Clinical Trial Results:
A Phase 2b/3, Multi-Center, Extension Study of V72P10 to Assess Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10.

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

Summary
EudraCT number	2014-004992-21
Trial protocol	Outside EU/EEA
Global end of trial date	17 Jan 2012

Results information
Results version number	v2(current)
This version publication date	01 Jun 2016
First version publication date	19 Mar 2015
Other versions	v1 (removed from public view)
Version creation reason	Correction of full data set re-QC study because of EudraCT system glitch and minor updates to results are required.

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

V72P10E1

ISRCTN number

US NCT number

NCT01148524

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Vaccines and Diagnostics

Sponsor organisation address

Via Fiorentina 1, Siena, Italy, 53100

Public contact

Posting director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com

Scientific contact

Posting director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com

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

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

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

Analysis stage

Final

Date of interim/final analysis

18 Oct 2012

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

17 Jan 2012

Was the trial ended prematurely?

Main objective of the trial

To explore antibody persistence at eighteen months after the completion of the vaccination course in subjects enrolled in the V72P10 study.

Protection of trial subjects

This trial was performed with the ethical principles that have their origin in the latest version of the Declaration of Helsinki accepted by the local authorities and that are consistent with Good Clinical Practices (GCPs) and the applicable regulatory requirement(s) for the country in which the trial is conducted, GCPs according to International Conference on Harmonization (ICH) guidelines, the applicable regulatory requirements(s) for the country in which the study is conducted, and applicable standard operating procedures (SOPs).

Background therapy

Evidence for comparator

Actual start date of recruitment

05 Aug 2010

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy

Long term follow-up duration

24 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Chile: 817

Worldwide total number of subjects

817

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)

611

Adults (18-64 years)

206

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Subjects were enrolled at 6 study centers in Chile.

Screening details

All enrolled subjects were included in the trial.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

rMenB0

Arm description

Subjects received 1 dose of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB+OMV-NZ) at 0 month and 3 doses of placebo at 1, 2 and 6 months in V72P10.

Arm type

Experimental

Investigational medicinal product name

rMenB+OMV NZ

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single of dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

rMenB06

Arm description

Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months in V72P10.

Arm type

Experimental

Investigational medicinal product name

rMenB+OMV NZ

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single of dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

rMenB01

Arm description

Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months in V71P10.

Arm type

Experimental

Investigational medicinal product name

rMenB+OMV NZ

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single of dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

rMenB016

Arm description

Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months in V72P10.

Arm type

Experimental

Investigational medicinal product name

rMenB+OMV NZ

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single of dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

rMenB02

Arm description

Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months in V72P10.

Arm type

Experimental

Investigational medicinal product name

rMenB+OMV NZ

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single of dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

rMenB026

Arm description

Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month in V72P10.

Arm type

Experimental

Investigational medicinal product name

rMenB+OMV NZ

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single of dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

rMenB012

Arm description

Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months in V72P10.

Arm type

Experimental

Investigational medicinal product name

rMenB+OMV NZ

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single of dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

rMenB6

Arm description

Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months in V72P10.

Arm type

Experimental

Investigational medicinal product name

rMenB+OMV NZ

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Single of dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

Naive

Arm description

Subjects did not receive any vaccination and were of similar age to the follow-on subjects from V72P10.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 1	rMenB0	rMenB06	rMenB01	rMenB016	rMenB02	rMenB026	rMenB012	rMenB6	Naive
Started	95	49	102	53	106	57	153	51	151
Completed	95	49	102	53	106	57	153	51	151

Baseline characteristics

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Reporting group title

rMenB0

Reporting group description

Reporting group title

rMenB06

Reporting group description

Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months in V72P10.

Reporting group title

rMenB01

Reporting group description

Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months in V71P10.

Reporting group title

rMenB016

Reporting group description

Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months in V72P10.

Reporting group title

rMenB02

Reporting group description

Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months in V72P10.

Reporting group title

rMenB026

Reporting group description

Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month in V72P10.

Reporting group title

rMenB012

Reporting group description

Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months in V72P10.

Reporting group title

rMenB6

Reporting group description

Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months in V72P10.

Reporting group title

Naive

Reporting group description

Subjects did not receive any vaccination and were of similar age to the follow-on subjects from V72P10.

Reporting group values	rMenB0	rMenB06	rMenB01	rMenB016	rMenB02	rMenB026	rMenB012	rMenB6	Naive	Total
Number of subjects	95	49	102	53	106	57	153	51	151	817
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	16 ( 2 )	16.2 ( 1.9 )	16.1 ( 1.9 )	16.2 ( 2.1 )	15.9 ( 1.8 )	15.6 ( 1.9 )	15.9 ( 1.9 )	16 ( 1.9 )	15.6 ( 1.7 )	-
Gender categorical
Units: Subjects
Female	53	30	57	33	61	38	96	33	61	462
Male	42	19	45	20	45	19	57	18	90	355

Subject analysis set title

All Enrolled Set

Subject analysis set type

Full analysis

Subject analysis set description

All subjects who enrolled in this study.

Subject analysis sets values	All Enrolled Set
Number of subjects	817
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	15.9 ( 1.9 )
Gender categorical
Units: Subjects
Female	462
Male	355

End points

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Reporting group title

rMenB0

Reporting group description

Reporting group title

rMenB06

Reporting group description

Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months in V72P10.

Reporting group title

rMenB01

Reporting group description

Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months in V71P10.

Reporting group title

rMenB016

Reporting group description

Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months in V72P10.

Reporting group title

rMenB02

Reporting group description

Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months in V72P10.

Reporting group title

rMenB026

Reporting group description

Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month in V72P10.

Reporting group title

rMenB012

Reporting group description

Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months in V72P10.

Reporting group title

rMenB6

Reporting group description

Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months in V72P10.

Reporting group title

Naive

Reporting group description

Subjects did not receive any vaccination and were of similar age to the follow-on subjects from V72P10.

Subject analysis set title

All Enrolled Set

Subject analysis set type

Full analysis

Subject analysis set description

All subjects who enrolled in this study.

Primary: 1. Percentage of subjects with hSBA titer ≥1:4 at 18 months after the completion of the vaccination course in subjects enrolled in the V72P10 study and in Naive Subjects.

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End point title

1. Percentage of subjects with hSBA titer ≥1:4 at 18 months after the completion of the vaccination course in subjects enrolled in the V72P10 study and in Naive Subjects. ^[1]

End point description

Immunogenicity was evaluated by measuring the percentage of subjects with serum bactericidal activity using human complement( hSBA) titter >1:4 against 44/76_SL, 5/99, NZ98/254 strains after 18 months. The analysis was performed as per the Modified Intention To Treat (MITT) dataset.

End point type

Primary

End point timeframe

Month 0 (bl=baseline), month 1 and Month 18 after last vaccination in V72P10 study.

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: There was no statistical null hypothesis associated with this immunogenicity objective.

End point values	rMenB0	rMenB06	rMenB01	rMenB016	rMenB02	rMenB026	rMenB012	rMenB6	Naive
Number of subjects analysed	95	49	102	53	106	57	153	51	151
Units: Percentage of Subjects
number (confidence interval 95%)
Str.44/76_SL-bl (N=95,49,102,53,106,57,153,51,0)	40 (30 to 51)	31 (18 to 45)	32 (23 to 42)	40 (26 to 54)	41 (31 to 51)	32 (20 to 45)	44 (36 to 52)	47 (33 to 62)	0 (0 to 0)
Str.44/76_SL-1m (N=95,49,102,53,106,57,153,51,0)	93 (85 to 97)	100 (93 to 100)	100 (96 to 100)	100 (93 to 100)	100 (97 to 100)	100 (94 to 100)	100 (98 to 100)	94 (84 to 99)	0 (0 to 0)
Str.44/76_SL-m18	73 (63 to 81)	84 (70 to 93)	82 (74 to 89)	92 (82 to 98)	81 (72 to 88)	86 (74 to 94)	83 (76 to 89)	73 (58 to 84)	50 (42 to 59)
Str.5/99-bl (N=95,49,102,53,106,57,153,51,0)	33 (23 to 43)	22 (12 to 37)	26 (18 to 36)	28 (17 to 42)	30 (22 to 40)	21 (11 to 34)	34 (27 to 42)	33 (21 to 48)	0 (0 to 0)
Str.5/99-1m (N=95,49,102,53,106,57,153,51,0)	96 (90 to 99)	98 (89 to 100)	100 (96 to 100)	100 (93 to 100)	100 (97 to 100)	100 (94 to 100)	100 (98 to 100)	88 (76 to 96)	0 (0 to 0)
Str.5/99-m18	65 (55 to 75)	94 (83 to 99)	93 (86 to 97)	98 (90 to 100)	95 (89 to 98)	100 (94 to 100)	96 (92 to 99)	73 (58 to 84)	25 (18 to 33)
Str.NZ98/254-bl (N=95,49,102,53,106,57,153,51,0)	31 (21 to 41)	29 (17 to 43)	24 (16 to 33)	32 (20 to 46)	30 (22 to 40)	21 (11 to 34)	30 (22 to 38)	29 (17 to 44)	0 (0 to 0)
Str.NZ98/254-1m (N=95,49,102,53,106,57,153,51,0)	94 (87 to 98)	100 (93 to 100)	100 (96 to 100)	100 (93 to 100)	100 (97 to 100)	98 (91 to 100)	99 (96 to 100)	92 (81 to 98)	0 (0 to 0)
Str.NZ98/254-m18	62 (52 to 72)	86 (73 to 94)	75 (65 to 83)	98 (90 to 100)	75 (66 to 83)	96 (88 to 100)	86 (79 to 91)	61 (46 to 74)	40 (32 to 48)

No statistical analyses for this end point

Primary: 2. Geometric Mean Titers (GMTs) at eighteen months after the completion of the vaccination course in subjects enrolled in the V72P10 study and in Naive Subjects.

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End point title

2. Geometric Mean Titers (GMTs) at eighteen months after the completion of the vaccination course in subjects enrolled in the V72P10 study and in Naive Subjects. ^[2]

End point description

Immunogenicity was evaluated by measuring the GMTs after primary and booster vaccination against 44/76_SL, 5/99, NZ98/254. The analysis was performed as per the MITT set.

End point type

Primary

End point timeframe

Month 0 (bl=baseline), month 1 and Month 18 after last vaccination in V72P10 study.

Notes
[2] - 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: There was no statistical null hypothesis associated with this immunogenicity objective.

End point values	rMenB0	rMenB06	rMenB01	rMenB016	rMenB02	rMenB026	rMenB012	rMenB6	Naive
Number of subjects analysed	95	49	102	53	106	57	153	51	151
Units: Titers
geometric mean (confidence interval 95%)
S.44/76 GMT-bl (N=95,49,102,53,106,57,153,51,0)	3.75 (2.75 to 5.12)	2.83 (1.85 to 4.31)	2.74 (2.04 to 3.68)	3.56 (2.37 to 5.34)	3.24 (2.43 to 4.34)	2.76 (1.86 to 4.1)	3.86 (3.02 to 4.93)	4.33 (2.86 to 6.56)	0 (0 to 0)
S.44/76 GMT-1m (N=95,49,102,53,106,57,153,51,0)	47 (36 to 60)	227 (161 to 320)	189 (149 to 241)	316 (227 to 439)	227 (179 to 287)	265 (192 to 365)	253 (208 to 309)	62 (44 to 86)	0 (0 to 0)
S.44/76 GMT-m18	16 (11 to 23)	27 (16 to 45)	29 (20 to 42)	50 (30 to 83)	34 (24 to 49)	44 (27 to 73)	42 (31 to 56)	19 (12 to 32)	4.52 (3.52 to 5.82)
S.5/99 GMT-bl (N=95,49,102,53,106,57,153,51,0)	2.65 (2.04 to 3.44)	2.31 (1.62 to 3.3)	2.22 (1.73 to 2.85)	2.55 (1.81 to 3.6)	2.36 (1.84 to 3.01)	1.72 (1.23 to 2.39)	2.63 (2.14 to 3.23)	2.67 (1.88 to 3.79)	0 (0 to 0)
S.5/99 GMT-1m (N=95,49,102,53,106,57,153,51,0)	63 (49 to 81)	802 (574 to 1121)	445 (352 to 562)	1181 (856 to 1630)	727 (577 to 916)	1105 (808 to 1510)	605 (499 to 735)	68 (49 to 94)	0 (0 to 0)
S.5/99 GMT-m18	7.1 (5.24 to 9.6)	65 (43 to 98)	40 (30 to 54)	121 (82 to 180)	43 (33 to 58)	100 (68 to 146)	73 (57 to 92)	9.85 (6.57 to 15)	2.13 (1.73 to 2.63)
S.NZ98/254 GMT-bl (N=95,49,102,53,106,57,153,51,0)	2.65 (1.99 to 3.53)	2.66 (1.8 to 3.92)	2.15 (1.63 to 2.82)	3.68 (2.53 to 5.35)	2.63 (2.01 to 3.44)	2.15 (1.5 to 3.1)	2.75 (2.19 to 3.44)	2.68 (1.82 to 3.93)	0 (0 to 0)
S.NZ98/254 GMT-1m (N=95,49,102,53,106,57,153,51,0)	33 (25 to 43)	154 (107 to 221)	78 (60 to 100)	174 (123 to 248)	115 (89 to 148)	170 (121 to 238)	129 (105 to 160)	43 (30 to 62)	0 (0 to 0)
S.NZ98/254 GMT-m18	8.71 (6.12 to 12)	27 (17 to 43)	17 (12 to 24)	42 (26 to 66)	19 (14 to 27)	41 (26 to 64)	23 (18 to 31)	9.16 (5.71 to 15)	3.23 (2.52 to 4.14)

No statistical analyses for this end point

Primary: 4. Geometric Mean Concentrations (GMCs) of antibodies to vaccine antigen 287-953.

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End point title

4. Geometric Mean Concentrations (GMCs) of antibodies to vaccine antigen 287-953. ^[3]

End point description

Immunogenicity was evaluated by measuring the GMCs against Antigen 287-953, at 18 months after the completion of the vaccination course in subjects enrolled in V72P10 Study and in Naive Subjects. The analysis was performed as per the MITT dataset.

End point type

Primary

End point timeframe

18 months after completion of vaccination course in the V72P10 study.

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: There was no statistical null hypothesis associated with this immunogenicity objective.

End point values	rMenB0	rMenB06	rMenB01	rMenB016	rMenB02	rMenB026	rMenB012	rMenB6	Naive
Number of subjects analysed	34	35	35	35	35	35	35	34	35
Units: IU/mL
geometric mean (confidence interval 95%)
18 m post-last vac. in V72P10	55 (37 to 82)	272 (186 to 397)	217 (148 to 319)	555 (376 to 818)	150 (101 to 221)	490 (333 to 721)	175 (119 to 256)	59 (40 to 88)	24 (20 to 27)

No statistical analyses for this end point

Primary: 3. Geometric Mean Ratio (GMRs) over baselines at month 0 and at one month after the last rMenB+OMV NZ vaccination in the V72P10 study.

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End point title

3. Geometric Mean Ratio (GMRs) over baselines at month 0 and at one month after the last rMenB+OMV NZ vaccination in the V72P10 study. ^[4]

End point description

Immunogenicity was evaluated by measuring the GMRs against meningococcal strains 44/76_SL, 5/99, NZ98/254. The analysis was performed as per the MITT dataset.

End point type

Primary

End point timeframe

Month 0 (bl=baseline), month 1 and Month 18 after last vaccination in V72P10 study.

Notes
[4] - 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: There was no statistical null hypothesis associated with this immunogenicity objective.

End point values	rMenB0	rMenB06	rMenB01	rMenB016	rMenB02	rMenB026	rMenB012	rMenB6	Naive
Number of subjects analysed	95	49	102	53	106	57	153	51	151
Units: Ratio
geometric mean (confidence interval 95%)
S.44/76_SL-1m/bl (N=95,49,102,53,106,57,153,51,0)	12 (9.18 to 17)	80 (53 to 122)	69 (52 to 92)	89 (60 to 133)	70 (52 to 93)	96 (65 to 141)	66 (52 to 83)	14 (9.47 to 21)	0 (0 to 0)
S.44/76_SL-18m/bl (N=95,49,102,53,106,57,153,51,0)	4.26 (3.01 to 6.03)	9.51 (5.93 to 15)	11 (7.6 to 15)	14 (8.95 to 22)	11 (7.67 to 15)	16 (10 to 25)	11 (8.2 to 14)	4.46 (2.8 to 7.11)	0 (0 to 0)
S.44/76_SL-18m/1m (N=95,49,102,53,106,57,153,51,0)	0.34 (0.25 to 0.47)	0.12 (0.077 to 0.18)	0.15 (0.11 to 0.21)	0.16 (0.1 to 0.24)	0.15 (0.11 to 0.21)	0.17 (0.11 to 0.25)	0.16 (0.13 to 0.21)	0.31 (0.2 to 0.48)	0 (0 to 0)
S.5/99-1m/bl (N=95,49,102,53,106,57,153,51,0)	24 (17 to 33)	347 (223 to 541)	200 (147 to 273)	462 (301 to 709)	309 (227 to 419)	644 (425 to 976)	230 (178 to 298)	25 (16 to 39)	0 (0 to 0)
S.5/99-18m/bl (N=95,49,102,53,106,57,153,51,0)	2.68 (1.94 to 3.7)	28 (18 to 44)	18 (13 to 25)	47 (31 to 73)	18 (14 to 25)	58 (38 to 87)	28 (21 to 36)	3.69 (2.39 to 5.7)	0 (0 to 0)
S.5/99-18m/1m (N=95,49,102,53,106,57,153,51,0)	0.11 (0.085 to 0.15)	0.081 (0.055 to 0.12)	0.091 (0.07 to 0.12)	0.1 (0.071 to 0.15)	0.06 (0.046 to 0.078)	0.09 (0.063 to 0.13)	0.12 (0.096 to 0.15)	0.15 (0.1 to 0.21)	0 (0 to 0)
S.NZ98/254-1m/bl (N=95,49,102,53,106,57,151,51,0)	12 (9.22 to 17)	58 (39 to 87)	36 (27 to 48)	47 (32 to 70)	44 (33 to 58)	79 (54 to 115)	47 (37 to 60)	16 (11 to 24)	0 (0 to 0)
S.NZ98/254-18m/bl (N=95,49,102,53,106,57,152,51,0)	3.29 (2.41 to 4.5)	10 (6.62 to 15)	7.93 (5.89 to 11)	11 (7.57 to 17)	7.37 (5.5 to 9.88)	19 (13 to 28)	8.42 (6.59 to 11)	3.43 (2.25 to 5.2)	0 (0 to 0)
S.NZ98/254-18m/1m (N=95,49,102,53,106,57,153,51,0)	0.27 (0.2 to 0.35)	0.17 (0.12 to 0.26)	0.22 (0.17 to 0.29)	0.24 (0.16 to 0.35)	0.17 (0.13 to 0.22)	0.24 (0.17 to 0.35)	0.18 (0.14 to 0.23)	0.21 (0.14 to 0.31)	0 (0 to 0)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

18 months after vaccination.

Adverse event reporting additional description

There was no vaccine administered in the study. Only Safety data related to the blood draw procedure were collected.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

rMenB06

Reporting group description

Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months in V72P10.

Reporting group title

rMenB0

Reporting group description

Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months in V72P10.

Reporting group title

rMenB02

Reporting group description

Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months in V72P10.

Reporting group title

Naive

Reporting group description

Subjects did not receive any vaccination and of similar age to the follow-on subjects from V72P10.

Reporting group title

rMenB012

Reporting group description

Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months in V72P10.

Reporting group title

rMenB01

Reporting group description

Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months in V71P10.

Reporting group title

rMenB6

Reporting group description

Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months in V72P10.

Reporting group title

rMenB016

Reporting group description

Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months in V72P10.

Reporting group title

rMenB026

Reporting group description

Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month in V71P10.

Serious adverse events	rMenB06	rMenB0	rMenB02	Naive	rMenB012	rMenB01	rMenB6	rMenB016	rMenB026
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 49 (0.00%)	0 / 95 (0.00%)	0 / 106 (0.00%)	0 / 151 (0.00%)	0 / 153 (0.00%)	0 / 102 (0.00%)	0 / 51 (0.00%)	0 / 53 (0.00%)	0 / 57 (0.00%)
number of deaths (all causes)	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

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

Non-serious adverse events	rMenB06	rMenB0	rMenB02	Naive	rMenB012	rMenB01	rMenB6	rMenB016	rMenB026
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 49 (0.00%)	0 / 95 (0.00%)	0 / 106 (0.00%)	0 / 151 (0.00%)	0 / 153 (0.00%)	0 / 102 (0.00%)	0 / 51 (0.00%)	0 / 53 (0.00%)	0 / 57 (0.00%)

Notes
[1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
Justification: All safety analyses were run in the safety population. No Serious Adverse Event occurred.

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Were there any global substantial amendments to the protocol? No

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

http://www.ncbi.nlm.nih.gov/pubmed/23811804

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Clinical trials

Clinical Trial Results:
A Phase 2b/3, Multi-Center, Extension Study of V72P10 to Assess Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: 1. Percentage of subjects with hSBA titer ≥1:4 at 18 months after the completion of the vaccination course in subjects enrolled in the V72P10 study and in Naive Subjects.

Primary: 1. Percentage of subjects with hSBA titer ≥1:4 at 18 months after the completion of the vaccination course in subjects enrolled in the V72P10 study and in Naive Subjects.

Primary: 2. Geometric Mean Titers (GMTs) at eighteen months after the completion of the vaccination course in subjects enrolled in the V72P10 study and in Naive Subjects.

Primary: 2. Geometric Mean Titers (GMTs) at eighteen months after the completion of the vaccination course in subjects enrolled in the V72P10 study and in Naive Subjects.

Primary: 4. Geometric Mean Concentrations (GMCs) of antibodies to vaccine antigen 287-953.

Primary: 4. Geometric Mean Concentrations (GMCs) of antibodies to vaccine antigen 287-953.

Primary: 3. Geometric Mean Ratio (GMRs) over baselines at month 0 and at one month after the last rMenB+OMV NZ vaccination in the V72P10 study.

Primary: 3. Geometric Mean Ratio (GMRs) over baselines at month 0 and at one month after the last rMenB+OMV NZ vaccination in the V72P10 study.

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

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Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 2b/3, Multi-Center, Extension Study of V72P10 to Assess Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: 1. Percentage of subjects with hSBA titer ≥1:4 at 18 months after the completion of the vaccination course in subjects enrolled in the V72P10 study and in Naive Subjects.

Primary: 1. Percentage of subjects with hSBA titer ≥1:4 at 18 months after the completion of the vaccination course in subjects enrolled in the V72P10 study and in Naive Subjects.

Primary: 2. Geometric Mean Titers (GMTs) at eighteen months after the completion of the vaccination course in subjects enrolled in the V72P10 study and in Naive Subjects.

Primary: 2. Geometric Mean Titers (GMTs) at eighteen months after the completion of the vaccination course in subjects enrolled in the V72P10 study and in Naive Subjects.

Primary: 4. Geometric Mean Concentrations (GMCs) of antibodies to vaccine antigen 287-953.

Primary: 4. Geometric Mean Concentrations (GMCs) of antibodies to vaccine antigen 287-953.

Primary: 3. Geometric Mean Ratio (GMRs) over baselines at month 0 and at one month after the last rMenB+OMV NZ vaccination in the V72P10 study.

Primary: 3. Geometric Mean Ratio (GMRs) over baselines at month 0 and at one month after the last rMenB+OMV NZ vaccination in the V72P10 study.

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
A Phase 2b/3, Multi-Center, Extension Study of V72P10 to Assess Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10.