Clinical Trial Results:
Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study Vaccines

Due to a system error, the data reported in v1 is not correct and has been removed from public view.

Summary
EudraCT number	2014-005014-36
Trial protocol	Outside EU/EEA
Global end of trial date	06 Jul 2012

Results information
Results version number	v2(current)
This version publication date	17 Jun 2016
First version publication date	22 Mar 2015
Other versions	v1 (removed from public view)
Version creation reason

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

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Trial information

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Sponsor protocol code

V102_02E1

ISRCTN number

US NCT number

NCT01367158

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Vaccines and Diagnostics S.r.l.

Sponsor organisation address

Via Fiorentina 1, Siena, Italy, 53100

Public contact

Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.com

Scientific contact

Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.com

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

Yes

EMA paediatric investigation plan number(s)

EMEA-001260-PIP01-11

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

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

Yes

Analysis stage

Final

Date of interim/final analysis

15 Jan 2014

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

06 Jul 2012

Was the trial ended prematurely?

Main objective of the trial

Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study vaccines.

Protection of trial subjects

This clinical study was designed, implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki.

Background therapy

Evidence for comparator

Actual start date of recruitment

23 Jul 2011

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

6 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Chile: 44

Country: Number of subjects enrolled

Colombia: 104

Country: Number of subjects enrolled

Panama: 292

Worldwide total number of subjects

440

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

374

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Subjects were enrolled from 6 study centres in Panama, 3 in Columbia and 2 in Chile

Screening details

Subjects previously allocated to groups I–V of the primary study were to be randomized in a 1:2 ratio to receive, either a third dose of the same vaccine as in the primary study (NCT number: NCT01210885) or a dose of tetanus, diphtheria and acellular pertussis vaccine (Tdap) respectively. Subjects in group VI received only Tdap in this study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Carer, Subject

Blinding implementation details

Study subjects and personnel assessing the safety and eligibility of subjects will remain blinded to the treatment assigned in this study.

Are arms mutually exclusive

Yes

3ABCWY

Arm description

Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study.

Arm type

Experimental

Investigational medicinal product name

Combined MenABCWY vaccine (rMenB (no OMV)+MenACWY lyophilized)

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL of injectable solution

2ABCWY

Arm description

Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study.

Arm type

Active comparator

Investigational medicinal product name

Tdap

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL of injectable solution.

3ABx2CWY

Arm description

Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study.

Arm type

Experimental

Investigational medicinal product name

Combined MenABCWY vaccine (rMenBx2doses (no OMV)+MenACWY lyophilized)

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

1.0 mL of injectable solution.

2ABx2CWY

Arm description

Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study.

Arm type

Active comparator

Investigational medicinal product name

Tdap

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL of injectable solution.

3ABCWY+OMV

Arm description

Two doses of MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study.

Arm type

Experimental

Investigational medicinal product name

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

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL of injectable solution.

2ABCWY+OMV

Arm description

Two doses of MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study.

Arm type

Active comparator

Investigational medicinal product name

Tdap

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL of injectable solution.

3ABCWYqOMV

Arm description

Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study.

Arm type

Experimental

Investigational medicinal product name

Combined MenABCWY vaccine (rMenB + 1/4 OMV liquid suspension +MenACWY lyophilized)

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and suspension for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL of injectable solution

2ABCWYqOMV

Arm description

Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study.

Arm type

Active comparator

Investigational medicinal product name

Tdap

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL of injectable solution

Men 3B

Arm description

Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study.

Arm type

Experimental

Investigational medicinal product name

Novartis rMenB vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL of injectable solution.

Men 2B

Arm description

Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study.

Arm type

Active comparator

Investigational medicinal product name

Tdap

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL of injectable solution

1ACWY

Arm description

One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study.

Arm type

Active comparator

Investigational medicinal product name

Tdap

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL of injectable solution

Number of subjects in period 1	3ABCWY	2ABCWY	3ABx2CWY	2ABx2CWY	3ABCWY+OMV	2ABCWY+OMV	3ABCWYqOMV	2ABCWYqOMV	Men 3B	Men 2B	1ACWY
Started	25	49	24	49	25	48	25	49	23	50	73
Completed	25	46	23	48	23	46	25	47	23	50	72
Not completed	0	3	1	1	2	2	0	2	0	0	1
Consent withdrawn by subject	-	2	1	-	2	-	-	1	-	-	-
Lost to follow-up	-	-	-	1	-	2	-	1	-	-	1
Protocol deviation	-	1	-	-	-	-	-	-	-	-	-

Baseline characteristics

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Reporting group title

3ABCWY

Reporting group description

Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study.

Reporting group title

2ABCWY

Reporting group description

Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study.

Reporting group title

3ABx2CWY

Reporting group description

Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study.

Reporting group title

2ABx2CWY

Reporting group description

Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study.

Reporting group title

3ABCWY+OMV

Reporting group description

Two doses of MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study.

Reporting group title

2ABCWY+OMV

Reporting group description

Two doses of MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study.

Reporting group title

3ABCWYqOMV

Reporting group description

Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study.

Reporting group title

2ABCWYqOMV

Reporting group description

Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study.

Reporting group title

Men 3B

Reporting group description

Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study.

Reporting group title

Men 2B

Reporting group description

Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study.

Reporting group title

1ACWY

Reporting group description

One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study.

Reporting group values	3ABCWY	2ABCWY	3ABx2CWY	2ABx2CWY	3ABCWY+OMV	2ABCWY+OMV	3ABCWYqOMV	2ABCWYqOMV	Men 3B	Men 2B	1ACWY	Total
Number of subjects	25	49	24	49	25	48	25	49	23	50	73	440
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0	0	0	0	0
Children (2-11 years)	1	0	1	2	1	2	1	4	3	2	1	18
Adolescents (12-17 years)	21	44	22	42	18	44	22	41	16	42	62	374
Adults (18-64 years)	3	5	1	5	6	2	2	4	4	6	10	48
From 65-84 years	0	0	0	0	0	0	0	0	0	0	0	0
85 years and over	0	0	0	0	0	0	0	0	0	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	14.3 ( 2.2 )	14.2 ( 2 )	14.4 ( 2.1 )	14.4 ( 2.1 )	14.9 ( 2.6 )	14.2 ( 2.1 )	14.3 ( 2 )	14.4 ( 2.1 )	14.8 ( 2.5 )	15 ( 2 )	14.8 ( 2.1 )	-
Gender categorical
Units: Subjects
Female	16	29	14	27	12	26	14	19	11	25	39	232
Male	9	20	10	22	13	22	11	30	12	25	34	208

End points

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Reporting group title

3ABCWY

Reporting group description

Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study.

Reporting group title

2ABCWY

Reporting group description

Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study.

Reporting group title

3ABx2CWY

Reporting group description

Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study.

Reporting group title

2ABx2CWY

Reporting group description

Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study.

Reporting group title

3ABCWY+OMV

Reporting group description

Two doses of MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study.

Reporting group title

2ABCWY+OMV

Reporting group description

Two doses of MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study.

Reporting group title

3ABCWYqOMV

Reporting group description

Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study.

Reporting group title

2ABCWYqOMV

Reporting group description

Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study.

Reporting group title

Men 3B

Reporting group description

Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study.

Reporting group title

Men 2B

Reporting group description

Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study.

Reporting group title

1ACWY

Reporting group description

One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study.

Subject analysis set title

Enrolled Set

Subject analysis set type

Intention-to-treat

Subject analysis set description

All subjects who signed an informed consent, underwent screening procedures, and were randomized.

Subject analysis set title

Safety Set

Subject analysis set type

Safety analysis

Subject analysis set description

All exposed subjects with adverse event data.

Subject analysis set title

MITT Set- Month 6

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Subjects who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; had no major protocol deviations .

Subject analysis set title

MITT Set- Month 7

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Subjects who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; had no major protocol deviations.

Subject analysis set title

MITT Set- Month 12

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Subjects who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; had no major protocol deviations.

Primary: Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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End point title

Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo ^[1] ^[2]

End point description

Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7). MITT Month 7.

End point type

Primary

End point timeframe

At month 6 and month 7

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: No statistical analyses for this end point.
[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: No statistical analyses for this end point.

End point values	3ABCWY	3ABx2CWY	3ABCWY+OMV	3ABCWYqOMV	Men 3B	1ACWY
Number of subjects analysed	25	24	25	25	23	72
Units: Percentage of subjects
number (confidence interval 95%)
Ser. A - month 6 (N=23,24,24,25,23,69)	52 (31 to 73)	79 (58 to 93)	75 (53 to 90)	68 (46 to 85)	35 (16 to 57)	55 (43 to 67)
Ser. A - month 7 (N=24,24,21,25,22,71)	100 (86 to 100)	100 (86 to 100)	100 (84 to 100)	100 (86 to 100)	91 (71 to 99)	58 (45 to 69)
Ser. C - month 6 (N=22,24,24,24,21,70)	100 (85 to 100)	96 (79 to 100)	100 (86 to 100)	100 (86 to 100)	33 (15 to 57)	76 (64 to 85)
Ser. C - month 7 (N=23,24,23,25,22,72)	100 (85 to 100)	100 (86 to 100)	100 (85 to 100)	100 (86 to 100)	73 (50 to 89)	68 (56 to 79)
Ser. W - month 6 (N=24,24,25,24,22,69)	100 (86 to 100)	96 (79 to 100)	100 (86 to 100)	100 (86 to 100)	55 (32 to 76)	97 (90 to 100)
Ser. W - month 7 (N=23,24,21,25,21,72)	100 (85 to 100)	100 (86 to 100)	100 (84 to 100)	100 (86 to 100)	90 (70 to 99)	96 (88 to 99)
Ser. Y - month 6 (N=24,24,24,25,23,72)	96 (79 to 100)	100 (86 to 100)	96 (79 to 100)	92 (74 to 99)	4 (0 to 22)	85 (74 to 92)
Ser. Y - month 7 (N=25,24,24,25,22,72)	100 (86 to 100)	96 (79 to 100)	100 (86 to 100)	100 (86 to 100)	14 (3 to 35)	85 (74 to 92)

No statistical analyses for this end point

Primary: Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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End point title

Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo ^[3] ^[4]

End point description

Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).

End point type

Primary

End point timeframe

At month 6 and month 7

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: No statistical analyses for this end point.
[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: No statistical analyses for this end point.

End point values	3ABCWY	3ABx2CWY	3ABCWY+OMV	3ABCWYqOMV	Men 3B	1ACWY
Number of subjects analysed	25	24	25	25	23	73
Units: Percentage of subjects
number (confidence interval 95%)
H44/76 (fHbp) - month 6 (N=25,24,25,24,23,72)	40 (21 to 61)	46 (26 to 67)	52 (31 to 72)	29 (13 to 51)	35 (16 to 57)	3 (0 to 10)
H44/76 (fHbp) - month 7 (N=25,24,24,25,22,73)	92 (74 to 99)	96 (79 to 100)	96 (79 to 100)	92 (74 to 99)	91 (71 to 99)	4 (1 to 12)
5/99 (NadA) - month 6 (N=25,24,24,25,23,72)	96 (80 to 100)	100 (86 to 100)	96 (79 to 100)	100 (86 to 100)	100 (85 to 100)	15 (8 to 26)
5/99 (NadA) - month 7 (N=25,24,24,25,23,73)	100 (86 to 100)	100 (86 to 100)	100 (86 to 100)	100 (86 to 100)	100 (85 to 100)	16 (9 to 27)
NZ98/254(PorA) - month 6 (N=25,24,24,25,23,72)	12 (3 to 31)	8 (1 to 27)	29 (13 to 51)	12 (3 to 31)	9 (1 to 28)	0 (0 to 5)
NZ98/254(PorA) - month 7 (N=25,24,24,25,23,73)	20 (7 to 41)	29 (13 to 51)	88 (68 to 97)	76 (55 to 91)	17 (5 to 39)	1 (0.035 to 7)
M14459(fHBP) - month 6 (N=25,24,25,25,23,71)	24 (9 to 45)	25 (10 to 47)	32 (15 to 54)	16 (5 to 36)	17 (5 to 39)	6 (2 to 14)
M14459(fHBP) - month 7 (N=25,24,23,25,22,73)	80 (59 to 93)	79 (58 to 93)	87 (66 to 97)	88 (69 to 97)	64 (41 to 83)	8 (3 to 17)
M07-0241084(NHBA) - month 6 (N=25,23,23,25,23,70)	20 (7 to 41)	35 (16 to 57)	39 (20 to 61)	52 (31 to 72)	30 (13 to 53)	30 (20 to 42)
M07-0241084(NHBA) - month 7 (N=25,23,22,25,21,72)	68 (46 to 85)	61 (39 to 80)	95 (77 to 100)	92 (74 to 99)	62 (38 to 82)	29 (19 to 41)
M01-0240364(NadA) - month 6 (N=25,21,24,24,21,71)	16 (5 to 36)	38 (18 to 62)	25 (10 to 47)	33 (16 to 55)	33 (15 to 57)	4 (1 to 12)
M01-0240364(NadA) - month 7 (N=24,23,24,25,23,71)	96 (79 to 100)	100 (85 to 100)	100 (86 to 100)	96 (80 to 100)	96 (78 to 100)	4 (1 to 12)

No statistical analyses for this end point

Secondary: Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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End point title

Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo ^[5]

End point description

Antibody response was measured as Geometric Mean hSBA Titers against N meningitidis Serogroups A, C, W and Y at One of Four MenABCWY Formulations or rMenB at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).

End point type

Secondary

End point timeframe

At month 6 and month 7

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: No statistical analyses for this end point.

End point values	3ABCWY	3ABx2CWY	3ABCWY+OMV	3ABCWYqOMV	Men 3B	1ACWY
Number of subjects analysed	25	24	25	25	23	72
Units: Titers
geometric mean (confidence interval 95%)
Ser. A - month 6 (N=23,24,24,25,23,69)	15 (6.66 to 33)	44 (20 to 96)	31 (14 to 68)	21 (9.53 to 44)	4.52 (2.02 to 10)	21 (13 to 34)
Ser. A - month 7 (N=24,24,21,25,22,71)	247 (120 to 509)	322 (157 to 659)	242 (113 to 521)	274 (136 to 553)	135 (64 to 287)	22 (14 to 33)
Ser. C - month 6 (N=22,24,24,24,21,70)	211 (125 to 355)	153 (93 to 251)	168 (102 to 278)	137 (83 to 224)	4.54 (2.66 to 7.75)	25 (18 to 34)
Ser. C - month 7 (N=23,24,23,25,22,72)	796 (472 to 1343)	716 (430 to 1193)	670 (397 to 1130)	634 (385 to 1044)	31 (18 to 53)	19 (14 to 26)
Ser. W - month 6 (N=24,24,25,24,22,69)	189 (116 to 305)	184 (144 to 296)	202 (127 to 324)	164 (102 to 263)	11 (6.67 to 18)	128 (95 to 173)
Ser. W - month 7 (N=23,24,21,25,21,72)	710 (442 to 1143)	695 (441 to 1096)	929 (570 to 1512)	684 (438 to 1069)	126 (77 to 207)	130 (98 to 172)
Ser. Y - month 6 (N=24,24,24,25,23,72)	203 (111 to 372)	233 (128 to 425)	158 (86 to 289)	129 (72 to 233)	1.72 (0.93 to 3.18)	97 (67 to 140)
Ser. Y - month 7 (N=25,24,24,25,22,72)	695 (385 to 1255)	629 (346 to 1144)	619 (339 to 1129)	432 (241 to 776)	2.64 (1.41 to 4.96)	85 (59 to 122)

No statistical analyses for this end point

Secondary: Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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End point title

Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo ^[6]

End point description

Antibody response was measured as Geometric Mean Ratio (95% CI), against N meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination (month 7) With One of Four MenABCWY Formulations or rMenB.

End point type

Secondary

End point timeframe

At month 7

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: No statistical analyses for this end point.

End point values	3ABCWY	3ABx2CWY	3ABCWY+OMV	3ABCWYqOMV	Men 3B	1ACWY
Number of subjects analysed	25	24	25	25	23	72
Units: Ratio
geometric mean (confidence interval 95%)
Ser. A (N=22,24,21,25,22,68)	15 (8.88 to 25)	7.53 (4.58 to 12)	10 (6.1 to 18)	14 (8.37 to 22)	34 (20 to 57)	1.05 (0.77 to 1.43)
Ser. C (N=21,24,22,24,20,70)	3.43 (2.59 to 4.54)	4.63 (3.56 to 6.02)	3.85 (2.92 to 5.06)	5.01 (3.85 to 6.5)	8.41 (6.31 to 11)	0.75 (0.64 to 0.89)
Ser. W (N=23,24,21,24,20,69)	3.42 (2.41 to 4.85)	3.66 (2.62 to 5.12)	3.98 (2.78 to 5.69)	4.05 (2.9 to 5.66)	11 (7.55 to 16)	1.01 (0.82 to 1.24)
Ser. Y (N=24,24,23,25,22,71)	3.33 (2.31 to 4.79)	2.68 (1.87 to 3.85)	4.45 (3.06 to 6.45)	3.32 (2.33 to 4.73)	1.46 (1 to 2.14)	0.81 (0.65 to 1.02)

No statistical analyses for this end point

Secondary: GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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End point title

GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo ^[7]

End point description

Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo.

End point type

Secondary

End point timeframe

At month 6 and month 7

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: No statistical analyses for this end point.

End point values	3ABCWY	3ABx2CWY	3ABCWY+OMV	3ABCWYqOMV	Men 3B	1ACWY
Number of subjects analysed	25	24	25	25	23	73
Units: Titers
geometric mean (confidence interval 95%)
H44/76 (fHbp) - month 6 (N=25,24,25,24,23,72)	5.9 (3.07 to 11)	6.88 (3.56 to 13)	12 (6.14 to 23)	5.25 (2.71 to 10)	6.42 (3.27 to 13)	1.18 (1.01 to 1.37)
H44/76 (fHbp) - month 7 (N=25,24,24,24,25,22,73)	109 (60 to 201)	154 (83 to 285)	181 (97 to 336)	114 (62 to 208)	109 (57 to 209)	1.21 (1.04 to 1.4)
5/99 (NadA) - month 6 (N=25,24,24,25,23,72)	78 (52 to 118)	122 (80 to 186)	46 (30 to 71)	84 (56 to 127)	152 (99 to 234)	1.74 (1.36 to 2.22)
5/99 (NadA) - month 7 (N=25,24,24,25,23,73)	546 (365 to 817)	740 (492 to 1112)	665 (441 to 1002)	527 (354 to 786)	832 (548 to 1263)	1.93 (1.5 to 2.48)
NZ98/254(PorA) - month 6 (N=25,24,24,25,23,72)	1.96 (1.29 to 3)	1.85 (1.21 to 2.85)	3.47 (2.26 to 5.35)	1.89 (1.24 to 2.88)	1.81 (1.17 to 2.81)	1.15 (1.05 to 1.25)
NZ98/254(PorA) - month 7 (N=25,24,24,25,23,73)	2.37 (1.5 to 3.74)	3.26 (2.06 to 5.17)	24 (15 to 37)	12 (7.57 to 19)	2.64 (1.65 to 4.23)	1.2 (1.07 to 1.33)
M14459(fHBP) - month 6 (N=25,24,25,25,23,71)	2.71 (1.72 to 4.27)	3.29 (2.08 to 5.21)	4.49 (2.85 to 7.06)	2.34 (1.49 to 3.67)	2.48 (1.55 to 3.97)	1.28 (1.11 to 1.49)
M14459(fHBP) - month 7 (N=25,24,23,25,22,73)	16 (10 to 27)	27 (17 to 44)	45 (27 to 75)	20 (13 to 33)	12 (7.07 to 20)	1.28 (1.1 to 1.49)
M07-0241084(NHBA) - month 6 (N=25,23,23,25,23,70)	3.37 (1.98 to 5.73)	3.66 (2.12 to 6.34)	6.92 (3.99 to 12)	6.45 (3.81 to 11)	3.32 (1.91 to 5.75)	2.99 (2.16 to 4.14)
M07-0241084(NHBA) - month 7 (N=25,23,22,25,21,72)	12 (7.07 to 21)	9.48 (5.37 to 17)	38 (21 to 69)	25 (15 to 44)	9.73 (5.33 to 18)	3.03 (2.22 to 4.15)
M01-0240364(NadA) - month 6 (N=25,21,24,24,21,71)	4.62 (2.15 to 9.95)	9.98 (4.37 to 23)	6.95 (3.19 to 15)	7.44 (3.44 to 16)	7.21 (3.15 to 17)	1.18 (1 to 1.39)
M01-0240364(NadA) - month 7 (N=24,23,24,25,23,71)	311 (152 to 637)	533 (259 to 1098)	385 (188 to 786)	286 (143 to 573)	474 (229 to 980)	1.18 (1 to 1.39)

No statistical analyses for this end point

Secondary: GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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End point title

GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo ^[8]

End point description

Antibody response was measured as Geometric Mean Ratio (95% CI), against Serogroup B Test Strains at One Month After the Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo.

End point type

Secondary

End point timeframe

At month 7

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: No statistical analyses for this end point.

End point values	3ABCWY	3ABx2CWY	3ABCWY+OMV	3ABCWYqOMV	Men 3B	1ACWY
Number of subjects analysed	25	24	25	25	23	73
Units: Ratio
geometric mean (confidence interval 95%)
H44/76 (fHbp) (N=25,24,24,24,22,72)	18 (12 to 29)	22 (14 to 36)	14 (8.88 to 23)	22 (14 to 36)	16 (9.83 to 26)	1.03 (0.98 to 1.08)
5/99 (NadA) (N=25,24,23,25,23,72)	6.96 (5.15 to 9.42)	6.04 (4.45 to 8.21)	14 (11 to 20)	6.25 (4.63 to 8.44)	5.47 (4 to 7.48)	1.12 (0.93 to 1.36)
NZ98/254 (PorA) (N=25,24,23,25,23,72)	1.21 (0.87 to 1.67)	1.76 (1.26 to 2.45)	6.56 (4.67 to 9.2)	6.29 (4.55 to 8.69)	1.45 (1.04 to 2.04)	1.05 (0.95 to 1.15)
M14459 (fHBP) (N=25,24,23,25,22,71)	5.99 (4.11 to 8.73)	8.1 (5.54 to 12)	9.08 (6.14 to 13)	8.58 (5.91 to 12)	4.37 (2.93 to 6.53)	1.01 (0.91 to 1.11)
M07-0241084 (NHBA) (N=25,22,20,25,21,69)	3.61 (2.57 to 5.09)	2.46 (1.71 to 3.54)	5.18 (3.53 to 7.58)	3.92 (2.8 to 5.51)	2.75 (1.89 to 4.01)	1.01 (0.91 to 1.12)
M01-0240364 (NadA) (N=24,20,23,24,21,69)	65 (37 to 114)	50 (27 to 92)	65 (37 to 116)	40 (23 to 71)	66 (36 to 120)	1 (0.97 to 1.04)

No statistical analyses for this end point

Secondary: Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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End point title

Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo ^[9]

End point description

Antibody response was measured as the percentage of subjects with seroresponse Against N meningitidis Serogroups A, C, W and Y, after the third vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo. Seroresponse to N meningitidis serogroups A, C, W and Y is defined as: For subjects with a prevaccination (month 6) hSBA <1:4, a postvaccination hSBA ≥1:8;For subjects with a prevaccination (month 6) hSBA ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.

End point type

Secondary

End point timeframe

At month 7

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: No statistical analyses for this end point.

End point values	3ABCWY	3ABx2CWY	3ABCWY+OMV	3ABCWYqOMV	Men 3B	1ACWY
Number of subjects analysed	24	24	23	25	22	71
Units: Percentage of Subjects
number (confidence interval 95%)
Ser. A (N=22,24,21,25,22,68)	59 (36 to 79)	67 (45 to 84)	67 (43 to 85)	72 (51 to 88)	82 (60 to 95)	3 (0 to 10)
Ser. C (N=21,24,22,24,20,70)	48 (26 to 70)	54 (33 to 74)	59 (36 to 79)	67 (45 to 84)	60 (36 to 81)	0 (0 to 5)
Ser. W (N=23,24,21,24,20,69)	35 (16 to 57)	38 (19 to 59)	48 (26 to 70)	58 (37 to 78)	60 (36 to 81)	3 (0 to 10)
Ser. Y (N=24,24,23,25,22,71)	29 (13 to 51)	38 (19 to 59)	43 (23 to 66)	32 (15 to 54)	5 (0 to 23)	0 (0 to 5)

No statistical analyses for this end point

Secondary: Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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End point title

Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo ^[10]

End point description

Antibody response was measured as the percentage of subjects with 4-fold Increase in human serum bactericidal assay (hSBA) titers and associated 95% CI, Against Serogroup B Test Strains at One Month After Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo (compared to month 6 values).

End point type

Secondary

End point timeframe

At month 7

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analyses for this end point.

End point values	3ABCWY	3ABx2CWY	3ABCWY+OMV	3ABCWYqOMV	Men 3B	1ACWY
Number of subjects analysed	25	24	24	25	23	72
Units: Percentage of subjects
number (confidence interval 95%)
H44/76 (fHbp) (N=25,24,24,24,22,72)	80 (59 to 93)	88 (68 to 97)	83 (63 to 95)	88 (68 to 97)	73 (50 to 89)	0 (0 to 5)
5/99 (NadA) (N=25,24,23,25,23,72)	80 (59 to 93)	67 (45 to 84)	83 (61 to 95)	76 (55 to 91)	57 (34 to 77)	3 (0 to 10)
NZ98/254 (PorA) (N=25,24,23,25,23,72)	4 (0 to 20)	17 (5 to 37)	61 (39 to 80)	44 (24 to 65)	17 (5 to 39)	1 (0.035 to 7)
M14459 (fHBP) (N=25,24,23,25,22,71)	56 (35 to 76)	54 (33 to 74)	65 (43 to 84)	52 (31 to 72)	50 (28 to 72)	1 (0.036 to 8)
M07-0241084 (NHBA) (N=25,22,20,25,21,69)	36 (18 to 57)	23 (8 to 45)	60 (36 to 81)	44 (24 to 65)	29 (11 to 52)	0 (0 to 5)
M01-0240364 (NadA) (N=24,20,23,24,21,69)	88 (68 to 97)	80 (56 to 94)	83 (61 to 95)	79 (58 to 93)	90 (70 to 99)	0 (0 to 5)

No statistical analyses for this end point

Secondary: GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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End point title

GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo ^[11]

End point description

Antibody response was measured as Geometric Mean hSBA Titers Against N meningitidis Serogroups A, C, W and Y after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, and after 6, 7 and 12 months of the first vaccination in the parent study (months 6, 7 and 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.

End point type

Secondary

End point timeframe

At months 0, 1, 3, 6, 7 and 12

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: No statistical analyses for this end point.

End point values	2ABCWY	2ABx2CWY	2ABCWY+OMV	2ABCWYqOMV	Men 2B	1ACWY
Number of subjects analysed	49	48	48	49	50	73
Units: Titers
geometric mean (confidence interval 95%)
Ser. A – month 0 (N=49,49,48,48,50,73)	1.65 (1.32 to 2.07)	1.41 (1.13 to 1.76)	1.38 (1.1 to 1.73)	1.2 (0.96 to 1.51)	1.34 (1.07 to 1.67)	1.43 (1.18 to 1.72)
Ser. A - month 1 (N=48,48,47,49,50,70)	61 (35 to 107)	61 (35 to 107)	49 (28 to 86)	37 (21 to 65)	2.96 (1.71 to 5.13)	107 (66 to 172)
Ser. A - month 3 (N=49,48,47,48,50,72)	162 (106 to 249)	206 (134 to 316)	183 (118 to 282)	169 (109 to 262)	44 (29 to 68)	36 (25 to 52)
Ser. A - month 6 (N=46,46,48,44,49,69)	28 (16 to 49)	44 (25 to 78)	21 (12 to 36)	24 (14 to 44)	4.22 (2.43 to 7.33)	20 (12 to 32)
Ser. A - month 7 (N=48,47,46,49,50,71)	24 (14 to 39)	28 (17 to 46)	17 (9.94 to 28)	17 (10 to 29)	3.18 (1.95 to 5.19)	21 (13 to 31)
Ser. A - month 12 (N=43,44,45,46,50,71)	10 (5.69 to 18)	9.73 (5.6 to 17)	8.88 (5.09 to 15)	8.08 (4.64 to 14)	2.21 (1.31 to 3.75)	14 (9.03 to 22)
Ser C – month 0 (N=49,49,48,47,50,72)	4.9 (3.37 to 7.13)	4.66 (3.21 to 6.75)	6.08 (4.17 to 8.86)	5.75 (3.92 to 8.43)	8 (5.53 to 12)	4.96 (3.61 to 6.81)
Ser. C - month 1 (N=48,48,48,48,50,71)	51 (33 to 80)	116 (75 to 180)	99 (64 to 155)	101 (64 to 159)	8.76 (5.63 to 14)	75 (51 to 109)
Ser. C - month 3 (N=49,47,46,48,50,71)	340 (252 to 460)	501 (370 to 680)	338 (248 to 461)	380 (278 to 520)	17 (12 to 22)	45 (35 to 58)
Ser. C - month 6 (N=46,48,47,48,49,70)	133 (94 to 189)	186 (133 to 261)	117 (83 to 165)	157 (111 to 223)	6.77 (4.82 to 9.52)	23 (17 to 31)
Ser. C - month 7 (N=48,47,46,49,50,72)	110 (78 to 156)	153 (108 to 217)	88 (61 to 126)	128 (90 to 183)	5.53 (3.9 to 7.84)	18 (13 to 24)
Ser. C - month 12 (N=44,46,46,46,50,72)	55 (38 to 81)	66 (45 to 95)	45 (31 to 65)	72 (49 to 105)	6.03 (4.19 to 8.69)	14 (10 to 19)
Ser W – month 0 (N=49,48,48,47,50,73)	19 (11 to 33)	21 (12 to 36)	29 (17 to 50)	24 (14 to 42)	31 (18 to 52)	24 (15 to 38)
Ser. W - month 1 (N=48,48,47,48,49,72)	163 (113 to 237)	243 (168 to 352)	173 (119 to 252)	233 (160 to 341)	29 (20 to 42)	210 (154 to 287)
Ser. W - month 3 (N=49,46,47,48,50,72)	370 (290 to 472)	514 (400 to 661)	349 (272 to 448)	435 (338 to 559)	140 (110 to 179)	166 (135 to 204)
Ser. W - month 6 (N=44,47,45,45,43,69)	202 (144 to 284)	196 (141 to 272)	143 (102 to 200)	194 (138 to 274)	15 (11 to 21)	117 (88 to 154)
Ser. W - month 7 (N=46,47,45,47,45,72)	173 (125 to 240)	167 (121 to 230)	118 (85 to 164)	168 (121 to 234)	13 (9.72 to 19)	121 (93 to 159)
Ser. W - month 12 (N=45,45,45,43,46,69)	119 (82 to 174)	113 (77 to 164)	83 (57 to 120)	109 (73 to 161)	11 (7.81 to 17)	75 (55 to 103)
Ser Y – month 0 (N=49,48,48,49,50,73)	5.1 (3.69 to 7.05)	4.84 (3.5 to 6.7)	5.6 (4.04 to 7.77)	4.98 (3.6 to 6.91)	6.52 (4.73 to 8.99)	7.07 (5.38 to 9.29)
Ser. Y - month 1 (N=48,48,48,49,49,73)	98 (66 to 145)	119 (80 to 177)	76 (51 to 113)	92 (62 to 136)	5.6 (3.77 to 8.32)	92 (66 to 128)
Ser. Y - month 3 (N=49,48,47,49,50,73)	214 (162 to 281)	283 (215 to 374)	195 (147 to 258)	226 (172 to 298)	4.7 (3.58 to 6.18)	72 (57 to 91)
Ser. Y - month 6 (N=48,48,48,48,49,72)	206 (134 to 315)	249 (162 to 382)	138 (90 to 212)	154 (100 to 237)	1.93 (1.26 to 2.95)	84 (58 to 120)
Ser. Y - month 7 (N=46,48,46,49,50,72)	180 (116 to 278)	213 (139 to 327)	100 (65 to 155)	127 (83 to 194)	2.05 (1.34 to 3.13)	75 (52 to 108)
Ser. Y - month 12 (N=45,47,45,46,50,70)	88 (55 to 141)	112 (71 to 178)	55 (34 to 88)	75 (47 to 121)	1.59 (1.01 to 2.5)	47 (31 to 69)

No statistical analyses for this end point

Secondary: GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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End point title

GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo ^[12]

End point description

Antibody response was measured as Geometric Mean Ratios (95%CI) Against N meningitidis Serogroups A, C, W and Y after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6, 7 and 12 months of the first vaccination (months 6, 7 and 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.

End point type

Secondary

End point timeframe

At month 1, 3, 6, 7 and 12

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: No statistical analyses for this end point.

End point values	2ABCWY	2ABx2CWY	2ABCWY+OMV	2ABCWYqOMV	Men 2B	1ACWY
Number of subjects analysed	49	48	48	49	50	73
Units: Ratio
geometric mean (confidence interval 95%)
Ser. A - month 1 (N=48,48,47,48,50,70)	41 (23 to 73)	45 (26 to 80)	36 (20 to 65)	30 (17 to 53)	2.25 (1.28 to 3.93)	78 (48 to 127)
Ser. A - month 3 (N=49,48,47,47,50,72)	107 (68 to 168)	150 (95 to 235)	135 (85 to 214)	137 (86 to 217)	34 (21 to 52)	26 (18 to 38)
Ser. A - month 6 (N=46,46,48,44,49,69)	19 (11 to 34)	32 (18 to 57)	15 (8.77 to 27)	20 (11 to 35)	3.19 (1.82 to 5.59)	15 (9.12 to 24)
Ser. A - month 7 (N=48,47,46,48,50,71)	16 (9.83 to 27)	21 (12 to 34)	12 (7.36 to 21)	14 (8.22 to 23)	2.41 (1.47 to 3.97)	15 (9.87 to 23)
Ser. A - month 12 (N=43,44,45,45,50,71)	6.97 (3.93 to 12)	7.18 (4.11 to 13)	6.61 (3.77 to 12)	6.42 (3.67 to 11)	1.68 (0.99 to 2.85)	11 (6.65 to 17)
Ser. C - month 1 (N=48,48,48,47,50,70)	11 (6.83 to 19)	26 (16 to 43)	19 (12 to 31)	20 (12 to 33)	1.42 (0.87 to 2.32)	16 (11 to 25)
Ser. C - month 3 (N=49,47,46,46,50,70)	72 (47 to 110)	114 (74 to 175)	60 (39 to 93)	71 (45 to 110)	2.36 (1.54 to 3.59)	9.54 (6.61 to 14)
Ser. C - month 6 (N=46,48,47,46,49,69)	29 (19 to 45)	41 (27 to 63)	22 (14 to 34)	31 (20 to 47)	1.07 (0.7 to 1.63)	5.14 (3.57 to 7.39)
Ser. C - month 7 (N=48,47,46,47,50,71)	24 (16 to 37)	33 (21 to 51)	16 (10 to 25)	25 (16 to 38)	0.85 (0.55 to 1.3)	3.9 (2.7 to 5.64)
Ser. C - month 12 (N=44,46,46,44,50,71)	12 (7.82 to 19)	16 (10 to 24)	8.88 (5.7 to 14)	15 (9.57 to 24)	0.99 (0.65 to 1.52)	3.06 (2.12 to 4.4)
Ser. W - month 1 (N=48,47,47,46,49,72)	9.2 (5.41 to 16)	13 (7.42 to 21)	7.41 (4.34 to 13)	10 (6.1 to 18)	1.15 (0.68 to 1.95)	10 (6.49 to 16)
Ser. W - month 3 (N=49,45,47,46,50,72)	20 (11 to 34)	27 (15 to 48)	12 (6.7 to 21)	19 (11 to 35)	4.83 (2.76 to 8.46)	7.32 (4.53 to 12)
Ser. W - month 6 (N=44,46,45,43,43,69)	11 (6.33 to 20)	9.75 (5.64 to 17)	5.44 (3.11 to 9.52)	9.75 (5.51 to 17)	0.58 (0.33 to 1.02)	5.17 (3.25 to 8.24)
Ser. W - month 7 (N=46,46,45,45,45,72)	9.21 (5.2 to 16)	8.17 (4.64 to 14)	4.84 (2.72 to 8.62)	7.94 (4.44 to 14)	0.55 (0.31 to 0.97)	5.47 (3.4 to 8.8)
Ser. W - month 12 (N=45,44,45,42,46,69)	7.33 (4.08 to 13)	6.54 (3.62 to 12)	3.52 (1.95 to 6.33)	4.83 (2.62 to 8.92)	0.49 (0.27 to 0.89)	3.62 (2.21 to 5.94)
Ser. Y - month 1 (N=48,47,48,49,49,73)	21 (13 to 32)	26 (17 to 40)	15 (9.89 to 24)	20 (13 to 31)	1.02 (0.66 to 1.58)	16 (11 to 23)
Ser. Y - month 3 (N=49,47,47,49,50,73)	44 (30 to 63)	59 (41 to 85)	37 (25 to 54)	47 (33 to 68)	0.8 (0.56 to 1.15)	12 (8.54 to 16)
Ser. Y - month 6 (N=48,47,48,48,49,72)	44 (27 to 71)	56 (34 to 91)	27 (16 to 44)	33 (20 to 54)	0.35 (0.21 to 0.56)	14 (9.04 to 21)
Ser. Y - month 7 (N=46,47,46,49,50,72)	37 (22 to 61)	45 (27 to 74)	19 (11 to 31)	26 (16 to 43)	0.35 (0.21 to 0.56)	12 (7.76 to 18)
Ser. Y - month 12 (N=45,46,45,46,50,70)	18 (11 to 31)	25 (15 to 42)	10 (6.14 to 18)	16 (9.64 to 28)	0.27 (0.16 to 0.45)	7.27 (4.68 to 11)

No statistical analyses for this end point

Secondary: GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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End point title

GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo ^[13]

End point description

Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, and 6, 7 and 12 months after the first vaccination with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.

End point type

Secondary

End point timeframe

At month 0, 1, 3, 6, 7 and 12

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: No statistical analyses for this end point.

End point values	2ABCWY	2ABx2CWY	2ABCWY+OMV	2ABCWYqOMV	Men 2B	1ACWY
Number of subjects analysed	49	49	48	49	50	73
Units: Titers
geometric mean (confidence interval 95%)
H44/76 (fHbp) - month 0 (N=49,48,47,48,50,73)	1.19 (0.93 to 1.53)	1.39 (1.08 to 1.79)	1.31 (1.01 to 1.69)	1.3 (1.01 to 1.68)	1.42 (1.1 to 1.82)	1.31 (1.05 to 1.65)
H44/76 (fHbp) - month 1 (N=48,48,48,49,50,73)	5.56 (3.44 to 8.99)	10 (6.38 to 17)	15 (9.5 to 25)	11 (6.93 to 18)	4.56 (2.84 to 7.3)	1.51 (1.19 to 1.92)
H44/76 (fHbp) - month 3 (N=49,48,46,48,50,72)	74 (53 to 102)	114 (82 to 158)	114 (81 to 159)	133 (96 to 186)	44 (32 to 61)	1.27 (1.07 to 1.5)
H44/76 (fHbp) - month 6 (N=47,48,48,48,50,72)	7.87 (5.04 to 12)	7.76 (4.98 to 12)	9.44 (6.04 to 15)	14 (9.2 to 23)	4.34 (2.81 to 6.71)	1.18 (1.01 to 1.37)
H44/76 (fHbp) - month 7 (N=48,48,47,49,49,73)	4.62 (3.04 to 7.02)	5.75 (3.79 to 8.73)	6.12 (4 to 9.37)	11 (7.15 to 17)	3.55 (2.35 to 5.37)	1.21 (1.04 to 1.4)
H44/76 (fHbp) - month 12 (N=45,47,45,46,50,71)	3.24 (2.18 to 4.8)	2.31 (1.57 to 3.39)	4 (2.69 to 5.97)	4.31 (2.91 to 6.4)	2.42 (1.66 to 3.52)	1.13 (1 to 1.29)
5/99 (NadA) - month 0 (N=49,49,48,48,50,73)	2.48 (1.81 to 3.39)	2.17 (1.59 to 2.96)	1.87 (1.36 to 2.56)	2.02 (1.47 to 2.78)	3.16 (2.32 to 4.32)	2.25 (1.77 to 2.85)
5/99 (NadA) - month 1 (N=48,48,47,49,50,72)	44 (29 to 65)	91 (62 to 135)	23 (15 to 34)	34 (23 to 51)	58 (39 to 85)	2.27 (1.82 to 2.85)
5/99 (NadA) - month 3 (N=49,48,47,47,50,71)	257 (203 to 324)	401 (318 to 507)	337 (266 to 427)	363 (285 to 462)	322 (255 to 406)	2.11 (1.65 to 2.7)
5/99 (NadA) - month 6 (N=47,49,48,48,48,72)	69 (51 to 93)	122 (91 to 163)	55 (41 to 74)	72 (53 to 97)	73 (54 to 98)	1.74 (1.36 to 2.22)
5/99 (NadA) - month 7 (N=47,48,47,49,50,73)	55 (42 to 73)	96 (72 to 127)	44 (33 to 58)	59 (45 to 79)	68 (51 to 90)	1.93 (1.5 to 2.48)
5/99 (NadA) - month 12 (N=45,47,46,46,50,72)	31 (22 to 44)	46 (33 to 64)	30 (21 to 42)	35 (25 to 49)	32 (23 to 44)	1.53 (1.25 to 1.88)
NZ98/254 (PorA) - month 0 (N=49,49,48,48,50,73)	1.76 (1.42 to 2.19)	1.62 (1.3 to 2.01)	1.77 (1.42 to 2.2)	1.76 (1.41 to 2.2)	2.37 (1.91 to 2.94)	1.5 (1.3 to 1.73)
NZ98/254 (PorA) - month 1 (N=48,48,48,49,50,72)	2.14 (1.58 to 2.9)	2.42 (1.8 to 3.26)	4.95 (3.66 to 6.7)	4.26 (3.15 to 5.77)	2.01 (1.49 to 2.71)	1.51 (1.32 to 1.74)
NZ98/254 (PorA) - month 3 (N=49,48,47,48,50,72)	2.98 (2.18 to 4.06)	3.86 (2.83 to 5.26)	14 (10 to 19)	12 (8.96 to 17)	2.81 (2.06 to 3.84)	1.49 (1.29 to 1.72)
NZ98/254 (PorA) - month 6 (N=48,49,48,48,49,72)	1.7 (1.28 to 2.26)	1.88 (1.42 to 2.48)	3.19 (2.4 to 4.25)	3.09 (2.31 to 4.13)	1.47 (1.1 to 1.95)	1.15 (1.05 to 1.25)
NZ98/254 (PorA) - month 7 (N=47,48,47,49,50,73)	1.45 (1.05 to 2)	1.76 (1.29 to 2.41)	2.62 (1.9 to 3.62)	2.49 (1.81 to 3.43)	1.45 (1.06 to 2)	1.2 (1.07 to 1.33)
NZ98/254 (PorA) - month 12 (N=45,47,46,46,50,72)	1.57 (1.2 to 2.06)	1.6 (1.23 to 2.09)	2.47 (1.89 to 3.24)	2.18 (1.66 to 2.86)	1.21 (0.93 to 1.57)	1.15 (1.05 to 1.25)
M14459 (fHBP) - month 0 (N=49,48,45,45,50,72)	1.29 (1.05 to 1.59)	1.43 (1.16 to 1.75)	1.43 (1.16 to 1.78)	1.38 (1.11 to 1.72)	1.89 (1.54 to 2.32)	1.33 (1.08 to 1.62)
M14459 (fHBP) - month 1 (N=48,48,47,49,50,72)	1.99 (1.44 to 2.75)	2.66 (1.92 to 3.68)	4.59 (3.28 to 6.44)	3.47 (2.47 to 4.89)	2.02 (1.46 to 2.8)	1.26 (1.08 to 1.47)
M14459 (fHBP) - month 3 (N=49,48,45,43,50,70)	6.31 (4.28 to 9.32)	13 (8.91 to 20)	17 (11 to 26)	20 (13 to 30)	5.04 (3.39 to 7.47)	1.29 (1.1 to 1.51)
M14459 (fHBP) - month 6 (N=47,47,48,48,50,71)	2.1 (1.59 to 2.79)	2.63 (1.99 to 3.49)	3.33 (2.49 to 4.44)	3.15 (2.35 to 4.24)	2.05 (1.55 to 2.71)	1.28 (1.11 to 1.49)
M14459 (fHBP) - month 7 (N=47,48,47,49,50,73)	1.79 (1.29 to 2.49)	2.4 (1.74 to 3.33)	2.75 (1.96 to 3.86)	3.59 (2.55 to 5.06)	1.87 (1.35 to 2.59)	1.28 (1.1 to 1.49)
M14459 (fHBP) - month 12 (N=45,47,45,47,50,72)	1.73 (1.31 to 2.27)	1.64 (1.25 to 2.14)	2.43 (1.83 to 3.23)	2.53 (1.91 to 3.36)	1.44 (1.1 to 1.87)	1.37 (1.15 to 1.64)
M07-0241084 (NHBA) - month 0 (N=48,46,37,44,50,67)	2.9 (1.97 to 4.27)	4.04 (2.74 to 5.97)	3.57 (2.3 to 5.56)	3.19 (2.13 to 4.78)	5.63 (3.85 to 8.22)	2.67 (1.88 to 3.79)
M07-0241084 (NHBA) - month 1 (N=48,48,48,48,50,72)	2.88 (2.17 to 3.81)	3.17 (2.39 to 4.21)	7.11 (5.18 to 9.76)	5.51 (4.12 to 7.36)	3.76 (2.85 to 4.97)	2.68 (1.93 to 3.7)
M07-0241084 (NHBA) - month 3 (N=48,48,42,45,49,68)	4.34 (3.27 to 5.75)	6.27 (4.71 to 8.33)	12 (8.71 to 17)	14 (10 to 19)	6.25 (4.71 to 8.28)	2.85 (2.08 to 3.91)
M07-0241084 (NHBA) - month 6 (N=47,48,48,48,49,70)	3.78 (2.88 to 4.95)	3.3 (2.51 to 4.34)	5.43 (4 to 7.37)	6.93 (5.23 to 9.19)	3.36 (2.56 to 4.4)	2.99 (2.16 to 4.14)
M07-0241084 (NHBA) - month 7 (N=47,48,47,48,50,72)	3.51 (2.54 to 4.85)	3.19 (2.3 to 4.41)	5.18 (3.58 to 7.48)	6.58 (4.7 to 9.22)	3.78 (2.74 to 5.2)	3.03 (2.22 to 4.15)
M07-0241084(NHBA) - month 12 (N=45,46,45,47,50,70)	3.71 (2.74 to 5.03)	2.82 (2.08 to 3.83)	4.92 (3.51 to 6.89)	6.16 (4.53 to 8.38)	3.09 (2.31 to 4.14)	2.91 (2.06 to 4.12)
M01-0240364 (NadA) - month 0 (N=49,47,44,45,50,72)	1.15 (0.9 to 1.46)	1.37 (1.08 to 1.75)	1.25 (0.97 to 1.61)	1.45 (1.12 to 1.86)	1.47 (1.16 to 1.86)	1.12 (1.01 to 1.24)
M01-0240364 (NadA) - month 1 (N=48,44,46,48,50,72)	5.46 (3.1 to 9.61)	6.42 (3.54 to 12)	4.7 (2.58 to 8.58)	4.24 (2.33 to 7.71)	4.25 (2.44 to 7.41)	1.12 (0.98 to 1.29)
M01-0240364 (NadA) - month 3 (N=48,48,44,42,49,70)	67 (38 to 118)	192 (109 to 339)	133 (72 to 245)	125 (67 to 233)	88 (50 to 154)	1.41 (1.07 to 1.85)
M01-0240364 (NadA) - month 6 (N=46,48,48,48,48,71)	8.59 (4.95 to 15)	17 (9.65 to 29)	11 (6.48 to 20)	6.27 (3.52 to 11)	7.02 (4.07 to 12)	1.18 (1 to 1.39)
M01-0240364 (NadA) - month 7 (N=44,48,48,48,50,71)	5.38 (3.2 to 9.03)	9.65 (5.83 to 16)	7.51 (4.45 to 13)	4.13 (2.43 to 7.01)	5.72 (3.49 to 9.35)	1.18 (1 to 1.39)
M01-0240364 (NadA) - month12 (N=43,45,44,44,50,72)	3.85 (2.16 to 6.84)	4.79 (2.72 to 8.44)	5.76 (3.19 to 10)	3.23 (1.78 to 5.87)	2.88 (1.68 to 4.92)	1.15 (0.97 to 1.37)

No statistical analyses for this end point

Secondary: GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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End point title

GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo ^[14]

End point description

Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, and after 6, 7 and 12 months of the first vaccination with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.

End point type

Secondary

End point timeframe

At month 1, 3, 6, 7 and 12

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: No statistical analyses for this end point.

End point values	2ABCWY	2ABx2CWY	2ABCWY+OMV	2ABCWYqOMV	Men 2B	1ACWY
Number of subjects analysed	49	49	48	49	50	73
Units: Ratio
geometric mean (confidence interval 95%)
H44/76 (fHbp) - month 1 (N=48,47,47,48,50,73)	4.42 (2.73 to 7.16)	7.99 (4.95 to 13)	12 (7.44 to 20)	8.82 (5.43 to 14)	3.53 (2.2 to 5.65)	1.15 (0.98 to 1.35)
H44/76 (fHbp) - month 3 (N=49,47,45,47,50,72)	61 (42 to 87)	84 (58 to 121)	87 (60 to 127)	103 (71 to 150)	32 (22 to 46)	1.05 (0.89 to 1.24)
H44/76 (fHbp) - month 6 (N=47,47,47,47,50,72)	6.3 (4.01 to 9.9)	5.94 (3.79 to 9.3)	7.37 (4.69 to 12)	11 (7.14 to 18)	3.31 (2.13 to 5.14)	0.89 (0.78 to 1.02)
H44/76 (fHbp) - month 7 (N=48,47,46,48,49,73)	3.73 (2.43 to 5.75)	4.34 (2.82 to 6.68)	4.75 (3.06 to 7.37)	8.48 (5.49 to 13)	2.66 (1.73 to 4.08)	0.92 (0.79 to 1.06)
H44/76 (fHbp) - month 12 (N=45,46,44,45,50,71)	2.58 (1.73 to 3.84)	1.77 (1.2 to 2.61)	3.11 (2.08 to 4.66)	3.41 (2.29 to 5.09)	1.85 (1.27 to 2.71)	0.86 (0.73 to 1.01)
5/99 (NadA) - month 1 (N=48,48,47,48,50,72)	18 (12 to 29)	42 (27 to 65)	12 (7.41 to 18)	16 (10 to 26)	21 (13 to 33)	1 (0.85 to 1.18)
5/99 (NadA) - month 3 (N=49,48,47,46,50,71)	106 (74 to 151)	184 (129 to 263)	176 (122 to 253)	174 (120 to 252)	107 (75 to 153)	1 (0.8 to 1.26)
5/99 (NadA) - month 6 (N=47,49,48,47,48,72)	28 (19 to 41)	56 (39 to 82)	29 (20 to 42)	35 (24 to 51)	25 (17 to 37)	0.78 (0.61 to 0.99)
5/99 (NadA) - month 7 (N=47,48,47,48,50,73)	23 (16 to 34)	44 (30 to 63)	23 (16 to 33)	29 (20 to 42)	23 (16 to 34)	0.86 (0.68 to 1.08)
5/99 (NadA) - month 12 (N=45,47,46,46,50,72)	13 (8.78 to 20)	21 (14 to 31)	15 (10 to 23)	18 (12 to 28)	11 (7.48 to 16)	0.7 (0.59 to 0.83)
NZ98/254 (PorA) - month 1 (N=48,48,48,48,50,72)	1.27 (0.93 to 1.73)	1.46 (1.07 to 1.98)	2.91 (2.14 to 3.96)	2.51 (1.84 to 3.42)	1.08 (0.8 to 1.46)	1 (0.87 to 1.16)
NZ98/254 (PorA) - month 3 (N=49,48,47,47,50,72)	1.74 (1.26 to 2.4)	2.33 (1.69 to 3.21)	8.25 (5.95 to 11)	7.17 (5.16 to 9.96)	1.46 (1.06 to 2.01)	0.99 (0.83 to 1.17)
NZ98/254 (PorA) - month 6 (N=48,49,48,47,49,72)	0.99 (0.73 to 1.33)	1.14 (0.85 to 1.53)	1.86 (1.38 to 2.52)	1.79 (1.32 to 2.44)	0.75 (0.56 to 1.02)	0.76 (0.65 to 0.89)
NZ98/254 (PorA) - month 7 (N=47,48,47,48,50,73)	0.85 (0.61 to 1.19)	1.07 (0.76 to 1.49)	1.53 (1.09 to 2.15)	1.45 (1.03 to 2.03)	0.73 (0.52 to 1.01)	0.8 (0.67 to 0.94)
NZ98/254 (PorA) - month 12 (N=45,47,46,45,50,72)	0.91 (0.68 to 1.22)	0.97 (0.73 to 1.29)	1.41 (1.05 to 1.88)	1.25 (0.93 to 1.68)	0.6 (0.46 to 0.8)	0.77 (0.66 to 0.9)
M14459 (fHBP) - month 1 (N=48,47,44,45,50,71)	1.57 (1.13 to 2.17)	2.09 (1.51 to 2.89)	3.61 (2.58 to 5.06)	2.73 (1.95 to 3.84)	1.57 (1.14 to 2.16)	0.95 (0.87 to 1.03)
M14459 (fHBP) - month 3 (N=49,47,42,41,50,69)	4.96 (3.35 to 7.36)	10 (6.77 to 15)	13 (8.66 to 20)	15 (9.83 to 23)	3.54 (2.4 to 5.23)	1.04 (0.9 to 1.2)
M14459 (fHBP) - month 6 (N=47,46,45,44,50,70)	1.65 (1.25 to 2.19)	2.04 (1.54 to 2.71)	2.58 (1.94 to 3.45)	2.46 (1.83 to 3.31)	1.53 (1.16 to 2.02)	0.99 (0.87 to 1.12)
M14459 (fHBP) - month 7 (N=47,47,44,45,50,72)	1.4 (1 to 1.96)	1.82 (1.31 to 2.54)	2.08 (1.48 to 2.94)	2.75 (1.95 to 3.9)	1.3 (0.94 to 1.8)	0.97 (0.83 to 1.13)
M14459 (fHBP) - month 12 ( n=45,46,42,43,50,71)	1.35 (1.02 to 1.77)	1.26 (0.96 to 1.65)	1.86 (1.4 to 2.47)	1.96 (1.48 to 2.61)	1.05 (0.81 to 1.37)	1.03 (0.87 to 1.24)
M07-0241084 (NHBA) - month 1 (N=47,45,37,44,50,66)	1.07 (0.81 to 1.42)	1.14 (0.86 to 1.52)	2.6 (1.89 to 3.57)	2.03 (1.52 to 2.73)	1.31 (1 to 1.72)	1.02 (0.87 to 1.19)
M07-0241084 (NHBA) - month 3 (N=47,45,33,40,49,65)	1.62 (1.19 to 2.19)	2.1 (1.55 to 2.85)	4.46 (3.11 to 6.39)	4.94 (3.56 to 6.84)	1.91 (1.42 to 2.56)	1.13 (0.89 to 1.44)
M07-0241084 (NHBA) - month 6 (N=46,45,37,43,49,65)	1.39 (1.04 to 1.85)	1.13 (0.85 to 1.5)	1.91 (1.39 to 2.64)	2.53 (1.88 to 3.4)	1.07 (0.81 to 1.42)	1.2 (0.97 to 1.49)
M07-0241084 (NHBA) - month 7 (N=46,45,36,43,50,66)	1.29 (0.91 to 1.82)	1.05 (0.74 to 1.48)	1.81 (1.22 to 2.68)	2.41 (1.68 to 3.46)	1.12 (0.8 to 1.57)	1.21 (0.96 to 1.51)
M07-0241084(NHBA) - month 12 (N=44,43,36,43,50,64)	1.38 (0.99 to 1.9)	0.94 (0.68 to 1.3)	1.7 (1.18 to 2.43)	2.24 (1.61 to 3.12)	0.94 (0.69 to 1.28)	1.19 (0.9 to 1.58)
M01-0240364 (NadA) - month 1 (N=48,42,42,44,50,71)	4.42 (2.51 to 7.77)	5.08 (2.8 to 9.2)	3.77 (2.07 to 6.88)	3.35 (1.84 to 6.08)	3.35 (1.93 to 5.83)	1 (0.86 to 1.16)
M01-0240364 (NadA) - month 3 (N=48,46,40,40,49,63)	57 (32 to 102)	145 (80 to 261)	105 (56 to 199)	89 (47 to 170)	64 (36 to 113)	1.28 (1.01 to 1.63)
M01-0240364 (NadA) - month 6 (N=46,46,44,44,48,70)	7.07 (4.05 to 12)	13 (7.46 to 22)	9.18 (5.17 to 16)	4.78 (2.68 to 8.54)	5.32 (3.08 to 9.19)	1.05 (0.9 to 1.23)
M01-0240364 (NadA) - month 7 (N=44,46,44,44,50,70)	4.46 (2.63 to 7.56)	7.43 (4.45 to 12)	6.03 (3.54 to 10)	3.11 (1.81 to 5.33)	4.29 (2.6 to 7.08)	1.07 (0.92 to 1.25)
M01-0240364 (NadA) - month12 (N=43,43,41,40,50,71)	3.17 (1.77 to 5.69)	3.77 (2.12 to 6.69)	4.65 (2.55 to 8.47)	2.52 (1.38 to 4.62)	2.17 (1.26 to 3.72)	1.03 (0.87 to 1.22)

No statistical analyses for this end point

Secondary: GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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End point title

GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo ^[15]

End point description

Antibody response was measured as Geometric Mean hSBA Titers Against Serogroups A, C, W and Y at baseline (month 0), after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.

End point type

Secondary

End point timeframe

At month 0. 1, 3, 6, 7 and 12

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: No statistical analyses for this end point.

End point values	3ABCWY	3ABx2CWY	3ABCWY+OMV	3ABCWYqOMV	Men 3B	1ACWY
Number of subjects analysed	25	24	25	25	23	73
Units: Titers
geometric mean (confidence interval 95%)
Ser. A - month 0 (N=25,24,25,25,23,73)	1.34 (0.99 to 1.83)	1.5 (1.1 to 2.06)	1.19 (0.88 to 1.63)	1.47 (1.08 to 1.99)	1.21 (0.88 to 1.67)	1.43 (1.18 to 1.72)
Ser. A - month 1 (N=24,24,24,25,23,70)	42 (19 to 92)	98 (45 to 213)	44 (20 to 95)	46 (21 to 98)	4.35 (1.97 to 9.6)	107 (66 to 172)
Ser. A - month 3 (N=25,24,25,25,23,72)	132 (73 to 237)	252 (139 to 456)	185 (103 to 333)	153 (86 to 275)	98 (53 to 181)	36 (25 to 52)
Ser. A - month 6 (N=23,24,24,25,23,69)	14 (6.54 to 32)	40 (19 to 86)	32 (15 to 69)	19 (8.99 to 41)	4.65 (2.12 to 10)	20 (12 to 32)
Ser. A - month 7 (N=24,24,21,25,22,71)	247 (124 to 495)	296 (149 to 591)	253 (121 to 530)	256 (130 to 503)	140 (68 to 289)	21 (13 to 31)
Ser. A - month 12 (N=25,23,21,25,22,71)	33 (16 to 68)	58 (27 to 123)	47 (21 to 103)	38 (18 to 78)	11 (5.1 to 24)	14 (9.03 to 22)
Ser. C - month 0 (N=25,24,25,25,23,72)	6.67 (3.99 to 11)	4.9 (2.91 to 8.25)	4.75 (2.84 to 7.96)	6.3 (3.78 to 11)	3.82 (2.24 to 6.52)	4.96 (3.61 to 6.81)
Ser. C - month 1 (N=25,24,24,25,23,71)	125 (68 to 230)	87 (47 to 161)	112 (61 to 208)	74 (41 to 136)	5.93 (3.16 to 11)	75 (51 to 109)
Ser. C - month 3 (N=25,24,25,24,23,71)	482 (318 to 731)	384 (252 to 585)	346 (228 to 523)	381 (250 to 580)	20 (13 to 31)	45 (35 to 58)
Ser. C - month 6 (N=22,24,24,24,21,70)	182 (111 to 297)	143 (90 to 229)	157 (98 to 251)	118 (74 to 189)	4.58 (2.77 to 7.57)	23 (17 to 31)
Ser. C - month 7 (N=23,24,23,25,22,72)	676 (410 to 1114)	676 (416 to 1097)	636 (387 to 1046)	553 (344 to 891)	33 (20 to 55)	18 (13 to 24)
Ser. C - month 12 (N=25,23,21,25,23,72)	202 (123 to 334)	185 (110 to 309)	153 (89 to 263)	157 (96 to 258)	7.8 (4.65 to 13)	14 (10 to 19)
Ser. W - month 0 (N=25,24,25,25,23,73)	28 (13 to 59)	20 (9.17 to 42)	21 (9.83 to 44)	27 (13 to 56)	27 (12 to 58)	24 (15 to 38)
Ser. W - month 1 (N=25,24,24,25,23,72)	152 (92 to 253)	180 (108 to 300)	237 (141 to 396)	144 (87 to 238)	19 (11 to 32)	210 (154 to 287)
Ser. W - month 3 (N=25,24,25,24,23,72)	398 (285 to 557)	455 (324 to 639)	499 (357 to 697)	406 (289 to 570)	139 (98 to 197)	166 (135 to 204)
Ser. W - month 6 (N=24,24,25,24,22,69)	166 (105 to 261)	176 (112 to 275)	191 (123 to 297)	148 (94 to 231)	10 (6.28 to 16)	117 (88 to 154)
Ser. W - month 7 (N=23,24,21,25,21,72)	640 (405 to 1014)	670 (432 to 1039)	876 (548 to 1402)	627 (407 to 965)	116 (72 to 187)	121 (93 to 159)
Ser. W - month 12(N=24,22,19,24,23,69)	264 (159 to 438)	258 (153 to 433)	257 (147 to 449)	212 (128 to 349)	17 (10 to 29)	75 (55 to 103)
Ser. Y - month 0 (N=25,24,25,25,23,73)	5.6 (3.58 to 8.74)	5.45 (3.47 to 8.57)	5.2 (3.33 to 8.13)	5.27 (3.38 to 8.2)	4.4 (2.77 to 6.99)	7.07 (5.38 to 9.29)
Ser. Y - month 1 (N=25,24,23,25,23,73)	75 (44 to 129)	48 (28 to 82)	62 (36 to 109)	71 (42 to 121)	4.38 (2.51 to 7.67)	92 (66 to 128)
Ser. Y - month 3 (N=25,24,25,25,23,73)	225 (154 to 328)	179 (122 to 262)	214 (147 to 312)	170 (117 to 247)	4.91 (3.32 to 7.26)	72 (57 to 91)
Ser. Y - month 6 (N=24,24,24,25,23,72)	185 (102 to 336)	216 (119 to 390)	147 (81 to 267)	121 (68 to 216)	1.69 (0.92 to 3.09)	84 (58 to 120)
Ser. Y - month 7 (N=25,24,24,25,22,72)	648 (362 to 1162)	590 (327 to 1066)	599 (331 to 1085)	408 (229 to 728)	2.56 (1.38 to 4.77)	75 (52 to 108)
Ser. Y - month 12 (N=25,23,21,25,23,70)	295 (158 to 550)	351 (184 to 670)	210 (107 to 413)	205 (110 to 381)	1.46 (0.76 to 2.78)	47 (31 to 69)

No statistical analyses for this end point

Secondary: GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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End point title

GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo ^[16]

End point description

Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.

End point type

Secondary

End point timeframe

At month 1, 3, 6, 7 and 12

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: No statistical analyses for this end point.

End point values	3ABCWY	3ABx2CWY	3ABCWY+OMV	3ABCWYqOMV	Men 3B	1ACWY
Number of subjects analysed	25	24	25	25	23	73
Units: Ratio
geometric mean (confidence interval 95%)
Ser. A - month 1 (N=24,24,24,25,23,70)	32 (15 to 71)	71 (32 to 155)	35 (16 to 77)	33 (15 to 72)	3.45 (1.54 to 7.73)	78 (48 to 127)
Ser. A - month 3 (N=25,24,25,25,23,72)	99 (53 to 185)	176 (94 to 330)	150 (81 to 280)	109 (59 to 202)	79 (42 to 150)	26 (18 to 38)
Ser. A - month 6 (N=23,24,24,25,23,69)	11 (4.86 to 24)	29 (13 to 63)	25 (12 to 56)	14 (6.47 to 30)	3.69 (1.66 to 8.2)	15 (9.12 to 24)
Ser. A - month 7 (N=24,24,21,25,22,71)	190 (94 to 385)	214 (106 to 432)	201 (95 to 425)	187 (94 to 372)	110 (53 to 230)	15 (9.87 to 23)
Ser. A - month 12 (N=25,23,21,25,22,71)	25 (12 to 52)	42 (20 to 90)	36 (16 to 81)	28 (13 to 57)	8.75 (4.01 to 19)	11 (6.65 to 17)
Ser. C - month 1 (N=25,24,24,25,23,70)	23 (11 to 45)	19 (9.55 to 38)	26 (13 to 52)	14 (7.09 to 28)	1.51 (0.74 to 3.07)	16 (11 to 25)
Ser. C - month 3 (N=25,24,25,24,23,70)	80 (44 to 143)	81 (45 to 148)	75 (42 to 135)	63 (35 to 114)	5.17 (2.81 to 9.52)	9.54 (6.61 to 14)
Ser. C - month 6 (N=22,24,24,24,21,69)	33 (18 to 61)	31 (17 to 56)	33 (19 to 60)	22 (12 to 39)	1.16 (0.62 to 2.18)	5.14 (3.57 to 7.39)
Ser. C - month 7 (N=23,24,23,25,22,71)	115 (62 to 214)	146 (80 to 266)	139 (75 to 258)	100 (56 to 181)	9.09 (4.84 to 17)	3.9 (2.7 to 5.64)
Ser. C - month 12 (N=25,23,21,25,23,71)	37 (21 to 67)	41 (22 to 75)	33 (18 to 63)	30 (17 to 53)	2.01 (1.09 to 3.69)	3.06 (2.12 to 4.4)
Ser. W - month 1 (N=25,24,24,25,23,72)	6.44 (3.12 to 13)	9.65 (4.64 to 20)	13 (6.09 to 27)	6.3 (3.07 to 13)	0.81 (0.38 to 1.72)	10 (6.49 to 16)
Ser. W - month 3 (N=25,24,25,24,23,72)	15 (6.85 to 33)	24 (11 to 52)	24 (11 to 53)	14 (6.51 to 31)	5.42 (2.42 to 12)	7.32 (4.53 to 12)
Ser. W - month 6 (N=24,24,25,24,22,69)	6.45 (3.03 to 14)	9.27 (4.4 to 20)	9.6 (4.6 to 20)	6.36 (3.02 to 13)	0.45 (0.21 to 0.98)	5.17 (3.25 to 8.24)
Ser. W - month 7 (N=23,24,21,25,21,72)	24 (11 to 54)	35 (16 to 76)	41 (18 to 94)	26 (12 to 55)	4.78 (2.08 to 11)	5.47 (3.4 to 8.8)
Ser. W - month 12(N=24,22,19,24,23,69)	11 (4.99 to 24)	15 (6.76 to 34)	15 (6.38 to 37)	9.44 (4.32 to 21)	0.75 (0.34 to 1.67)	3.62 (2.21 to 5.94)
Ser. Y - month 1 (N=25,24,23,25,23,73)	15 (8.32 to 28)	9.78 (5.33 to 18)	13 (6.88 to 24)	15 (8.2 to 27)	1.02 (0.55 to 1.9)	16 (11 to 23)
Ser. Y - month 3 (N=25,24,25,25,23,73)	43 (26 to 71)	35 (21 to 58)	43 (26 to 72)	34 (21 to 56)	1.13 (0.67 to 1.9)	12 (8.54 to 16)
Ser. Y - month 6 (N=24,24,24,25,23,72)	36 (18 to 70)	43 (22 to 84)	30 (15 to 59)	25 (13 to 48)	0.39 (0.2 to 0.78)	14 (9.04 to 21)
Ser. Y - month 7 (N=25,24,24,25,22,72)	123 (63 to 242)	115 (58 to 227)	129 (65 to 257)	81 (42 to 159)	0.55 (0.27 to 1.14)	12 (7.76 to 18)
Ser. Y - month 12 (N=25,23,21,25,23,70)	56 (28 to 114)	67 (32 to 139)	43 (20 to 93)	41 (20 to 83)	0.33 (0.16 to 0.69)	7.27 (4.68 to 11)

No statistical analyses for this end point

Secondary: GMT against N Meningitidis Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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End point title

GMT against N Meningitidis Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo ^[17]

End point description

Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains at baseline (month 0), after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.

End point type

Secondary

End point timeframe

At month 0, 1, 3, 6, 7 and 12

Notes
[17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analyses for this end point.

End point values	3ABCWY	3ABx2CWY	3ABCWY+OMV	3ABCWYqOMV	Men 3B	1ACWY
Number of subjects analysed	25	24	25	25	23	73
Units: Titers
geometric mean (confidence interval 95%)
H44/76 (fHbp) - month 0 (N=25,24,25,25,23,73)	1.32 (0.93 to 1.87)	1.36 (0.96 to 1.93)	1.43 (1.01 to 2.02)	1.2 (0.85 to 1.7)	1.37 (0.96 to 1.96)	1.31 (1.05 to 1.65)
H44/76 (fHbp) - month 1 (N=25,24,24,24,23,73)	4.84 (2.52 to 9.3)	14 (7 to 26)	22 (11 to 42)	11 (5.83 to 22)	5.03 (2.55 to 9.9)	1.51 (1.19 to 1.92)
H44/76 (fHbp) - month 3 (N=25,24,24,25,23,72)	62 (40 to 97)	115 (73 to 180)	153 (97 to 241)	110 (71 to 171)	71 (45 to 112)	1.27 (1.07 to 1.5)
H44/76 (fHbp) - month 6 (N=25,24,25,24,23,72)	5.75 (3.15 to 11)	6.56 (3.56 to 12)	11 (5.95 to 20)	5.41 (2.93 to 9.98)	6.1 (3.27 to 11)	1.18 (1.01 to 1.37)
H44/76 (fHbp) - month 7 (N=25,24,24,25,22,73)	108 (61 to 190)	149 (84 to 264)	169 (95 to 302)	118 (67 to 208)	104 (57 to 191)	1.21 (1.04 to 1.4)
H44/76 (fHbp) - month 12 (N=25,23,21,25,23,71)	5.42 (3.22 to 9.11)	9.63 (5.64 to 16)	22 (12 to 38)	8.09 (4.84 to 14)	9.02 (5.26 to 15)	1.13 (1 to 1.29)
5/99 (NadA) - month 0 (N=25,24,25,25,23,73)	2.48 (1.61 to 3.82)	2.16 (1.4 to 3.34)	2 (1.3 to 3.07)	2.17 (1.42 to 3.33)	1.92 (1.23 to 3)	2.25 (1.77 to 2.85)
5/99 (NadA) - month 1 (N=25,24,24,25,23,72)	54 (31 to 93)	128 (74 to 222)	29 (17 to 51)	42 (24 to 71)	157 (90 to 276)	2.27 (1.82 to 2.85)
5/99 (NadA) - month 3 (N=24,24,25,24,23,71)	328 (237 to 455)	426 (308 to 589)	367 (267 to 506)	382 (277 to 528)	454 (326 to 632)	2.11 (1.65 to 2.7)
5/99 (NadA) - month 6 (N=25,24,24,25,23,72)	75 (50 to 112)	122 (81 to 183)	48 (32 to 72)	84 (56 to 125)	156 (103 to 237)	1.74 (1.36 to 2.22)
5/99 (NadA) - month 7 (N=25,24,24,25,23,73)	530 (361 to 779)	741 (502 to 1092)	674 (456 to 996)	527 (360 to 771)	856 (575 to 1274)	1.93 (1.5 to 2.48)
5/99 (NadA) - month 12 (N=25,23,21,25,23,72)	140 (89 to 220)	202 (127 to 322)	126 (77 to 206)	127 (81 to 199)	274 (172 to 439)	1.53 (1.25 to 1.88)
NZ98/254 (PorA) - month 0 (N=25,24,25,25,23,73)	1.78 (1.32 to 2.4)	1.69 (1.25 to 2.29)	1.77 (1.32 to 2.39)	1.78 (1.33 to 2.4)	1.66 (1.22 to 2.27)	1.5 (1.3 to 1.73)
NZ98/254 (PorA) - month 1 (N=25,24,24,25,23,72)	2.13 (1.41 to 3.21)	2.22 (1.46 to 3.36)	6.22 (4.09 to 9.45)	2.92 (1.95 to 4.39)	1.76 (1.15 to 2.7)	1.51 (1.32 to 1.74)
NZ98/254 (PorA) - month 3 (N=25,24,25,24,23,72)	2.87 (1.87 to 4.4)	3.14 (2.04 to 4.83)	18 (12 to 27)	8.95 (5.82 to 14)	2.75 (1.77 to 4.28)	1.49 (1.29 to 1.72)
NZ98/254 (PorA) - month 6 (N=25,24,24,25,23,72)	1.9 (1.29 to 2.81)	1.85 (1.25 to 2.74)	3.33 (2.24 to 4.96)	1.83 (1.24 to 2.69)	1.83 (1.22 to 2.73)	1.15 (1.05 to 1.25)
NZ98/254 (PorA) - month 7 (N=25,24,24,25,23,73)	2.3 (1.49 to 3.54)	3.24 (2.09 to 5.02)	23 (15 to 35)	12 (7.5 to 18)	2.65 (1.69 to 4.14)	1.2 (1.07 to 1.33)
NZ98/254 (PorA) - month 12 (N=25,23,21,25,23,72)	1.41 (0.98 to 2.02)	1.94 (1.34 to 2.81)	5.01 (3.4 to 7.39)	2.39 (1.68 to 3.42)	1.79 (1.23 to 2.59)	1.15 (1.05 to 1.25)
M14459 (fHBP) - month 0 (N=25,24,25,22,23,72)	1.57 (1.19 to 2.09)	1.64 (1.23 to 2.18)	1.45 (1.09 to 1.93)	1.32 (0.98 to 1.78)	1.41 (1.05 to 1.9)	1.33 (1.08 to 1.62)
M14459 (fHBP) - month 1 (N=25,24,24,25,23,72)	1.87 (1.2 to 2.91)	2.78 (1.78 to 4.36)	4.4 (2.8 to 6.91)	2.69 (1.69 to 4.29)	2.08 (1.32 to 3.3)	1.26 (1.08 to 1.47)
M14459 (fHBP) - month 3 (N=25,24,25,24,23,70)	5.94 (3.47 to 10)	15 (8.59 to 25)	22 (13 to 38)	11 (6.03 to 19)	9.66 (5.55 to 17)	1.29 (1.1 to 1.51)
M14459 (fHBP) - month 6 (N=25,24,25,25,23,71)	2.25 (1.54 to 3.3)	2.64 (1.8 to 3.89)	4 (2.73 to 5.86)	2.11 (1.42 to 3.15)	2.27 (1.53 to 3.37)	1.28 (1.11 to 1.49)
M14459 (fHBP) - month 7 (N=25,24,23,25,22,73)	14 (9.12 to 22)	23 (14 to 36)	41 (26 to 65)	17 (11 to 27)	11 (6.77 to 17)	1.28 (1.1 to 1.49)
M14459 (fHBP) - month 12 (N=25,23,21,25,23,72)	1.79 (1.25 to 2.57)	2.663 (1.81 to 3.81)	5.99 (4.06 to 8.85)	2.35 (1.61 to 3.43)	2.8 (1.93 to 4.07)	1.37 (1.15 to 1.64)
M07-0241084(NHBA) - month 0 (N=24,23,23,21,23,67)	2.79 (1.64 to 4.76)	3.33 (1.94 to 5.72)	3.24 (1.88 to 5.58)	3.46 (1.95 to 6.12)	2.42 (1.41 to 4.16)	2.67 (1.88 to 3.79)
M07-0241084(NHBA) - month 1 (N=25,24,23,23,23,72)	3.42 (2.33 to 5.02)	3.23 (2.19 to 4.75)	6.8 (4.57 to 10)	5.73 (3.76 to 8.71)	4.07 (2.76 to 6.01)	2.68 (1.93 to 3.7)
M07-0241084 (NHBA) - month 3 (N=25,24,22,21,22,68)	4.04 (2.75 to 5.93)	5.1 (3.46 to 7.53)	12 (8.04 to 19)	8.09 (5.18 to 13)	6.48 (4.35 to 9.66)	2.85 (2.08 to 3.91)
M07-0241084 (NHBA) - month 6 (N=25,23,23,25,23,70)	3.27 (2.26 to 4.73)	3.21 (2.19 to 4.69)	5.91 (3.99 to 8.74)	4.57 (3.08 to 6.78)	3.67 (2.52 to 5.34)	2.99 (2.16 to 4.14)
M07-0241084 (NHBA) - month 7 (N=25,23,22,25,21,72)	12 (7.85 to 19)	8.91 (5.64 to 14)	33 (20 to 53)	22 (14 to 35)	11 (6.65 to 17)	3.03 (2.22 to 4.15)
M07-0241084(NHBA) - month 12 (N=25,23,21,25,23,70)	2.77 (1.85 to 4.13)	3.05 (2.01 to 4.61)	9.99 (6.39 to 16)	4.92 (3.2 to 7.56)	5.74 (3.82 to 8.64)	2.91 (2.06 to 4.12)
M01-0240364 (NadA) - month 0 (N=25,24,24,22,23,72)	1.37 (0.99 to 1.91)	1.32 (0.95 to 1.84)	1.18 (0.84 to 1.65)	1.11 (0.79 to 1.57)	1.11 (0.79 to 1.56)	1.12 (1.01 to 1.24)
M01-0240364 (NadA) - month 1 (N=23,24,24,25,23,72)	2.94 (1.32 to 6.58)	10 (4.75 to 22)	6 (2.71 to 13)	5.52 (2.46 to 12)	3.84 (1.74 to 8.52)	1.12 (0.98 to 1.29)
M01-0240364 (NadA) - month 3 (N=25,24,24,24,23,70)	41 (19 to 88)	245 (113 to 532)	126 (57 to 280)	205 (91 to 459)	226 (102 to 501)	1.41 (1.07 to 1.85)
M01-0240364 (NadA) - month 6 (N=25,21,24,24,21,71)	4.39 (2.09 to 9.19)	9.54 (4.3 to 21)	7.3 (3.44 to 15)	9.08 (4.1 to 20)	7.87 (3.54 to 18)	1.18 (1 to 1.39)
M01-0240364 (NadA) - month 7 (N=24,23,24,25,23,71)	294 (147 to 589)	513 (255 to 1035)	409 (202 to 829)	280 (137 to 572)	507 (251 to 1027)	1.18 (1 to 1.39)
M01-0240364(NadA) - month 12 (N=23,21,20,25,22,72)	7.32 (3.4 to 16)	24 (11 to 54)	17 (7.37 to 38)	19 (8.71 to 41)	41 (19 to 88)	1.15 (0.97 to 1.37)

No statistical analyses for this end point

Secondary: GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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End point title

GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo ^[18]

End point description

Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.

End point type

Secondary

End point timeframe

At month 6 and month 7

Notes
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analyses for this end point.

End point values	3ABCWY	3ABx2CWY	3ABCWY+OMV	3ABCWYqOMV	Men 3B	1ACWY
Number of subjects analysed	25	24	25	25	23	73
Units: Ratio
geometric mean (confidence interval 95%)
H44/76 (fHbp) - month 1 (N=25,24,24,24,23,73)	3.79 (1.97 to 7.29)	11 (5.45 to 20)	17 (8.59 to 33)	8.95 (4.62 to 17)	3.92 (1.99 to 7.72)	1.15 (0.98 to 1.35)
H44/76 (fHbp) - month 3 (N=25,24,24,25,23,72)	48 (29 to 78)	86 (52 to 143)	111 (67 to 185)	90 (55 to 147)	53 (32 to 89)	1.05 (0.89 to 1.24)
H44/76 (fHbp) - month 6 (N=25,24,25,24,23,72)	4.47 (2.43 to 8.23)	5.06 (2.73 to 9.37)	8.28 (4.5 to 15)	4.31 (2.32 to 8.01)	4.7 (2.5 to 8.85)	0.89 (0.78 to 1.02)
H44/76 (fHbp) - month 7 (N=25,24,24,25,22,73)	83 (46 to 150)	113 (63 to 206)	126 (69 to 229)	95 (53 to 170)	79 (42 to 147)	0.92 (0.79 to 1.06)
H44/76 (fHbp) - month 12 (N=25,23,21,25,23,71)	4.22 (2.49 to 7.14)	7.44 (4.33 to 13)	16 (9.28 to 29)	6.45 (3.83 to 11)	6.97 (4.04 to 12)	0.86 (0.73 to 1.01)
5/99 (NadA) - month 1 (N=25,24,24,25,23,72)	23 (12 to 42)	60 (32 to 110)	14 (7.59 to 26)	19 (11 to 35)	79 (42 to 148)	1 (0.85 to 1.18)
5/99 (NadA) - month 3 (N=24,24,25,24,23,71)	131 (79 to 216)	197 (120 to 324)	182 (112 to 298)	182 (111 to 299)	233 (140 to 387)	1 (0.8 to 1.26)
5/99 (NadA) - month 6 (N=25,24,24,25,23,72)	31 (19 to 53)	56 (34 to 95)	24 (14 to 41)	39 (23 to 64)	79 (46 to 134)	0.78 (0.61 to 0.99)
5/99 (NadA) - month 7 (N=25,24,24,25,23,73)	221 (133 to 368)	344 (206 to 574)	325 (194 to 545)	244 (147 to 403)	435 (257 to 736)	0.86 (0.68 to 1.08)
5/99 (NadA) - month 12 (N=25,23,21,25,23,72)	58 (34 to 101)	95 (54 to 167)	62 (34 to 111)	58 (34 to 100)	138 (78 to 243)	0.7 (0.59 to 0.83)
NZ98/254 (PorA) - month 1 (N=25,24,24,25,23,72)	1.25 (0.82 to 1.9)	1.32 (0.86 to 2.02)	3.63 (2.37 to 5.57)	1.71 (1.13 to 2.6)	1.06 (0.68 to 1.63)	1 (0.87 to 1.16)
NZ98/254 (PorA) - month 3 (N=25,24,25,24,23,72)	1.67 (1.07 to 2.6)	1.86 (1.19 to 2.91)	10 (6.67 to 16)	5.16 (3.31 to 8.06)	1.64 (1.04 to 2.6)	0.99 (0.83 to 1.17)
NZ98/254 (PorA) - month 6 (N=25,24,24,25,23,72)	1.11 (0.73 to 1.67)	1.1 (0.73 to 1.67)	1.93 (1.27 to 2.92)	1.06 (0.71 to 1.59)	1.09 (0.71 to 1.67)	0.76 (0.65 to 0.89)
NZ98/254 (PorA) - month 7 (N=25,24,24,25,23,73)	1.33 (0.84 to 2.1)	1.93 (1.21 to 3.07)	13 (8.14 to 21)	6.66 (4.23 to 10)	1.59 (0.99 to 2.55)	0.8 (0.67 to 0.94)
NZ98/254 (PorA) - month 12 (N=25,23,21,25,23,72)	0.81 (0.55 to 1.19)	1.13 (0.76 to 1.69)	2.81 (1.85 to 4.27)	1.37 (0.94 to 2.02)	1.06 (0.71 to 1.58)	0.77 (0.66 to 0.9)
M14459 (fHBP) - month 1 (N=25,24,24,22,23,71)	1.46 (0.94 to 2.27)	2.18 (1.39 to 3.4)	3.46 (2.2 to 5.42)	2.12 (1.33 to 3.38)	1.64 (1.04 to 2.59)	0.95 (0.87 to 1.03)
M14459 (fHBP) - month 3 (N=25,24,25,22,23,69)	4.41 (2.57 to 7.57)	11 (6.28 to 19)	17 (9.77 to 29)	8.26 (4.68 to 15)	7.4 (4.22 to 13)	1.04 (0.9 to 1.2)
M14459 (fHBP) - month 6 (N=25,24,25,22,23,70)	1.73 (1.18 to 2.53)	2.02 (1.37 to 2.96)	3.1 (2.12 to 4.54)	1.66 (1.11 to 2.48)	1.77 (1.19 to 2.63)	0.99 (0.87 to 1.12)
M14459 (fHBP) - month 7 (N=25,24,23,22,22,72)	10 (6.66 to 16)	16 (10 to 26)	31 (19 to 49)	13 (8.26 to 21)	8.18 (5.06 to 13)	0.97 (0.83 to 1.13)
M14459 (fHBP) - month 12 (N=25,23,21,22,23,71)	1.35 (0.94 to 1.94)	1.97 (1.35 to 2.86)	4.57 (3.09 to 6.77)	1.83 (1.25 to 2.68)	2.16 (1.48 to 3.14)	1.03 (0.87 to 1.24)
M07-0241084 (NHBA) - month 1 (N=24,23,22,20,23,66)	1.28 (0.87 to 1.89)	1.19 (0.8 to 1.75)	2.5 (1.67 to 3.74)	2.1 (1.38 to 3.21)	1.55 (1.05 to 2.29)	1.02 (0.87 to 1.19)
M07-0241084 (NHBA) - month 3 (N=24,23,20,18,22,65)	1.52 (1 to 2.3)	1.82 (1.2 to 2.77)	4.54 (2.89 to 7.11)	2.81 (1.74 to 4.54)	2.56 (1.67 to 3.93)	1.13 (0.89 to 1.44)
M07-0241084 (NHBA) - month 6 (N=24,22,21,21,23,65)	1.22 (0.83 to 1.8)	1.14 (0.76 to 1.7)	2.14 (1.42 to 3.23)	1.62 (1.07 to 2.46)	1.42 (0.95 to 2.1)	1.2 (0.97 to 1.49)
M07-0241084 (NHBA) - month 7 (N=24,22,20,21,21,66)	4.55 (2.84 to 7.29)	3.1 (1.9 to 5.05)	12 (6.98 to 20)	7.7 (4.65 to 13)	4.15 (2.49 to 6.9)	1.21 (0.96 to 1.51)
M07-0241084 (NHBA) - month 12(N=24,22,19,21,23,64)	1.03 (0.67 to 1.59)	1.07 (0.68 to 1.66)	3.56 (2.21 to 5.75)	1.73 (1.09 to 2.74)	2.24 (1.44 to 3.46)	1.19 (0.9 to 1.58)
M01-0240364 (NadA) - month 1 (N=23,24,23,22,23,71)	2.33 (1.04 to 5.2)	8.23 (3.79 to 18)	4.84 (2.19 to 11)	4.48 (2 to 10)	3.12 (1.41 to 6.91)	1 (0.86 to 1.16)
M01-0240364 (NadA) - month 3 (N=25,24,23,22,23,69)	31 (14 to 68)	190 (85 to 424)	105 (46 to 239)	177 (77 to 408)	196 (86 to 446)	1.28 (1.01 to 1.63)
M01-0240364 (NadA) - month 6 (N=25,21,24,21,21,70)	3.41 (1.62 to 7.2)	7.46 (3.33 to 17)	5.97 (2.79 to 13)	7.56 (3.39 to 17)	6.57 (2.93 to 15)	1.05 (0.9 to 1.23)
M01-0240364 (NadA) - month 7 (N=24,23,23,22,23,70)	226 (111 to 459)	401 (196 to 820)	336 (164 to 690)	236 (114 to 488)	428 (209 to 879)	1.07 (0.92 to 1.25)
M01-0240364 (NadA) - month 12(N=23,21,20,22,22,71)	5.61 (2.58 to 12)	19 (8.45 to 42)	14 (6.13 to 32)	16 (7.28 to 35)	34 (16 to 76)	1.03 (0.87 to 1.22)

No statistical analyses for this end point

Secondary: Number of Subjects Reporting Unsolicited Adverse Events After Vaccination

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End point title

Number of Subjects Reporting Unsolicited Adverse Events After Vaccination

End point description

Unsolicited AEs were collected with onset from Day 1 through Day 7 After Vaccination.

End point type

Secondary

End point timeframe

From Day 1 to Day 7 after vaccination

End point values	3ABCWY	2ABCWY	3ABx2CWY	2ABx2CWY	3ABCWY+OMV	2ABCWY+OMV	3ABCWYqOMV	2ABCWYqOMV	Men 3B	Men 2B	1ACWY
Number of subjects analysed	24	49	24	49	25	48	24	49	23	50	73
Units: Number of Subjects
number (not applicable)
Any AEs	3	6	1	4	2	3	3	2	2	6	6
At least possibly related AEs	1	4	0	2	1	1	3	0	1	3	3
SAEs	0	0	0	0	0	0	1	0	0	0	0
At least possibly related SAEs	0	0	0	0	0	0	1	0	0	0	0

No statistical analyses for this end point

Secondary: Numbers of Subjects With Other Unsolicited AEs

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End point title

Numbers of Subjects With Other Unsolicited AEs

End point description

Unsolicited AEs were collected from Day 8 After vaccination Through Study Termination.

End point type

Secondary

End point timeframe

Day 8 After vaccination Through Study Termination

End point values	3ABCWY	2ABCWY	3ABx2CWY	2ABx2CWY	3ABCWY+OMV	2ABCWY+OMV	3ABCWYqOMV	2ABCWYqOMV	Men 3B	Men 2B	1ACWY
Number of subjects analysed	24	48	24	49	25	48	24	49	23	50	73
Units: Number of Subjects
number (not applicable)
Medically attended AEs	5	7	4	10	6	7	2	5	4	14	15
AEs leading to Withdrawal	0	0	0	0	0	0	0	0	0	0	0
At least possibly related AEs	0	0	0	0	0	0	0	0	0	0	1
SAEs	0	0	1	1	0	0	0	1	0	1	0
At least possibly related SAEs	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination

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End point title

Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination

End point description

Solicited local and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination.

End point type

Secondary

End point timeframe

From Day 1 to Day 7 after vaccination.

End point values	3ABCWY	2ABCWY	3ABx2CWY	2ABx2CWY	3ABCWY+OMV	2ABCWY+OMV	3ABCWYqOMV	2ABCWYqOMV	Men 3B	Men 2B	1ACWY
Number of subjects analysed	24	48	24	49	25	48	24	49	23	50	73
Units: Number of Subjects
number (not applicable)
Any Solicited Local AEs	18	33	18	35	23	36	20	30	17	38	53
Injection site erythema	5	13	7	12	12	11	13	3	9	13	19
Injection site induration	7	14	11	12	10	17	11	6	7	14	18
Injection site pain	18	33	15	35	23	35	19	30	17	36	52
Injection site Swelling	5	11	9	10	10	14	13	5	7	14	14
Any Solicited Systemic AEs	10	33	14	25	20	23	18	24	14	34	43
Chills	3	10	4	2	7	7	4	5	5	5	8
Malaise	6	12	7	14	8	9	7	8	5	13	13
Myalgia	6	23	9	20	6	18	14	19	9	21	32
Arthralgia	2	6	5	7	6	5	8	3	2	8	9
Headache	5	20	6	17	9	11	10	15	6	18	27
Fatigue	3	9	3	9	5	11	4	7	3	10	9
Nausea	4	6	2	3	4	6	6	3	2	4	6
Rash	1	2	2	1	0	1	1	0	1	1	2
Fever (≥38°C)	3	5	0	3	3	0	3	1	2	2	4
Any other indicators of reactogenicity	4	8	3	5	6	3	7	4	3	5	11
Stay home	0	5	0	2	1	0	3	1	0	0	3

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Safety was assessed up to 6 months after vaccination.

Adverse event reporting additional description

The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

15.0

Reporting group title

1ACWY

Reporting group description

One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study

Reporting group title

Men 3B

Reporting group description

Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study

Reporting group title

Men 2B

Reporting group description

Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study.

Reporting group title

3ABCWYqOMV

Reporting group description

Two doses of MenABCWY +1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study.

Reporting group title

2ABCWY+OMV

Reporting group description

Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study.

Reporting group title

2ABCWYqOMV

Reporting group description

Two doses of MenABCWY+ 1/4OMV vaccine in the primary study and one dose of Tdap in the current study.

Reporting group title

3ABx2CWY

Reporting group description

Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study.

Reporting group title

3ABCWY+OMV

Reporting group description

Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study.

Reporting group title

2ABx2CWY

Reporting group description

Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study

Reporting group title

3ABCWY

Reporting group description

Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study.

Reporting group title

2ABCWY

Reporting group description

Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study.

Serious adverse events	1ACWY	Men 3B	Men 2B	3ABCWYqOMV	2ABCWY+OMV	2ABCWYqOMV	3ABx2CWY	3ABCWY+OMV	2ABx2CWY	3ABCWY	2ABCWY
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 73 (0.00%)	0 / 23 (0.00%)	1 / 50 (2.00%)	1 / 24 (4.17%)	0 / 48 (0.00%)	1 / 50 (2.00%)	1 / 24 (4.17%)	0 / 25 (0.00%)	1 / 49 (2.04%)	0 / 24 (0.00%)	0 / 49 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Burns Second Degree
subjects affected / exposed	0 / 73 (0.00%)	0 / 23 (0.00%)	1 / 50 (2.00%)	0 / 24 (0.00%)	0 / 48 (0.00%)	0 / 50 (0.00%)	0 / 24 (0.00%)	0 / 25 (0.00%)	0 / 49 (0.00%)	0 / 24 (0.00%)	0 / 49 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vaccination Complication
subjects affected / exposed	0 / 73 (0.00%)	0 / 23 (0.00%)	0 / 50 (0.00%)	1 / 24 (4.17%)	0 / 48 (0.00%)	0 / 50 (0.00%)	0 / 24 (0.00%)	0 / 25 (0.00%)	0 / 49 (0.00%)	0 / 24 (0.00%)	0 / 49 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendiceal Abscess
subjects affected / exposed	0 / 73 (0.00%)	0 / 23 (0.00%)	0 / 50 (0.00%)	0 / 24 (0.00%)	0 / 48 (0.00%)	0 / 50 (0.00%)	1 / 24 (4.17%)	0 / 25 (0.00%)	0 / 49 (0.00%)	0 / 24 (0.00%)	0 / 49 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 73 (0.00%)	0 / 23 (0.00%)	0 / 50 (0.00%)	0 / 24 (0.00%)	0 / 48 (0.00%)	1 / 50 (2.00%)	0 / 24 (0.00%)	0 / 25 (0.00%)	0 / 49 (0.00%)	0 / 24 (0.00%)	0 / 49 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonsillar Abscess
subjects affected / exposed	0 / 73 (0.00%)	0 / 23 (0.00%)	0 / 50 (0.00%)	0 / 24 (0.00%)	0 / 48 (0.00%)	0 / 50 (0.00%)	0 / 24 (0.00%)	0 / 25 (0.00%)	1 / 49 (2.04%)	0 / 24 (0.00%)	0 / 49 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	1ACWY	Men 3B	Men 2B	3ABCWYqOMV	2ABCWY+OMV	2ABCWYqOMV	3ABx2CWY	3ABCWY+OMV	2ABx2CWY	3ABCWY	2ABCWY
Total subjects affected by non serious adverse events
subjects affected / exposed	56 / 73 (76.71%)	19 / 23 (82.61%)	40 / 50 (80.00%)	22 / 24 (91.67%)	37 / 48 (77.08%)	38 / 50 (76.00%)	20 / 24 (83.33%)	23 / 25 (92.00%)	36 / 49 (73.47%)	20 / 24 (83.33%)	38 / 49 (77.55%)
Nervous system disorders
Headache
subjects affected / exposed	27 / 73 (36.99%)	7 / 23 (30.43%)	18 / 50 (36.00%)	10 / 24 (41.67%)	11 / 48 (22.92%)	15 / 50 (30.00%)	6 / 24 (25.00%)	9 / 25 (36.00%)	17 / 49 (34.69%)	5 / 24 (20.83%)	20 / 49 (40.82%)
occurrences all number	35	8	23	14	13	15	6	11	21	7	25
General disorders and administration site conditions
Chills
subjects affected / exposed	8 / 73 (10.96%)	5 / 23 (21.74%)	5 / 50 (10.00%)	4 / 24 (16.67%)	8 / 48 (16.67%)	5 / 50 (10.00%)	4 / 24 (16.67%)	7 / 25 (28.00%)	2 / 49 (4.08%)	3 / 24 (12.50%)	10 / 49 (20.41%)
occurrences all number	8	5	5	5	8	7	4	7	3	4	11
Fatigue
subjects affected / exposed	9 / 73 (12.33%)	3 / 23 (13.04%)	10 / 50 (20.00%)	4 / 24 (16.67%)	11 / 48 (22.92%)	7 / 50 (14.00%)	3 / 24 (12.50%)	5 / 25 (20.00%)	9 / 49 (18.37%)	3 / 24 (12.50%)	9 / 49 (18.37%)
occurrences all number	12	3	11	4	13	9	3	6	9	3	10
Injection Site Erythema
subjects affected / exposed	20 / 73 (27.40%)	10 / 23 (43.48%)	14 / 50 (28.00%)	16 / 24 (66.67%)	12 / 48 (25.00%)	5 / 50 (10.00%)	7 / 24 (29.17%)	13 / 25 (52.00%)	14 / 49 (28.57%)	5 / 24 (20.83%)	16 / 49 (32.65%)
occurrences all number	21	10	14	17	12	5	7	14	15	6	16
Injection Site Pain
subjects affected / exposed	52 / 73 (71.23%)	17 / 23 (73.91%)	36 / 50 (72.00%)	19 / 24 (79.17%)	35 / 48 (72.92%)	31 / 50 (62.00%)	15 / 24 (62.50%)	23 / 25 (92.00%)	35 / 49 (71.43%)	18 / 24 (75.00%)	33 / 49 (67.35%)
occurrences all number	56	19	38	20	39	32	15	24	38	19	36
Injection Site Swelling
subjects affected / exposed	16 / 73 (21.92%)	8 / 23 (34.78%)	14 / 50 (28.00%)	14 / 24 (58.33%)	14 / 48 (29.17%)	6 / 50 (12.00%)	9 / 24 (37.50%)	11 / 25 (44.00%)	11 / 49 (22.45%)	5 / 24 (20.83%)	11 / 49 (22.45%)
occurrences all number	17	8	14	15	16	6	9	12	13	6	11
Malaise
subjects affected / exposed	13 / 73 (17.81%)	5 / 23 (21.74%)	13 / 50 (26.00%)	8 / 24 (33.33%)	9 / 48 (18.75%)	8 / 50 (16.00%)	7 / 24 (29.17%)	8 / 25 (32.00%)	14 / 49 (28.57%)	6 / 24 (25.00%)	12 / 49 (24.49%)
occurrences all number	15	5	13	9	11	9	7	8	15	6	14
Pyrexia
subjects affected / exposed	4 / 73 (5.48%)	2 / 23 (8.70%)	3 / 50 (6.00%)	5 / 24 (20.83%)	0 / 48 (0.00%)	1 / 50 (2.00%)	0 / 24 (0.00%)	3 / 25 (12.00%)	3 / 49 (6.12%)	3 / 24 (12.50%)	6 / 49 (12.24%)
occurrences all number	4	2	5	5	0	1	0	3	3	3	8
Injection Site Induration
subjects affected / exposed	19 / 73 (26.03%)	8 / 23 (34.78%)	15 / 50 (30.00%)	13 / 24 (54.17%)	17 / 48 (35.42%)	8 / 50 (16.00%)	11 / 24 (45.83%)	12 / 25 (48.00%)	13 / 49 (26.53%)	7 / 24 (29.17%)	16 / 49 (32.65%)
occurrences all number	22	8	15	14	18	8	12	13	14	7	16
Gastrointestinal disorders
Nausea
subjects affected / exposed	6 / 73 (8.22%)	2 / 23 (8.70%)	4 / 50 (8.00%)	6 / 24 (25.00%)	7 / 48 (14.58%)	3 / 50 (6.00%)	2 / 24 (8.33%)	4 / 25 (16.00%)	3 / 49 (6.12%)	4 / 24 (16.67%)	6 / 49 (12.24%)
occurrences all number	6	3	4	8	7	4	2	4	3	4	7
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	2 / 73 (2.74%)	1 / 23 (4.35%)	1 / 50 (2.00%)	1 / 24 (4.17%)	1 / 48 (2.08%)	0 / 50 (0.00%)	2 / 24 (8.33%)	0 / 25 (0.00%)	1 / 49 (2.04%)	1 / 24 (4.17%)	2 / 49 (4.08%)
occurrences all number	2	1	2	1	1	0	2	0	1	1	2
Musculoskeletal and connective tissue disorders
Athralgia
subjects affected / exposed	9 / 73 (12.33%)	2 / 23 (8.70%)	8 / 50 (16.00%)	8 / 24 (33.33%)	5 / 48 (10.42%)	3 / 50 (6.00%)	5 / 24 (20.83%)	6 / 25 (24.00%)	7 / 49 (14.29%)	2 / 24 (8.33%)	6 / 49 (12.24%)
occurrences all number	11	2	8	8	5	3	5	6	8	2	6
Myalgia
subjects affected / exposed	32 / 73 (43.84%)	9 / 23 (39.13%)	21 / 50 (42.00%)	14 / 24 (58.33%)	18 / 48 (37.50%)	19 / 50 (38.00%)	9 / 24 (37.50%)	15 / 25 (60.00%)	20 / 49 (40.82%)	6 / 24 (25.00%)	23 / 49 (46.94%)
occurrences all number	37	9	23	14	18	20	9	18	22	7	27
Infections and infestations
Nasopharyngitis
subjects affected / exposed	4 / 73 (5.48%)	1 / 23 (4.35%)	3 / 50 (6.00%)	1 / 24 (4.17%)	1 / 48 (2.08%)	2 / 50 (4.00%)	0 / 24 (0.00%)	1 / 25 (4.00%)	4 / 49 (8.16%)	2 / 24 (8.33%)	2 / 49 (4.08%)
occurrences all number	4	1	3	1	1	2	0	1	4	2	2

More information

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Were there any global substantial amendments to the protocol? Yes

31 Aug 2011

After study completion, once the database is locked and the study is unblinded, subjects randomized in study Group V will be offered the Menveo vaccination (in countries where it is licensed), out of the scope of the trial.

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

Clinical Trial Results: Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study Vaccines

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Primary: Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Primary: Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Primary: Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Secondary: GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMT against N Meningitidis Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMT against N Meningitidis Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Secondary: Number of Subjects Reporting Unsolicited Adverse Events After Vaccination

Secondary: Number of Subjects Reporting Unsolicited Adverse Events After Vaccination

Secondary: Numbers of Subjects With Other Unsolicited AEs

Secondary: Numbers of Subjects With Other Unsolicited AEs

Secondary: Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination

Secondary: Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study Vaccines