Meningococcal Disease, Meningococcal Meningitis
Conditions
Keywords
Meningococcal disease, Vaccines, Adolescents
Brief summary
This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence at 18 months after the vaccination course in study V72P10 (NCT00661713). Subjects who participated in study V72P10, and who meet all other enrollment criteria for this extension study, and a group of naïve subjects (defined as subjects who had never received rMenB+OMV NZ or other experimental MenB vaccines) of similar age to the subjects who were eligible to participate in this extension study, performed one study visit in which a single blood sample was drawn for MenB serological analyses.
Interventions
BIOLOGICALNo Vaccine
BIOLOGICALrMenB+OMV-NZ
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
Sponsors
Novartis Vaccines
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
Informed consent was obtained from all the subjects before enrollment into the study after the nature of the study had been explained. Inclusion criteria for naive subjects, newly enrolled: 1. Healthy adolescents, 13-19 years of age (the age window is defined as the first day the subject turns 13 years of age up to the day before the subject turns 20 years of age). 2. For Minor subjects: * subjects who had given their written assent and whose parent or legal guardians had given written informed consent at the time of enrollment, after the nature of the study had been explained. For Adult subjects: * subjects who had given their written informed consent at the time of enrollment, after the nature of the study had been explained. 3. Were available for the visit scheduled in the study. 4. Were in good health as determined by medical history, physical examination, clinical judgment of the investigator. Inclusion criteria for subjects who participated in the V72P10 study (follow-on subjects): 1. For Minor subjects: (≤18 years of age) * subjects who had given their written assent and whose parent or legal guardians had given written informed consent at the time of enrollment, after the nature of the study had been explained. For Adult subjects: (older than 18 years of age) * subjects who had given their written informed consent at the time of enrollment, after the nature of the study had been explained. 2. Who had participated in the V72P10 study and had received their last vaccination 18 months (-30 + 90 days) before enrollment in V72P10E1. 3. Who had completed the vaccination course in study V72P10, according to the protocol. 4. Who had provided at least the blood sample one month after the last vaccination in V72P10 (blood sample at visit 6, month 7), according to the protocol. 5. Were available for the study visit scheduled in the study. 6. Were in good health as determined by medical history, physical examination, clinical judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study. | 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). |
| Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. | month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study. | 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. |
| 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. | month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study. | 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. |
| Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. | 18 months after last vaccination V72P10 study. | 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. |
Countries
Chile
Participant flow
Recruitment details
Subjects were enrolled at six study sites in Chile.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| rMenB06 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. | 49 |
| 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. | 95 |
| 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. | 53 |
| 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. | 102 |
| 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. | 57 |
| 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. | 106 |
| 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. | 153 |
| 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. | 51 |
| Naive Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines | 151 |
| Total | 817 |
Baseline characteristics
| Characteristic | rMenB06 | rMenB0 | rMenB016 | rMenB01 | rMenB026 | rMenB02 | rMenB012 | rMenB6 | Naive | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 16.2 Years STANDARD_DEVIATION 1.9 | 16.0 Years STANDARD_DEVIATION 2 | 16.2 Years STANDARD_DEVIATION 2.1 | 16.1 Years STANDARD_DEVIATION 1.9 | 15.6 Years STANDARD_DEVIATION 1.9 | 15.9 Years STANDARD_DEVIATION 1.8 | 15.9 Years STANDARD_DEVIATION 1.9 | 16.0 Years STANDARD_DEVIATION 1.9 | 15.6 Years STANDARD_DEVIATION 1.7 | 15.9 Years STANDARD_DEVIATION 1.9 |
| Sex: Female, Male Female | 30 Participants | 53 Participants | 33 Participants | 57 Participants | 38 Participants | 61 Participants | 96 Participants | 33 Participants | 61 Participants | 462 Participants |
| Sex: Female, Male Male | 19 Participants | 42 Participants | 20 Participants | 45 Participants | 19 Participants | 45 Participants | 57 Participants | 18 Participants | 90 Participants | 355 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 95 | 0 / 53 | 0 / 102 | 0 / 57 | 0 / 106 | 0 / 153 | 0 / 51 | 0 / 151 |
| serious Total, serious adverse events | 0 / 49 | 0 / 95 | 0 / 53 | 0 / 102 | 0 / 57 | 0 / 106 | 0 / 153 | 0 / 51 | 0 / 151 |
Outcome results
Primary
Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.
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.
Time frame: 18 months after last vaccination V72P10 study.
Population: Analysis was performed on the MITT dataset.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| rMenB06 | 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 |
| rMenB0 | Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. | 55 UI/mL |
| rMenB016 | Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. | 555 UI/mL |
| rMenB01 | Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. | 217 UI/mL |
| rMenB026 | Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. | 490 UI/mL |
| rMenB02 | Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. | 150 UI/mL |
| rMenB012 | Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. | 175 UI/mL |
| rMenB6 | Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. | 59 UI/mL |
| Naive | Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. | 24 UI/mL |
Primary
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB0 | 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 | 7.1 Geometric mean titers |
| rMenB0 | 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) | 63 Geometric mean titers |
| rMenB0 | 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) | 33 Geometric mean titers |
| rMenB0 | 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) | 2.65 Geometric mean titers |
| rMenB0 | 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) | 3.75 Geometric mean titers |
| rMenB0 | 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 | 8.71 Geometric mean titers |
| rMenB0 | 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) | 47 Geometric mean titers |
| rMenB0 | 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 | 16 Geometric mean titers |
| rMenB0 | 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) | 2.65 Geometric mean titers |
| rMenB016 | 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) | 3.68 Geometric mean titers |
| rMenB016 | 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 | 121 Geometric mean titers |
| rMenB016 | 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) | 1181 Geometric mean titers |
| rMenB016 | 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 | 50 Geometric mean titers |
| rMenB016 | 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) | 3.56 Geometric mean titers |
| rMenB016 | 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) | 316 Geometric mean titers |
| rMenB016 | 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 | 42 Geometric mean titers |
| rMenB016 | 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) | 174 Geometric mean titers |
| rMenB016 | 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) | 2.55 Geometric mean titers |
| rMenB01 | 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) | 2.74 Geometric mean titers |
| rMenB01 | 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) | 189 Geometric mean titers |
| rMenB01 | 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) | 78 Geometric mean titers |
| rMenB01 | 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 | 40 Geometric mean titers |
| rMenB01 | 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 | 29 Geometric mean titers |
| rMenB01 | 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) | 2.22 Geometric mean titers |
| rMenB01 | 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) | 2.15 Geometric mean titers |
| rMenB01 | 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) | 445 Geometric mean titers |
| rMenB01 | 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 | 17 Geometric mean titers |
| rMenB026 | 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) | 1105 Geometric mean titers |
| rMenB026 | 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) | 2.76 Geometric mean titers |
| rMenB026 | 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) | 265 Geometric mean titers |
| rMenB026 | 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 | 44 Geometric mean titers |
| rMenB026 | 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) | 1.72 Geometric mean titers |
| rMenB026 | 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 | 100 Geometric mean titers |
| rMenB026 | 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) | 2.15 Geometric mean titers |
| rMenB026 | 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) | 170 Geometric mean titers |
| rMenB026 | 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 | 41 Geometric mean titers |
| rMenB02 | 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) | 3.24 Geometric mean titers |
| rMenB02 | 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) | 2.36 Geometric mean titers |
| rMenB02 | 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) | 115 Geometric mean titers |
| rMenB02 | 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 | 34 Geometric mean titers |
| rMenB02 | 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) | 727 Geometric mean titers |
| rMenB02 | 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) | 2.63 Geometric mean titers |
| rMenB02 | 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 | 43 Geometric mean titers |
| rMenB02 | 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 |
| rMenB02 | 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 | 19 Geometric mean titers |
| rMenB012 | 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 | 23 Geometric mean titers |
| rMenB012 | 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) | 3.86 Geometric mean titers |
| rMenB012 | 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) | 605 Geometric mean titers |
| rMenB012 | 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) | 2.63 Geometric mean titers |
| rMenB012 | 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 | 42 Geometric mean titers |
| rMenB012 | 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 | 73 Geometric mean titers |
| rMenB012 | 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) | 2.75 Geometric mean titers |
| rMenB012 | 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) | 253 Geometric mean titers |
| rMenB012 | 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) | 129 Geometric mean titers |
| rMenB6 | 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) | 2.67 Geometric mean titers |
| rMenB6 | 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) | 62 Geometric mean titers |
| rMenB6 | 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) | 43 Geometric mean titers |
| rMenB6 | 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) | 68 Geometric mean titers |
| rMenB6 | 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 | 9.16 Geometric mean titers |
| rMenB6 | 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 | 9.85 Geometric mean titers |
| rMenB6 | 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) | 4.33 Geometric mean titers |
| rMenB6 | 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) | 2.68 Geometric mean titers |
| rMenB6 | 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 | 19 Geometric mean titers |
| Naive | 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) | NA Geometric mean titers |
| Naive | 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 | 2.13 Geometric mean titers |
| Naive | 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 | 4.52 Geometric mean titers |
| Naive | 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) | NA Geometric mean titers |
| Naive | 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) | NA Geometric mean titers |
| Naive | 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) | NA Geometric mean titers |
| Naive | 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) | NA Geometric mean titers |
| Naive | 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 | 3.23 Geometric mean titers |
| Naive | 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) | NA Geometric mean titers |
Primary
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.
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.
Time frame: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB0 | 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) | 0.34 Geometric mean ratio |
| rMenB0 | 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) | 12 Geometric mean ratio |
| rMenB0 | 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) | 24 Geometric mean ratio |
| rMenB0 | 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) | 3.29 Geometric mean ratio |
| rMenB0 | 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) | 2.68 Geometric mean ratio |
| rMenB0 | 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) | 0.27 Geometric mean ratio |
| rMenB0 | 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) | 4.26 Geometric mean ratio |
| rMenB0 | 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) | 0.11 Geometric mean ratio |
| rMenB0 | 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) | 12 Geometric mean ratio |
| rMenB016 | 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) | 0.16 Geometric mean ratio |
| rMenB016 | 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) | 0.1 Geometric mean ratio |
| rMenB016 | 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) | 0.24 Geometric mean ratio |
| rMenB016 | 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) | 14 Geometric mean ratio |
| rMenB016 | 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) | 89 Geometric mean ratio |
| rMenB016 | 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) | 11 Geometric mean ratio |
| rMenB016 | 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) | 462 Geometric mean ratio |
| rMenB016 | 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) | 47 Geometric mean ratio |
| rMenB016 | 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) | 47 Geometric mean ratio |
| rMenB01 | 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) | 200 Geometric mean ratio |
| rMenB01 | 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) | 0.15 Geometric mean ratio |
| rMenB01 | 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) | 18 Geometric mean ratio |
| rMenB01 | 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) | 7.93 Geometric mean ratio |
| rMenB01 | 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) | 11 Geometric mean ratio |
| rMenB01 | 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) | 0.22 Geometric mean ratio |
| rMenB01 | 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) | 36 Geometric mean ratio |
| rMenB01 | 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) | 69 Geometric mean ratio |
| rMenB01 | 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) | 0.091 Geometric mean ratio |
| rMenB026 | 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) | 58 Geometric mean ratio |
| rMenB026 | 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) | 96 Geometric mean ratio |
| rMenB026 | 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) | 16 Geometric mean ratio |
| rMenB026 | 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) | 0.17 Geometric mean ratio |
| rMenB026 | 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) | 644 Geometric mean ratio |
| rMenB026 | 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) | 0.09 Geometric mean ratio |
| rMenB026 | 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) | 79 Geometric mean ratio |
| rMenB026 | 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) | 19 Geometric mean ratio |
| rMenB026 | 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) | 0.24 Geometric mean ratio |
| rMenB02 | 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) | 11 Geometric mean ratio |
| rMenB02 | 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) | 70 Geometric mean ratio |
| rMenB02 | 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) | 44 Geometric mean ratio |
| rMenB02 | 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) | 0.15 Geometric mean ratio |
| rMenB02 | 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) | 309 Geometric mean ratio |
| rMenB02 | 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 |
| rMenB02 | 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) | 18 Geometric mean ratio |
| rMenB02 | 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) | 7.37 Geometric mean ratio |
| rMenB02 | 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) | 0.06 Geometric mean ratio |
| rMenB012 | 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) | 8.42 Geometric mean ratio |
| rMenB012 | 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) | 66 Geometric mean ratio |
| rMenB012 | 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 |
| rMenB012 | 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) | 47 Geometric mean ratio |
| rMenB012 | 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) | 230 Geometric mean ratio |
| rMenB012 | 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) | 0.16 Geometric mean ratio |
| rMenB012 | 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) | 11 Geometric mean ratio |
| rMenB012 | 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) | 0.18 Geometric mean ratio |
| rMenB012 | 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) | 0.12 Geometric mean ratio |
| rMenB6 | 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) | 0.21 Geometric mean ratio |
| rMenB6 | 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) | 0.15 Geometric mean ratio |
| rMenB6 | 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) | 25 Geometric mean ratio |
| rMenB6 | 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) | 0.31 Geometric mean ratio |
| rMenB6 | 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) | 16 Geometric mean ratio |
| rMenB6 | 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) | 4.46 Geometric mean ratio |
| rMenB6 | 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) | 3.43 Geometric mean ratio |
| rMenB6 | 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) | 14 Geometric mean ratio |
| rMenB6 | 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) | 3.69 Geometric mean ratio |
Primary
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.
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB06 | 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 |
| rMenB0 | 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 | 65 Percentage of subjects |
| rMenB0 | 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) | 96 Percentage of subjects |
| rMenB0 | 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) | 94 Percentage of subjects |
| rMenB0 | 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) | 33 Percentage of subjects |
| rMenB0 | 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) | 40 Percentage of subjects |
| rMenB0 | 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 | 62 Percentage of subjects |
| rMenB0 | 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) | 93 Percentage of subjects |
| rMenB0 | 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 | 73 Percentage of subjects |
| rMenB0 | 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) | 31 Percentage of subjects |
| rMenB016 | 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) | 32 Percentage of subjects |
| rMenB016 | 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 | 98 Percentage of subjects |
| rMenB016 | 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) | 100 Percentage of subjects |
| rMenB016 | 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 | 92 Percentage of subjects |
| rMenB016 | 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) | 40 Percentage of subjects |
| rMenB016 | 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 |
| rMenB016 | 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 | 98 Percentage of subjects |
| rMenB016 | 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 |
| rMenB016 | 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) | 28 Percentage of subjects |
| rMenB01 | 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) | 32 Percentage of subjects |
| rMenB01 | 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 |
| rMenB01 | 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 |
| rMenB01 | 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 | 93 Percentage of subjects |
| rMenB01 | 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 | 82 Percentage of subjects |
| rMenB01 | 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) | 26 Percentage of subjects |
| rMenB01 | 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) | 24 Percentage of subjects |
| rMenB01 | 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) | 100 Percentage of subjects |
| rMenB01 | 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 | 75 Percentage of subjects |
| rMenB026 | 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) | 100 Percentage of subjects |
| rMenB026 | 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) | 32 Percentage of subjects |
| rMenB026 | 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 |
| rMenB026 | 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 | 86 Percentage of subjects |
| rMenB026 | 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) | 21 Percentage of subjects |
| rMenB026 | 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 | 100 Percentage of subjects |
| rMenB026 | 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) | 21 Percentage of subjects |
| rMenB026 | 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) | 98 Percentage of subjects |
| rMenB026 | 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 | 96 Percentage of subjects |
| rMenB02 | 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) | 41 Percentage of subjects |
| rMenB02 | 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) | 30 Percentage of subjects |
| rMenB02 | 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 |
| rMenB02 | 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 | 81 Percentage of subjects |
| rMenB02 | 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) | 100 Percentage of subjects |
| rMenB02 | 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) | 30 Percentage of subjects |
| rMenB02 | 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 | 95 Percentage of subjects |
| rMenB02 | 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 |
| rMenB02 | 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 | 75 Percentage of subjects |
| rMenB012 | 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 |
| rMenB012 | 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) | 44 Percentage of subjects |
| rMenB012 | 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) | 100 Percentage of subjects |
| rMenB012 | 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) | 34 Percentage of subjects |
| rMenB012 | 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 | 83 Percentage of subjects |
| rMenB012 | 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 | 96 Percentage of subjects |
| rMenB012 | 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) | 30 Percentage of subjects |
| rMenB012 | 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 |
| rMenB012 | 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) | 99 Percentage of subjects |
| rMenB6 | 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) | 33 Percentage of subjects |
| rMenB6 | 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) | 94 Percentage of subjects |
| rMenB6 | 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) | 92 Percentage of subjects |
| rMenB6 | 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) | 88 Percentage of subjects |
| rMenB6 | 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 | 61 Percentage of subjects |
| rMenB6 | 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 | 73 Percentage of subjects |
| rMenB6 | 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) | 47 Percentage of subjects |
| rMenB6 | 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 |
| rMenB6 | 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 | 73 Percentage of subjects |
| Naive | 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) | NA Percentage of subjects |
| Naive | 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 | 25 Percentage of subjects |
| Naive | 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 | 50 Percentage of subjects |
| Naive | 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) | NA Percentage of subjects |
| Naive | 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) | NA Percentage of subjects |
| Naive | 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) | NA Percentage of subjects |
| Naive | 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) | NA Percentage of subjects |
| Naive | 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 | 40 Percentage of subjects |
| Naive | 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) | NA Percentage of subjects |