 to 0)
Serogroup Y; Day 38 (N=0;0;0;0;20)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	100 (83.2 to 100.0)
Serogroup Y; Day 61 (N=0;12;15;23;20)	0 (0 to 0)	100 (73.5 to 100.0)	100 (78.2 to 100.0)	100 (85.2 to 100.0)	95 (75.1 to 99.87)

No statistical analyses for this end point

Secondary: Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

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End point title

Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

End point description

Kinetics of immune response against N. meningitidis serogroup B test strains in previously vaccinated subjects, at Days 1, 4, 8, 31, 34, 38 and 61, as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity kinetics population set, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay results were available for at least one strain.

End point type

Secondary

End point timeframe

At Days 1, 4, 8, 31, 34, 38 and 61

End point values	MenABCWY+OMV Group (A)	MenACWY Group (B1)	MenACWY group (B2)	Naive Group (C1)	Naive Group (C2)
Number of subjects analysed	33	23	23	26	24
Units: Percentages of subjects
number (confidence interval 95%)
Serogroup B, M14459; Day 1 (N=33;23;23;26;24)	18 (7.0 to 35.5)	9 (1.1 to 28.0)	0 (0.0 to 14.8)	8 (0.9 to 25.1)	8 (1.0 to 27.0)
Serogroup B, M14459; Day 4 (N=33;23;0;0;0)	21 (9.0 to 38.9)	4 (0.11 to 21.9)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Serogroup B, M14459; Day 8 (N=33;0;22;0;0)	79 (61.1 to 91.0)	0 (0 to 0)	14 (2.9 to 34.9)	0 (0 to 0)	0 (0 to 0)
Serogroup B, M14459; Day 31 (N=33;23;22;26;24)	85 (68.1 to 94.9)	35 (16.4 to 57.3)	27 (10.7 to 50.2)	46 (26.6 to 66.6)	33 (15.6 to 55.3)
Serogroup B, M14459; Day 34 (N=0;0;0;26;0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	42 (23.4 to 63.1)	0 (0 to 0)
Serogroup B, M14459; Day 38 (N=0;0;0;0;24)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	71 (48.9 to 87.4)
Serogroup B, M14459; Day 61 (N=0;23;23;25;24)	0 (0 to 0)	43 (23.2 to 65.5)	48 (26.8 to 69.4)	80 (59.3 to 93.2)	54 (32.8 to 74.4)
Serogroup B, M01-0240364; Day 1(N=31;22;22;26;24)	13 (3.6 to 29.8)	9 (1.1 to 29.2)	0 (0.0 to 15.4)	4 (0.10 to 19.6)	4 (0.11 to 21.1)
Serogroup B, M01-0240364; Day 4 (N=30;23;0;0;0)	17 (5.6 to 34.7)	4 (0.11 to 21.9)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Serogroup B, M01-0240364; Day 8 (N=29;0;21;0;0)	93 (77.2 to 99.2)	0 (0 to 0)	10 (1.2 to 30.4)	0 (0 to 0)	0 (0 to 0)
Serogroup B, M01-0240364;Day 31(N=30;21;23;24;21)	97 (82.8 to 99.92)	29 (11.3 to 52.2)	22 (7.5 to 43.7)	33 (15.6 to 55.3)	24 (8.2 to 47.2)
Serogroup B, M01-0240364; Day 34 (N=0;0;0;25;0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	40 (21.1 to 61.3)	0 (0 to 0)
Serogroup B, M01-0240364; Day 38 (N=0;0;0;0;22)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	82 (59.7 to 94.8)
Serogroup B, M01-0240364; Day 61(N=0;23;23;23;24)	0 (0 to 0)	65 (42.7 to 83.6)	65 (42.7 to 83.6)	70 (47.1 to 86.8)	71 (48.9 to 87.4)
Serogroup B, NZ98/254; Day 1 (N=33;23;23;26;24)	15 (5.1 to 31.9)	4 (0.11 to 21.9)	0 (0.0 to 14.8)	8 (0.9 to 25.1)	4 (0.11 to 21.1)
Serogroup B, NZ98/254; Day 4 (N=33;23;0;0;0)	12 (3.4 to 28.2)	13 (2.8 to 33.6)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Serogroup B, NZ98/254; Day 8 (N=33;0;22;0;0)	67 (48.2 to 82.0)	0 (0 to 0)	9 (1.1 to 29.2)	0 (0 to 0)	0 (0 to 0)
Serogroup B, NZ98/254; Day 31 (N=33;23;23;26;24)	82 (64.5 to 93.0)	48 (26.8 to 69.4)	26 (10.2 to 48.4)	58 (36.9 to 76.6)	46 (25.6 to 67.2)
Serogroup B, NZ98/254; Day 34 (N=0;0;0;26;0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	50 (29.9 to 70.1)	0 (0 to 0)
Serogroup B, NZ98/254; Day 38 (N=0;0;0;0;24)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	75 (53.3 to 90.2)
Serogroup B, NZ98/254; Day 61 (N=0;23;23;25;24)	0 (0 to 0)	52 (30.6 to 73.2)	39 (19.7 to 61.5)	72 (50.6 to 87.9)	50 (29.1 to 70.9)
Serogroup B, M10713; Day 1 (N=33;23;23;26;24)	48 (30.8 to 66.5)	48 (26.8 to 69.4)	17 (5.0 to 38.8)	38 (20.2 to 59.4)	38 (18.8 to 59.4)
Serogroup B, M10713; Day 4 (N=32;23;0;0;0)	56 (37.7 to 73.6)	39 (19.7 to 61.5)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Serogroup B, M10713; Day 8 (N=33;0;22;0;0)	79 (61.1 to 91.0)	0 (0 to 0)	32 (13.9 to 54.9)	0 (0 to 0)	0 (0 to 0)
Serogroup B, M10713; Day 31 (N=33;23;23;26;24)	85 (68.1 to 94.9)	70 (47.1 to 86.8)	35 (16.4 to 57.3)	62 (40.6 to 79.8)	54 (32.8 to 74.4)
Serogroup B, M10713; Day 34 (N=0;0;0;23;0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	57 (34.5 to 76.8)	0 (0 to 0)
Serogroup B, M10713; Day 38 (N=0;0;0;0;24)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	67 (44.7 to 84.4)
Serogroup B, M10713; Day 61 (N=0;23;23;25;24)	0 (0 to 0)	65 (42.7 to 83.6)	43 (23.2 to 65.5)	68 (46.5 to 85.1)	63 (40.6 to 81.2)
Serogroup B, H44/76; Day 1 (N=33;23;23;26;24)	27 (13.3 to 45.5)	9 (1.1 to 28.0)	0 (0.0 to 14.8)	12 (2.4 to 30.2)	8 (1.0 to 27.0)
Serogroup B, H44/76; Day 4 (N=33;23;0;0;0)	21 (9.0 to 38.9)	4 (0.11 to 21.9)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Serogroup B, H44/76; Day 8 (N=33;0;22;0;0)	94 (79.8 to 99.3)	0 (0 to 0)	14 (2.9 to 34.9)	0 (0 to 0)	0 (0 to 0)
Serogroup B, H44/76; Day 31 (N=33;23;23;26;24)	97 (84.2 to 99.92)	52 (30.6 to 73.2)	52 (30.6 to 73.2)	73 (52.2 to 88.4)	46 (25.6 to 67.2)
Serogroup B, H44/76; Day 34 (N=0;0;0;26;0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	69 (48.2 to 85.7)	0 (0 to 0)
Serogroup B, H44/76; Day 38 (N=0;0;0;0;24)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	96 (78.9 to 99.89)
Serogroup B, H44/76; Day 61 (N=0;23;23;25;24)	0 (0 to 0)	78 (56.3 to 92.5)	91 (72.0 to 98.9)	96 (79.6 to 99.90)	79 (57.8 to 92.9)
Serogroup B, 5/99; Day 1 (N=33;23;23;26;24)	70 (51.3 to 84.4)	22 (7.5 to 43.7)	13 (2.8 to 33.6)	19 (6.6 to 39.4)	13 (2.7 to 32.4)
Serogroup B, 5/99; Day 4 (N=33;23;0;0;0)	79 (61.1 to 91.0)	9 (1.1 to 28.0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
Serogroup B, 5/99; Day 8 (N=33;0;22;0;0)	100 (89.4 to 100.0)	0 (0 to 0)	9 (1.1 to 29.2)	0 (0 to 0)	0 (0 to 0)
Serogroup B, 5/99; Day 31 (N=33;23;23;26;24)	100 (89.4 to 100.0)	78 (56.3 to 92.5)	78 (56.3 to 92.5)	85 (65.1 to 95.6)	79 (57.8 to 92.9)
Serogroup B, 5/99; Day 34 (N=0;0;0;26;0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	85 (65.1 to 95.6)	0 (0 to 0)
Serogroup B, 5/99; Day 38 (N=0;0;0;0;24)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	100 (85.8 to 100.0)
Serogroup B, 5/99; Day 61 (N=0;23;23;25;24)	0 (0 to 0)	100 (85.2 to 100.0)	100 (85.2 to 100.0)	100 (86.3 to 100.0)	100 (85.8 to 100.0)

No statistical analyses for this end point

Secondary: Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

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End point title

Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. ^[20]

End point description

GMTs at Day 1, 4, 8, 31 as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY. This outcome measure reports data only for the MenABCWY+OMV and MenACWY Groups as per protocol. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity kinetics population set, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay results were available for at least one strain.

End point type

Secondary

End point timeframe

At Days 1, 4, 8 and 31

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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	MenABCWY+OMV Group	MenACWY Group
Number of subjects analysed	33	46
Units: Titers
geometric mean (confidence interval 95%)
Serogroup B, M14459; Day 1 (N=33;46)	2.04 (1.46 to 2.83)	1.37 (1.12 to 1.69)
Serogroup B, M14459; Day 4 (N=33;23)	1.99 (1.44 to 2.75)	1.22 (0.96 to 1.54)
Serogroup B, M14459; Day 8 (N=33;22)	17 (9.31 to 30)	1.52 (1.05 to 2.20)
Serogroup B, M14459; Day 31 (N=33;45)	24 (14 to 42)	2.83 (1.88 to 4.24)
Serogroup B, M01-0240364; Day 1 (N=31;44)	2.26 (1.26 to 4.08)	1.14 (0.97 to 1.35)
Serogroup B, M01-0240364; Day 4 (N=30;23)	2.50 (1.25 to 5.02)	1.36 (1.02 to 1.82)
Serogroup B, M01-0240364; Day 8 (N=29;21)	525 (257 to 1074)	1.65 (0.79 to 3.43)
Serogroup B, M01-0240364; Day 31 (N=30;44)	601 (339 to 1064)	3.05 (1.77 to 5.26)
Serogroup B, NZ98/254; Day 1 (N=33;46)	1.81 (1.30 to 2.51)	1.35 (1.15 to 1.59)
Serogroup B, NZ98/254; Day 4 (N=33;23)	1.90 (1.41 to 2.57)	1.89 (1.38 to 2.59)
Serogroup B, NZ98/254; Day 8 (N=33;22)	8.19 (5.45 to 12)	1.52 (1.12 to 2.06)
Serogroup B, NZ98/254; Day 31 (N=33;46)	13 (8.50 to 18)	3.57 (2.37 to 5.38)
Serogroup B, M10713; Day 1 (N=33;46)	3.66 (2.38 to 5.62)	2.56 (1.74 to 3.75)
Serogroup B, M10713; Day 4 (N=32;23)	4.16 (2.70 to 6.41)	3.73 (2.10 to 6.65)
Serogroup B, M10713; Day 8 (N=33;22)	15 (9.26 to 23)	2.03 (1.30 to 3.17)
Serogroup B, M10713; Day 31 (N=33;46)	20 (13 to 31)	5.51 (3.45 to 8.79)
Serogroup B, H44/76; Day 1 (N=33;46)	2.33 (1.57 to 3.45)	1.21 (1.03 to 1.42)
Serogroup B, H44/76; Day 4 (N=33;23)	2.58 (1.78 to 3.75)	1.38 (1.05 to 1.81)
Serogroup B, H44/76; Day 8 (N=33;22)	64 (38 to 109)	1.84 (1.18 to 2.89)
Serogroup B, H44/76; Day 31 (N=33;46)	98 (57 to 170)	5.78 (3.59 to 9.31)
Serogroup B, 5/99; Day 1 (N=33;46)	13 (7.29 to 22)	1.78 (1.36 to 2.34)
Serogroup B, 5/99; Day 4 (N=33;23)	17 (9.56 to 31)	1.99 (1.36 to 2.92)
Serogroup B, 5/99; Day 8 (N=33;22)	1768 (1204 to 2596)	1.97 (0.88 to 4.42)
Serogroup B, 5/99; Day 31 (N=33;46)	1426 (940 to 2164)	19 (11 to 34)
Serogroup A; Day 1 (N=33;46)	4.06 (2.22 to 7.44)	6.64 (3.56 to 12)
Serogroup A; Day 4 (N=33;23)	3.85 (2.00 to 7.42)	9.69 (3.90 to 24)
Serogroup A; Day 8 (N=33;22)	474 (321 to 701)	61 (25 to 146)
Serogroup A; Day 31 (N=33;46)	396 (288 to 545)	149 (106 to 210)
Serogroup C; Day 1 (N=32;46)	17 (7.80 to 37)	6.62 (4.10 to 11)
Serogroup C; Day 4 (N=30;22)	21 (9.93 to 43)	12 (5.13 to 29)
Serogroup C; Day 8 (N=29;19)	2664 (1840 to 3855)	1710 (979 to 2985)
Serogroup C; Day 31 (N=30;38)	1676 (1164 to 2414)	1199 (849 to 1692)
Serogroup W; Day 1 (N=32;46)	28 (15 to 53)	25 (15 to 40)
Serogroup W; Day 4 (N=25;22)	19 (8.77 to 41)	20 (8.11 to 51)
Serogroup W; Day 8 (N=25;16)	1285 (900 to 1833)	1693 (924 to 3103)
Serogroup W; Day 31 (N=28;38)	1823 (1163 to 2856)	2259 (1678 to 3041)
Serogroup Y; Day 1 (N=32;44)	6.17 (3.00 to 13)	12 (6.29 to 22)
Serogroup Y; Day 4 (N=31;22)	6.53 (3.05 to 14)	9.60 (3.56 to 26)
Serogroup Y; Day 8 (N=23;13)	722 (429 to 1216)	1133 (710 to 1809)
Serogroup Y; Day 31 (N=23;23)	779 (430 to 1413)	1692 (1206 to 2373)

No statistical analyses for this end point

Secondary: Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

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End point title

Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. ^[21]

End point description

GMTs at Day 1, 31, 34, 38, 61 as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who were not primed with any meningococcal vaccine (i.e., Naïve Group). This outcome measure reports data for only the Naïve Group as per protocol. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity kinetics population set, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay results were available for at least one strain.

End point type

Secondary

End point timeframe

At Days 1, 31, 34, 38 and 61

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

End point values	Naive Group
Number of subjects analysed	50
Units: Titers
geometric mean (confidence interval 95%)
Serogroup B, M14459; Day 1 (N=50)	1.48 (1.18 to 1.85)
Serogroup B, M14459; Day 31 (N=50)	4.02 (2.67 to 6.06)
Serogroup B, M14459; Day 34 (N=26)	5.06 (2.96 to 8.66)
Serogroup B, M14459; Day 38 (N=24)	9.16 (5.35 to 16)
Serogroup B, M14459; Day 61 (N=49)	9.78 (6.42 to 15)
Serogroup B, M01-0240364; Day 1 (N=50)	1.23 (1.02 to 1.47)
Serogroup B, M01-0240364; Day 31 (N=45)	3.11 (1.76 to 5.51)
Serogroup B, M01-0240364; Day 34 (N=25)	5.13 (2.171 to 12)
Serogroup B, M01-0240364; Day 38 (N=22)	75 (29 to 199)
Serogroup B, M01-0240364; Day 61 (N=47)	21 (11 to 38)
Serogroup B, NZ98/254; Day 1 (N=50)	1.45 (1.18 to 1.77)
Serogroup B, NZ98/254; Day 31 (N=50)	5.75 (3.95 to 8.37)
Serogroup B, NZ98/254; Day 34 (N=26)	6.93 (4.02 to 12)
Serogroup B, NZ98/254; Day 38 (N=24)	7.92 (5.03 to 12)
Serogroup B, NZ98/254; Day 61 (N=49)	7.50 (5.12 to 11)
Serogroup B, M10713; Day 1 (N=50)	3.10 (2.16 to 4.45)
Serogroup B, M10713; Day 31 (N=50)	7.70 (5.04 to 12)
Serogroup B, M10713; Day 34 (N=23)	6.70 (3.37 to 13)
Serogroup B, M10713; Day 38 (N=24)	8.94 (4.91 to 16)
Serogroup B, M10713; Day 61 (N=49)	8.73 (5.80 to 13)
Serogroup B, H44/76; Day 1 (N=50)	1.44 (1.14 to 1.80)
Serogroup B, H44/76; Day 31 (N=50)	7.27 (4.53 to 12)
Serogroup B, H44/76; Day 34 (N=26)	8.91 (4.62 to 17)
Serogroup B, H44/76; Day 38 (N=24)	35 (20 to 60)
Serogroup B, H44/76; Day 61 (N=49)	32 (21 to 49)
Serogroup B, 5/99; Day 1 (N=50)	1.90 (1.42 to 2.53)
Serogroup B, 5/99; Day 31 (N=50)	25 (15 to 42)
Serogroup B, 5/99; Day 34 (N=26)	40 (18 to 90)
Serogroup B, 5/99; Day 38 (N=24)	432 (273 to 683)
Serogroup B, 5/99; Day 61 (N=49)	256 (194 to 338)
Serogroup A; Day 1 (N=50)	1.20 (1.05 to 1.37)
Serogroup A; Day 31 (N=50)	22 (14 to 35)
Serogroup A; Day 34 (N=26)	31 (15 to 67)
Serogroup A; Day 38 (N=24)	107 (64 to 179)
Serogroup A; Day 61 (N=47)	74 (51 to 108)
Serogroup C; Day 1 (N=49)	5.11 (3.49 to 7.48)
Serogroup C; Day 31 (N=48)	58 (35 to 96)
Serogroup C; Day 34 (N=20)	94 (54 to 162)
Serogroup C; Day 38 (N=22)	259 (149 to 449)
Serogroup C; Day 61 (N=47)	188 (132 to 266)
Serogroup W; Day 1(N=47)	8.37 (4.78 to 15)
Serogroup W; Day 31 (N=46)	117 (83 to 166)
Serogroup W; Day 34 (N=19)	180 (107 to 305)
Serogroup W; Day 38 (N=20)	188 (129 to 272)
Serogroup W; Day 61 (N=41)	168 (129 to 218)
Serogroup Y; Day 1 (N=47)	2.00 (1.40 to 2.85)
Serogroup Y; Day 31 (N=46)	85 (45 to 163)
Serogroup Y; Day 34 (N=23)	109 (55 to 215)
Serogroup Y; Day 38 (N=20)	299 (180 to 495)
Serogroup Y; Day 61 (N=43)	224 (147 to 343)

No statistical analyses for this end point

Secondary: GMR against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

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End point title

GMR against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. ^[22]

End point description

GMRs as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity kinetics population set, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay results were available for at least one strain.

End point type

Secondary

End point timeframe

At Days 4, 8 and 31 versus Day 1

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

End point values	MenABCWY+OMV Group	MenACWY Group
Number of subjects analysed	33	46
Units: Ratios
geometric mean (confidence interval 95%)
Serogroup B, M14459; Dy 4/Day 1 (N=33;23)	0.98 (0.88 to 1.09)	0.80 (0.60 to 1.05)
Serogroup B, M14459; Day 8/Day 1 (N=33;22)	8.19 (4.58 to 15)	1.21 (0.80 to 1.83)
Serogroup B, M14459; Day 31/Day 1 (N=33;45)	12 (6.88 to 20)	2.11 (1.45 to 3.07)
Serogroup B, M01-0240364; Day 4/Day 1 (N=30;22)	1.08 (0.68 to 1.71)	1.06 (0.90 to 1.25)
Serogroup B, M01-0240364; Day 8/Day 1 (N=28;20)	210 (85 to 517)	1.69 (0.78 to 3.66)
Serogroup B, M01-0240364; Day 31/Day 1 (N=28;42)	229 (108 to 485)	2.80 (1.59 to 4.96)
Serogroup B, NZ98/254; Day 4/Day 1 (N=33;23)	1.05 (0.84 to 1.31)	1.19 (0.90 to 1.58)
Serogroup B, NZ98/254; Day 8/Day 1 (N=33;22)	4.53 (2.93 to 7.02)	1.31 (0.90 to 1.90)
Serogroup B, NZ98/254; Day 31/Day 1 (N=33;46)	6.92 (4.61 to 10)	2.64 (1.73 to 4.02)
Serogroup B, M10713; Day 4/Day 1 (N=32;23)	1.09 (0.93 to 1.28)	0.93 (0.76 to 1.14)
Serogroup B, M10713; Day 8/Day 1 (N=33;22)	4.02 (2.74 to 5.88)	1.22 (0.89 to 1.67)
Serogroup B, M10713; Day 31/Day 1 (N=33;46)	5.38 (3.54 to 8.17)	2.15 (1.46 to 3.17)
Serogroup B, H44/76; Day 4/Day 1 (N=33;23)	1.11 (0.88 to 1.4128)	1.00 (0.79 to 1.27)
Serogroup B, H44/76; Day 8/Day 1 (N=33;22)	28 (15 to 50)	1.73 (1.06 to 2.81)
Serogroup B, H44/76; Day 31/Day 1 (N=33;46)	42 (25 to 72)	4.78 (2.90 to 7.89)
Serogroup B, 5/99; Day 4/Day 1 (N=33;23)	1.35 (0.90 to 2.04)	0.93 (0.68 to 1.26)
Serogroup B, 5/99; Day 8/Day 1 (N=33;22)	139 (77 to 248)	1.30 (0.66 to 2.57)
Serogroup B, 5/99; Day 31/Day 1 (N=33;46)	112 (68 to 185)	11 (6.09 to 19)
Serogroup A; Day 4/Day 1 (N=33;23)	0.95 (0.72 to 1.24)	0.87 (0.61 to 1.24)
Serogroup A; Day 8/Day 1 (N=33;22)	117 (59 to 232)	17 (7.78 to 37)
Serogroup A; Day 31/Day 1 (N=33;46)	98 (54 to 177)	22 (13 to 38)
Serogroup C; Day 4/Day 1 (N=29;22)	1.30 (0.98 to 1.73)	1.20 (0.92 to 1.56)
Serogroup C; Day 8/Day 1 (N=28;19)	164 (65 to 411)	491 (211 to 1141)
Serogroup C; Day 31/Day 1 (N=30;38)	105 (49 to 222)	238 (145 to 392)
Serogroup W; Day 4/Day 1 (N=25;22)	0.90 (0.56 to 1.442)	0.97 (0.68 to 1.37)
Serogroup W; Day 8/Day 1 (N=24;16)	61 (29 to 131)	67 (27 to 168)
Serogroup W; Day 31/Day 1 (N=28;38)	67 (34 to 132)	112 (65 to 191)
Serogroup Y; Day 4/Day 1 (N=30;22)	1.06 (0.79 to 1.41)	0.73 (0.49 to 1.09)
Serogroup Y; Day 8/Day 1 (N=22;13)	156 (62 to 390)	132 (33 to 535)
Serogroup Y; Day 31/Day 1 (N=22;22)	162 (70 to 375)	216 (80 to 580)

No statistical analyses for this end point

Secondary: GMR against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

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End point title

GMR against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. ^[23]

End point description

GMRs as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity kinetics population set, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay results were available for at least one strain.

End point type

Secondary

End point timeframe

At Days 31, 34, 38 and 61 versus Day 1

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

End point values	Naive Group
Number of subjects analysed	50
Units: Ratios
geometric mean (confidence interval 95%)
Serogroup B, M14459; Day 31/Day 1 (N=50)	2.72 (1.91 to 3.87)
Serogroup B, M14459; Day 34/Day 1 (N=26)	3.45 (2.09 to 5.72)
Serogroup B, M14459; Day 38/Day 1 (N=24)	6.15 (3.65 to 10)
Serogroup B, M14459; Day 61/Day 1 (N=49)	6.78 (4.51 to 10)
Serogroup B, M01-0240364; Day 31/Day 1 (N=45)	2.48 (1.51 to 4.07)
Serogroup B, M01-0240364; Day 34/Day 1 (N=25)	3.97 (1.79 to 8.80)
Serogroup B, M01-0240364; Day 38/Day 1 (N=22)	64 (24 to 167)
Serogroup B, M01-0240364; Day 61/Day 1 (N=47)	18 (9.90 to 33)
Serogroup B, NZ98/254; Day 31/Day 1 (N=50)	3.98 (2.73 to 5.79)
Serogroup B, NZ98/254; Day 34/Day 1 (N=26)	4.52 (2.60 to 7.84)
Serogroup B, NZ98/254; Day 38/Day 1 (N=24)	5.84 (3.34 to 10)
Serogroup B, NZ98/254; Day 61/Day 1 (N=49)	5.28 (3.61 to 7.74)
Serogroup B, M10713; Day 31/Day 1 (N=50)	2.48 (1.78 to 3.45)
Serogroup B, M10713; Day 34/Day 1 (N=23)	2.54 (1.67 to 3.86)
Serogroup B, M10713; Day 38/Day 1 (N=24)	2.83 (1.64 to 4.87)
Serogroup B, M10713; Day 61/Day 1 (N=49)	2.85 (1.98 to 4.11)
Serogroup B, H44/76; Day 31/Day 1 (N=50)	5.06 (3.21 to 7.97)
Serogroup B, H44/76; Day 34/Day 1 (N=26)	6.17 (3.33 to 11)
Serogroup B, H44/76; Day 38/Day 1 (N=24)	24 (14 to 42)
Serogroup B, H44/76; Day 61/Day 1 (N=49)	23 (15 to 35)
Serogroup B, 5/99; Day 31/Day 1 (N=50)	13 (8.14 to 22)
Serogroup B, 5/99; Day 34/Day 1 (N=26)	20 (8.58 to 49)
Serogroup B, 5/99; Day 38/Day 1 (N=24)	233 (141 to 385)
Serogroup B, 5/99; Day 61/Day 1 (N=49)	141 (106 to 189)
Serogroup A; Day 31/Day 1 (N=50)	18 (12 to 29)
Serogroup A; Day 34/Day 1 (N=26)	28 (13 to 61)
Serogroup A; Day 38/Day 1 (N=24)	82 (48 to 140)
Serogroup A; Day 61/Day 1 (N=47)	61 (41 to 90)
Serogroup C; Day 31/Day 1 (N=48)	12 (6.88 to 19)
Serogroup C; Day 34/Day 1 (N=19)	18 (8.98 to 36)
Serogroup C; Day 38/Day 1 (N=22)	64 (32 to 128)
Serogroup C; Day 61/Day 1 (N=46)	39 (25 to 61)
Serogroup W; Day 31/Day 1 (N=44)	16 (8.35 to 30)
Serogroup W; Day 34/Day 1 (N=18)	42 (15 to 116)
Serogroup W; Day 38/Day 1 (N=19)	16 (6.68 to 40)
Serogroup W; Day 61/Day 1 (N=38)	22 (11 to 42)
Serogroup Y; Day 31/Day 1 (N=43)	46 (23 to 92)
Serogroup Y; Day 34/Day 1 (N=20)	69 (30 to 1601)
Serogroup Y; Day 38/Day 1 (N=20)	134 (68 to 264)
Serogroup Y; Day 61/Day 1 (N=40)	106 (62 to 182)

No statistical analyses for this end point

Secondary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

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End point title

Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

End point description

End point type

Secondary

End point timeframe

At Day 61

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	0 ^[24]	0 ^[25]	0 ^[26]
Units: Percentages of subjects
number (confidence interval 95%)	( to )	( to )	( to )

Notes
[24] - No additional data generation with new HT-hSBA LLOQ cut-offs
[25] - No additional data generation with new HT-hSBA LLOQ cut-offs
[26] - No additional data generation with new HT-hSBA LLOQ cut-offs.

No statistical analyses for this end point

Secondary: Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

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End point title

Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y. ^[27]

End point description

Immunogenicity against N. meningitidis serogroup A, C, W and Y following 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61, as measured by percentages of subjects with hSBA ≥ 8. The analysis was performed on FAS immunogenicity persistence population set Day 61, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay results were available for at least one serogroup/test strain.

End point type

Secondary

End point timeframe

At Day 61

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

End point values	MenACWY Group	Naive Group
Number of subjects analysed	46	47
Units: Percentages of subjects
number (confidence interval 95%)
Serogroup A (N=46;47)	100 (92.3 to 100.0)	94 (82.5 to 98.7)
Serogroup C (N=34;47)	100 (89.7 to 100.0)	100 (92.5 to 100.0)
Serogroup W (N=32;41)	100 (89.1 to 100.0)	100 (91.4 to 100.0)
Serogroup Y (N=27;43)	100 (87.2 to 100.0)	98 (87.7 to 99.94)

No statistical analyses for this end point

Secondary: Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

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End point title

Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains. ^[28]

End point description

Immunogenicity against N. meningitidis serogroup B test strains following 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61, as measured by percentages of subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity persistence population set Day 61, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay results were available for at least one serogroup/test strain.

End point type

Secondary

End point timeframe

At Day 61

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

End point values	MenACWY Group	Naive Group
Number of subjects analysed	46	49
Units: Percentages of subjects
number (confidence interval 95%)
Serogroup B, M14459 (N=46;49)	46 (30.9 to 61.0)	67 (52.5 to 80.1)
Serogroup B, M01-0240364 (N=46;47)	65 (49.8 to 78.6)	70 (55.1 to 82.7)
Serogroup B, NZ98/254 (N=46;49)	46 (30.9 to 61.0)	61 (46.2 to 74.8)
Serogroup B, M10713 (N=46;49)	54 (39.0 to 69.1)	65 (50.4 to 78.3)
Serogroup B, H44/76 (N=46;49)	85 (71.1 to 93.7)	88 (75.2 to 95.4)
Serogroup B, 5/99 (N=46;49)	100 (92.3 to 100.0)	100 (92.7 to 100.0)

No statistical analyses for this end point

Secondary: GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

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End point title

GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. ^[29]

End point description

GMTs as measure of the immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity persistence population set Day 61, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay results were available for at least one serogroup/test strain.

End point type

Secondary

End point timeframe

At Day 61

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

End point values	MenACWY Group	Naive Group
Number of subjects analysed	46	49
Units: Titers
geometric mean (confidence interval 95%)
Serogroup B, M14459 (N=46;49)	4.82 (3.26 to 7.12)	9.78 (6.42 to 15)
Serogroup B, M01-0240364 (N=46;47)	19 (10 to 34)	21 (11 to 38)
Serogroup B, NZ98/254 (N=46;49)	6.24 (4.47 to 8.70)	7.50 (5.12 to 11)
Serogroup B, M10713 (N=46;49)	6.91 (4.43 to 11)	8.73 (5.80 to 13)
Serogroup B, H44/76 (N=46;49)	19 (13 to 28)	32 (21 to 49)
Serogroup B, 5/99 (N=46;49)	196 (149 to 257)	256 (194 to 338)
Serogroup A (N=46;47)	222 (170 to 290)	74 (51 to 108)
Serogroup C (N=34;47)	879 (712 to 1085)	188 (132 to 266)
Serogroup W (N=32;41)	1440 (1078 to 1924)	168 (129 to 218)
Serogroup Y (N=27;43)	1576 (1190 to 2087)	224 (147 to 343)

Statistical analysis 1

Statistical analysis description

Between-group GMT ratios against N. meningitidis Serogroup B, M14459

Comparison groups

MenACWY Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.49

Confidence interval

level

95%

sides

2-sided

lower limit

0.28

upper limit

0.87

Statistical analysis 2

Statistical analysis description

Between-group GMT ratios against N. meningitidis Serogroup B, M01-0240364

Comparison groups

MenACWY Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.91

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

2.11

Statistical analysis 3

Statistical analysis description

Between-group GMT ratios against N. meningitidis serogroup B, NZ98/254

Comparison groups

MenACWY Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.83

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

1.38

Statistical analysis 4

Statistical analysis description

Between-group GMT ratios against N. meningitidis serogroup B, M10713

Comparison groups

MenACWY Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.79

Confidence interval

level

95%

sides

2-sided

lower limit

0.44

upper limit

1.44

Statistical analysis 5

Statistical analysis description

Between-group GMT ratios against N. meningitidis serogroup B, H44/76

Comparison groups

MenACWY Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.34

upper limit

1.07

Statistical analysis 6

Statistical analysis description

Between-group GMT ratios against N. meningitidis serogroup B, 5/99

Comparison groups

MenACWY Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

0.77

Confidence interval

level

95%

sides

2-sided

lower limit

0.52

upper limit

1.12

Statistical analysis 7

Statistical analysis description

Between-group GMT ratios against N. meningitidis serogroup A

Comparison groups

MenACWY Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

2.99

Confidence interval

level

95%

sides

2-sided

lower limit

1.89

upper limit

4.75

Statistical analysis 8

Statistical analysis description

Between-group GMT ratios against N. meningitidis serogroup C

Comparison groups

MenACWY Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

4.69

Confidence interval

level

95%

sides

2-sided

lower limit

3.01

upper limit

7.31

Statistical analysis 9

Statistical analysis description

Between-group GMT ratios against N. meningitidis serogroup W

Comparison groups

MenACWY Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

8.6

Confidence interval

level

95%

sides

2-sided

lower limit

5.84

upper limit

Statistical analysis 10

Statistical analysis description

Between-group GMT ratios against N. meningitidis serogroup Y

Comparison groups

MenACWY Group v Naive Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

Method

Miettinen & Nurminen score method

Parameter type

Geometric mean ratio

Point estimate

7.03

Confidence interval

level

95%

sides

2-sided

lower limit

3.96

upper limit

Secondary: GMRs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

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End point title

GMRs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains. ^[30]

End point description

GMRs as measure of the immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. The analysis was performed on FAS immunogenicity persistence population set Day 61, which included all subjects in the Enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay results were available for at least one serogroup/test strain.

End point type

Secondary

End point timeframe

Day 61 versus Day 1 (baseline)

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

End point values	MenACWY Group	Naive Group
Number of subjects analysed	46	49
Units: Ratios
geometric mean (confidence interval 95%)
Serogroup B, M14459 (N=46;49)	3.50 (2.33 to 5.26)	6.78 (4.51 to 10)
Serogroup B, M01-0240364 (N=44;47)	16 (8.77 to 31)	18 (9.90 to 33)
Serogroup B, NZ98/254 (N=46;49)	4.61 (3.22 to 6.60)	5.28 (3.61 to 7.74)
Serogroup B, M10713 (N=46;49)	2.70 (1.94 to 3.77)	2.85 (1.98 to 4.11)
Serogroup B, H44/76 (N=46;49)	16 (10 to 24)	23 (15 to 35)
Serogroup B, 5/99 (N=46;49)	110 (76 to 159)	141 (106 to 189)
Serogroup A (N=46;47)	33 (20 to 56)	61 (41 to 90)
Serogroup C (N=34;46)	181 (108 to 303)	39 (25 to 61)
Serogroup W (N=32;38)	85 (46 to 155)	22 (11 to 42)
Serogroup Y (N=26;40)	264 (117 to 598)	106 (62 to 182)

No statistical analyses for this end point

Secondary: Number of subjects reporting any unsolicited and solicited adverse events (AEs) within 30 min after each vaccination.

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End point title

Number of subjects reporting any unsolicited and solicited adverse events (AEs) within 30 min after each vaccination.

End point description

Any solicited and unsolicited AEs reported within 30 minutes after each vaccination. Assessed solicited local symptoms were: Erythema and Induration. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site. Assessed solicited general symptoms were: Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of Pain and/or Fever and Treatment of Pain and/or Fever. Any = occurrence of the symptom regardless of intensity grade. Note: There were no unsolicited AEs reported within 30 minutes after vaccination. The analysis was performed on the Solicited safety Set, which included all subjects in the FAS Immunogenicity population who provided post vaccination safety data.

End point type

Secondary

End point timeframe

Within 30 min after each vaccination

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Subjects
Erythema (1st vaccination) (N=33;46;50)	0	1	0
Erythema (2nd vaccination) (N=0;44;50)	0	1	0
Induration (1st vaccination) (N=33;46;50)	0	0	0
Induration (2nd vaccination) (N=0;44;50)	0	0	0
Pain (1st vaccination) (N=33;46;50)	4	8	6
Pain (2nd vaccination) (N=0;44;50)	0	3	4
Arthralgia (1st vaccination) (N=33;46;50)	0	0	0
Arthralgia (2nd vaccination) (N=0;44;50)	0	0	0
Chills (1st vaccination) (N=33;46;50)	0	0	0
Chills (2nd vaccination) (N=0;44;50)	0	0	0
Fatigue (1st vaccination) (N=33;46;50)	0	0	0
Fatigue (2nd vaccination) (N=0;44;50)	0	0	1
Headache (1st vaccination) (N=33;46;50)	1	0	0
Headache (2nd vaccination) (N=0;44;50)	0	0	1
Loss of Appetite (1st vaccination) (N=33;46;50)	0	0	0
Loss of Appetite (2nd vaccination) (N=0;44;50)	0	0	0
Myalgia (1st vaccination) (N=33;46;50)	0	0	0
Myalgia (2nd vaccination) (N=0;44;50)	0	0	0
Nausea (1st vaccination) (N=33;46;50)	0	0	0
Nausea (2nd vaccination) (N=0;44;50)	0	0	0
Fever (1st vaccination) (N=33;46;50)	0	0	0
Fever (2nd vaccination) (N=0;44;50)	0	0	0
Prevention of Pain/Fever (1st vacc.) (N=33;45;50)	0	0	0
Prevention of Pain/Fever (2nd vacc.) (N=0;44;50)	0	0	1
Treatment of Pain/Fever (1st vacc.) (N=33;45;50)	0	0	0
Treatment of Pain/Fever (2nd vacc.) (N=0;44;50)	0	0	2

No statistical analyses for this end point

Secondary: Number of subjects with any solicited local symptoms.

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End point title

Number of subjects with any solicited local symptoms.

End point description

Assessed solicited local symptoms were Erythema, Induration and Pain. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site. The analysis was performed on the Solicited safety Set, which included all subjects in the FAS Immunogenicity population who provided post vaccination safety data.

End point type

Secondary

End point timeframe

From Day 1 (6 hours) to Day 7 after each vaccination

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Subjects
Any local AEs (1st vaccination) (N=33;46;50)	31	41	47
Erythema (1st vaccination) (N=33;45;50)	8	7	8
Induration (1st vaccination) (N=33;46;50)	12	7	13
Pain (1st vaccination) (N=33;46;50)	31	41	47
Any local AEs (2nd vaccination) (N=0;45;50)	0	35	41
Erythema (2nd vaccination) (N=0;45;49)	0	6	7
Induration (2nd vaccination) (N=0;45;50)	0	9	8
Pain (2nd vaccination) (N=0;45;50)	0	34	41

No statistical analyses for this end point

Secondary: Number of subjects with solicited systemic symptoms and other solicited data.

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End point title

Number of subjects with solicited systemic symptoms and other solicited data.

End point description

Assessed solicited systemic symptoms were Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of pain and/or fever and Treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade. The analysis was performed on the Solicited safety Set, which included all subjects in the FAS Immunogenicity population who provided post vaccination safety data.

End point type

Secondary

End point timeframe

From Day 1 (6 hours) to Day 7 after each vaccination

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Subjects
Any systemic AEs (1st vaccination) (N=33;46;50)	24	35	37
Arthralgia (1st vaccination) (N=33;46;50)	8	8	15
Chills (1st vaccination) (N=33;46;50)	5	11	11
Fatigue (1st vaccination) (N=33;45;50)	14	19	24
Headache (1st vaccination) (N=33;46;50)	19	20	23
Loss of Appetite (1st vaccination) (N=33;45;50)	5	9	9
Myalgia (1st vaccination) (N=33;46;50)	18	22	23
Nausea (1st vaccination) (N=33;46;50)	4	10	13
Fever (1st vaccination) (N=33;46;50)	0	4	8
Prevention of Pain/Fever (1st vacc.) (N=33;44;50)	0	1	1
Treatment of Pain/Fever (1st vacc.) (N=33;44;50)	8	7	11
Any systemic AEs (2nd vaccination) (N=0;45;50)	0	22	28
Arthralgia (2nd vaccination) (N=0;45;50)	0	4	7
Chills (2nd vaccination) (N=0;45;50)	0	5	9
Fatigue (2nd vaccination) (N=0;44;50)	0	10	12
Headache (2nd vaccination) (N=0;44;50)	0	11	18
Loss of Appetite (2nd vaccination) (N=0;45;50)	0	3	5
Myalgia (2nd vaccination) (N=0;45;50)	0	12	14
Nausea (2nd vaccination) (N=0;45;50)	0	4	4
Fever (2nd vaccination) (N=0;45;50)	0	4	2
Prevention of Pain/Fever (2nd vacc.) (N=0;45;50)	0	1	3
Treatment of Pain/Fever (2nd vacc.) (N=0;45;50)	0	2	6

No statistical analyses for this end point

Secondary: Number of subjects with unsolicited Adverse Events (AEs).

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End point title

Number of subjects with unsolicited Adverse Events (AEs).

End point description

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Possibly or Probably related = AE assessed by the investigator as related to the vaccination. The analysis was performed on the Unsolicited Safety Set, which included all subjects in the Exposed Set who had post vaccination unsolicited adverse event records.

End point type

Secondary

End point timeframe

From Day 1 to Day 31 after each vaccination (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Subjects
Any AEs	11	21	20
Possibly or Probably Related AEs	3	11	8

No statistical analyses for this end point

Secondary: Number of subjects with medically attended AEs reported during the entire study period.

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End point title

Number of subjects with medically attended AEs reported during the entire study period.

End point description

Medically attended AEs = were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) = Occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination. The analysis was performed on the Unsolicited Safety Set, which included all subjects in the Exposed Set who had post vaccination unsolicited adverse event records.

End point type

Secondary

End point timeframe

During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Subjects
Medically attended AEs	2	6	5

No statistical analyses for this end point

Secondary: Number of subjects with unsolicited AEs leading to premature withdrawal from study reported during the entire study period.

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End point title

Number of subjects with unsolicited AEs leading to premature withdrawal from study reported during the entire study period.

End point description

The number of subjects who reported unsolicited AEs leading to premature withdrawal from study after any vaccination. The analysis was performed on the Unsolicited Safety Set, which included all subjects in the Exposed Set who had post vaccination unsolicited adverse event records.

End point type

Secondary

End point timeframe

From Day 1 to Day 31 (MenABCWY+OMV Group) and from Day 1 to Day 61 (MenACWY and Naive Groups)

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Subjects
AEs leading to premature withdrawal	0	1	0

No statistical analyses for this end point

Secondary: Number of subjects with serious adverse events (SAEs) reported during the entire study period.

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End point title

Number of subjects with serious adverse events (SAEs) reported during the entire study period.

End point description

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Possibly or probably related SAE(s) = SAE(s) assessed by the investigator as related to the vaccination. The analysis was performed on the Unsolicited Safety Set, which included all subjects in the Exposed Set who had post vaccination unsolicited adverse event records.

End point type

Secondary

End point timeframe

During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)

End point values	MenABCWY+OMV Group	MenACWY Group	Naive Group
Number of subjects analysed	33	46	50
Units: Subjects
Any SAEs	0	0	0
Possibly or probably related SAEs	0	0	0
AEs leading to death	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited local and systemic symptoms: from Day 1 (6 hours) to Day 7 after each study vaccination; Unsolicited AEs: from Day 1 to Day 31 after each study vaccination; SAEs: during the entire study period (from Day 1 to Day 61).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

MenABCWY+OMV Group

Reporting group description

Reporting group title

Naive Group

Reporting group description

Reporting group title

MenACWY Group

Reporting group description

Serious adverse events	MenABCWY+OMV Group	Naive Group	MenACWY Group
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 33 (0.00%)	0 / 50 (0.00%)	0 / 46 (0.00%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0

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

Non-serious adverse events	MenABCWY+OMV Group	Naive Group	MenACWY Group
Total subjects affected by non serious adverse events
subjects affected / exposed	33 / 33 (100.00%)	48 / 50 (96.00%)	44 / 46 (95.65%)
Nervous system disorders
Headache
subjects affected / exposed	19 / 33 (57.58%)	28 / 50 (56.00%)	23 / 46 (50.00%)
occurrences all number	43	120	84
General disorders and administration site conditions
Chills
subjects affected / exposed	5 / 33 (15.15%)	16 / 50 (32.00%)	14 / 46 (30.43%)
occurrences all number	10	31	25
Fatigue
subjects affected / exposed	14 / 33 (42.42%)	27 / 50 (54.00%)	20 / 46 (43.48%)
occurrences all number	29	82	75
Injection site erythema
subjects affected / exposed	11 / 33 (33.33%)	30 / 50 (60.00%)	26 / 46 (56.52%)
occurrences all number	45	123	135
Injection site induration
subjects affected / exposed	18 / 33 (54.55%)	30 / 50 (60.00%)	27 / 46 (58.70%)
occurrences all number	75	169	173
Injection site pain
subjects affected / exposed	31 / 33 (93.94%)	48 / 50 (96.00%)	42 / 46 (91.30%)
occurrences all number	114	333	295
Pyrexia
subjects affected / exposed	0 / 33 (0.00%)	10 / 50 (20.00%)	8 / 46 (17.39%)
occurrences all number	0	13	12
Gastrointestinal disorders
Nausea
subjects affected / exposed	4 / 33 (12.12%)	15 / 50 (30.00%)	10 / 46 (21.74%)
occurrences all number	11	25	30
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	8 / 33 (24.24%)	19 / 50 (38.00%)	11 / 46 (23.91%)
occurrences all number	14	51	35
Myalgia
subjects affected / exposed	18 / 33 (54.55%)	26 / 50 (52.00%)	25 / 46 (54.35%)
occurrences all number	42	96	85
Infections and infestations
Nasopharyngitis
subjects affected / exposed	1 / 33 (3.03%)	1 / 50 (2.00%)	6 / 46 (13.04%)
occurrences all number	1	1	6
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	5 / 33 (15.15%)	13 / 50 (26.00%)	11 / 46 (23.91%)
occurrences all number	11	30	25

More information

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Were there any global substantial amendments to the protocol? Yes

18 Nov 2014

Allow pregnancy test be performed in urine or blood sample.

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: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Primary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Primary: Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

Primary: Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

Primary: Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

Primary: Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

Primary: Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Primary: Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Primary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and B test strains.

Primary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and B test strains.

Primary: Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

Primary: Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

Primary: Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

Primary: Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

Primary: Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Primary: Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Primary: Geometric Mean hSBA Ratio (GMRs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Primary: Geometric Mean hSBA Ratio (GMRs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

Secondary: Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

Secondary: Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

Secondary: Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

Secondary: Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: Geometric Mean hSBA Titers (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: GMR against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: GMR against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: GMR against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: GMR against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: Percentages of Subjects with hSBA ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

Secondary: Percentages of Subjects with hSBA ≥ 8 against N. meningitidis serogroups A, C, W and Y.

Secondary: Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

Secondary: Percentages of Subjects with hSBA ≥ 5 against N. meningitidis serogroup B test strains.

Secondary: GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: GMRs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: GMRs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.

Secondary: Number of subjects reporting any unsolicited and solicited adverse events (AEs) within 30 min after each vaccination.

Secondary: Number of subjects reporting any unsolicited and solicited adverse events (AEs) within 30 min after each vaccination.

Secondary: Number of subjects with any solicited local symptoms.

Secondary: Number of subjects with any solicited local symptoms.

Secondary: Number of subjects with solicited systemic symptoms and other solicited data.

Secondary: Number of subjects with solicited systemic symptoms and other solicited data.

Secondary: Number of subjects with unsolicited Adverse Events (AEs).

Secondary: Number of subjects with unsolicited Adverse Events (AEs).

Secondary: Number of subjects with medically attended AEs reported during the entire study period.

Secondary: Number of subjects with medically attended AEs reported during the entire study period.

Secondary: Number of subjects with unsolicited AEs leading to premature withdrawal from study reported during the entire study period.

Secondary: Number of subjects with unsolicited AEs leading to premature withdrawal from study reported during the entire study period.

Secondary: Number of subjects with serious adverse events (SAEs) reported during the entire study period.

Secondary: Number of subjects with serious adverse events (SAEs) reported during the entire study period.

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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