Clinical Trial Results:
A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, when Administered to Healthy Infants 6-8 months old

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

Summary
EudraCT number	2006-005589-38
Trial protocol	GB
Global end of trial date	15 Jul 2008

Results information
Results version number	v2(current)
This version publication date	15 Jun 2016
First version publication date	08 Jan 2015
Other versions	v1 (removed from public view)
Version creation reason	Correction of full data set Data points need to be updated.

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

V72P9

ISRCTN number

US NCT number

NCT00433914

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Vaccines and Diagnostics S.r.l

Sponsor organisation address

S.r.l. - 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-000139-PIP01-07

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

24 Feb 2009

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

15 Jul 2008

Was the trial ended prematurely?

Main objective of the trial

To explore the immunogenicity of Novartis rMenB Vaccine +/- OMV when administered to healthy infants, at 30 days after the second and the third dose, by evaluation of the breadth of bactericidal activity (BCA) response against a panel of genetically distinct meningococcal strains. To explore the safety and tolerability of Novartis rMenB with or without OMV throughout the clinical study.

Protection of trial subjects

Study vaccines were not administered to individuals with known hypersensitivity to any component of the vaccines. An oral temperature ≥38.0°C (≥100.4°F) or serious active infection was a reason for delaying vaccination. Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine is not injected into a blood vessel.

Background therapy

Evidence for comparator

Actual start date of recruitment

16 Feb 2007

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

United Kingdom: 60

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Subjects were enrolled at one study center in the UK.

Screening details

All subjects enrolled were included in the trial.

Period 1 title

Per arm in the baseline period (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Subject

Blinding implementation details

The trial was designed as a single-blind study with the study personnel being aware of the vaccine administered, but the enrolled subjects and their parents unaware of the vaccine received.

Are arms mutually exclusive

Yes

rMenB

Arm description

6-8 month-old infants were administered 3 doses of Novartis rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.

Arm type

Experimental

Investigational medicinal product name

Novartis rMenB vaccine

Investigational medicinal product code

Other name

Serogroup B meningococcal recombinant vaccine without OMV-NZ

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Vaccination consisted of three 0.5 mL doses of rMenB vaccine administered IM into anterolateral area of the right thigh

rMenB + OMV

Arm description

6-8 month-old infants were administered 3 doses of Novartis rMenB with OMV-NZ vaccine at 6-8 months of age, 2 months later and at 12 months of age.

Arm type

Experimental

Investigational medicinal product name

Novartis rMenB + OMV

Investigational medicinal product code

Other name

Serogroup B meningococcal recombinant vaccine with OMV-NZ

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Vaccination consisted of three 0.5 mL doses of rMenB + OMV vaccine administered IM into anterolateral area of the right thigh

Number of subjects in period 1	rMenB	rMenB + OMV
Started	30	30
Completed	30	27
Not completed	0	3
Consent withdrawn by subject	-	2
Lost to follow-up	-	1

Baseline characteristics

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Reporting group title

rMenB

Reporting group description

6-8 month-old infants were administered 3 doses of Novartis rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.

Reporting group title

rMenB + OMV

Reporting group description

6-8 month-old infants were administered 3 doses of Novartis rMenB with OMV-NZ vaccine at 6-8 months of age, 2 months later and at 12 months of age.

Reporting group values	rMenB	rMenB + OMV	Total
Number of subjects	30	30	60
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	30	30	60
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	0	0	0
From 65-84 years	0	0	0
85 years and over	0	0	0
Age continuous
6-8 month-old infants were administered 3 doses of Novartis rMenB vaccine with or without OMV-NZ at 6-8, 2 months later and at 12 months of age.
Units: months
arithmetic mean (standard deviation)	228.1 ± 18	230.1 ± 19.4	-
Gender categorical
6-8 month-old infants were administered 3 doses of Novartis rMenB vaccine with or without OMV-NZ at 6-8, 2 months later and at 12 months of age.
Units: Subjects
Female	14	18	32
Male	16	12	28

End points

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Reporting group title

rMenB

Reporting group description

6-8 month-old infants were administered 3 doses of Novartis rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.

Reporting group title

rMenB + OMV

Reporting group description

6-8 month-old infants were administered 3 doses of Novartis rMenB with OMV-NZ vaccine at 6-8 months of age, 2 months later and at 12 months of age.

Subject analysis set title

All enrolled population

Subject analysis set type

Intention-to-treat

Subject analysis set description

All subjects who had data in the DEMOG panel.

Subject analysis set title

Per-protocol Populatoin

Subject analysis set type

Per protocol

Subject analysis set description

All enrolled subjects who correctly received the vaccine, provided evaluable serum samples at the relevant time points (Visit 3), and had no major protocol violation as defined prior to the end of the study.

Subject analysis set title

Safety Population

Subject analysis set type

Safety analysis

Subject analysis set description

All subjects who received the study vaccine and provided some post-vaccination safety data

Primary: Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

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End point title

Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ ^[1]

End point description

Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). The analysis was performed on the per-protocol population.

End point type

Primary

End point timeframe

Baseline and one month after second and third vaccination

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.

End point values	rMenB	rMenB + OMV
Number of subjects analysed	25	24
Units: Percentage of subjects
number (confidence interval 95%)
Strain 44/76-SL - Baseline	8 (1 to 26)	29 (13 to 51)
Strain 44/76-SL - Post- 2nd vaccination (N=25,23)	100 (86 to 100)	100 (85 to 100)
Strain 44/76-SL - Post-3rd vaccination (N=24,24)	100 (86 to 100)	100 (86 to 100)
Strain 5/99 - Baseline	0 (0 to 14)	0 (0 to 14)
Strain 5/99 - Post-2nd vaccination (N=25,23)	100 (86 to 100)	100 (85 to 100)
Strain 5/99 - Post-3rd vaccination (N=24,24)	100 (86 to 100)	100 (86 to 100)
Strain NZ98/254 - Baseline	0 (0 to 14)	0 (0 to 14)
Strain NZ98/254 - Post-2nd vaccination (N=24,22)	4 (0 to 21)	95 (77 to 100)
Strain NZ98/254 - Post-3rd vaccination (N=22,24)	9 (1 to 29)	96 (79 to 100)
Strain UK P1.7-2,4 -Baseline (N=24,21)	0 (0 to 14)	0 (0 to 16)
Strain UKP1.7-2,4 - Post-2nd vaccination (N=23,19)	0 (0 to 15)	100 (82 to 100)
Strain UKP1.7-2,4 - Post-3rd vaccination (N=21,22)	5 (0 to 24)	100 (85 to 100)
Strain GB101 - Baseline (N=24,21)	0 (0 to 14)	10 (1 to 30)
Strain GB101 - Post-2nd vaccination (N=22,21)	23 (8 to 45)	67 (43 to 85)
Strain GB101 - Post-3rd vaccination (N=22,22)	27 (11 to 50)	73 (50 to 89)
Strain GB355 - Baseline (N=12,11)	0 (0 to 26)	0 (0 to 28)
Strain GB355 - Post-2nd vaccination (N=11,14)	0 (0 to 28)	7 (0 to 34)
Strain GB355 – Post 3rd vaccination (N=12,11)	0 (0 to 26)	18 (2 to 52)
Strain GB364 - Baseline (N=22,17)	9 (1 to 29)	12 (1 to 36)
Strain GB364 - Post-2nd vaccination (N=19,16)	95 (74 to 100)	88 (62 to 98)
Strain GB364 - Post-3rd vaccination (N=17,19)	88 (64 to 99)	95 (74 to 100)

No statistical analyses for this end point

Primary: Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

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End point title

Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ ^[2]

End point description

Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). The analysis was performed on the per-protocol population.

End point type

Primary

End point timeframe

Baseline and one month after second and third vaccination

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: No statistical analyses for this end point.

End point values	rMenB	rMenB + OMV
Number of subjects analysed	25	24
Units: Percentage of subjects
number (confidence interval 95%)
Strain 44/76-SL - Baseline	0 (0 to 14)	4 (0 to 21)
Strain 44/76-SL - Post- 2nd Vaccination (N=25,23)	96 (80 to 100)	100 (85 to 100)
Strain 44/76-SL - Post-3rd Vaccination (N=24,24)	100 (86 to 100)	100 (86 to 100)
Strain 5/99 - Baseline	0 (0 to 14)	0 (0 to 14)
Strain 5/99 - Post-2nd Vaccination (N=25,23)	100 (86 to 100)	100 (85 to 100)
Strain 5/99 - Post-3rd Vaccination (N=24,24)	100 (86 to 100)	100 (86 to 100)
Strain NZ98/254 - Baseline	0 (0 to 14)	0 (0 to 14)
Strain NZ98/254 - Post- 2nd Vaccination (N=24,22)	0 (0 to 14)	91 (71 to 99)
Strain NZ98/254 - Post- 3rd Vaccination (N=22,24)	5 (0 to 23)	96 (79 to 100)
Strain UK P1.7-2,4 - Baseline (N=24,21)	0 (0 to 14)	0 (0 to 16)
Strain UKP1.7-2,4 - Post- 2nd Vaccination (N=23,19	0 (0 to 15)	84 (60 to 97)
Strain UKP1.7-2,4 - Post- 3rd Vaccination (N=21,22	0 (0 to 16)	95 (77 to 100)
Strain GB101 – Baseline (N=24,21)	0 (0 to 14)	10 (1 to 30)
Strain GB101 - Post-2nd Vaccination (N=22,21)	9 (1 to 29)	33 (15 to 57)
Strain GB101 - Post-3rd Vaccination (N=22,22)	14 (3 to 35)	45 (24 to 68)
Strain GB355 – Baseline (N=12,11)	0 (0 to 26)	0 (0 to 28)
Strain GB355 - Post-2nd Vaccination (N=11,14)	0 (0 to 28)	0 (0 to 23)
Strain GB355 – Post 3rd Vaccination (N=12,11)	0 (0 to 26)	0 (0 to 28)
Strain GB364 – Baseline (N=22,17)	0 (0 to 15)	0 (0 to 20)
Strain GB364 - Post-2nd Vaccination (N=19,16)	74 (49 to 91)	69 (41 to 89)
Strain GB364 - Post-3rd Vaccination (N=17,19)	71 (44 to 90)	84 (60 to 97)

No statistical analyses for this end point

Secondary: Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

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End point title

Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

End point description

Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). The analysis was performed on the per-protocol population.

End point type

Secondary

End point timeframe

One month after second and third vaccination

End point values	rMenB	rMenB + OMV
Number of subjects analysed	25	24
Units: Percentage of subjects
number (confidence interval 95%)
Strain 44/76-SL - Post- 2nd Vaccination (N=25,23)	96 (80 to 100)	100 (85 to 100)
Strain 44/76-SL - Post-3rd Vaccination	100 (86 to 100)	100 (86 to 100)
Strain 5/99 - Post-2nd Vaccination (N=25,23)	100 (86 to 100)	100 (85 to 100)
Strain 5/99 - Post-3rd Vaccination	100 (86 to 100)	100 (86 to 100)
Strain NZ98/254 - Post-2nd Vaccination (N=24,22)	0 (0 to 14)	91 (71 to 99)
Strain NZ98/254 - Post- 3rd Vaccination (N=22,24)	5 (0 to 23)	96 (79 to 100)
Strain UKP1.7-2,4 - Post-2nd Vaccination (N=22,17)	0 (0 to 15)	88 (64 to 99)
Strain UKP1.7-2,4 - Post-3rd Vaccination (N=20,20)	0 (0 to 17)	95 (75 to 100)
Strain GB101 - Post-2nd Vaccination (N=21,18)	10 (1 to 30)	22 (6 to 48)
Strain GB101 - Post-3rd Vaccination (N=21,19)	14 (3 to 36)	32 (13 to 57)
Strain GB355 - Post-2nd Vaccination (N=5,7)	0 (0 to 52)	0 (0 to 41)
Strain GB355 - Post-3rd Vaccination (N=7,6)	0 (0 to 41)	0 (0 to 46)
Strain GB364 - Post-2nd Vaccination (N=17,14)	76 (50 to 93)	64 (35 to 87)
Strain GB364 - Post-3rd Vaccination (N=15,15)	80 (52 to 96)	80 (52 to 96)
287-953proteinantigen-Post-2ndVaccination(N=25,23)	100 (86 to 100)	100 (85 to 100)
287-953proteinantigen-Post-3rdVaccination(N=24,25)	100 (86 to 100)	100 (86 to 100)

No statistical analyses for this end point

Secondary: Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

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End point title

Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

End point description

The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254, before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). The analysis was performed on the per-protocol population.

End point type

Secondary

End point timeframe

Baseline and one month after second and third vaccination

End point values	rMenB	rMenB + OMV
Number of subjects analysed	25	24
Units: Titers
geometric mean (confidence interval 95%)
Strain 44/76-SL - Baseline	1.16 (0.89 to 1.52)	1.7 (1.29 to 2.24)
Strain 44/76-SL - Post- 2nd Vaccination (N=25,23)	94 (66 to 134)	250 (173 to 361)
Strain 44/76-SL - Post-3rd Vaccination (N=24,24)	109 (79 to 153)	189 (136 to 263)
Strain 5/99 - Baseline	1 (0.94 to 1.07)	1.05 (0.98 to 1.12)
Strain 5/99 - Post-2nd Vaccination (N=25,23)	710 (532 to 947)	534 (395 to 721)
Strain 5/99 - Post-3rd Vaccination (N=24,24)	1202 (929 to 1555)	906 (700 to 1172)
Strain NZ98/254 - Baseline	1 (1 to 1)	1 (1 to 1)
Strain NZ98/254 - Post- 2nd Vaccination (N=24,22)	1.06 (0.82 to 1.38)	27 (21 to 36)
Strain NZ98/254 - Post- 3rd Vaccination (N=22,24)	1.21 (0.86 to 1.72)	44 (32 to 62)
Strain UK P1.7-2,4 - Baseline (N=24,21)	1 (1 to 1)	1 (1 to 1)
Strain UKP1.7-2,4 - Post- 2nd Vaccination (N=23,19	1 (0.75 to 1.34)	17 (12 to 24)
Strain UKP1.7-2,4 - Post- 3rd Vaccination (N=21,22	1.07 (0.72 to 1.58)	34 (23 to 50)
Strain GB101 - Baseline (N=24,21)	1.12 (0.81 to 1.56)	1.49 (1.05 to 2.11)
Strain GB101 - Post-2nd Vaccination (N=22,21)	1.82 (1.14 to 2.9)	4.56 (2.83 to 7.35)
Strain GB101 - Post-3rd Vaccination (N=22,22)	2.2 (1.14 to 4.23)	9.36 (4.87 to 18)
Strain GB355 - Baseline (N=12,11)	1 (1 to 1)	1 (1 to 1)
Strain GB355 - Post-2nd Vaccination (N=11,14)	1 (0.83 to 1.21)	1.16 (0.98 to 1.37)
Strain GB355 – Post 3rd Vaccination (N=12,11)	1.06 (0.82 to 1.36)	1.46 (1.12 to 1.9)
Strain GB364 - Baseline (N=22,17)	1.46 (1.19 to 1.79)	1.5 (1.19 to 1.9)
Strain GB364 - Post-2nd Vaccination (N=19,16)	11 (6.39 to 19)	12 (6.75 to 23)
Strain GB364 - Post-3rd Vaccination (N=17,19)	12 (6.17 to 22)	21 (11 to 37)

No statistical analyses for this end point

Secondary: Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

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End point title

Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

End point description

The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbant assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). The analysis was performed on the per-protocol population.

End point type

Secondary

End point timeframe

Baseline and one month after second and third vaccination

End point values	rMenB	rMenB + OMV
Number of subjects analysed	25	25
Units: Titers
geometric mean (confidence interval 95%)
Antigen 287-953 - Baseline	24 (21 to 28)	21 (18 to 24)
Antigen 287-953 - Post-2nd Vaccination (N=25,23)	1759 (1331 to 2324)	2912 (2178 to 3894)
Antigen 287-953 - Post-3rd Vaccination (N=24,25)	2298 (1778 to 2970)	3521 (2739 to 4527)

No statistical analyses for this end point

Secondary: Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

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End point title

Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

End point description

Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). The analysis was performed on the per-protocol population.

End point type

Secondary

End point timeframe

One month after second and third vaccination

End point values	rMenB	rMenB + OMV
Number of subjects analysed	25	25
Units: Percentage of subjects
number (confidence interval 95%)
Antigen 287-953 - Post-2nd Vaccination (N=25,23)	100 (86 to 100)	100 (85 to 100)
Antigen 287-953 - Post-3rd Vaccination (N=24,25)	100 (86 to 100)	100 (86 to 100)

No statistical analyses for this end point

Secondary: Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ

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End point title

Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ

End point description

Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3). Analysis was done on safety set.

End point type

Secondary

End point timeframe

Day 1 through day 7 after each vaccination

End point values	rMenB	rMenB + OMV
Number of subjects analysed	30	30
Units: Number of subjects
Local reactions	29	29
Tenderness - Vaccination 1	4	9
Tenderness - Vaccination 2 (N=30,28)	5	11
Tenderness - Vaccination 3 (N=30,27)	12	10
Erythema - Vaccination 1	26	26
Erythema - Vaccination 2 (N=30,28)	22	25
Erythema - Vaccination 3 (N=30,27)	24	26
Induration - Vaccination 1	15	18
Induration - Vaccination 2 (N=30,28)	12	16
Induration - Vaccination 3 (N=30,27)	15	18
Swelling - Vaccination 1	4	11
Swelling - Vaccination 2 (N=30,28)	9	10
Swelling - Vaccination 3 (N=30,27)	11	9
Systemic reactions	22	28
Change in eating habits - Vaccination 1 (N=30,29)	6	8
Change in eating habits - Vaccination 2 (N=30,27)	1	7
Change in eating habits - Vaccination 3 (N=30,27)	8	5
Sleepiness - Vaccination 1	7	11
Sleepiness - Vaccination 2 (N=30,28)	7	8
Sleepiness - Vaccination 3 (N=30,27)	7	4
Vomiting - Vaccination 1	6	4
Vomiting - Vaccination 2 (N=30,28)	1	3
Vomiting - Vaccination 3 (N=30,27)	6	2
Diarrhea - Vaccination 1	2	5
Diarrhea - Vaccination 2 (N=30,28)	4	1
Diarrhea - Vaccination 3 (N=30,27)	5	5
Unusual crying - Vaccination 1	2	3
Unusual crying - Vaccination 2 (N=30,28)	2	2
Unusual crying - Vaccination 3 (N=30,27)	4	7
Irritability - Vaccination 1	14	14
Irritability - Vaccination 2 (N=30,28)	10	17
Irritability - Vaccination 3 (N=30,28)	13	18
Rash - Vaccination 1	3	3
Rash - Vaccination 2 (N=30,28)	5	4
Rash - Vaccination 3 (N=30,27)	5	4
Fever (≥38 °C) - Vaccination 1	1	3
Fever (≥38 °C) - Vaccination 2 (N=30,28)	2	3
Fever (≥38 °C) - Vaccination 3 (N=30,27)	4	1
Analg/Antipyr medications used - Vaccination 1	10	18
Analg/Antipyr medications used - Vaccination 2	12	17
Analg/Antipyr medications used - Vaccination 3	15	16

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

17.0

Reporting group title

rMenB + OMV

Reporting group description

6-8 month-old infants were administered 3 doses of Novartis rMenB with OMV-NZ vaccine at 6-8, 2 months later and at 12 months of age.

Reporting group title

rMenB

Reporting group description

6-8 month-old infants were administered 3 doses of Novartis rMenB vaccine without OMV-NZ at 6-8, 2 months later and at 12 months of age.

Serious adverse events	rMenB + OMV	rMenB
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 30 (3.33%)	5 / 30 (16.67%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Nervous system disorders
Febrile convulsion
subjects affected / exposed	1 / 30 (3.33%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Wheezing
subjects affected / exposed	0 / 30 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Cellulitis
subjects affected / exposed	0 / 30 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Croup infectious
subjects affected / exposed	0 / 30 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 30 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	0 / 30 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	rMenB + OMV	rMenB
Total subjects affected by non serious adverse events
subjects affected / exposed	30 / 30 (100.00%)	30 / 30 (100.00%)
Nervous system disorders
Somnolence
subjects affected / exposed	16 / 30 (53.33%)	14 / 30 (46.67%)
occurrences all number	27	27
General disorders and administration site conditions
Induration
subjects affected / exposed	4 / 30 (13.33%)	1 / 30 (3.33%)
occurrences all number	4	2
Injection site erythema
subjects affected / exposed	28 / 30 (93.33%)	28 / 30 (93.33%)
occurrences all number	82	73
Injection site induration
subjects affected / exposed	26 / 30 (86.67%)	20 / 30 (66.67%)
occurrences all number	54	43
Injection site swelling
subjects affected / exposed	17 / 30 (56.67%)	14 / 30 (46.67%)
occurrences all number	30	26
Pyrexia
subjects affected / exposed	6 / 30 (20.00%)	7 / 30 (23.33%)
occurrences all number	7	10
Swelling
subjects affected / exposed	3 / 30 (10.00%)	0 / 30 (0.00%)
occurrences all number	5	0
Crying
subjects affected / exposed	10 / 30 (33.33%)	5 / 30 (16.67%)
occurrences all number	13	8
Injection site pain
subjects affected / exposed	18 / 30 (60.00%)	13 / 30 (43.33%)
occurrences all number	30	21
Vaccination site erythema
subjects affected / exposed	0 / 30 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	2
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	10 / 30 (33.33%)	9 / 30 (30.00%)
occurrences all number	13	16
Teething
subjects affected / exposed	8 / 30 (26.67%)	8 / 30 (26.67%)
occurrences all number	13	11
Vomiting
subjects affected / exposed	7 / 30 (23.33%)	11 / 30 (36.67%)
occurrences all number	10	16
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	6 / 30 (20.00%)	3 / 30 (10.00%)
occurrences all number	6	3
Rhinorrhoea
subjects affected / exposed	1 / 30 (3.33%)	2 / 30 (6.67%)
occurrences all number	1	2
Skin and subcutaneous tissue disorders
Eczema
subjects affected / exposed	2 / 30 (6.67%)	1 / 30 (3.33%)
occurrences all number	2	1
Erythema
subjects affected / exposed	4 / 30 (13.33%)	1 / 30 (3.33%)
occurrences all number	7	2
Rash
subjects affected / exposed	9 / 30 (30.00%)	8 / 30 (26.67%)
occurrences all number	16	19
Psychiatric disorders
Irritability
subjects affected / exposed	25 / 30 (83.33%)	18 / 30 (60.00%)
occurrences all number	58	53
Eating disorder
subjects affected / exposed	14 / 30 (46.67%)	13 / 30 (43.33%)
occurrences all number	27	20
Infections and infestations
Conjunctivitis
subjects affected / exposed	5 / 30 (16.67%)	1 / 30 (3.33%)
occurrences all number	6	1
Gastroenteritis
subjects affected / exposed	4 / 30 (13.33%)	0 / 30 (0.00%)
occurrences all number	4	0
Lower respiratory tract infection
subjects affected / exposed	3 / 30 (10.00%)	2 / 30 (6.67%)
occurrences all number	3	2
Nasopharyngitis
subjects affected / exposed	3 / 30 (10.00%)	1 / 30 (3.33%)
occurrences all number	3	1
Otitis media
subjects affected / exposed	1 / 30 (3.33%)	2 / 30 (6.67%)
occurrences all number	1	2
Rhinitis
subjects affected / exposed	3 / 30 (10.00%)	5 / 30 (16.67%)
occurrences all number	4	5
Tonsillitis
subjects affected / exposed	2 / 30 (6.67%)	1 / 30 (3.33%)
occurrences all number	2	1
Upper respiratory tract infection
subjects affected / exposed	2 / 30 (6.67%)	0 / 30 (0.00%)
occurrences all number	3	0
Varicella
subjects affected / exposed	0 / 30 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	2
Viral rash
subjects affected / exposed	2 / 30 (6.67%)	2 / 30 (6.67%)
occurrences all number	2	2
Viral upper respiratory tract infection
subjects affected / exposed	0 / 30 (0.00%)	4 / 30 (13.33%)
occurrences all number	0	4

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Were there any global substantial amendments to the protocol? Yes

11 Jul 2008

The amendment was done to include the following: 1. An additional laboratory was included in the study where serology tests for this trial could be performed. 2. The laboratory related procedures for both laboratories involved in the study were drafted and aligned with the protocol accordingly. 3. Additionally, an immune response by ELISA testing was further explored for the subject’s immune response in the trial and this was to demonstrate the possibility of performing additional future tests for future vaccine related projects according to subject’s consent. 4. The sponsor’s administrative structure, the cover page and the sponsor signature page were updated. 5. Blood draws were delayed for subjects taking antibiotics until 3 days after completion of antibiotic therapy. 6. Additional 30 minutes data on the Local & Systemic reaction page, was to be reported directly on the CRFs and are considered to be source data along with: demographics, medical history, pre-immunization axillary temperature, sites of immunizations. In addition to this, it was planned to categorize the measurements of body temperature as <38°C, 38-<39°C, 39-<40°C and ≥40°C, but was instead categorized as <38°C, 38-<38.5, 38.5-<39°C, 39-<39.5, 39.5-<40°C and ≥40°C. The root MSE from the PROC GLM output was used in the calculation of the 95% confidence intervals for each vaccine group associated with the geometric mean titers (GMTs) and geometric mean ratios (GMRs) for each visit and meningococcal strain, instead of the within group estimate of error at that visit, as specified in the AP.

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/20844462

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Clinical trials

Clinical Trial Results:
A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, when Administered to Healthy Infants 6-8 months old

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Primary: Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Primary: Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Primary: Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

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Clinical trials

Clinical Trial Results: A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, when Administered to Healthy Infants 6-8 months old

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Primary: Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Primary: Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Primary: Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ

Secondary: Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, when Administered to Healthy Infants 6-8 months old