Meningococcal Disease
Conditions
Keywords
Meningococcal disease, prevention, vaccination
Brief summary
To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.
Interventions
BIOLOGICALrMenB
One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
BIOLOGICALrMenB+OMV
One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to 8 Months
Healthy volunteers
Yes
Inclusion criteria
* healthy 6-8 months old infants
Exclusion criteria
* previous receipt of any meningococcal B vaccine; * previous ascertained or suspected disease caused by N meningitidis; * history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; * any present or suspected serious acute or chronic disease * known or suspected autoimmune disease or impairment /alteration of immune function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Baseline and one month after second and third vaccination | Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age). |
| Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Baseline and one month after second and third vaccination | Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Baseline and one month after second and third vaccination | The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). |
| Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | One month after second and third vaccination | Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). |
| Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Day 1 through day 7 after each vaccination | Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3). |
| Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | One month after second and third vaccination | Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). |
| Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Baseline and one month after second and third vaccination | The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). |
Countries
United Kingdom
Participant flow
Recruitment details
Subjects were enrolled at one study center in the United Kingdom (UK).
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| rMenB 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age. | 30 |
| rMenB+OMV 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | rMenB | rMenB+OMV | Total |
|---|---|---|---|
| Age, Continuous | 7.0 Months STANDARD_DEVIATION 0.8 | 7.1 Months STANDARD_DEVIATION 0.7 | 7.1 Months STANDARD_DEVIATION 0.7 |
| Sex: Female, Male Female | 14 Participants | 18 Participants | 32 Participants |
| Sex: Female, Male Male | 16 Participants | 12 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 30 | 30 / 30 |
| serious Total, serious adverse events | 5 / 30 | 1 / 30 |
Outcome results
Primary
Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).
Time frame: Baseline and one month after second and third vaccination
Population: Analysis was performed on the per protocol (PP) population set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-2nd Vaccination (N=22,21) | 23 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Baseline | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-3rd Vaccination (N=22,22) | 27 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-3rd Vaccination (N=22,24) | 9 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Baseline (N=12,11) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Baseline | 8 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-3rd Vaccination (N=24,24) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-3rd Vaccination (N=12,11) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UK P1.7-2,4 - Baseline (N=24,21) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Baseline (N=22,17) | 9 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Baseline | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-2nd Vaccination (N=19,16) | 95 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-3rd Vaccination (N=17,19) | 88 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-2nd Vaccination (N=25,23) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-2nd Vaccination (N=25,23) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22) | 5 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-3rd Vaccination (N=24,24) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Baseline (N=24,21) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-2nd Vaccination (N=24,22) | 4 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-2nd Vaccination (N=11,14) | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Baseline (N=12,11) | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Baseline | 29 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-3rd Vaccination (N=24,24) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Baseline | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-2nd Vaccination (N=25,23) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-3rd Vaccination (N=24,24) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Baseline | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-2nd Vaccination (N=24,22) | 95 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-3rd Vaccination (N=22,24) | 96 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UK P1.7-2,4 - Baseline (N=24,21) | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-2nd Vaccination (N=22,21) | 67 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-3rd Vaccination (N=22,22) | 73 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-2nd Vaccination (N=11,14) | 7 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-3rd Vaccination (N=12,11) | 18 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Baseline (N=22,17) | 12 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-2nd Vaccination (N=19,16) | 88 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-3rd Vaccination (N=17,19) | 95 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-2nd Vaccination (N=25,23) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Baseline (N=24,21) | 10 Percentage of subjects |
Primary
Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time frame: Baseline and one month after second and third vaccination
Population: Analysis was performed on the per protocol (PP) population set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Baseline | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-2nd Vaccination (N=25,23) | 96 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-3rd Vaccination (N=24,24) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Baseline | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-2nd Vaccination (N=25,23) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-3rd Vaccination (N=24,24) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Baseline | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-2nd Vaccination (N=24,22) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-3rd Vaccination (N=22,24) | 5 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UK P1.7-2,4 - Baseline (N=24,21) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Baseline (N=24,21) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-2nd Vaccination (N=22,21) | 9 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-3rd Vaccination (N=22,22) | 14 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Baseline (N=12,11) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-2nd Vaccination (N=11,14) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-3rd Vaccination (N=12,11) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Baseline (N=22,17) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-2nd Vaccination (N=19,16) | 74 Percentage of subjects |
| rMenB | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-3rd Vaccination (N=17,19) | 71 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19) | 84 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Baseline | 4 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Baseline (N=22,17) | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-2nd Vaccination (N=25,23) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22) | 95 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-3rd Vaccination (N=24,24) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-2nd Vaccination (N=11,14) | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Baseline | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Baseline (N=24,21) | 10 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-2nd Vaccination (N=25,23) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-3rd Vaccination (N=17,19) | 84 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-3rd Vaccination (N=24,24) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-2nd Vaccination (N=22,21) | 33 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Baseline | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-3rd Vaccination (N=12,11) | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-2nd Vaccination (N=24,22) | 91 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-3rd Vaccination (N=22,22) | 45 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-3rd Vaccination (N=22,24) | 96 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-2nd Vaccination (N=19,16) | 69 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UK P1.7-2,4 - Baseline (N=24,21) | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Baseline (N=12,11) | 0 Percentage of subjects |
Secondary
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time frame: Baseline and one month after second and third vaccination
Population: Analysis was performed on the per protocol (PP) population set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-3rd Vaccination (N=17,19) | 12 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-2nd Vaccination (N=25,23) | 94 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-3rd Vaccination (N=24,24) | 109 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Baseline | 1.00 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-2nd Vaccination (N=25,23) | 710 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-3rd Vaccination (N=24,24) | 1202 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UK P1.7-2,4 - Baseline (N=24,21) | 1.00 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19) | 1.00 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Baseline (N=24,21) | 1.12 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-2nd Vaccination (N=22,21) | 1.82 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-3rd Vaccination (N=22,22) | 2.20 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Baseline (N=12,11) | 1.00 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-2nd Vaccination (N=11,14) | 1.00 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-3rd Vaccination (N=12,11) | 1.06 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Baseline (N=22,17) | 1.46 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-2nd Vaccination (N=19,16) | 11 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Baseline | 1.16 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Baseline | 1.00 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-2nd Vaccination (N=24,22) | 1.06 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-3rd Vaccination (N=22,24) | 1.21 Geometric mean titers |
| rMenB | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22) | 1.07 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-2nd Vaccination (N=24,22) | 27 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Baseline | 1.70 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-3rd Vaccination (N=22,22) | 9.36 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-2nd Vaccination (N=25,23) | 250 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-3rd Vaccination (N=17,19) | 21 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-3rd Vaccination (N=24,24) | 189 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-3rd Vaccination (N=24,24) | 906 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Baseline | 1.05 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-2nd Vaccination (N=11,14) | 1.16 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-2nd Vaccination (N=25,23) | 534 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Baseline (N=12,11) | 1.00 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-3rd Vaccination (N=22,24) | 44 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-3rd Vaccination (N=12,11) | 1.46 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UK P1.7-2,4 - Baseline (N=24,21) | 1.00 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Baseline | 1.00 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19) | 17 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22) | 34 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Baseline (N=22,17) | 1.50 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Baseline (N=24,21) | 1.49 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-2nd Vaccination (N=19,16) | 12 Geometric mean titers |
| rMenB+OMV | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-2nd Vaccination (N=22,21) | 4.56 Geometric mean titers |
Secondary
Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time frame: Baseline and one month after second and third vaccination
Population: Analysis was performed on the per protocol (PP) population set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB | Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Antigen 287-953 - Baseline | 24 µg/mL |
| rMenB | Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Antigen 287-953 - Post-2nd Vaccination (N=25,23) | 1759 µg/mL |
| rMenB | Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Antigen 287-953 - Post-3rd Vaccination (N=24,25) | 2298 µg/mL |
| rMenB+OMV | Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Antigen 287-953 - Baseline | 21 µg/mL |
| rMenB+OMV | Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Antigen 287-953 - Post-2nd Vaccination (N=25,23) | 2912 µg/mL |
| rMenB+OMV | Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Antigen 287-953 - Post-3rd Vaccination (N=24,25) | 3521 µg/mL |
Secondary
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3).
Time frame: Day 1 through day 7 after each vaccination
Population: Analysis was performed on the safety set, i.e. all subjects in the exposed population who provided post-baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Tenderness - Vaccination 3 (N=30,27) | 12 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Vomiting - Vaccination 2 (N=30,28) | 1 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Swelling - Vaccination 2 (N=30,28) | 9 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Vomiting - Vaccination 3 (N=30,27) | 6 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Erythema - Vaccination 3 (N=30,27) | 24 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Diarrhea - Vaccination 1 | 2 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Swelling - Vaccination 3 (N=30,27) | 11 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Diarrhea - Vaccination 2 (N=30,28) | 4 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Tenderness - Vaccination 2 (N=30,28) | 5 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Diarrhea - Vaccination 3 (N=30,27) | 5 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Systemic reactions | 22 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Unusual crying - Vaccination 1 | 2 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Induration - Vaccination 1 | 15 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Unusual crying - Vaccination 2 (N=30,28) | 2 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Change in eating habits - Vaccination 1 (N=30,29) | 6 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Irritability - Vaccination 1 | 14 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Erythema - Vaccination 1 | 26 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Irritability - Vaccination 2 (N=30,28) | 10 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Change in eating habits - Vaccination 2 (N=30,27) | 1 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Rash - Vaccination 1 | 3 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Induration - Vaccination 2 (N=30,28) | 12 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Rash - Vaccination 2 (N=30,28) | 5 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Change in eating habits - Vaccination 3 (N=30,27) | 8 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Rash - Vaccination 3 (N=30,27) | 5 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Tenderness - Vaccination 1 | 4 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Fever (≥38 °C) - Vaccination 1 | 1 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Sleepiness - Vaccination 1 | 7 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Fever (≥38 °C) - Vaccination 2 (N=30,28) | 2 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Induration - Vaccination 3 (N=30,27) | 15 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Fever (≥38 °C) - Vaccination 3 (N=30,27) | 4 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Sleepiness - Vaccination 2 (N=30,28) | 7 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Analg/Antipyr medications used - Vaccination 1 | 10 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Erythema - Vaccination 2 (N=30,28) | 22 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Analg/Antipyr medications used - Vaccination 2 | 12 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Sleepiness - Vaccination 3 (N=30,27) | 7 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Analg/Antipyr medications used - Vaccination 3 | 15 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Swelling - Vaccination 1 | 4 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Vomiting - Vaccination 1 | 6 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Unusual crying - Vaccination 3 (N=30,27) | 4 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Irritability - Vaccination 3 (N=30,28) | 13 Number of subjects |
| rMenB | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Local reactions | 29 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Irritability - Vaccination 3 (N=30,28) | 18 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Local reactions | 29 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Tenderness - Vaccination 1 | 9 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Tenderness - Vaccination 2 (N=30,28) | 11 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Tenderness - Vaccination 3 (N=30,27) | 10 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Erythema - Vaccination 1 | 26 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Erythema - Vaccination 2 (N=30,28) | 25 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Erythema - Vaccination 3 (N=30,27) | 26 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Induration - Vaccination 1 | 18 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Induration - Vaccination 2 (N=30,28) | 16 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Induration - Vaccination 3 (N=30,27) | 18 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Swelling - Vaccination 1 | 11 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Swelling - Vaccination 2 (N=30,28) | 10 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Swelling - Vaccination 3 (N=30,27) | 9 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Systemic reactions | 28 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Change in eating habits - Vaccination 1 (N=30,29) | 8 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Change in eating habits - Vaccination 2 (N=30,27) | 7 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Change in eating habits - Vaccination 3 (N=30,27) | 5 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Sleepiness - Vaccination 1 | 11 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Sleepiness - Vaccination 2 (N=30,28) | 8 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Sleepiness - Vaccination 3 (N=30,27) | 4 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Vomiting - Vaccination 1 | 4 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Vomiting - Vaccination 2 (N=30,28) | 3 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Vomiting - Vaccination 3 (N=30,27) | 2 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Diarrhea - Vaccination 1 | 5 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Diarrhea - Vaccination 2 (N=30,28) | 1 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Diarrhea - Vaccination 3 (N=30,27) | 5 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Unusual crying - Vaccination 1 | 3 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Unusual crying - Vaccination 3 (N=30,27) | 7 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Irritability - Vaccination 1 | 14 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Irritability - Vaccination 2 (N=30,28) | 17 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Rash - Vaccination 1 | 3 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Rash - Vaccination 2 (N=30,28) | 4 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Rash - Vaccination 3 (N=30,27) | 4 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Fever (≥38 °C) - Vaccination 1 | 3 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Fever (≥38 °C) - Vaccination 2 (N=30,28) | 3 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Fever (≥38 °C) - Vaccination 3 (N=30,27) | 1 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Analg/Antipyr medications used - Vaccination 1 | 18 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Analg/Antipyr medications used - Vaccination 2 | 17 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Analg/Antipyr medications used - Vaccination 3 | 16 Number of subjects |
| rMenB+OMV | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Unusual crying - Vaccination 2 (N=30,28) | 2 Number of subjects |
Secondary
Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time frame: One month after second and third vaccination
Population: Analysis was performed on the per protocol (PP) population set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-2nd Vaccination (N=25,23) | 96 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-3rd Vaccination (N=24,24) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-2nd Vaccination (N=25,23) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-3rd Vaccination | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-2nd Vaccination (N=24,22) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-3rd Vaccination (N=22,24) | 5 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-3rd Vaccination (N=20,20) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-2nd Vaccination (N=21,18) | 10 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-3rd Vaccination (N=21,19) | 14 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-2nd Vaccination (N=5,7) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-2nd Vaccination (N=17,14) | 76 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-3rd Vaccination (N=15,15) | 80 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | 287-953proteinantigen-Post-2ndVaccination(N=25,23) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | 287-953proteinantigen-Post-3rdVaccination(N=24,25) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-2nd Vaccination (N=22,17) | 0 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-3rd Vaccination (N=7,6) | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-2nd Vaccination (N=21,18) | 22 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-2nd Vaccination (N=25,23) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | 287-953proteinantigen-Post-2ndVaccination(N=25,23) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 44/76-SL - Post-3rd Vaccination (N=24,24) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB101 - Post-3rd Vaccination (N=21,19) | 32 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-2nd Vaccination (N=25,23) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-3rd Vaccination (N=15,15) | 80 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain 5/99 - Post-3rd Vaccination | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-2nd Vaccination (N=5,7) | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-2nd Vaccination (N=24,22) | 91 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB355 - Post-3rd Vaccination (N=7,6) | 0 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain NZ98/254 - Post-3rd Vaccination (N=22,24) | 96 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-2nd Vaccination (N=22,17) | 88 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | 287-953proteinantigen-Post-3rdVaccination(N=24,25) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain UKP1.7-2,4 - Post-3rd Vaccination (N=20,20) | 95 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Strain GB364 - Post-2nd Vaccination (N=17,14) | 64 Percentage of subjects |
Secondary
Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time frame: One month after second and third vaccination
Population: Analysis was performed on the per protocol (PP) population set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB | Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Antigen 287-953 - Post-2nd Vaccination (N=25,23) | 100 Percentage of subjects |
| rMenB | Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Antigen 287-953 - Post-3rd Vaccination (N=24,25) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Antigen 287-953 - Post-2nd Vaccination (N=25,23) | 100 Percentage of subjects |
| rMenB+OMV | Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Antigen 287-953 - Post-3rd Vaccination (N=24,25) | 100 Percentage of subjects |