Clinical Trial Results:
Title of the trial: A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1 to Assess Antibody Persistence at One Year After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting at 12 Months of Age and to Evaluate the Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age.

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

Summary
EudraCT number	2009-018101-52
Trial protocol	FI CZ
Global end of trial date	08 Sep 2011

Results information
Results version number	v2(current)
This version publication date	01 Jun 2016
First version publication date	26 Dec 2014
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

V72P13E2

ISRCTN number

US NCT number

NCT01139021

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)

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

02 May 2012

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

08 Sep 2011

Was the trial ended prematurely?

Main objective of the trial

Immunogenicity: To explore antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ, administered at 12 months of age to toddlers enrolled in study V72P13E1 who previously received a three-dose primary series of rMenB+OMV NZ (administered at 2, 4, and 6 months of age) as infants in the original parent study V72P13.

Protection of trial subjects

This clinical study was designed, implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for GCP, with applicable local regulations, including the European Directive 2001/20/EC, the US CFR Title 21, and the Japanese Ministry of Health, Labor, and Welfare, Novartis codes on the protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki.

Background therapy

Evidence for comparator

Actual start date of recruitment

09 Jun 2010

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?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Czech Republic: 345

Country: Number of subjects enrolled

Finland: 163

Worldwide total number of subjects

508

EEA total number of subjects

508

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)

466

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

Participants were enrolled from two study centers.

Screening details

The eligible subjects from V72P13E1 (NCT00847145) who originally participated in the open-label, immunogenicity subset of parent study V72P13 (NCT00657709) and a naïve group, at 24 months of age, who did not previously participate in V72P13 (or V72P13E1) were enrolled in this study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Blinding implementation details

Not Applicable

Are arms mutually exclusive

Yes

B246_12M12

Arm description

Subjects assessed one year post administration of rMenB+OMV NZ and Measles, Mumps, Rubella, Varicella (MMRV) at 12th month after primary vaccination at 2nd ,4th and 6th months of age.

Arm type

Experimental

Investigational medicinal product name

Not Applicable

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Each dose 0.5 mL of injectable solution was administered intramuscularly.

B246_12M13

Arm description

Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.

Arm type

Experimental

Investigational medicinal product name

Not Applicable

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Each dose 0.5 mL of injectable solution was administered intramuscularly.

B13_15_27

Arm description

Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.

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

Each dose 0.5 mL of injectable solution was administered intramuscularly.

B12_14_26

Arm description

Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.

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

Each dose 0.5 mL of injectable solution was administered intramuscularly.

B_24_26

Arm description

Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

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

Each dose 0.5 mL of injectable solution was administered intramuscularly.

B12M13

Arm description

Subject was randomized in group B13_15_27 but treated as group B12_M13

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

Each dose 0.5 mL of injectable solution was administered intramuscularly.

Number of subjects in period 1	B246_12M12	B246_12M13	B13_15_27	B12_14_26	B_24_26	B12M13
Started	152	153	67	19	116	1
Completed	151	153	67	18	107	1
Not completed	1	0	0	1	9	0
Consent withdrawn by subject	-	-	-	1	4	-
Adverse Event	-	-	-	-	1	-
Lost to follow-up	-	-	-	-	2	-
Protocol deviation	1	-	-	-	2	-

Baseline characteristics

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Reporting group title

B246_12M12

Reporting group description

Subjects assessed one year post administration of rMenB+OMV NZ and Measles, Mumps, Rubella, Varicella (MMRV) at 12th month after primary vaccination at 2nd ,4th and 6th months of age.

Reporting group title

B246_12M13

Reporting group description

Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.

Reporting group title

B13_15_27

Reporting group description

Reporting group title

B12_14_26

Reporting group description

Reporting group title

B_24_26

Reporting group description

Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

Reporting group title

B12M13

Reporting group description

Subject was randomized in group B13_15_27 but treated as group B12_M13

Reporting group values	B246_12M12	B246_12M13	B13_15_27	B12_14_26	B_24_26	B12M13	Total
Number of subjects	152	153	67	19	116	1	508
Age categorical
Units: Subjects
Age continuous
Units: months
arithmetic mean (standard deviation)	25 ( 1 )	25.3 ( 0.9 )	27.3 ( 0.9 )	26.6 ( 1.2 )	24.7 ( 1.4 )	26 ( 0 )	-
Gender categorical
Units: Subjects
Female	65	85	30	10	55	1	246
Male	87	68	37	9	61	0	262

End points

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Reporting group title

B246_12M12

Reporting group description

Subjects assessed one year post administration of rMenB+OMV NZ and Measles, Mumps, Rubella, Varicella (MMRV) at 12th month after primary vaccination at 2nd ,4th and 6th months of age.

Reporting group title

B246_12M13

Reporting group description

Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.

Reporting group title

B13_15_27

Reporting group description

Reporting group title

B12_14_26

Reporting group description

Reporting group title

B_24_26

Reporting group description

Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

Reporting group title

B12M13

Reporting group description

Subject was randomized in group B13_15_27 but treated as group B12_M13

Subject analysis set title

Enrolled Population

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All subjects who were enrolled in this study.

Subject analysis set title

Safety Population Included

Subject analysis set type

Safety analysis

Subject analysis set description

All subjects enrolled who had received at least one rMenB+OMV NZ vaccination and provided post-baseline safety data.

Subject analysis set title

Modified ITT (Primary)

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All subjects in the enrolled population who provided an evaluable serum sample (visit 1, i.e., 12 months after booster or 2 dose catch-up schedule or prior to vaccination naive controls). In case of randomization errors, subjects were to be analyzed as planned in MITT population

Subject analysis set title

Modified ITT (Secondary)

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All subjects in the enrolled population who: actually received a study vaccination, and provided at least an evaluable serum sample after vaccination (groups B13_15_27 and B12_14_26, visit 2), or at least an evaluable serum sample before vaccination and 30 days after the second vaccination (B24_26). In case of randomization errors, subjects were to be analyzed as planned in MITT population

Subject analysis set title

B246_12Tot

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age

Subject analysis set title

B12+B13Tot

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th or 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26th or 27th months of age.

Primary: Geometric Mean Titers (GMTs) to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination

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End point title

Geometric Mean Titers (GMTs) to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination ^[1] ^[2]

End point description

To assess the immunogenicity in terms of human Serum Bactericidal Assay (hSBA) GMTs, through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately). Analysis was done on Modified Intention-To-Treat (MITT) population (Primary).

End point type

Primary

End point timeframe

12 months post booster (4th) 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: There was no statistical null hypothesis associated with this immunogenicity objective.
[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: There was no statistical null hypothesis associated with this immunogenicity objective.

End point values	B246_12M12	B246_12M13	B246_12Tot
Number of subjects analysed	147	153	300
Units: Titers
geometric mean (confidence interval 95%)
H44/76-SL (N=147,152,299)	7.38 (5.55 to 9.83)	8.3 (6.17 to 11)	6.5 (5.63 to 7.5)
5/99 (N=147,151,298)	68 (52 to 91)	90 (67 to 121)	81 (71 to 94)
NZ98/254 (N=147,153,300)	1.57 (1.24 to 1.99)	1.79 (1.4 to 2.29)	1.91 (1.7 to 2.15)
M10713 (N=143,148,291)	4.37 (3.24 to 5.9)	3.62 (2.65 to 4.94)	3.35 (2.88 to 3.9)

No statistical analyses for this end point

Primary: Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination

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End point title

Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination ^[3] ^[4]

End point description

To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 & hSBA ≥1:8 through antibody persistence at 1 year after a booster (4th) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2,4,6 months of age. Group B246_12M12 received MMRV at 12 months (concomitantly) & B246_12M13 received MMRV at 13 months of age (separately). Analysis was done on MITT population (Primary).

End point type

Primary

End point timeframe

12 months post booster (4th) vaccination.

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

End point values	B246_12M12	B246_12M13	B246_12Tot
Number of subjects analysed	147	153	300
Units: Percentage of subjects
number (confidence interval 95%)
H44/76-SL (hSBA ≥1:5) (N=147, 152, 299)	60 (51 to 68)	64 (56 to 71)	62 (56 to 67)
5/99 (hSBA ≥1:5) (N=147, 151, 298)	96 (91 to 98)	99 (95 to 100)	97 (95 to 99)
NZ98/254 (hSBA ≥1:5) (N=147, 153, 300)	18 (12 to 25)	17 (11 to 24)	17 (13 to 22)
M10713 (hSBA ≥1:5) (N=143, 148, 291)	40 (32 to 48)	32 (25 to 41)	36 (31 to 42)
H44/76-SL (hSBA ≥1:8) (N=147, 152, 299)	44 (35 to 52)	47 (39 to 55)	45 (39 to 51)
5/99 (hSBA ≥1:8) (N=147, 151, 298)	96 (91 to 98)	98 (94 to 100)	97 (94 to 99)
NZ98/254 (hSBA ≥1:8) (N=147, 153, 300)	12 (7 to 19)	14 (9 to 21)	13 (10 to 18)
M10713 (hSBA ≥1:8) (N=143, 148, 291)	31 (23 to 39)	24 (17 to 31)	27 (22 to 33)

No statistical analyses for this end point

Primary: Geometric Mean concentrations (GMCs) to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination

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End point title

Geometric Mean concentrations (GMCs) to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination ^[5] ^[6]

End point description

To assess the immunogenicity in terms of GMCs determined by ELISA through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately)against vaccine antigen 287-953. Analysis was done on MITT population (Primary).

End point type

Primary

End point timeframe

12 months post booster (4th) vaccination

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There was no statistical null hypothesis associated with this immunogenicity objective.
[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: There was no statistical null hypothesis associated with this immunogenicity objective.

End point values	B246_12M12	B246_12M13	B246_12Tot
Number of subjects analysed	148	153	301
Units: Concentration
geometric mean (confidence interval 95%)
287-953	360 (293 to 442)	389 (314 to 482)	352 (317 to 391)

No statistical analyses for this end point

Secondary: GMTs to assess antibody persistence at 12 months after two catch-up doses and 6 months after booster dose of rMenB+OMV NZ Vaccination

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End point title

GMTs to assess antibody persistence at 12 months after two catch-up doses and 6 months after booster dose of rMenB+OMV NZ Vaccination ^[7]

End point description

To assess the immunogenicity in terms of hSBA GMTs at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.Both the groups received MMRV at 12 months of age. Analysis was done on MITT population (Secondary).

End point type

Secondary

End point timeframe

6 months or 12 months post two catch-up dose vaccination.

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

End point values	B13_15_27	B12_14_26	B12+B13Tot
Number of subjects analysed	67	18	85
Units: Titers
geometric mean (confidence interval 95%)
H44/76-SL (12months) (N= 67, 18, 85)	14 (9.01 to 23)	8.4 (4.13 to 17)	10 (8 to 13)
5/99 (12months) (N= 67, 18, 85)	73 (43 to 123)	71 (32 to 154)	65 (49 to 85)
NZ98/254 (12months) (N= 67, 18, 85)	1.67 (1.09 to 2.55)	1.2 (0.64 to 2.27)	1.75 (1.39 to 2.2)
M10713 (12months) (N= 64, 18, 82)	3.74 (2.14 to 6.54)	3.29 (1.43 to 7.56)	3.4 (2.5 to 4.61)
H44/76-SL (6months) (N= 67, 17, 84)	68 (41 to 113)	70 (32 to 151)	51 (38 to 68)
5/99 (6months) (N= 67, 17, 84)	524 (332 to 827)	525 (263 to 1047)	518 (405 to 664)
NZ98/254 (6months) (N= 67, 17, 84)	8.87 (5.23 to 15)	16 (7.13 to 35)	8.8 (6.63 to 12)
M10713 (6months) (N= 66, 16, 82)	30 (18 to 49)	36 (17 to 78)	26 (20 to 33)

No statistical analyses for this end point

Secondary: Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody persistence at 12 months after two catch up doses and 6 months after a booster doses of rMenB+OMV NZ Vaccination.

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End point title

Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody persistence at 12 months after two catch up doses and 6 months after a booster doses of rMenB+OMV NZ Vaccination. ^[8]

End point description

To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age. Both the groups received MMRV at 12 months of age. Analysis was done on MITT population (Secondary).

End point type

Secondary

End point timeframe

6month and 12 months post two catch-up dose vaccination.

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

End point values	B13_15_27	B12_14_26	B12+B13Tot
Number of subjects analysed	67	18	85
Units: Percentage of subjects
number (confidence interval 95%)
H44/76-SL (hSBA ≥1:5) (12months) (N= 67, 18, 85)	75 (63 to 84)	56 (31 to 78)	71 (60 to 80)
5/99 (hSBA ≥1:5) (12months) (N= 67, 18, 85)	97 (90 to 100)	94 (73 to 100)	96 (90 to 99)
NZ98/254 (hSBA ≥1:5) (12months) (N= 67, 18, 85)	18 (10 to 29)	6 (0 to 27)	15 (8 to 25)
M10713 (hSBA ≥1:5) (12months) (N= 64, 18, 82)	39 (27 to 52)	28 (10 to 53)	37 (26 to 48)
H44/76-SL (hSBA ≥1:5) (6months) (N= 67, 17, 84)	99 (92 to 100)	100 (80 to 100)	99 (94 to 100)
5/99 (hSBA ≥1:5) (6months) (N= 67, 18, 84)	100 (95 to 100)	100 (80 to 100)	100 (96 to 100)
NZ98/254 (hSBA ≥1:5) (6months) (N= 67, 18, 84)	73 (61 to 83)	82 (57 to 96)	75 (64 to 84)
M10713 (hSBA ≥1:5) (6months) (N= 66, 16, 82)	92 (83 to 97)	94 (70 to 100)	93 (85 to 97)
H44/76-SL (hSBA ≥1:8) (12months) (N= 67, 18, 85)	63 (50 to 74)	56 (31 to 78)	61 (50 to 72)
5/99 (hSBA ≥1:8) (12months) (N= 67, 18, 85)	96 (87 to 99)	94 (73 to 100)	95 (88 to 99)
NZ98/254 (hSBA ≥1:8) (12months) (N= 67, 18, 85)	15 (7 to 26)	6 (0 to 27)	13 (7 to 22)
M10713 (hSBA ≥1:8) (12months) (N= 64, 18, 82)	27 (16 to 39)	22 (6 to 48)	26 (17 to 36)
H44/76-SL (hSBA ≥1:8) (6months) (N= 67, 17, 84)	91 (82 to 97)	100 (80 to 100)	93 (85 to 97)
5/99 (hSBA ≥1:8) (6months) (N= 67, 18, 84)	100 (95 to 100)	94 (71 to 100)	99 (94 to 100)
NZ98/254 (hSBA ≥1:8) (6months) (N= 67, 18, 84)	52 (40 to 65)	65 (38 to 86)	55 (44 to 66)
M10713 (hSBA ≥1:8) (6months) (N= 66, 16, 82)	86 (76 to 94)	81 (54 to 96)	85 (76 to 92)

No statistical analyses for this end point

Secondary: Percentage of subjects with at least four fold increase in hSBA titers to evaluate antibody response 1 month post booster dose of rMenB+OMV NZ Vaccination

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End point title

Percentage of subjects with at least four fold increase in hSBA titers to evaluate antibody response 1 month post booster dose of rMenB+OMV NZ Vaccination ^[9]

End point description

To assess the immunogenicity in terms of percentage of subjects with at least four fold increase in hSBA titers 1 month post booster dose of rMenB+OMV NZ administered at 26 or 27 months of age, in children previously administered two catch-up doses of rMenB+OMV NZ at either 12 and 14 or 13 and 15 months of age. Both the groups received MMRV at 12 months of age. Analysis was done on MITT population (Secondary).

End point type

Secondary

End point timeframe

1 month post booster dose versus prebooster

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

End point values	B13_15_27	B12_14_26	B12+B13Tot
Number of subjects analysed	67	18	85
Units: Percentage of Subjects
number (confidence interval 95%)
H44/76-SL (N= 66, 18, 84)	100 (95 to 100)	100 (81 to 100)	100 (96 to 100)
5/99 (N= 67, 18, 85)	99 (92 to 100)	100 (81 to 100)	99 (94 to 100)
NZ98/254 (N= 65, 18, 83)	97 (89 to 100)	94 (73 to 100)	96 (90 to 99)
M10713 (N= 62, 16, 78)	82 (70 to 91)	88 (62 to 98)	83 (73 to 91)

No statistical analyses for this end point

Secondary: GMCs to assess antibody persistence at one year after two catch-up doses and 6 months after booster of rMenB+OMV NZ Vaccination against 287-953 strain.

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End point title

GMCs to assess antibody persistence at one year after two catch-up doses and 6 months after booster of rMenB+OMV NZ Vaccination against 287-953 strain. ^[10]

End point description

To assess the immunogenicity in terms of GMCs determined by ELISA at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age. Both the groups received MMRV at 12 months of age. Analysis was done on MITT population (Secondary).

End point type

Secondary

End point timeframe

12 months post two catch-up dose vaccination and 6 months post booster dose

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

End point values	B13_15_27	B12_14_26	B12+B13Tot
Number of subjects analysed	67	18	85
Units: Concentration
geometric mean (confidence interval 95%)
287-953 (12months) (N=67, 18, 85)	219 (149 to 322)	246 (138 to 437)	227 (185 to 278)
287-953 (6months) (N=67, 17, 84)	2314 (1596 to 3355)	3259 (1859 to 5712)	2597 (2104 to 3205)

No statistical analyses for this end point

Secondary: GMTs to characterize antibody response at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

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End point title

GMTs to characterize antibody response at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. ^[11]

End point description

To assess the immunogenicity in terms of GMTs through antibody response at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. Analysis was done on MITT population (Secondary).

End point type

Secondary

End point timeframe

1 month and 6 months post two catch-up doses.

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

End point values	B_24_26
Number of subjects analysed	108
Units: Titers
geometric mean (confidence interval 95%)
H44/76-SL (1 month) (N= 105)	220 (186 to 261)
5/99 (1 month) (N= 103)	455 (372 to 556)
NZ98/254 (1 month) (N=108 )	27 (23 to 32)
M10713 (1 month) (N=100)	38 (32 to 45)
H44/76-SL (6 months) (N=104)	22 (18 to 27)
5/99 (6 months) (N= 104)	71 (57 to 89)
NZ98/254 (6 months) (N= 104)	1.88 (1.57 to 2.26)
M10713 (6 months) (N= 104)	8.04 (6.39 to 10)

No statistical analyses for this end point

Secondary: Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

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End point title

Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age ^[12]

End point description

To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody response at at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. Analysis was done on MITT population (Secondary).

End point type

Secondary

End point timeframe

1 month and 6 months post two catch-up doses

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

End point values	B_24_26
Number of subjects analysed	108
Units: Percentage of subjects
number (confidence interval 95%)
H44/76-SL (hSBA ≥1:5) (1months) (N=105)	100 (97 to 100)
5/99 (hSBA ≥1:5) (1months) (N= 103)	99 (95 to 100)
NZ98/254 (hSBA ≥1:5) (1months) (N= 108)	98 (93 to 100)
M10713 (hSBA ≥1:5) (1months) (N= 100)	97 (91 to 99)
H44/76-SL (hSBA ≥1:5) (6months) (N=104)	93 (87 to 97)
5/99 (hSBA ≥1:5) (6months) (N= 104 )	96 (90 to 99)
NZ98/254 (hSBA ≥1:5) (6months) (N= 104)	18 (11 to 27)
M10713 (hSBA ≥1:5) (6months) (N= 104)	70 (60 to 79)
H44/76-SL (hSBA ≥1:8) (1months) (N=105)	100 (97 to 100)
5/99 (hSBA ≥1:8) (1months) (N= 103)	99 (95 to 100)
NZ98/254 (hSBA ≥1:8) (1months) (N= 108)	96 (91 to 99)
M10713 (hSBA ≥1:8) (1months) (N= 100)	95 (89 to 98)
H44/76-SL (hSBA ≥1:8) (6months) (N=104)	88 (80 to 93)
5/99 (hSBA ≥1:8) (6months) (N= 104)	96 (90 to 99)
NZ98/254 (hSBA ≥1:8) (6months) (N= 104)	12 (6 to 19)
M10713 (hSBA ≥1:8) (6months) (N= 104)	52 (42 to 62)

No statistical analyses for this end point

Secondary: Percentage of subjects with fourfold increases in hSBA to assess antibody response at 1 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

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End point title

Percentage of subjects with fourfold increases in hSBA to assess antibody response at 1 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age ^[13]

End point description

To assess the immunogenicity in terms of percentage of subjects with fourfold increases in hSBA titers at 1 month post two catch-up doses of rMenB+OMV NZ in children previously administered to naive children at 24 and 26 months of age against 4 strains. Analysis was done on MITT population (Secondary).

End point type

Secondary

End point timeframe

1 month post two catch-up doses versus prevaccination

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

End point values	B_24_26
Number of subjects analysed	108
Units: Percentage of subjects
geometric mean (confidence interval 95%)
H44/76-SL (N=105)	100 (97 to 100)
5/99 (N= 101)	99 (95 to 100)
NZ98/254 (N=108 )	96 (91 to 99)
M10713 (N= 99)	85 (76 to 91)

No statistical analyses for this end point

Secondary: GMCs to assess antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain.

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End point title

GMCs to assess antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain. ^[14]

End point description

To assess the immunogenicity in terms of GMCs to assess through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain. Analysis was done on MITT population (Secondary).

End point type

Secondary

End point timeframe

1 month and 6 months post two catch-up doses

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

End point values	B_24_26
Number of subjects analysed	112
Units: Concentration
geometric mean (confidence interval 95%)
287-953 strain (1 month, N=108)	5448 (4630 to 6411)
287-953 strain (6 months, N=105)	383 (319 to 459)

No statistical analyses for this end point

Secondary: Number of subjects reporting solicited local and systemic AEs after receiving a booster (3rd) dose of rMenB+OMV NZ administered at 1year after 2 catch-up doses of rMenB+OMV NZ, previously administered at either 12 & 14 or 13 & 15 months of age in V72P13E1

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End point title

Number of subjects reporting solicited local and systemic AEs after receiving a booster (3rd) dose of rMenB+OMV NZ administered at 1year after 2 catch-up doses of rMenB+OMV NZ, previously administered at either 12 & 14 or 13 & 15 months of age in V72P13E1 ^[15]

End point description

To assess the safety and tolerability by reporting solicited local and systemic AEs of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1. The analysis was done on safety subset.

End point type

Secondary

End point timeframe

Up to 7 days after any vaccination

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: All safety analyses were run in the safety population. EudraCT

End point values	B13_15_27	B12_14_26
Number of subjects analysed	67	18
Units: Number of Subjects
Any Local	64	16
Tenderness (N=67,17)	63	16
Erythema (N=67,17)	47	13
Induration (N=67,17)	37	9
Swelling (N=67,17)	35	9
Any Systemic	53	15
Change Eat. Habits (N=67,17)	25	9
Sleepiness (N=67,17)	22	7
Vomiting (N=67,17)	4	0
Diarrhoea (N=67,17)	4	1
Irritability (N=67,17)	40	14
Unusual Crying (N=67,17)	16	5
Rash (N=67,17)	1	0
Fever ( >= 38C )	22	6
Temperature (>= 40 C) (N=67,17)	0	0
Medical Attend. Fever (N=67,17)	0	0
Antipyr. Med. Used Prev. (N=67,17)	12	5
Antipyr. Med. Used Trt. (N=67,17)	20	6

No statistical analyses for this end point

Secondary: Number of Subjects Reporting Unsolicited AEs after receiving a booster (3rd) dose of rMenB+OMV NZ administered at 1 year after 2 catch-up doses of rMenB+OMV NZ,previously administered to children at either 12 & 14 or 13 &15 months of age in V72P13E2

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End point title

Number of Subjects Reporting Unsolicited AEs after receiving a booster (3rd) dose of rMenB+OMV NZ administered at 1 year after 2 catch-up doses of rMenB+OMV NZ,previously administered to children at either 12 & 14 or 13 &15 months of age in V72P13E2 ^[16]

End point description

To assess the safety and tolerability in terms of number of subjects reporting unsolicited AEs of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1. The analysis was done on safety subset.

End point type

Secondary

End point timeframe

Up to 7 days after any vaccination

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: All safety analyses were run in the safety population. EudraCT

End point values	B13_15_27	B12_14_26
Number of subjects analysed	67	18
Units: Number of Subjects
Any AE	45	10
Serious AEs	2	1
At least possibly related SAEs	0	0
AEs leading to withdrawal	0	0

No statistical analyses for this end point

Secondary: Number of subjects reporting solicited local and systemic AEs after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

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End point title

Number of subjects reporting solicited local and systemic AEs after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. ^[17]

End point description

To assess the safety and tolerability by reporting solicited local and systemic AEs of two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. The analysis was done on safety subset.

End point type

Secondary

End point timeframe

Up to 7 days after any vaccination

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: All safety analyses were run in the safety population. EudraCT

End point values	B_24_26
Number of subjects analysed	112
Units: Number of subjects)
Any Local	110
Tenderness	109
Erythema	103
Induration	75
Swelling	58
Any Systemic	98
Change Eat. Habits	53
Sleepiness	70
Vomiting	14
Diarrhea	23
Irritability	84
Unusual Crying	47
Rash	14
Fever ( >= 38C )	44
Temperature (>= 40 C)	1
Medical Attend. Fever	2
Antipyr. Med. Used Prev	33
Antipyr. Med. Used Trt	38

No statistical analyses for this end point

Secondary: Number of Subjects Reporting Unsolicited Adverse Events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

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End point title

Number of Subjects Reporting Unsolicited Adverse Events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. ^[18]

End point description

To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. The analysis was done on safety subset.

End point type

Secondary

End point timeframe

Up to 7 days after any vaccination

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: All safety analyses were run in the safety population. EudraCT

End point values	B_24_26
Number of subjects analysed	112
Units: Number of Subjects
Any AE	96
Serious AEs	6
At least possibly related SAEs	0
AEs leading to withdrawal	1

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Throughout the study (solicited and unsolicited from Day 1 to Day 209)

Adverse event reporting additional description

Any solicited and unsolicited adverse events were reported up to day 7 post vaccination. Unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

B13_15_27

Reporting group description

Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.

Reporting group title

B24_26

Reporting group description

Subjects assessed for safety and tolerability after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Reporting group title

B12_14_26

Reporting group description

Serious adverse events	B13_15_27	B24_26	B12_14_26
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 67 (2.99%)	6 / 112 (5.36%)	1 / 18 (5.56%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
subjects affected / exposed	0 / 67 (0.00%)	1 / 112 (0.89%)	0 / 18 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Enteritis
subjects affected / exposed	0 / 67 (0.00%)	1 / 112 (0.89%)	0 / 18 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Adenoidal Hypertrophy
subjects affected / exposed	0 / 67 (0.00%)	1 / 112 (0.89%)	0 / 18 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Bronchitis
subjects affected / exposed	1 / 67 (1.49%)	1 / 112 (0.89%)	0 / 18 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Laryngitis
subjects affected / exposed	1 / 67 (1.49%)	0 / 112 (0.00%)	0 / 18 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oral Herpes
subjects affected / exposed	0 / 67 (0.00%)	0 / 112 (0.00%)	1 / 18 (5.56%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Otitis Media
subjects affected / exposed	0 / 67 (0.00%)	1 / 112 (0.89%)	0 / 18 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia Respiratory Syncytial Viral
subjects affected / exposed	0 / 67 (0.00%)	1 / 112 (0.89%)	0 / 18 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Diabetes Mellitus
subjects affected / exposed	0 / 67 (0.00%)	1 / 112 (0.89%)	0 / 18 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	B13_15_27	B24_26	B12_14_26
Total subjects affected by non serious adverse events
subjects affected / exposed	67 / 67 (100.00%)	110 / 112 (98.21%)	18 / 18 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Somnolence
subjects affected / exposed	22 / 67 (32.84%)	70 / 112 (62.50%)	7 / 18 (38.89%)
occurrences all number	22	109	7
Nervous system disorders
Speech Disorder Developmental
subjects affected / exposed	0 / 67 (0.00%)	0 / 112 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	1
General disorders and administration site conditions
Crying
subjects affected / exposed	16 / 67 (23.88%)	47 / 112 (41.96%)	5 / 18 (27.78%)
occurrences all number	17	70	5
Induration
subjects affected / exposed	1 / 67 (1.49%)	4 / 112 (3.57%)	1 / 18 (5.56%)
occurrences all number	1	4	1
Injection Site Erythema
subjects affected / exposed	47 / 67 (70.15%)	103 / 112 (91.96%)	13 / 18 (72.22%)
occurrences all number	52	177	14
Injection Site Induration
subjects affected / exposed	37 / 67 (55.22%)	75 / 112 (66.96%)	9 / 18 (50.00%)
occurrences all number	54	156	12
Injection Site Pain
subjects affected / exposed	63 / 67 (94.03%)	109 / 112 (97.32%)	16 / 18 (88.89%)
occurrences all number	68	208	16
Injection Site Swelling
subjects affected / exposed	35 / 67 (52.24%)	58 / 112 (51.79%)	9 / 18 (50.00%)
occurrences all number	39	83	11
Pyrexia
subjects affected / exposed	22 / 67 (32.84%)	46 / 112 (41.07%)	6 / 18 (33.33%)
occurrences all number	23	61	6
Tenderness
subjects affected / exposed	1 / 67 (1.49%)	0 / 112 (0.00%)	1 / 18 (5.56%)
occurrences all number	1	0	1
Gastrointestinal disorders
Constipation
subjects affected / exposed	1 / 67 (1.49%)	2 / 112 (1.79%)	1 / 18 (5.56%)
occurrences all number	1	2	1
Diarrhoea
subjects affected / exposed	5 / 67 (7.46%)	24 / 112 (21.43%)	1 / 18 (5.56%)
occurrences all number	5	28	2
Vomiting
subjects affected / exposed	4 / 67 (5.97%)	15 / 112 (13.39%)	0 / 18 (0.00%)
occurrences all number	4	17	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	3 / 67 (4.48%)	14 / 112 (12.50%)	0 / 18 (0.00%)
occurrences all number	3	18	0
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	1 / 67 (1.49%)	18 / 112 (16.07%)	0 / 18 (0.00%)
occurrences all number	1	20	0
Psychiatric disorders
Eating Disorder
subjects affected / exposed	25 / 67 (37.31%)	53 / 112 (47.32%)	9 / 18 (50.00%)
occurrences all number	26	80	9
Irritability
subjects affected / exposed	40 / 67 (59.70%)	84 / 112 (75.00%)	14 / 18 (77.78%)
occurrences all number	43	140	14
Infections and infestations
Bronchitis
subjects affected / exposed	4 / 67 (5.97%)	14 / 112 (12.50%)	1 / 18 (5.56%)
occurrences all number	4	16	1
Conjunctivitis
subjects affected / exposed	5 / 67 (7.46%)	16 / 112 (14.29%)	0 / 18 (0.00%)
occurrences all number	5	19	0
Ear Infection
subjects affected / exposed	1 / 67 (1.49%)	6 / 112 (5.36%)	0 / 18 (0.00%)
occurrences all number	1	6	0
Exanthema Subitum
subjects affected / exposed	0 / 67 (0.00%)	1 / 112 (0.89%)	1 / 18 (5.56%)
occurrences all number	0	1	1
Gastroenteritis
subjects affected / exposed	0 / 67 (0.00%)	6 / 112 (5.36%)	0 / 18 (0.00%)
occurrences all number	0	6	0
Nasopharyngitis
subjects affected / exposed	5 / 67 (7.46%)	9 / 112 (8.04%)	2 / 18 (11.11%)
occurrences all number	5	10	2
Otitis Media
subjects affected / exposed	7 / 67 (10.45%)	18 / 112 (16.07%)	1 / 18 (5.56%)
occurrences all number	9	23	1
Pharyngitis
subjects affected / exposed	2 / 67 (2.99%)	9 / 112 (8.04%)	0 / 18 (0.00%)
occurrences all number	2	10	0
Pneumonia
subjects affected / exposed	0 / 67 (0.00%)	0 / 112 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	1
Rhinitis
subjects affected / exposed	2 / 67 (2.99%)	8 / 112 (7.14%)	0 / 18 (0.00%)
occurrences all number	2	10	0
Upper Respiratory Tract Infection
subjects affected / exposed	5 / 67 (7.46%)	20 / 112 (17.86%)	1 / 18 (5.56%)
occurrences all number	6	29	2
Viral Infection
subjects affected / exposed	7 / 67 (10.45%)	14 / 112 (12.50%)	1 / 18 (5.56%)
occurrences all number	8	15	2

More information

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Were there any global substantial amendments to the protocol? Yes

01 Dec 2010

To perform assessment of persistence data generated one year after the booster (fourth) dose of rMenB+OMV NZ (groups B246_12M12 and B246_12M13) and one year after the two catch-up doses of rMenB+OMV NZ (groups B13_15_27 and B12_14_26) with a comparison against baseline titers of naive subjects at 24 months of age (group B_24_26).

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Geometric Mean Titers (GMTs) to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination

Primary: Geometric Mean Titers (GMTs) to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination

Primary: Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination

Primary: Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination

Primary: Geometric Mean concentrations (GMCs) to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination

Primary: Geometric Mean concentrations (GMCs) to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination

Secondary: GMTs to assess antibody persistence at 12 months after two catch-up doses and 6 months after booster dose of rMenB+OMV NZ Vaccination

Secondary: GMTs to assess antibody persistence at 12 months after two catch-up doses and 6 months after booster dose of rMenB+OMV NZ Vaccination

Secondary: Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody persistence at 12 months after two catch up doses and 6 months after a booster doses of rMenB+OMV NZ Vaccination.

Secondary: Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody persistence at 12 months after two catch up doses and 6 months after a booster doses of rMenB+OMV NZ Vaccination.

Secondary: Percentage of subjects with at least four fold increase in hSBA titers to evaluate antibody response 1 month post booster dose of rMenB+OMV NZ Vaccination

Secondary: Percentage of subjects with at least four fold increase in hSBA titers to evaluate antibody response 1 month post booster dose of rMenB+OMV NZ Vaccination

Secondary: GMCs to assess antibody persistence at one year after two catch-up doses and 6 months after booster of rMenB+OMV NZ Vaccination against 287-953 strain.

Secondary: GMCs to assess antibody persistence at one year after two catch-up doses and 6 months after booster of rMenB+OMV NZ Vaccination against 287-953 strain.

Secondary: GMTs to characterize antibody response at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Secondary: GMTs to characterize antibody response at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Secondary: Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

Secondary: Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

Secondary: Percentage of subjects with fourfold increases in hSBA to assess antibody response at 1 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

Secondary: Percentage of subjects with fourfold increases in hSBA to assess antibody response at 1 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

Secondary: GMCs to assess antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain.

Secondary: GMCs to assess antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain.

Secondary: Number of subjects reporting solicited local and systemic AEs after receiving a booster (3rd) dose of rMenB+OMV NZ administered at 1year after 2 catch-up doses of rMenB+OMV NZ, previously administered at either 12 & 14 or 13 & 15 months of age in V72P13E1

Secondary: Number of subjects reporting solicited local and systemic AEs after receiving a booster (3rd) dose of rMenB+OMV NZ administered at 1year after 2 catch-up doses of rMenB+OMV NZ, previously administered at either 12 & 14 or 13 & 15 months of age in V72P13E1

Secondary: Number of Subjects Reporting Unsolicited AEs after receiving a booster (3rd) dose of rMenB+OMV NZ administered at 1 year after 2 catch-up doses of rMenB+OMV NZ,previously administered to children at either 12 & 14 or 13 &15 months of age in V72P13E2

Secondary: Number of Subjects Reporting Unsolicited AEs after receiving a booster (3rd) dose of rMenB+OMV NZ administered at 1 year after 2 catch-up doses of rMenB+OMV NZ,previously administered to children at either 12 & 14 or 13 &15 months of age in V72P13E2

Secondary: Number of subjects reporting solicited local and systemic AEs after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Secondary: Number of subjects reporting solicited local and systemic AEs after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Secondary: Number of Subjects Reporting Unsolicited Adverse Events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Secondary: Number of Subjects Reporting Unsolicited Adverse Events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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