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Clinical Trial Results:
A Phase 2b, Open-Label, Multi-Center Study Assessing the Immunological Persistence of Antibodies at Approximately 2 years After the last Meningococcal Vaccination in Study V102_15 and the Response to a Booster dose of GSK MenABCWY or Meningococcal Serogroup B Vaccines, in Healthy Adolescents

Summary
EudraCT number	2016-002230-69
Trial protocol	FI PL
Global end of trial date	11 Oct 2018

Results information
Results version number	v2(current)
This version publication date	01 Sep 2019
First version publication date	21 Apr 2019
Other versions	v1
Version creation reason	Correction of full data set In response to NIH comments, further information has been added in the measure description for endpoints 1 and 2, to clarify that subjects in the group B_0_2 did not receive MenACWY vaccination in the parent study.

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

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Trial information

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Sponsor protocol code

205613

ISRCTN number

US NCT number

NCT02946385

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

Rue del ' 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

08 Feb 2019

Is this the analysis of the primary completion data?

Yes

Primary completion date

13 Feb 2018

Global end of trial reached?

Yes

Global end of trial date

11 Oct 2018

Was the trial ended prematurely?

Main objective of the trial

To assess the persistence of bactericidal antibodies in subjects who previously received 2 or 3 doses of MenABCWY (administered according to 0, 2, 0, 6 & 0, 2, 6-month schedules) or 2 doses of rMenB+OMV (given at a 0, 2-mth schedule), 24 months after the last meningococcal vaccination in study V102_15 compared with baseline antibody levels in meningococcal naive subjects at enrolment, as measured by percent-ages of subjects with HT-hSBA titers ≥ lower limit of quantitation (LLOQ) and HT-hSBA geometric mean titers (GMTs) against N. meningitidis test strains for serogroup B, and serogroups A, C, W, and Y.

Protection of trial subjects

All subjects will be observed for at least 30 minutes after vaccination/product administration with appropriate medical treatment readily available. Vaccines will be administered by qualified and trained personnel. Vaccines will be administered only to eligible subjects that have no contraindications to any components of the vaccines. Subjects will be followed-up for 180 days after the last vaccination administration (i.e. Day 181 for follow-on subjects and Day 241 for vaccine naïve subjects).

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Nov 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Finland: 283

Country: Number of subjects enrolled

Poland: 321

Worldwide total number of subjects

604

EEA total number of subjects

604

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)

342

Adults (18-64 years)

262

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

All subjects enrolled in the study started the study.

Screening details

Participant flow,baseline characteristics & immunogenicity analyses were performed on "randomized" population & Safety analysis on "treated" population.2 subjects from Naïve_ABCWY group received rMenB+OMV vaccine & not MenABCWY.Hence,number of subjects analyzed in Naïve_B & Naive_ABCWY groups in treated population differ from randomized population

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Blinding implementation details

This was an open label study. No blinding methods were used.

Are arms mutually exclusive

Yes

B_0_2

Arm description

Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study

Arm type

Experimental

Investigational medicinal product name

rMenB +OMV Vaccine

Investigational medicinal product code

Other name

Bexsero

Pharmaceutical forms

Suspension for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection of one booster dose of the rMenB+OMV vaccine to subjects in the B_0_2 group, primed with 2 doses of the vaccine and intramuscular injection of 2 doses at Days 1 and 61 in the deltoid area of the non-dominant arm to naïve subjects in the rMenB+OMV Naïve group

ABCWY_0_2

Arm description

Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Arm type

Experimental

Investigational medicinal product name

MenABCWY 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

Intramuscular injection of one booster dose at Day 1 to follow-on subjects in the ABCWY_ 0_2 Group, ABCWY_ 0_2_6 Group and ABCWY_ 0_6 Group, primed with 2 or 3 doses of the study vaccine and 2 doses at Days 1 and 61 to naïve subjects in the ABCWY naïve group

Naive_B

Arm description

Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study

Arm type

Active comparator

Investigational medicinal product name

rMenB +OMV Vaccine

Investigational medicinal product code

Other name

Bexsero

Pharmaceutical forms

Suspension for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

ABCWY_0_6

Arm description

Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Arm type

Experimental

Investigational medicinal product name

MenABCWY 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

Naive_ABCWY

Arm description

Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study

Arm type

Active comparator

Investigational medicinal product name

MenABCWY 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

ABCWY_0_2_6

Arm description

Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Arm type

Experimental

Investigational medicinal product name

MenABCWY 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

Number of subjects in period 1	B_0_2	ABCWY_0_2	Naive_B	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Started	126	127	99	74	101	77
Completed	126	127	96	74	99	76
Not completed	0	0	3	0	2	1
Lost to follow-up	-	-	3	-	2	1

Baseline characteristics

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Reporting group title

B_0_2

Reporting group description

Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study

Reporting group title

ABCWY_0_2

Reporting group description

Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Reporting group title

Naive_B

Reporting group description

Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study

Reporting group title

ABCWY_0_6

Reporting group description

Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Reporting group title

Naive_ABCWY

Reporting group description

Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study

Reporting group title

ABCWY_0_2_6

Reporting group description

Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Reporting group values	B_0_2	ABCWY_0_2	Naive_B	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6	Total
Number of subjects	126	127	99	74	101	77	604
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0	0
Adolescents (12-17 years)	73	73	57	40	57	42	342
Adults (18-64 years)	53	54	42	34	44	35	262
From 65-84 years	0	0	0	0	0	0	0
85 years and over	0	0	0	0	0	0	0
Age continuous
Units: years
geometric mean (standard deviation)	16.8 ± 3.06	16.6 ± 3.15	16.2 ± 2.8	17.3 ± 2.96	16.5 ± 2.78	17.1 ± 2.98	-
Sex: Female, Male
Units: Subjects
Female	82	69	58	44	60	50	363
Male	44	58	41	30	41	27	241
Race/Ethnicity, Customized
Units: Subjects
AMERICAN INDIAN OR ALASKA NATIVE	0	0	0	0	1	0	1
ASIAN	0	0	0	0	0	1	1
OTHER	0	0	2	1	0	1	4
WHITE	126	127	97	73	100	75	598

End points

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Reporting group title

B_0_2

Reporting group description

Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study

Reporting group title

ABCWY_0_2

Reporting group description

Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Reporting group title

Naive_B

Reporting group description

Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study

Reporting group title

ABCWY_0_6

Reporting group description

Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Reporting group title

Naive_ABCWY

Reporting group description

Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study

Reporting group title

ABCWY_0_2_6

Reporting group description

Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Subject analysis set title

Naive_ALL

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study

Primary: Percentages of subjects with hSBA titers ≥LLOQ against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects

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End point title

Percentages of subjects with hSBA titers ≥LLOQ against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects ^[1] ^[2]

End point description

The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the percentage of subjects with High-Throughput Human Serum Bactericidal Assay (HT-hSBA) titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The analysis population included all subjects in the full analysis set (FAS) persistence (24 months after last vaccination in V102_15/Day 1) who were randomized(if naive), and provided evaluable serum sample with hSBA results for at least one serogroup B test strain or serogroups A, C,W or Y at Day 1 in the extension study.Subjects in the group B_0_2 did not receive MenACWY vaccine in the parent study V102_15.

End point type

Primary

End point timeframe

At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjects

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this endpoint was descriptive analysis. Therefore, no statistical analyses were performed on this endpoint.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The 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	B_0_2	ABCWY_0_2	ABCWY_0_6	ABCWY_0_2_6	Naive_ALL
Number of subjects analysed	125	127	74	75	198
Units: Percentage of subjects
number (confidence interval 95%)
M14459 (N-121,74,72,123,198)	17 (10.9 to 24.9)	18 (11.8 to 26.2)	25 (15.5 to 36.6)	16 (8.7 to 26.6)	5 (2.1 to 8.5)
96217(N-127,74,74,124,198)	81 (73.5 to 87.9)	71 (62.1 to 78.6)	73 (61.4 to 82.6)	81 (70.3 to 89.3)	34 (27.3 to 40.9)
NZ98/254(N-127,75,74,124,198)	15 (9.5 to 22.9)	16 (9.9 to 23.3)	18 (9.7 to 28.2)	15 (7.6 to 24.7)	3 (0.8 to 5.8)
M07-0241084(N-126,75,73,125,196)	28 (20.3 to 36.7)	29 (21.6 to 38.1)	36 (24.7 to 47.7)	31 (20.5 to 42.4)	17 (12.3 to 23.4)
Meningitis A(N-125,72,74,0,99)	0 (0 to 0)	15 (9.4 to 22.7)	27 (17.4 to 38.6)	25 (15.5 to 36.6)	3 (0.6 to 8.6)
Meningitis C(N-127,74,74,0,100)	0 (0 to 0)	83 (75.8 to 89.5)	85 (75.0 to 92.3)	86 (76.5 to 93.3)	32 (23.0 to 42.1)
Meningiti5 W(N-127,75,72,0,98)	0 (0 to 0)	52 (42.9 to 60.9)	64 (51.7 to 74.9)	73 (61.9 to 82.9)	27 (18.1 to 36.4)
Meningitis Y(N-126,73,73,0,99)	0 (0 to 0)	52 (43.3 to 61.3)	62 (49.5 to 72.8)	75 (63.9 to 84.7)	7 (2.9 to 14.0)

No statistical analyses for this end point

Primary: hSBA GMTs against each of four serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects

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End point title

hSBA GMTs against each of four serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects ^[3] ^[4]

End point description

The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The analysis population included all subjects in the full analysis set (FAS) persistence (24 months after last vaccination in V102_15/Day 1) who were randomized(if naive), and provided evaluable serum sample with hSBA results for at least one serogroup B test strain or serogroups A, C,W or Y at Day 1 in the extension study.Subjects in the group B_0_2 did not receive MenACWY vaccine in the parent study V102_15.

End point type

Primary

End point timeframe

At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjects

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The scope of this endpoint was descriptive analysis. Therefore, no statistical analyses were performed on this endpoint.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The 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	B_0_2	ABCWY_0_2	ABCWY_0_6	ABCWY_0_2_6	Naive_ALL
Number of subjects analysed	125	127	74	75	198
Units: Titers
geometric mean (confidence interval 95%)
M14459(N-121,74,72,123,198)	2.02 (1.66 to 2.45)	2.05 (1.68 to 2.50)	2.55 (1.98 to 3.30)	2 (1.55 to 2.57)	1.21 (1.04 to 1.42)
96217(N-127,74,74,124,198)	20 (15 to 26)	13 (10 to 17)	15 (11 to 22)	19 (14 to 27)	3.63 (2.94 to 4.48)
NZ98/254(N-127,75,74,124,198)	1.72 (1.42 to 2.08)	1.78 (1.48 to 2.16)	2.1 (1.64 to 2.69)	1.72 (1.34 to 2.19)	1.1 (0.95 to 1.28)
M07-0241084(N-126,75,73,125,196)	4.21 (3.29 to 5.38)	3.95 (3.09 to 5.05)	5.2 (3.77 to 7.18)	4.22 (3.07 to 5.80)	2.27 (1.87 to 2.77)
Meningitis A(N-125,72,74,0,99)	0 (0 to 0)	2.25 (1.72 to 2.95)	4.89 (3.45 to 6.94)	4.52 (3.18 to 6.44)	1.21 (0.89 to 1.63)
Meningitis C(N-127,84,74,0,100)	0 (0 to 0)	18 (14 to 23)	20 (14 to 28)	29 (21 to 41)	2.92 (2.19 to 3.89)
Meningitis W(N-127,75,72,0,98)	0 (0 to 0)	39 (29 to 51)	44 (30 to 64)	53 (36 to 76)	6.32 (4.59 to 8.70)
Meningitis Y(N-126,73,73,0,99)	0 (0 to 0)	9.19 (6.85 to 12)	16 (11 to 24)	29 (20 to 43)	1.52 (1.09 to 2.12)

No statistical analyses for this end point

Secondary: Percentages of Subjects with HT-hSBA Titers ≥ LLOQ against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1

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End point title

Percentages of Subjects with HT-hSBA Titers ≥ LLOQ against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1 ^[5]

End point description

The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with HT-hSBA titers greater than or equal to (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The analysis population included all subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive),received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.

End point type

Secondary

End point timeframe

Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group

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

End point values	ABCWY_0_2	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Number of subjects analysed	127	73	100	77
Units: Percentage of subjects
number (confidence interval 95%)
M14459(N-126,75,73,100)	87 (79.3 to 91.9)	95 (86.6 to 98.5)	29 (20.4 to 38.9)	85 (75.3 to 92.4)
96217(N-127,77,73,100)	100 (97.1 to 100)	100 (95.1 to 100)	62 (51.7 to 71.5)	100 (95.3 to 100)
NZ98/254(N-127,76,72,100)	69 (60.5 to 77.2)	81 (69.5 to 88.9)	27 (18.6 to 36.8)	68 (56.7 to 78.6)
M07-0241084(N-126,77,73,100)	87 (79.3 to 91.9)	81 (69.9 to 89.1)	30 (21.2 to 40.0)	84 (74.4 to 91.7)
Meningitis A(N-125,77,73,98)	98 (94.3 to 99.81)	99 (92.6 to 99.97)	55 (44.7 to 65.2)	100 (95.3 to 100)
Meningitis C(N-127,75,73,100)	100 (97.1 to 100)	100 (95.1 to 100)	91 (83.6 to 95.8)	100 (95.2 to 100)
Meningitis W(N-124,74,73,100)	100 (97.1 to 100)	100 (95.1 to 100)	78 (68.6 to 85.7)	100 (95.1 to 100)
Meningitis Y(N-127,76,73,98)	100 (97.1 to 100)	99 (92.6 to 99.97)	71 (61.4 to 80.1)	100 (95.3 to 100)

No statistical analyses for this end point

Secondary: Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1

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End point title

Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1 ^[6]

End point description

The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA. The analysis population included all subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive),received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.

End point type

Secondary

End point timeframe

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

End point values	ABCWY_0_2	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Number of subjects analysed	127	73	99	75
Units: Percentage of subjects
number (confidence interval 95%)
M14459(N-120,73,72,99)	54 (44.8 to 63.3)	65 (53.1 to 76.1)	8 (3.6 to 15.3)	49 (37.4 to 61.3)
96217(N-127,74,73,99)	91 (84.1 to 95.0)	97 (90.5 to 99.67)	17 (10.3 to 26.1)	95 (86.7 to 98.5)
NZ98/254(N-127,75,72,99)	22 (15.2 to 30.3)	14 (6.9 to 24.1)	16 (9.5 to 24.9)	17 (9.6 to 27.8)
M07-0241084(N-125,75,72,99)	38 (29.1 to 46.7)	17 (8.9 to 27.3)	11 (5.7 to 19.0)	19 (10.6 to 29.3)
Meningitis A(N-123,72,73,97)	82 (74.2 to 88.4)	88 (77.9 to 94.2)	23 (14.8 to 32.3)	83 (72.7 to 91.1)
Meningitis C(N-127,74,73,99)	94 (88.0 to 97.2)	93 (84.7 to 97.7)	54 (43.2 to 63.6)	86 (76.5 to 93.3)
Meningitis W(N-124,72,71,97)	93 (86.7 to 96.6)	85 (74.0 to 92.0)	36 (26.6 to 46.5)	92 (82.7 to 96.9)
Meningitis Y(N-126,73,72,96)	94 (87.9 to 97.2)	90 (81.0 to 96.0)	46 (35.6 to 56.3)	89 (79.5 to 95.1)

No statistical analyses for this end point

Secondary: hSBA GMTs against each of four serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1

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End point title

hSBA GMTs against each of four serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1 ^[7]

End point description

The immunogenicity of MenABCWY vaccine, was measured as the HT-hSBA Geometric Mean Titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y . The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The analysis population included all subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive),received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.

End point type

Secondary

End point timeframe

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

End point values	ABCWY_0_2	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Number of subjects analysed	127	73	100	77
Units: Titers
geometric mean (confidence interval 95%)
M14459(N-126,75,73,100)	32 (25 to 41)	61 (44 to 85)	3.12 (2.34 to 4.14)	30 (22 to 42)
96217(N-127,77,73,100)	580 (467 to 722)	544 (408 to 725)	11 (8.25 to 13)	529 (400 to 700)
NZ98/254(N-127,76,72,100)	16 (12 to 21)	16 (12 to 23)	3.14 (2.32 to 4.24)	13 (9.04 to 18)
M07-0241084(N-126,77,73,100)	32 (26 to 41)	21 (16 to 29)	4.48 (3.47 to 5.78)	25 (18 to 33)
Meningitis A(N-125,77,73,98)	271 (211 to 348)	340 (245 to 472)	17 (13 to 22)	267 (194 to 367)
Meningitis C(N-125,75,73,100)	628 (498 to 791)	529 (391 to 718)	48 (37 to 62)	602 (446 to 812)
Meningitis W(N-124,74,73,100)	1309 (1062 to 1614)	979 (746 to 1286)	129 (102 to 162)	1078 (823 to 1413)
Meningitis Y(N-127,76,73,98)	616 (479 to 791)	578 (415 to 803)	33 (25 to 44)	606 (439 to 836)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥LLOQ against 4 serogroup B test strains, and N. meningitidis serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups

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End point title

Percentages of subjects with hSBA titers ≥LLOQ against 4 serogroup B test strains, and N. meningitidis serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups ^[8]

End point description

The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N.meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. All subjects in FAS immunogenicity(Days 6 and 31, after booster [follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.

End point type

Secondary

End point timeframe

At Day 1, Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 1, Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group

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

End point values	ABCWY_0_2	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Number of subjects analysed	127	72	96	75
Units: Percentage of subjects
number (confidence interval 95%)
M14459,Day1(N-119,72,70,94)	18 (12.0 to 26.6)	26 (16.0 to 37.6)	6 (2.4 to 13.4)	17 (8.9 to 27.3)
M14459, Day 6 Post Vacc(N-119,72,70,94)	64 (54.6 to 72.5)	89 (78.7 to 94.9)	64 (53.3 to 73.5)	82 (71.1 to 90.0)
M14459,1 MTH Post Vacc(N-119,72,70,94)	86 (78.1 to 91.5)	94 (86.0 to 98.4)	72 (62.2 to 81.1)	85 (74.3 to 92.1)
96217, Day 1(N-125,74,72,96)	71 (62.4 to 78.9)	74 (61.9 to 83.3)	32 (23.1 to 42.6)	81 (70.3 to 89.3)
96217,Day 6 Post Vacc(N-125,74,72,96)	98 (94.3 to 99.81)	97 (90.3 to 99.66)	91 (82.9 to 95.6)	100 (95.1 to 100.0)
96217,1 MTH Post Vacc(N-125,74,72,96)	100 (97.1 to 100.0)	100 (95.0 to 100.0)	98 (92.7 to 99.75)	100 (95.1 to 100.0)
NZ98/254, Day 1(N-127,74,71,94)	16 (9.9 to 23.3)	18 (10.1 to 29.3)	2 (0.26 to 7.5)	14 (6.7 to 23.5)
NZ98/254, Day 6 Post Vacc(N-127,74,71,94)	44 (35.3 to 53.2)	66 (54.0 to 77.0)	56 (45.8 to 66.6)	53 (40.7 to 64.4)
NZ98/254,1 MTH Post Vacc(N-127,74,71,94)	69 (60.5 to 77.2)	80 (69.1 to 88.8)	73 (63.3 to 82.0)	70 (58.5 to 80.3)
M07-0241084, Day 1(N-124,75,71,95)	30 (22.0 to 38.7)	37 (25.5 to 48.9)	18 (10.8 to 27.1)	31 (20.5 to 42.4)
M07-0241084, Day 6 Post Vacc(N-124,75,71,95)	65 (55.4 to 72.9)	76 (64.5 to 85.4)	55 (44.2 to 65.0)	72 (60.4 to 81.8)
M07-0241084,1 MTH Post Vacc(N-124,75,71,95)	86 (79.0 to 91.8)	80 (69.1 to 88.8)	62 (51.6 to 71.9)	85 (75.3 to 92.4)
Meningitis A, Day 1(N-122,71,72,93)	16 (9.6 to 23.2)	28 (17.9 to 39.6)	3 (0.7 to 9.1)	25 (15.8 to 37.1)
Meningitis A,Day 6 Post Vacc(N-122,71,72,93)	88 (80.5 to 93.0)	89 (79.3 to 95.1)	82 (72.4 to 89.0)	96 (88.1 to 99.1)
Meningitis A,1 MTH Post Vacc(N-122,71,72,93)	98 (94.2 to 99.80)	99 (92.5 to 99.96)	94 (86.5 to 97.6)	100 (94.9 to 100.0)
Meningitis C, Day 1(N-127,74,72,95)	83 (75.8 to 89.5)	86 (75.9 to 93.1)	32 (22.4 to 41.9)	86 (76.5 to 93.3)
Meningitis C,Day 6 Post Vacc(N-127,74,72,95)	99 (95.7 to 99.98)	99 (92.5 to 99.96)	99 (94.3 to 99.97)	100 (95.1 to 100.0)
Meningitis C,1 MTH Post Vacc(N-127,74,72,95)	100 (97.1 to 100.0)	100 (95.0 to 100.0)	100 (96.2 to 100.0)	100 (95.1 to 100.0)
Meningitis W, Day 1(N-121,71,69,93)	52 (42.8 to 61.2)	64 (51.3 to 75.0)	27 (18.2 to 37.1)	73 (61.4 to 83.1)
Meningitis W,Day 6 Post Vacc(N-121,71,69,93)	99 (95.5 to 99.98)	97 (89.9 to 99.65)	98 (92.4 to 99.74)	99 (92.4 to 99.96)
Meningitis W,1 MTH Post Vacc(N-121,71,69,93)	100 (97.0 to 100.0)	100 (94.8 to 100.0)	98 (92.4 to 99.74)	100 (94.9 to 100.0)
Meningitis Y, Day 1(N-125,72,71,94)	52 (42.9 to 61.0)	62 (49.7 to 73.2)	7 (3.0 to 14.7)	76 (64.9 to 85.6)
Meningitis Y, Day 6 Post Vacc(N-125,72,71,94)	97 (92.0 to 99.1)	97 (90.2 to 99.66)	95 (88.0 to 98.3)	100 (95.0 to 100.0)
Meningitis Y,1 MTH Post Vacc(N-125,72,71,94)	100 (97.1 to 100.0)	99 (92.4 to 99.96)	95 (88.0 to 98.3)	100 (95.0 to 100.0)

No statistical analyses for this end point

Secondary: Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups

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End point title

Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups ^[9]

End point description

The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA. The analysis was performed on all subjects in FAS immunogenicity(Days 6 and 31, after booster [follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.

End point type

Secondary

End point timeframe

At Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group

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

End point values	ABCWY_0_2	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Number of subjects analysed	127	72	96	75
Units: Percentage of subjects
number (confidence interval 95%)
M14459, Day 6 Post Vacc(N-119,72,70,94)	26 (18.4 to 34.9)	50 (37.8 to 62.2)	30 (20.8 to 40.1)	36 (25.1 to 48.3)
M14459, 1 MTH Post Vacc(N-119,72,70,94)	55 (45.2 to 63.8)	64 (51.9 to 75.4)	24 (16.2 to 34.4)	49 (36.7 to 60.7)
96217, Day 6 Post Vacc(N-125,73,72,96)	86 (79.1 to 91.9)	85 (74.3 to 92.1)	65 (54.2 to 74.1)	92 (83.2 to 97.0)
96217,1 MTH Post Vacc(N-125,73,72,96)	90 (83.8 to 94.9)	97 (90.3 to 99.66)	73 (62.9 to 81.5)	95 (86.7 to 98.5)
NZ98/254, Day 6 Post Vacc(N-127,74,71,94)	4 (1.3 to 8.9)	14 (7.0 to 24.4)	24 (16.2 to 34.4)	8 (3.0 to 16.8)
NZ98/254,1 MTH Post Vacc(N-127,74,71,94)	22 (15.2 to 30.3)	14 (7.0 to 24.4)	21 (13.5 to 30.9)	18 (9.7 to 28.2)
M07-0241084, Day 6 Post Vacc(N-124,75,71,95)	14 (8.2 to 21.0)	8 (3.2 to 17.5)	8 (3.7 to 15.9)	11 (4.7 to 19.9)
M07-0241084,1 MTH Post Vacc(N-124,75,71,95)	37 (28.6 to 46.2)	15 (8.0 to 26.0)	16 (9.1 to 24.7)	19 (10.6 to 29.3)
Meningitis A, Day 6 Post Vacc(N-122,71,72,93)	66 (56.4 to 73.9)	75 (63.4 to 85.4)	53 (42.1 to 63.1)	76 (64.5 to 85.4)
Meningitis A,1 MTH Post Vacc(N-122,71,72,93)	82 (74.0 to 88.3)	88 (77.6 to 94.1)	46 (35.8 to 56.9)	85 (74.0 to 92.0)
Meningitis C, Day 6 Post Vacc(N-127,74,72,95)	88 (81.3 to 93.2)	78 (66.4 to 86.7)	83 (74.1 to 90.1)	86 (76.5 to 93.3)
Meningitis C,1 MTH Post Vacc(N-127,74,72,95)	94 (88.0 to 97.2)	93 (84.5 to 97.7)	91 (82.8 to 95.6)	86 (76.5 to 93.3)
Meningitis W, Day 6 Post Vacc(N-121,71,69,93)	80 (71.9 to 86.9)	75 (63.5 to 84.9)	62 (51.7 to 72.2)	85 (74.0 to 92.0)
Meningitis W,1 MTH Post Vacc(N-121,71,69,93)	93 (86.3 to 96.5)	84 (73.3 to 91.8)	71 (60.6 to 79.9)	92 (82.5 to 96.8)
Meningitis Y, Day 6 Post Vacc(N-125,72,71,94)	81 (72.8 to 87.3)	79 (67.6 to 87.7)	78 (67.9 to 85.6)	85 (74.3 to 92.1)
Meningitis Y,1 MTH Post Vacc(N-125,72,71,94)	94 (87.8 to 97.2)	90 (80.7 to 95.9)	83 (73.8 to 89.9)	89 (79.3 to 95.1)

No statistical analyses for this end point

Secondary: hSBA GMTs against each of four serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups

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End point title

hSBA GMTs against each of four serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups ^[10]

End point description

The immunogenicity of MenABCWY vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y . The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The analysis was performed on all subjects in FAS immunogenicity(Days 6 and 31, after booster [follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.

End point type

Secondary

End point timeframe

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

End point values	ABCWY_0_2	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Number of subjects analysed	127	72	96	75
Units: Titers
geometric mean (confidence interval 95%)
M14459, Day 1(N-119,72,70,94)	2.08 (1.70 to 2.54)	2.62 (2.02 to 3.41)	1.28 (1.02 to 1.61)	2.04 (1.58 to 2.64)
M14459, Day 6 post Vacc(N-119,72,70,94)	13 (9.77 to 18)	40 (27 to 58)	10 (7.48 to 14)	21 (14 to 31)
M14459,1 MTH Post Vacc(N-119,72,70,94)	30 (24 to 39)	61 (44 to 84)	14 (10 to 18)	30 (22 to 42)
96217, Day 1(N-125,74,72,96)	13 (10 to 17)	16 (11 to 23)	3.12 (2.31 to 4.22)	19 (14 to 27)
96217, Day 6 post Vacc(N-125,74,72,96)	376 (287 to 493)	401 (281 to 571)	70 (51 to 95)	486 (343 to 690)
96217 Ab,1 MTH post Vacc(N-125,74,72,96)	587 (496 to 695)	550 (440 to 687)	94 (77 to 114)	524 (421 to 652)
NZ98/254, Day 1(N-127,74,71,94)	1.78 (1.47 to 2.16)	2.17 (1.68 to 2.80)	1.07 (0.85 to 1.33)	1.66 (1.30 to 2.14)
NZ98/254, Day 6 post Vacc(N-127,74,71,94)	6.02 (4.58 to 7.92)	12 (8.56 to 18)	8.95 (6.52 to 12)	7.63 (5.33 to 11)
NZ98/254,1 MTH post Vacc(N-127,74,71,94)	17 (13 to 21)	17 (12 to 23)	14 (10 to 18)	14 (10 to 19)
M07-0241084, Day 1(N-124,75,71,95)	3.97 (3.10 to 5.09)	5.3 (3.81 to 7.35)	2.18 (1.64 to 2.89)	4.22 (3.07 to 5.80)
M07-0241084, Day 6 post Vacc(N-124,75,71,95)	14 (11 to 18)	16 (12 to 23)	8.68 (6.52 to 12)	17 (12 to 24)
M07-0241084,1 MTH Post Vacc(N-124,75,71,95)	32 (26 to 40)	22 (16 to 28)	11 (8.60 to 14)	26 (20 to 34)
Meningitis A, Day 1(N-122,71,72,93)	2.31 (1.75 to 3.04)	5.13 (3.59 to 7.34)	1.22 (0.89 to 1.68)	4.53 (3.16 to 6.48)
Meningitis A, Day 6 post Vacc(N-122,71,72,93)	137 (98 to 191)	229 (149 to 352)	59 (41 to 87)	221 (143 to 341)
Meningitis A,1 MTH post Vacc(N-122,71,72,93)	270 (222 to 327)	340 (264 to 437)	85 (68 to 106)	275 (213 to 354)
Meningitis C, Day 1(N-127,74,72,95)	18 (14 to 23)	21 (15 to 29)	2.91 (2.17 to 3.92)	29 (21 to 41)
Meningitis C,Day 6 post Vacc(N-127,74,72,95)	524 (414 to 662)	520 (381 to 710)	153 (117 to 200)	694 (511 to 942)
Meningitis C,1 MTH post Vacc(N-127,74,72,95)	628 (523 to 753)	539 (423 to 686)	177 (143 to 218)	612 (482 to 776)
Meningitis W, Day 1(N-121,71,69,93)	38 (28 to 51)	44 (30 to 65)	6.25 (4.48 to 8.72)	51 (35 to 75)
Meningitis W,Day 6 post Vacc(N-121,71,69,93)	820 (665 to 1011)	916 (694 to 1208)	279 (220 to 353)	993 (756 to 1304)
Meningitis W,1 MTH post Vacc(N-121,71,69,93)	1345 (1142 to 1584)	999 (805 to 1240)	298 (247 to 359)	1050 (849 to 1299)
Meningitis Y, Day 1(N-125,72,71,94)	9.11 (6.77 to 12)	17 (12 to 25)	1.54 (1.10 to 2.16)	31 (21 to 45)
Meningitis Y,Day 6 Post Vacc(N-125,72,71,94)	351 (274 to 449)	425 (307 to 589)	145 (109 to 192)	606 (439 to 837)
Meningitis Y,1 MTH Post Vacc(N-125,72,71,94)	623 (517 to 750)	586 (458 to 750)	129 (104 to 159)	646 (506 to 824)

No statistical analyses for this end point

Secondary: Percentages of Subjects with HT-hSBA Titers ≥ LLOQ against 4 serogroup B test strains at Day 31 After rMenB+OMV Vaccination in V102_15E1

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End point title

Percentages of Subjects with HT-hSBA Titers ≥ LLOQ against 4 serogroup B test strains at Day 31 After rMenB+OMV Vaccination in V102_15E1 ^[11]

End point description

The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The analysis was performed on all subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive),received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain at Day 31 in the extension study.

End point type

Secondary

End point timeframe

Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMVl vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B Group

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

End point values	B_0_2	Naive_B
Number of subjects analysed	124	98
Units: Percentage of subjects
number (confidence interval 95%)
Meningitis B M14459 Ab(N-123,96)	94 (88.6 to 97.7)	28 (19.4 to 38.2)
Meningitis B 96217 Ab	100 (97.1 to 100.0)	74 (64.7 to 82.8)
Meningitis B NZ98/254 Ab	87 (79.9 to 92.4)	27 (18.1 to 36.4)
Meningitis B M07-0241084 Ab	95 (89.8 to 98.2)	33 (23.5 to 42.9)

No statistical analyses for this end point

Secondary: Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains at Day 31 After rMenB+OMV Vaccination in V102_15E1

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End point title

Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains at Day 31 After rMenB+OMV Vaccination in V102_15E1 ^[12]

End point description

The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA. The analysis was performed on all subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive),received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain at Day 31 in the extension study.

End point type

Secondary

End point timeframe

Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B Group

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

End point values	B_0_2	Naive_B
Number of subjects analysed	123	97
Units: Percentage of subjects
number (confidence interval 95%)
Meningitis B M14459 Ab(N-120,95)	67 (57.5 to 75.0)	15 (8.3 to 23.5)
Meningitis B 96217 Ab(N-122,97)	97 (91.8 to 99.1)	19 (11.4 to 27.7)
Meningitis B NZ98/254 Ab(N-122,97)	40 (31.4 to 49.4)	16 (9.7 to 25.4)
Meningitis B M07-0241084 Ab(N-123,95)	53 (43.6 to 61.9)	8 (3.7 to 15.9)

No statistical analyses for this end point

Secondary: hSBA GMTs against each of four serogroup B test strains, at Day 31 After rMenB+OMV Vaccination in V102_15E1

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End point title

hSBA GMTs against each of four serogroup B test strains, at Day 31 After rMenB+OMV Vaccination in V102_15E1 ^[13]

End point description

The immunogenicity of rMenB+OMV vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The analysis was performed on all subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive),received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain at Day 31 in the extension study.

End point type

Secondary

End point timeframe

Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B Group

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The 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	B_0_2	Naive_B
Number of subjects analysed	124	98
Units: Titers
geometric mean (confidence interval 95%)
Meningitis B M14459 Ab(N-123,96)	50 (39 to 65)	3.48 (2.60 to 4.65)
Meningitis B 96217 Ab	820 (658 to 1023)	18 (14 to 23)
Meningitis B NZ98/254 Ab	27 (21 to 35)	3.14 (2.32 to 4.26)
Meningitis B M07-0241084 Ab	59 (47 to 74)	4.82 (3.72 to 6.24)

No statistical analyses for this end point

Secondary: Percentages of subjects with hSBA titers ≥LLOQ against 4 serogroup B test strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV groups

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End point title

Percentages of subjects with hSBA titers ≥LLOQ against 4 serogroup B test strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV groups ^[14]

End point description

The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The analysis was performed on all subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.

End point type

Secondary

End point timeframe

At Day 1, at Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 1, at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B Group

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The 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	B_0_2	Naive_B
Number of subjects analysed	122	94
Units: Percentage of subjects
number (confidence interval 95%)
Meningitis B 96217 Ab, Day 1(N-121,94)	82 (73.8 to 88.2)	36 (26.5 to 46.7)
Meningitis B 96217 Ab, Day 6 Post Vacc(N-121,94)	98 (92.9 to 99.5)	88 (80.0 to 94.0)
Meningitis B 96217 Ab, 1 month Post Vacc(N-121,94)	100 (97.0 to 100.0)	98 (92.5 to 99.74)
Meningitis B M07-0241084, Day 1(N-122,92)	28 (20.1 to 36.7)	16 (9.4 to 25.5)
Meningitis B M07-0241084,Day 6 Post Vacc(N-122,92)	70 (60.7 to 77.7)	57 (45.8 to 66.8)
Meningitis B M07-0241084,1 MTH Post Vacc(N-122,92)	95 (89.6 to 98.2)	72 (61.4 to 80.6)
Meningitis B M14459 Ab, Day 1(N-119,94)	18 (11.3 to 25.7)	3 (0.7 to 9.0)
Meningitis B M14459 Ab, Day 6 Post Vacc(N-119,94)	70 (60.7 to 77.8)	68 (57.7 to 77.3)
Meningitis B M14459 Ab,1 month Post Vacc(N-119,94)	94 (88.3 to 97.6)	78 (67.9 to 85.6)
Meningitis B NZ98/254, Day 1(N-121,94)	16 (9.7 to 23.4)	3 (0.7 to 9.0)
Meningitis B NZ98/254 Ab,Day 6 Post Vacc(N-121,94)	49 (39.6 to 58.0)	62 (51.1 to 71.5)
Meningitis B NZ98/254 Ab,1 MTH Post Vacc(N-121,94)	87 (79.4 to 92.2)	82 (72.6 to 89.1)

No statistical analyses for this end point

Secondary: Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV groups

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End point title

Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV groups ^[15]

End point description

The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA. The analysis was performed on all subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.

End point type

Secondary

End point timeframe

At Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B Group

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The 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	B_0_2	Naive_B
Number of subjects analysed	116	78
Units: Percentage of subjects
number (confidence interval 95%)
Meningitis B M14459,Day 6 Post Vacc(N-113,77)	34 (25.0 to 43.1)	22 (13.4 to 33.0)
Meningitis B M14459,1 MTH Post Vacc(N-113,77)	66 (56.9 to 75.0)	31 (21.1 to 42.7)
Meningitis B 96217, Day 6 Post Vacc(N-116,77)	78 (69.9 to 85.5)	69 (57.3 to 78.9)
Meningitis B 96217, 1 MTH Post Vacc(N-116,77)	97 (92.6 to 99.5)	81 (69.9 to 88.7)
Meningitis B NZ98/254,Day 6 Post Vacc(N-115,78)	13 (7.5 to 20.6)	21 (12.2 to 31.2)
Meningitis B NZ98/254,1 MTH Post Vacc(N-115,78)	41 (31.8 to 50.4)	41 (30.0 to 52.7)
Meningitis B M07-0241084,Day 6 Post vacc(N-116,76)	21 (13.7 to 29.2)	14 (7.5 to 24.4)
Meningitis B M07-0241084,1 MTH Post Vacc(N-116,76)	53 (43.1 to 61.9)	24 (14.7 to 34.8)

No statistical analyses for this end point

Secondary: hSBA GMTs against each of four serogroup B test strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV groups

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End point title

hSBA GMTs against each of four serogroup B test strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV groups ^[16]

End point description

The immunogenicity of rMenB+OMV vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The analysis was performed on all subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.

End point type

Secondary

End point timeframe

Notes
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The 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	B_0_2	Naive_B
Number of subjects analysed	122	94
Units: Titers
geometric mean (confidence interval 95%)
Meningitis B M14459 Ab, Day 1(N-119,94)	2.04 (1.67 to 2.49)	1.18 (0.94 to 1.47)
Meningitis B M14459 Ab,Day 6 post Vacc(N-119,94)	14 (11 to 19)	12 (8.41 to 16)
Meningitis B M14459 Ab,1 MTH Post Vacc(N-119,94)	49 (38 to 63)	16 (12 to 21)
Meningitis B 96217 Ab, Day 1(N-121,94)	20 (15 to 26)	4.38 (3.23 to 5.93)
Meningitis B 96217 Ab,Day 6 post Vacc(N-121,94)	341 (259 to 448)	85 (63 to 116)
Meningitis B 96217 Ab,1 MTH post Vacc(N-121,94)	822 (692 to 975)	122 (100 to 148)
Meningitis B NZ98/254 Ab,Day 1(N-121,94)	1.72 (1.41 to 2.09)	1.15 (0.92 to 1.44)
Meningitis B NZ98/254 Ab,Day 6 post Vacc(N-121,94)	6.39 (4.83 to 8.45)	9.38 (6.83 to 13)
Meningitis B NZ98/254 Ab,1 MTH post Vacc(N-121,94)	27 (21 to 34)	22 (17 to 29)
Meningitis B M07-0241084 Ab,Day 1(N-122,92)	4.24 (3.30 to 5.45)	2.36 (1.77 to 3.15)
Meningitis B M07-0241084,Day 6 post Vacc(N-122,92)	17 (13 to 21)	11 (8.54 to 15)
Meningitis B M07-0241084,1 MTH post Vacc(N-122,92)	59 (47 to 72)	17 (13 to 22)

No statistical analyses for this end point

Secondary: Number of subjects with any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after vaccination

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End point title

Number of subjects with any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after vaccination

End point description

Assessed solicited symptoms were Pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C). Analysis was done on subjects in Solicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of the subject’s randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination solicited adverse events data.

End point type

Secondary

End point timeframe

within 30 minutes after vaccination at Day 1 (for all subjects) and also Day 61 (for naive subjects only)

End point values	B_0_2	ABCWY_0_2	Naive_B	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Number of subjects analysed	126	127	99 ^[17]	74	101 ^[18]	77
Units: Participants
number (not applicable)
Local: Erythema(N-125,77,74,125,99,101)	0	1	0	1	0	1
Local: Induration(N-126,77,74,125,99,101)	0	0	0	0	0	1
Local: Pain	11	6	13	3	10	4
Systemic: Arthralgia	0	0	0	0	1	0
Systemic: Chills	0	0	0	0	0	0
Systemic: Fatigue	2	0	2	0	3	1
Systemic: Fever	0	0	0	0	0	0
Systemic: Headache	0	1	1	1	2	0
Systemic: Loss Of Appetite	0	0	0	0	1	0
Systemic: Myalgia	0	1	0	0	2	0
Systemic: Nausea(N-127,77,74,125,99,101)	1	1	2	0	0	0
Indicator: Prevention Of Pain / Fever	0	0	0	0	0	0
Indicator: Treatment Of Pain / Fever	0	0	0	0	0	0

Notes
[17] - 2 subjects from Naïve_ABCWY group received Bexsero and not ABCWY(99+2=101 analyzed in this group)
[18] - 2 subjects from Naïve_ABCWY group received Bexsero and not ABCWY (101-2=99 analyzed in this group)

No statistical analyses for this end point

Secondary: Number of subjects with any unsolicited AEs within 30 minutes after vaccination

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End point title

Number of subjects with any unsolicited AEs within 30 minutes after vaccination

End point description

An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a subject and/or parent/legal guardian who has signed the informed consent. Number of subjects reporting any unsolicited AE within 30 minutes after each vaccination. Note: unsolicited AEs within 30 minutes were not collected Analysis was to be done on subjects in Unsolicited Safety Set but was not performed as AEs within 30 minutes after vaccination were not collected.

End point type

Secondary

End point timeframe

Within 30 minutes after vaccination at Day 1 (for all subjects) and also Day 61 (for naive subjects only)

End point values	B_0_2	ABCWY_0_2	Naive_B	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Number of subjects analysed	0 ^[19]	0 ^[20]	0 ^[21]	0 ^[22]	0 ^[23]	0 ^[24]
Units: Participants
number (not applicable)

Notes
[19] - unsolicited AEs within 30 minutes were not collected
[20] - unsolicited AEs within 30 minutes were not collected
[21] - unsolicited AEs within 30 minutes were not collected
[22] - unsolicited AEs within 30 minutes were not collected
[23] - unsolicited AEs within 30 minutes were not collected
[24] - unsolicited AEs within 30 minutes were not collected

No statistical analyses for this end point

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

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End point title

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

End point description

Assessed solicited symptoms were pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C). Analysis was done on subjects in Solicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of the subject’s randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination solicited adverse events data.

End point type

Secondary

End point timeframe

At Day 1 (6 hours) to Day 7 after vaccination at Day 1 (for all subjects) and Day 61 to Day 67 (for naive subjects only)

End point values	B_0_2	ABCWY_0_2	Naive_B	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Number of subjects analysed	126	127	99 ^[25]	74	101 ^[26]	77
Units: Participants
number (not applicable)
Local: Erythema	22	22	20	14	23	10
Local: Induration	20	18	15	6	22	14
Local: Pain	115	108	93	64	95	67
Systemic: Arthralgia	15	12	17	9	19	5
Systemic: Chills	27	23	26	12	25	8
Systemic: Fatigue	64	58	55	31	59	33
Systemic: Fever	6	8	6	1	3	3
Systemic: Headache	61	55	45	28	61	19
Systemic: Loss Of Appetite	20	15	16	7	20	9
Systemic: Myalgia	22	26	21	14	26	13
Systemic: Nausea	24	13	19	8	20	8
Indicator: Prevention Of Pain / Fever	29	21	26	8	24	8
Indicator: Treatment Of Pain / Fever	56	37	39	19	47	18

Notes
[25] - 2 subjects from Naïve_ABCWY group received Bexsero and not ABCWY(99+2=101 analyzed in this group)
[26] - 2 subjects from Naïve_ABCWY group received Bexsero and not ABCWY (101-2=99 analyzed in this group)

No statistical analyses for this end point

Secondary: Number of subjects with unsolicited AEs, 30 days after any vaccination

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End point title

Number of subjects with unsolicited AEs, 30 days after any vaccination

End point description

An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a subject and/or parent/legal guardian who has signed the informed consent. Number of subjects reporting any unsolicited AE within 30 minutes after each vaccination. Analysis was done on subjects in Unsolicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of subject’s randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination unsolicited adverse events data.

End point type

Secondary

End point timeframe

From Day 1 to Day 31 for all subjects and Day 61 to Day 91 for naive subjects

End point values	B_0_2	ABCWY_0_2	Naive_B	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Number of subjects analysed	126	127	99 ^[27]	74	101 ^[28]	77
Units: Participants
number (not applicable)	26	27	36	10	40	12

Notes
[27] - 2 subjects from Naïve_ABCWY group received Bexsero and not ABCWY(99+2=101 analyzed in this group)
[28] - 2 subjects from Naïve_ABCWY group received Bexsero and not ABCWY (101-2=99 analyzed in this group)

No statistical analyses for this end point

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

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End point title

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

End point description

Serious adverse events (SAEs), medically attended adverse events & AEs leading to withdrawal are reported. An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: Death,Is life-threatening,Required or prolonged hospitalization,Persistent or significant disability/incapacity,congenital anomaly/or birth defect,An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.Analysis was done on subjects in Unsolicited Safety Set: all screened subjects who provided informed consent, demographic &/or other baseline screening measurements, regardless of subject’s randomization & vaccination status in the trial, received subject ID & study vaccination & provided post-vaccination unsolicited adverse events data

End point type

Secondary

End point timeframe

During the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects)

End point values	B_0_2	ABCWY_0_2	Naive_B	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Number of subjects analysed	126	127	99 ^[29]	74	101 ^[30]	77
Units: Participants
number (not applicable)
Any medically attended AE	20	18	21	8	24	7
Any serious AE	2	0	1	0	0	0
AEs leading to premature withdrawal	0	0	0	0	0	0

Notes
[29] - 2 subjects from Naïve_ABCWY group received Bexsero and not ABCWY(99+2=101 analyzed in this group)
[30] - 2 subjects from Naïve_ABCWY group received Bexsero and not ABCWY (101-2=99 analyzed in this group)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).

Adverse event reporting additional description

Safety analysis was performed on the treated population.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

B_0_2

Reporting group description

Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study

Reporting group title

ABCWY_0_2

Reporting group description

Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Reporting group title

Naive_B

Reporting group description

Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study

Reporting group title

ABCWY_0_6

Reporting group description

Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Reporting group title

Naive_ABCWY

Reporting group description

Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study

Reporting group title

ABCWY_0_2_6

Reporting group description

Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Serious adverse events	B_0_2	ABCWY_0_2	Naive_B	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 126 (1.59%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0
Nervous system disorders
Headache
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Gastroenteritis
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	B_0_2	ABCWY_0_2	Naive_B	ABCWY_0_6	Naive_ABCWY	ABCWY_0_2_6
Total subjects affected by non serious adverse events
subjects affected / exposed	120 / 126 (95.24%)	116 / 127 (91.34%)	99 / 101 (98.02%)	67 / 74 (90.54%)	96 / 99 (96.97%)	70 / 77 (90.91%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Chills
subjects affected / exposed	27 / 126 (21.43%)	23 / 127 (18.11%)	26 / 101 (25.74%)	12 / 74 (16.22%)	25 / 99 (25.25%)	8 / 77 (10.39%)
occurrences all number	50	39	62	20	51	12
Fatigue
subjects affected / exposed	64 / 126 (50.79%)	58 / 127 (45.67%)	55 / 101 (54.46%)	31 / 74 (41.89%)	59 / 99 (59.60%)	33 / 77 (42.86%)
occurrences all number	164	114	206	77	201	67
Hangover
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	1 / 77 (1.30%)
occurrences all number	0	0	0	0	0	1
Influenza like illness
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Injection site erythema
subjects affected / exposed	59 / 126 (46.83%)	50 / 127 (39.37%)	49 / 101 (48.51%)	27 / 74 (36.49%)	45 / 99 (45.45%)	23 / 77 (29.87%)
occurrences all number	129	100	137	67	148	53
Injection site haemorrhage
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	2 / 101 (1.98%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	2	0	0	0
Injection site induration
subjects affected / exposed	40 / 126 (31.75%)	43 / 127 (33.86%)	43 / 101 (42.57%)	18 / 74 (24.32%)	46 / 99 (46.46%)	23 / 77 (29.87%)
occurrences all number	117	107	172	51	200	58
Injection site pain
subjects affected / exposed	116 / 126 (92.06%)	108 / 127 (85.04%)	93 / 101 (92.08%)	64 / 74 (86.49%)	95 / 99 (95.96%)	67 / 77 (87.01%)
occurrences all number	421	321	683	226	593	227
Injection site pruritus
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	1 / 77 (1.30%)
occurrences all number	0	0	0	0	0	1
Injection site rash
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Injection site reaction
subjects affected / exposed	0 / 126 (0.00%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	1	0	0	0	0
Injection site swelling
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	1 / 74 (1.35%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	0	1	0	0
Injection site warmth
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	1 / 74 (1.35%)	2 / 99 (2.02%)	0 / 77 (0.00%)
occurrences all number	0	0	0	1	2	0
Malaise
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Pain
subjects affected / exposed	0 / 126 (0.00%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	1	0	0	0	0
Pyrexia
subjects affected / exposed	7 / 126 (5.56%)	10 / 127 (7.87%)	6 / 101 (5.94%)	1 / 74 (1.35%)	5 / 99 (5.05%)	4 / 77 (5.19%)
occurrences all number	7	11	6	1	6	5
Vaccination site pain
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Immune system disorders
Allergy to animal
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	0	0	0	0
Hypersensitivity
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	1	0	0	0	1	0
Seasonal allergy
subjects affected / exposed	0 / 126 (0.00%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	1	0	0	0	0
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	1 / 126 (0.79%)	1 / 127 (0.79%)	3 / 101 (2.97%)	3 / 74 (4.05%)	2 / 99 (2.02%)	0 / 77 (0.00%)
occurrences all number	1	1	5	3	2	0
Scrotal varicose veins
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	0	0	0	0
Cough
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	0	0	0	0
Epistaxis
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	0	0	0	0
Nasal congestion
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Oropharyngeal pain
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	2 / 101 (1.98%)	0 / 74 (0.00%)	2 / 99 (2.02%)	0 / 77 (0.00%)
occurrences all number	1	0	2	0	2	0
Rhinitis allergic
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	1 / 74 (1.35%)	2 / 99 (2.02%)	0 / 77 (0.00%)
occurrences all number	1	0	0	1	2	0
Rhinorrhoea
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	1	0	0	0
Sinus polyp
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	1 / 77 (1.30%)
occurrences all number	0	0	0	0	0	1
Upper respiratory tract irritation
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Psychiatric disorders
Anxiety
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	0	0	0	0
Dyssomnia
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Investigations
Body temperature increased
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Injury, poisoning and procedural complications
Clavicle fracture
subjects affected / exposed	0 / 126 (0.00%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	1	0	0	0	0
Hand fracture
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Ligament rupture
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Ligament sprain
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	1 / 74 (1.35%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	1	0	0	1	1	0
Nail injury
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Post procedural complication
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	1 / 77 (1.30%)
occurrences all number	0	0	0	0	0	1
Wrist fracture
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	1 / 77 (1.30%)
occurrences all number	0	0	0	0	0	1
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	2 / 99 (2.02%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	3	0
Headache
subjects affected / exposed	62 / 126 (49.21%)	55 / 127 (43.31%)	46 / 101 (45.54%)	28 / 74 (37.84%)	62 / 99 (62.63%)	20 / 77 (25.97%)
occurrences all number	132	96	160	64	183	41
Hypoaesthesia
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Migraine
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	0	0	0	0
Migraine-triggered seizure
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Syncope
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Blood and lymphatic system disorders
Iron deficiency anaemia
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Lymphadenopathy
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Microcytic anaemia
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	0	0	0	0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	2	0	1	0
Eye disorders
Swelling of eyelid
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	1 / 77 (1.30%)
occurrences all number	0	0	0	0	0	1
Vision blurred
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	0	0	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 126 (0.79%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	1	0	0	0	0
Abdominal pain upper
subjects affected / exposed	0 / 126 (0.00%)	1 / 127 (0.79%)	1 / 101 (0.99%)	0 / 74 (0.00%)	1 / 99 (1.01%)	1 / 77 (1.30%)
occurrences all number	0	1	1	0	2	1
Diarrhoea
subjects affected / exposed	1 / 126 (0.79%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	1	1	0	0	1	0
Dyspepsia
subjects affected / exposed	1 / 126 (0.79%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	2	1	0	0	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 126 (0.00%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	1	0	0	0	0
Nausea
subjects affected / exposed	26 / 126 (20.63%)	13 / 127 (10.24%)	21 / 101 (20.79%)	8 / 74 (10.81%)	20 / 99 (20.20%)	8 / 77 (10.39%)
occurrences all number	39	20	39	10	39	10
Noninfective sialoadenitis
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Retching
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	0	0	0	0
Tooth impacted
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Tooth loss
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Toothache
subjects affected / exposed	1 / 126 (0.79%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	1	1	0	0	1	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 126 (0.00%)	2 / 127 (1.57%)	2 / 101 (1.98%)	2 / 74 (2.70%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	2	2	2	0	0
Alopecia
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	1 / 77 (1.30%)
occurrences all number	0	0	0	0	0	1
Dermatitis
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Dermatitis contact
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Hyperhidrosis
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Pruritus
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	1 / 74 (1.35%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	1	1	0
Psoriasis
subjects affected / exposed	0 / 126 (0.00%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	1	0	0	0	0
Rash
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	2 / 99 (2.02%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	2	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	15 / 126 (11.90%)	13 / 127 (10.24%)	17 / 101 (16.83%)	9 / 74 (12.16%)	20 / 99 (20.20%)	6 / 77 (7.79%)
occurrences all number	33	21	33	18	38	9
Bursitis
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	1 / 74 (1.35%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	0	1	0	0
Muscle spasms
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Musculoskeletal pain
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	1 / 77 (1.30%)
occurrences all number	0	0	0	0	0	1
Myalgia
subjects affected / exposed	22 / 126 (17.46%)	26 / 127 (20.47%)	21 / 101 (20.79%)	14 / 74 (18.92%)	26 / 99 (26.26%)	13 / 77 (16.88%)
occurrences all number	42	36	40	34	57	17
Neck pain
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	1 / 77 (1.30%)
occurrences all number	0	0	0	0	0	1
Pain in extremity
subjects affected / exposed	0 / 126 (0.00%)	1 / 127 (0.79%)	0 / 101 (0.00%)	1 / 74 (1.35%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	1	0	1	0	0
Spinal flattening
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	1 / 77 (1.30%)
occurrences all number	0	0	0	0	0	1
Infections and infestations
Bronchitis
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	2 / 101 (1.98%)	0 / 74 (0.00%)	2 / 99 (2.02%)	0 / 77 (0.00%)
occurrences all number	1	0	2	0	2	0
Cellulitis
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Chlamydial infection
subjects affected / exposed	0 / 126 (0.00%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	1	0	0	0	0
Conjunctivitis
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	1	0	0	0
Cystitis
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	1 / 74 (1.35%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	0	1	0	0
Ear infection
subjects affected / exposed	2 / 126 (1.59%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	2	1	0	0	0	0
Gastroenteritis
subjects affected / exposed	0 / 126 (0.00%)	2 / 127 (1.57%)	1 / 101 (0.99%)	0 / 74 (0.00%)	2 / 99 (2.02%)	0 / 77 (0.00%)
occurrences all number	0	2	1	0	2	0
Infectious mononucleosis
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Influenza
subjects affected / exposed	4 / 126 (3.17%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	4	1	0	0	1	0
Nasopharyngitis
subjects affected / exposed	4 / 126 (3.17%)	1 / 127 (0.79%)	3 / 101 (2.97%)	1 / 74 (1.35%)	6 / 99 (6.06%)	1 / 77 (1.30%)
occurrences all number	5	1	4	1	7	1
Otitis media
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	1	0	0	0	1	0
Peritonsillar abscess
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	1 / 74 (1.35%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	0	1	0	0
Pharyngitis
subjects affected / exposed	1 / 126 (0.79%)	8 / 127 (6.30%)	2 / 101 (1.98%)	0 / 74 (0.00%)	4 / 99 (4.04%)	0 / 77 (0.00%)
occurrences all number	1	8	2	0	4	0
Pharyngitis bacterial
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	2 / 101 (1.98%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	2	0	0	0
Pneumonia
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	1	0	0	0
Pyelonephritis
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Respiratory tract infection
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	1 / 74 (1.35%)	0 / 99 (0.00%)	2 / 77 (2.60%)
occurrences all number	1	0	0	1	0	2
Respiratory tract infection viral
subjects affected / exposed	0 / 126 (0.00%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	1	0	0	0	0
Rhinitis
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	1	0	0	0
Sinusitis
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	2 / 101 (1.98%)	0 / 74 (0.00%)	2 / 99 (2.02%)	0 / 77 (0.00%)
occurrences all number	2	0	2	0	2	0
Tonsillitis
subjects affected / exposed	1 / 126 (0.79%)	3 / 127 (2.36%)	0 / 101 (0.00%)	2 / 74 (2.70%)	2 / 99 (2.02%)	1 / 77 (1.30%)
occurrences all number	1	4	0	2	2	1
Tonsillitis bacterial
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	0	0	0	0
Tonsillitis streptococcal
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Tooth infection
subjects affected / exposed	1 / 126 (0.79%)	0 / 127 (0.00%)	2 / 101 (1.98%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	1	0	2	0	0	0
Tracheitis
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Upper respiratory tract infection
subjects affected / exposed	5 / 126 (3.97%)	8 / 127 (6.30%)	11 / 101 (10.89%)	4 / 74 (5.41%)	6 / 99 (6.06%)	1 / 77 (1.30%)
occurrences all number	5	8	13	4	8	1
Urinary tract infection
subjects affected / exposed	1 / 126 (0.79%)	1 / 127 (0.79%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	1	1	0	0	1	0
Viral pharyngitis
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	0 / 101 (0.00%)	0 / 74 (0.00%)	1 / 99 (1.01%)	0 / 77 (0.00%)
occurrences all number	0	0	0	0	1	0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	2 / 99 (2.02%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	2	0
Wound infection
subjects affected / exposed	0 / 126 (0.00%)	0 / 127 (0.00%)	1 / 101 (0.99%)	0 / 74 (0.00%)	0 / 99 (0.00%)	0 / 77 (0.00%)
occurrences all number	0	0	1	0	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	20 / 126 (15.87%)	15 / 127 (11.81%)	16 / 101 (15.84%)	7 / 74 (9.46%)	20 / 99 (20.20%)	9 / 77 (11.69%)
occurrences all number	39	15	38	13	49	11

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Were there any global substantial amendments to the protocol? Yes

04 Apr 2018

Following up on the response to CBER comments, to change the defined criterion for concluding relative vaccine effectiveness, the Company agreed to remove it from the V102_15E1 study protocol and all analyses for the vaccine effectiveness objectives to be descriptive in nature. Further to this decision, in this amendment the effectiveness of the MenABCWY vaccine using enc-hSBA will no longer be assessed in any of the V102_15E1 study objectives (primary, secondary or exploratory). All the study objectives will aim to evaluate the immunogenicity of the MenABCWY vaccine against N. meningitidis serogroup B test strains (M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA) and M07-0241084 (NHBA)) using HT-hSBA, accordingly.

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 titers ≥LLOQ against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects

Primary: Percentages of subjects with hSBA titers ≥LLOQ against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects

Primary: hSBA GMTs against each of four serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects

Primary: hSBA GMTs against each of four serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects

Secondary: Percentages of Subjects with HT-hSBA Titers ≥ LLOQ against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1

Secondary: Percentages of Subjects with HT-hSBA Titers ≥ LLOQ against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1

Secondary: Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1

Secondary: Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1

Secondary: hSBA GMTs against each of four serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1

Secondary: hSBA GMTs against each of four serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1

Secondary: Percentages of subjects with hSBA titers ≥LLOQ against 4 serogroup B test strains, and N. meningitidis serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups

Secondary: Percentages of subjects with hSBA titers ≥LLOQ against 4 serogroup B test strains, and N. meningitidis serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups

Secondary: Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups

Secondary: Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups

Secondary: hSBA GMTs against each of four serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups

Secondary: hSBA GMTs against each of four serogroup B test strains, and against N. meningitidis serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups

Secondary: Percentages of Subjects with HT-hSBA Titers ≥ LLOQ against 4 serogroup B test strains at Day 31 After rMenB+OMV Vaccination in V102_15E1

Secondary: Percentages of Subjects with HT-hSBA Titers ≥ LLOQ against 4 serogroup B test strains at Day 31 After rMenB+OMV Vaccination in V102_15E1

Secondary: Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains at Day 31 After rMenB+OMV Vaccination in V102_15E1

Secondary: Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains at Day 31 After rMenB+OMV Vaccination in V102_15E1

Secondary: hSBA GMTs against each of four serogroup B test strains, at Day 31 After rMenB+OMV Vaccination in V102_15E1

Secondary: hSBA GMTs against each of four serogroup B test strains, at Day 31 After rMenB+OMV Vaccination in V102_15E1

Secondary: Percentages of subjects with hSBA titers ≥LLOQ against 4 serogroup B test strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV groups

Secondary: Percentages of subjects with hSBA titers ≥LLOQ against 4 serogroup B test strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV groups

Secondary: Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV groups

Secondary: Percentages of Subjects with 4-Fold Increase in HT-hSBA Titers against 4 serogroup B test strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV groups

Secondary: hSBA GMTs against each of four serogroup B test strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV groups

Secondary: hSBA GMTs against each of four serogroup B test strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV groups

Secondary: Number of subjects with any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after vaccination

Secondary: Number of subjects with any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after vaccination

Secondary: Number of subjects with any unsolicited AEs within 30 minutes after vaccination

Secondary: Number of subjects with any unsolicited AEs within 30 minutes after vaccination

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

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

Secondary: Number of subjects with unsolicited AEs, 30 days after any vaccination

Secondary: Number of subjects with unsolicited AEs, 30 days after any vaccination

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

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

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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