Trial Outcomes & Findings for Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10 (NCT NCT01148524)

Results Overview

The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

817 participants

Primary outcome timeframe

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

Results posted on

2018-06-15

Participant Flow

Subjects were enrolled at six study sites in Chile.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	rMenB06 Subjects who had received 2 doses each of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB+OMV-NZ) (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.	rMenB0 Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.	rMenB016 Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.	rMenB01 Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.	rMenB026 Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.	rMenB02 Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.	rMenB012 Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.	rMenB6 Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.	Naive Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
Overall Study STARTED	49	95	53	102	57	106	153	51	151
Overall Study COMPLETED	49	95	53	102	57	106	153	51	151
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rMenB06 n=49 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.	rMenB0 n=95 Participants Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.	rMenB016 n=53 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.	rMenB01 n=102 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.	rMenB026 n=57 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.	rMenB02 n=106 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.	rMenB012 n=153 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.	rMenB6 n=51 Participants Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.	Naive n=151 Participants Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines	Total n=817 Participants Total of all reporting groups
Age, Continuous	16.2 Years STANDARD_DEVIATION 1.9 • n=5 Participants	16.0 Years STANDARD_DEVIATION 2.0 • n=7 Participants	16.2 Years STANDARD_DEVIATION 2.1 • n=5 Participants	16.1 Years STANDARD_DEVIATION 1.9 • n=4 Participants	15.6 Years STANDARD_DEVIATION 1.9 • n=21 Participants	15.9 Years STANDARD_DEVIATION 1.8 • n=10 Participants	15.9 Years STANDARD_DEVIATION 1.9 • n=115 Participants	16.0 Years STANDARD_DEVIATION 1.9 • n=6 Participants	15.6 Years STANDARD_DEVIATION 1.7 • n=6 Participants	15.9 Years STANDARD_DEVIATION 1.9 • n=64 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	53 Participants n=7 Participants	33 Participants n=5 Participants	57 Participants n=4 Participants	38 Participants n=21 Participants	61 Participants n=10 Participants	96 Participants n=115 Participants	33 Participants n=6 Participants	61 Participants n=6 Participants	462 Participants n=64 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	42 Participants n=7 Participants	20 Participants n=5 Participants	45 Participants n=4 Participants	19 Participants n=21 Participants	45 Participants n=10 Participants	57 Participants n=115 Participants	18 Participants n=6 Participants	90 Participants n=6 Participants	355 Participants n=64 Participants

PRIMARY outcome

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

Population: Analysis was performed on the modified intention-to-treat (MITT) data set, i.e. all subjects who provided evaluable serum samples. Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator.

The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA).

Outcome measures

Outcome measures
Measure	rMenB06 n=49 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.	rMenB0 n=95 Participants Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.	rMenB016 n=53 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.	rMenB01 n=102 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.	rMenB026 n=57 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.	rMenB02 n=106 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.	rMenB012 n=153 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.	rMenB6 n=51 Participants Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.	Naive n=151 Participants Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.44/76-SL-bl (N=49,95,53,102,57,106,153,51,0)	31 Percentage of subjects Interval 18.0 to 45.0	40 Percentage of subjects Interval 30.0 to 51.0	40 Percentage of subjects Interval 26.0 to 54.0	32 Percentage of subjects Interval 23.0 to 42.0	32 Percentage of subjects Interval 20.0 to 45.0	41 Percentage of subjects Interval 31.0 to 51.0	44 Percentage of subjects Interval 36.0 to 52.0	47 Percentage of subjects Interval 33.0 to 62.0	NA Percentage of subjects Data were not collected since the Naive subjects were enrolled in this study as comparator.
Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.44/76-SL-1m (N=49,95,53,102,57,106,153,51,0)	100 Percentage of subjects Interval 93.0 to 100.0	93 Percentage of subjects Interval 85.0 to 97.0	100 Percentage of subjects Interval 93.0 to 100.0	100 Percentage of subjects Interval 96.0 to 100.0	100 Percentage of subjects Interval 94.0 to 100.0	100 Percentage of subjects Interval 97.0 to 100.0	100 Percentage of subjects Interval 98.0 to 100.0	94 Percentage of subjects Interval 84.0 to 99.0	NA Percentage of subjects Data were not collected since the Naive subjects were enrolled in this study as comparator.
Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.44/76-SL-18m	84 Percentage of subjects Interval 70.0 to 93.0	73 Percentage of subjects Interval 63.0 to 81.0	92 Percentage of subjects Interval 82.0 to 98.0	82 Percentage of subjects Interval 74.0 to 89.0	86 Percentage of subjects Interval 74.0 to 94.0	81 Percentage of subjects Interval 72.0 to 88.0	83 Percentage of subjects Interval 76.0 to 89.0	73 Percentage of subjects Interval 58.0 to 84.0	50 Percentage of subjects Interval 42.0 to 59.0
Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.5/99-bl (N=49,95,53,102,57,106,153,51,0)	22 Percentage of subjects Interval 12.0 to 37.0	33 Percentage of subjects Interval 23.0 to 43.0	28 Percentage of subjects Interval 17.0 to 42.0	26 Percentage of subjects Interval 18.0 to 36.0	21 Percentage of subjects Interval 11.0 to 34.0	30 Percentage of subjects Interval 22.0 to 40.0	34 Percentage of subjects Interval 27.0 to 42.0	33 Percentage of subjects Interval 21.0 to 48.0	NA Percentage of subjects Data were not collected since the Naive subjects were enrolled in this study as comparator.
Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.5/99-1m (N=49,95,53,102,57,106,153,51,0)	98 Percentage of subjects Interval 89.0 to 100.0	96 Percentage of subjects Interval 90.0 to 99.0	100 Percentage of subjects Interval 93.0 to 100.0	100 Percentage of subjects Interval 96.0 to 100.0	100 Percentage of subjects Interval 94.0 to 100.0	100 Percentage of subjects Interval 97.0 to 100.0	100 Percentage of subjects Interval 98.0 to 100.0	88 Percentage of subjects Interval 76.0 to 96.0	NA Percentage of subjects Data were not collected since the Naive subjects were enrolled in this study as comparator.
Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.5/99-18m	94 Percentage of subjects Interval 83.0 to 99.0	65 Percentage of subjects Interval 55.0 to 75.0	98 Percentage of subjects Interval 90.0 to 100.0	93 Percentage of subjects Interval 86.0 to 97.0	100 Percentage of subjects Interval 94.0 to 100.0	95 Percentage of subjects Interval 89.0 to 98.0	96 Percentage of subjects Interval 92.0 to 99.0	73 Percentage of subjects Interval 58.0 to 84.0	25 Percentage of subjects Interval 18.0 to 33.0
Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.NZ98/254-bl (N=49,95,53,102,57,106,153,51,0)	29 Percentage of subjects Interval 17.0 to 43.0	31 Percentage of subjects Interval 21.0 to 41.0	32 Percentage of subjects Interval 20.0 to 46.0	24 Percentage of subjects Interval 16.0 to 33.0	21 Percentage of subjects Interval 11.0 to 34.0	30 Percentage of subjects Interval 22.0 to 40.0	30 Percentage of subjects Interval 22.0 to 38.0	29 Percentage of subjects Interval 17.0 to 44.0	NA Percentage of subjects Data were not collected since the Naive subjects were enrolled in this study as comparator.
Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.NZ98/254-1m (N=49,95,53,102,57,106,153,51,0)	100 Percentage of subjects Interval 93.0 to 100.0	94 Percentage of subjects Interval 87.0 to 98.0	100 Percentage of subjects Interval 93.0 to 100.0	100 Percentage of subjects Interval 96.0 to 100.0	98 Percentage of subjects Interval 91.0 to 100.0	100 Percentage of subjects Interval 97.0 to 100.0	99 Percentage of subjects Interval 96.0 to 100.0	92 Percentage of subjects Interval 81.0 to 98.0	NA Percentage of subjects Data were not collected since the Naive subjects were enrolled in this study as comparator.
Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.NZ98/254-18m	86 Percentage of subjects Interval 73.0 to 94.0	62 Percentage of subjects Interval 52.0 to 72.0	98 Percentage of subjects Interval 90.0 to 100.0	75 Percentage of subjects Interval 65.0 to 83.0	96 Percentage of subjects Interval 88.0 to 100.0	75 Percentage of subjects Interval 66.0 to 83.0	86 Percentage of subjects Interval 79.0 to 91.0	61 Percentage of subjects Interval 46.0 to 74.0	40 Percentage of subjects Interval 32.0 to 48.0

PRIMARY outcome

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

Population: Analysis was performed on the MITT data set.Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator.

The immune response was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.

Outcome measures

Outcome measures
Measure	rMenB06 n=49 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.	rMenB0 n=95 Participants Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.	rMenB016 n=53 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.	rMenB01 n=102 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.	rMenB026 n=57 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.	rMenB02 n=106 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.	rMenB012 n=153 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.	rMenB6 n=51 Participants Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.	Naive n=151 Participants Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.44/76-SL-bl (N=49,95,53,102,57,106,153,51,0)	2.83 Geometric mean titers Interval 1.85 to 4.31	3.75 Geometric mean titers Interval 2.75 to 5.12	3.56 Geometric mean titers Interval 2.37 to 5.34	2.74 Geometric mean titers Interval 2.04 to 3.68	2.76 Geometric mean titers Interval 1.86 to 4.1	3.24 Geometric mean titers Interval 2.43 to 4.34	3.86 Geometric mean titers Interval 3.02 to 4.93	4.33 Geometric mean titers Interval 2.86 to 6.56	NA Geometric mean titers Data were not collected since the Naive subjects were enrolled in this study as comparator.
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.44/76-SL-1m (N=49,95,53,102,57,106,153,51,0)	227 Geometric mean titers Interval 161.0 to 320.0	47 Geometric mean titers Interval 36.0 to 60.0	316 Geometric mean titers Interval 227.0 to 439.0	189 Geometric mean titers Interval 149.0 to 241.0	265 Geometric mean titers Interval 192.0 to 365.0	227 Geometric mean titers Interval 179.0 to 287.0	253 Geometric mean titers Interval 208.0 to 309.0	62 Geometric mean titers Interval 44.0 to 86.0	NA Geometric mean titers Data were not collected since the Naive subjects were enrolled in this study as comparator.
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.44/76-SL-18m	27 Geometric mean titers Interval 16.0 to 45.0	16 Geometric mean titers Interval 11.0 to 23.0	50 Geometric mean titers Interval 30.0 to 83.0	29 Geometric mean titers Interval 20.0 to 42.0	44 Geometric mean titers Interval 27.0 to 73.0	34 Geometric mean titers Interval 24.0 to 49.0	42 Geometric mean titers Interval 31.0 to 56.0	19 Geometric mean titers Interval 12.0 to 32.0	4.52 Geometric mean titers Interval 3.52 to 5.82
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.5/99-bl (N=49,95,53,102,57,106,153,51,0)	2.31 Geometric mean titers Interval 1.62 to 3.3	2.65 Geometric mean titers Interval 2.04 to 3.44	2.55 Geometric mean titers Interval 1.81 to 3.6	2.22 Geometric mean titers Interval 1.73 to 2.85	1.72 Geometric mean titers Interval 1.23 to 2.39	2.36 Geometric mean titers Interval 1.84 to 3.01	2.63 Geometric mean titers Interval 2.14 to 3.23	2.67 Geometric mean titers Interval 1.88 to 3.79	NA Geometric mean titers Data were not collected since the Naive subjects were enrolled in this study as comparator.
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.5/99-1m (N=49,95,53,102,57,106,153,51,0)	802 Geometric mean titers Interval 574.0 to 1121.0	63 Geometric mean titers Interval 49.0 to 81.0	1181 Geometric mean titers Interval 856.0 to 1630.0	445 Geometric mean titers Interval 352.0 to 562.0	1105 Geometric mean titers Interval 808.0 to 1510.0	727 Geometric mean titers Interval 577.0 to 916.0	605 Geometric mean titers Interval 499.0 to 735.0	68 Geometric mean titers Interval 49.0 to 94.0	NA Geometric mean titers Data were not collected since the Naive subjects were enrolled in this study as comparator.
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.5/99-18m	65 Geometric mean titers Interval 43.0 to 98.0	7.1 Geometric mean titers Interval 5.24 to 9.6	121 Geometric mean titers Interval 82.0 to 180.0	40 Geometric mean titers Interval 30.0 to 54.0	100 Geometric mean titers Interval 68.0 to 146.0	43 Geometric mean titers Interval 33.0 to 58.0	73 Geometric mean titers Interval 57.0 to 92.0	9.85 Geometric mean titers Interval 6.57 to 15.0	2.13 Geometric mean titers Interval 1.73 to 2.63
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.NZ98/254-bl (N=49,95,53,102,57,106,153,51,0)	2.66 Geometric mean titers Interval 1.8 to 3.92	2.65 Geometric mean titers Interval 1.99 to 3.53	3.68 Geometric mean titers Interval 2.53 to 5.35	2.15 Geometric mean titers Interval 1.63 to 2.82	2.15 Geometric mean titers Interval 1.5 to 3.1	2.63 Geometric mean titers Interval 2.01 to 3.44	2.75 Geometric mean titers Interval 2.19 to 3.44	2.68 Geometric mean titers Interval 1.82 to 3.93	NA Geometric mean titers Data were not collected since the Naive subjects were enrolled in this study as comparator.
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.NZ98/254-1m (N=49,95,53,102,57,106,153,51,0)	154 Geometric mean titers Interval 107.0 to 221.0	33 Geometric mean titers Interval 25.0 to 43.0	174 Geometric mean titers Interval 123.0 to 248.0	78 Geometric mean titers Interval 60.0 to 100.0	170 Geometric mean titers Interval 121.0 to 238.0	115 Geometric mean titers Interval 89.0 to 148.0	129 Geometric mean titers Interval 105.0 to 160.0	43 Geometric mean titers Interval 30.0 to 62.0	NA Geometric mean titers Data were not collected since the Naive subjects were enrolled in this study as comparator.
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. S.NZ98/254-18m	27 Geometric mean titers Interval 17.0 to 43.0	8.71 Geometric mean titers Interval 6.12 to 12.0	42 Geometric mean titers Interval 26.0 to 66.0	17 Geometric mean titers Interval 12.0 to 24.0	41 Geometric mean titers Interval 26.0 to 64.0	19 Geometric mean titers Interval 14.0 to 27.0	23 Geometric mean titers Interval 18.0 to 31.0	9.16 Geometric mean titers Interval 5.71 to 15.0	3.23 Geometric mean titers Interval 2.52 to 4.14

PRIMARY outcome

Timeframe: month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study.

Population: Analysis was performed on the MITT data set. Naive group was not reported for this endpoint since GMR data for this group were not collected (subjects were enrolled in this study and no GMT values at 1m and 18 m after last vaccination in V72P10 are available).

The immune response was measured as the geometric mean ratio (GMRs) of hSBA GMTs against meningococcal strains 44/76-SL, 5/99 and NZ98/254 as follow: GMTs at 1 month after last vaccination to baseline GMTs; GMTs at 18 months after last vaccination to baselines GMTs; and GMTs at 18 months after last vaccination to GMTs at 1 month after last vaccination.

Outcome measures

Outcome measures
Measure	rMenB06 n=49 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.	rMenB0 n=95 Participants Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.	rMenB016 n=53 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.	rMenB01 n=102 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.	rMenB026 n=57 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.	rMenB02 n=106 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.	rMenB012 n=153 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.	rMenB6 n=51 Participants Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.	Naive Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study. S.44/76-SL (1 m postvaccination to baseline)	80 Geometric mean ratio Interval 53.0 to 122.0	12 Geometric mean ratio Interval 9.18 to 17.0	89 Geometric mean ratio Interval 60.0 to 133.0	69 Geometric mean ratio Interval 52.0 to 92.0	96 Geometric mean ratio Interval 65.0 to 141.0	70 Geometric mean ratio Interval 52.0 to 93.0	66 Geometric mean ratio Interval 52.0 to 83.0	14 Geometric mean ratio Interval 9.47 to 21.0	—
Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study. S.44/76-SL (18 m postvaccination to baseline)	9.51 Geometric mean ratio Interval 5.93 to 15.0	4.26 Geometric mean ratio Interval 3.01 to 6.03	14 Geometric mean ratio Interval 8.95 to 22.0	11 Geometric mean ratio Interval 7.6 to 15.0	16 Geometric mean ratio Interval 10.0 to 25.0	11 Geometric mean ratio Interval 7.67 to 15.0	11 Geometric mean ratio Interval 8.2 to 14.0	4.46 Geometric mean ratio Interval 2.8 to 7.11	—
Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study. S.44/76-SL (18 m to 1 m postvaccination)	0.12 Geometric mean ratio Interval 0.077 to 0.18	0.34 Geometric mean ratio Interval 0.25 to 0.47	0.16 Geometric mean ratio Interval 0.1 to 0.24	0.15 Geometric mean ratio Interval 0.11 to 0.21	0.17 Geometric mean ratio Interval 0.11 to 0.25	0.15 Geometric mean ratio Interval 0.11 to 0.21	0.16 Geometric mean ratio Interval 0.13 to 0.21	0.31 Geometric mean ratio Interval 0.2 to 0.48	—
Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study. S.5/99 (1 m postvaccination to baseline)	347 Geometric mean ratio Interval 223.0 to 541.0	24 Geometric mean ratio Interval 17.0 to 33.0	462 Geometric mean ratio Interval 301.0 to 709.0	200 Geometric mean ratio Interval 147.0 to 273.0	644 Geometric mean ratio Interval 425.0 to 976.0	309 Geometric mean ratio Interval 227.0 to 419.0	230 Geometric mean ratio Interval 178.0 to 298.0	25 Geometric mean ratio Interval 16.0 to 39.0	—
Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study. S.5/99 (18 m postvaccination to baseline)	28 Geometric mean ratio Interval 18.0 to 44.0	2.68 Geometric mean ratio Interval 1.94 to 3.7	47 Geometric mean ratio Interval 31.0 to 73.0	18 Geometric mean ratio Interval 13.0 to 25.0	58 Geometric mean ratio Interval 38.0 to 87.0	18 Geometric mean ratio Interval 14.0 to 25.0	28 Geometric mean ratio Interval 21.0 to 36.0	3.69 Geometric mean ratio Interval 2.39 to 5.7	—
Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study. S.5/99 (18 m to 1 m postvaccination)	0.081 Geometric mean ratio Interval 0.055 to 0.12	0.11 Geometric mean ratio Interval 0.085 to 0.15	0.1 Geometric mean ratio Interval 0.071 to 0.15	0.091 Geometric mean ratio Interval 0.07 to 0.12	0.09 Geometric mean ratio Interval 0.063 to 0.13	0.06 Geometric mean ratio Interval 0.046 to 0.078	0.12 Geometric mean ratio Interval 0.096 to 0.15	0.15 Geometric mean ratio Interval 0.1 to 0.21	—
Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study. SNZ98/254 (1 m postvacc to baseline)	58 Geometric mean ratio Interval 39.0 to 87.0	12 Geometric mean ratio Interval 9.22 to 17.0	47 Geometric mean ratio Interval 32.0 to 70.0	36 Geometric mean ratio Interval 27.0 to 48.0	79 Geometric mean ratio Interval 54.0 to 115.0	44 Geometric mean ratio Interval 33.0 to 58.0	47 Geometric mean ratio Interval 37.0 to 60.0	16 Geometric mean ratio Interval 11.0 to 24.0	—
Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study. S.NZ98/254 (18 m postvacc to baseline)	10 Geometric mean ratio Interval 6.62 to 15.0	3.29 Geometric mean ratio Interval 2.41 to 4.5	11 Geometric mean ratio Interval 7.57 to 17.0	7.93 Geometric mean ratio Interval 5.89 to 11.0	19 Geometric mean ratio Interval 13.0 to 28.0	7.37 Geometric mean ratio Interval 5.5 to 9.88	8.42 Geometric mean ratio Interval 6.59 to 11.0	3.43 Geometric mean ratio Interval 2.25 to 5.2	—
Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study. S.NZ98/254 (18 m to 1 m postvaccination)	0.17 Geometric mean ratio Interval 0.12 to 0.26	0.27 Geometric mean ratio Interval 0.2 to 0.35	0.24 Geometric mean ratio Interval 0.16 to 0.35	0.22 Geometric mean ratio Interval 0.17 to 0.29	0.24 Geometric mean ratio Interval 0.17 to 0.35	0.17 Geometric mean ratio Interval 0.13 to 0.22	0.18 Geometric mean ratio Interval 0.14 to 0.23	0.21 Geometric mean ratio Interval 0.14 to 0.31	—

PRIMARY outcome

Timeframe: 18 months after last vaccination V72P10 study.

Population: Analysis was performed on the MITT dataset.

The immune response was measured as the geometric mean concentrations (GMCs) directed against meningococcal 287-953 antigen, evaluated using enzyme-linked immunosorbent assay (ELISA), at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.

Outcome measures

Outcome measures
Measure	rMenB06 n=35 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.	rMenB0 n=34 Participants Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.	rMenB016 n=35 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.	rMenB01 n=35 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.	rMenB026 n=35 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.	rMenB02 n=35 Participants Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.	rMenB012 n=35 Participants Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.	rMenB6 n=34 Participants Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.	Naive n=35 Participants Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.	272 UI/mL Interval 186.0 to 397.0	55 UI/mL Interval 37.0 to 82.0	555 UI/mL Interval 376.0 to 818.0	217 UI/mL Interval 148.0 to 319.0	490 UI/mL Interval 333.0 to 721.0	150 UI/mL Interval 101.0 to 221.0	175 UI/mL Interval 119.0 to 256.0	59 UI/mL Interval 40.0 to 88.0	24 UI/mL Interval 20.0 to 27.0

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60