Prevention of the Meningococcal Disease
Conditions
Keywords
Meningococcal disease,, Adults
Brief summary
The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).
Interventions
BIOLOGICALrMenB+OMV NZ
Recombinant MenB with Outer Member Vesicle (OMV) from the New Zealand strain
Sponsors
GlaxoSmithKline
Novartis Vaccines
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment; 2. Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period); 3. In good health as determined by medical history, physical examination and clinical judgment of the investigator; 4. Who are or might be routinely exposed to cultures of N. meningitidis serogroup B. Sponsor's employees are considered eligible to participate in the trial as per inclusion criteria.
Exclusion criteria
1. Pregnancy or nursing (breastfeeding) mothers; 2. Females of reproductive age who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 60 days prior to study entry; 3. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease); 4. Individuals with history of any progressive or severe neurologic disorder, or seizure disorder. A single episode of febrile convulsion is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | Day1 and Day 91 | The immunogenicity was assessed to evaluate the human serum bactericidal activity (hSBA) against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and M10713 strain at baseline and at one month after the second vaccination. |
| Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | Day1 and Day 91 | The immunogenicity was assessed to evaluate the hSBA in terms of geometric mean ratios within subjects against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 at one month after the second vaccination versus baseline. |
| Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | Day1 and Day91 | The immunogenicity was assessed to evaluate the hSBA titers ≥ 1:5 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine. |
| Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | Day1 and Day91 | The immunogenicity was assessed to evaluate the human serum bactericidal activity titers ≥ 1:8 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine. |
| Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule. | Day 91 | The antibody responses were assessed to evaluate the four fold increase in human serum bactericidal activity titers in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine. |
| Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule | Day 1 and Day 91 | The antibody responses were assessed to evaluate the geometric mean concentrations as measured by Enzyme Linked Immunosorbent Assay (ELISA) in terms of percentages of subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at baseline and at one month the second vaccination. |
| Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule. | Day 1 and Day 91 | The antibody responses were assessed to evaluate the geometric mean ratios as measured by ELISA within the subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month after the second vaccination versus baseline. |
| Percentages of Subjects With Four Fold Increase From Baseline For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule. | Day 1 and Day 91 | The antibody responses were assessed to evaluate the four fold increases in ELISA concentrations as measured by ELISA to the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month the second vaccination over baseline. |
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Day 1 through Day 7 postvaccination. | The number of subjects with solicited local and systemic adverse events after receiving rMenB+OMV NZ (a two dose vaccination schedule) collected from day 1 through day 7 are reported. |
| Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | Day 1 through Day 91 postvaccination. | Safety was assessed as the number of subjects who reported unsolicited adverse events as collected from Day 1 to Day 91 following rMenB+OMV vaccination (a two dose schedule). Unsolicited adverse events were collected from day 1 through day 7 after each vaccination, while serious adverse events, medically attended adverse events and adverse events leading to withdrawal from study were reported from day 1 through day 91. |
| Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | Day 1 through Day 91 postvaccination. | Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported. |
Countries
Germany
Participant flow
Recruitment details
Subjects were recruited from single study center in Germany.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| rMenB+OMV NZ Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | rMenB+OMV NZ |
|---|---|
| Age, Continuous | 38.5 year STANDARD_DEVIATION 12.2 |
| Sex: Female, Male FEMALE | 10 Participants |
| Sex: Female, Male MALE | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule
The antibody responses were assessed to evaluate the geometric mean concentrations as measured by Enzyme Linked Immunosorbent Assay (ELISA) in terms of percentages of subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at baseline and at one month the second vaccination.
Time frame: Day 1 and Day 91
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+OMV NZ | Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule | Prevaccination (Day 1) | 22 U/mL |
| rMenB+OMV NZ | Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule | Post second vaccination (Day 91) | 1200 U/mL |
Primary
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
The immunogenicity was assessed to evaluate the human serum bactericidal activity (hSBA) against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and M10713 strain at baseline and at one month after the second vaccination.
Time frame: Day1 and Day 91
Population: Analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+OMV NZ | Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | M10713 Prevaccination (Day 1) | 21 Titers |
| rMenB+OMV NZ | Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | H44/76 Prevaccination (Day 1) | 1.18 Titers |
| rMenB+OMV NZ | Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | Post 2nd vaccination (Day 91) | 53 Titers |
| rMenB+OMV NZ | Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | 5/99 Prevaccination (Day 1) | 2.27 Titers |
| rMenB+OMV NZ | Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | After 2nd vaccination (Day 91)(N=12) | 143 Titers |
| rMenB+OMV NZ | Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | NZ98/254 Prevaccination (Day 1) | 1.09 Titers |
| rMenB+OMV NZ | Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | Post 2nd vaccination (Day 91)(N=12) | 15 Titers |
| rMenB+OMV NZ | Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | Post second vaccination (Day 91)(N=12) | 56 Titers |
Primary
Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule
The immunogenicity was assessed to evaluate the hSBA in terms of geometric mean ratios within subjects against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 at one month after the second vaccination versus baseline.
Time frame: Day1 and Day 91
Population: The analysis was done on the Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+OMV NZ | Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | H44/76 (Day 91/Day 1) | 45 ratio |
| rMenB+OMV NZ | Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | 5/99 (Day 91/Day 1)(N=12) | 59 ratio |
| rMenB+OMV NZ | Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | NZ98/254 (Day 91/Day 1)(N=12) | 14 ratio |
| rMenB+OMV NZ | Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule | M10713 (Day 91/Day 1)(N=12) | 2.99 ratio |
Primary
Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.
The antibody responses were assessed to evaluate the geometric mean ratios as measured by ELISA within the subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month after the second vaccination versus baseline.
Time frame: Day 1 and Day 91
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| rMenB+OMV NZ | Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule. | 54 Ratio |
Primary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)
The number of subjects with solicited local and systemic adverse events after receiving rMenB+OMV NZ (a two dose vaccination schedule) collected from day 1 through day 7 are reported.
Time frame: Day 1 through Day 7 postvaccination.
Population: Analysis was done on Solicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Any local | 13 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Injection site induration | 1 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Injection site pain | 13 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Any Systemic | 9 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Nausea | 2 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Prophylactic use of antipyretics/analgesics | 0 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Therapeutic use of antipyretics/analgesics | 4 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Injection site erythema | 0 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Injection site swelling | 0 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Myalgia | 3 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Arthralgia | 3 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Fatigue | 5 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Headache | 8 Number of Subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination) | Fever (≥38°C) | 1 Number of Subjects |
Primary
Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).
Safety was assessed as the number of subjects who reported unsolicited adverse events as collected from Day 1 to Day 91 following rMenB+OMV vaccination (a two dose schedule). Unsolicited adverse events were collected from day 1 through day 7 after each vaccination, while serious adverse events, medically attended adverse events and adverse events leading to withdrawal from study were reported from day 1 through day 91.
Time frame: Day 1 through Day 91 postvaccination.
Population: Analysis was done on Unsolicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | Any unsolicited AEs | 8 Number of subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | At least possibly related unsolicited AEs | 7 Number of subjects |
Primary
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
Time frame: Day 1 through Day 91 postvaccination.
Population: Analysis was done on Unsolicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | AEs leading to study withdrawal | 0 Number of subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | Any SAEs | 0 Number of subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | Medically attended AEs | 2 Number of subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | At least possibly related SAEs | 0 Number of subjects |
| rMenB+OMV NZ | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination). | AEs leading to death | 0 Number of subjects |
Primary
Percentages of Subjects With Four Fold Increase From Baseline For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.
The antibody responses were assessed to evaluate the four fold increases in ELISA concentrations as measured by ELISA to the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month the second vaccination over baseline.
Time frame: Day 1 and Day 91
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rMenB+OMV NZ | Percentages of Subjects With Four Fold Increase From Baseline For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule. | 85 Percentage of Subjects |
Primary
Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule.
The antibody responses were assessed to evaluate the four fold increase in human serum bactericidal activity titers in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.
Time frame: Day 91
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV NZ | Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule. | H44/76 | 100 Percentage of subjects |
| rMenB+OMV NZ | Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule. | 5/99 (N=12) | 92 Percentage of subjects |
| rMenB+OMV NZ | Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule. | NZ98/254 (N=12) | 75 Percentage of subjects |
| rMenB+OMV NZ | Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule. | M10713 (N=12) | 33 Percentage of subjects |
Primary
Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
The immunogenicity was assessed to evaluate the hSBA titers ≥ 1:5 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.
Time frame: Day1 and Day91
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | H44/76 Prevaccination (Day 1) | 0 Percentages of subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | Post 2nd vaccination (Day 91) | 100 Percentages of subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | Post second vaccination (Day 91)(N=12) | 100 Percentages of subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | 5/99 Prevaccination (Day 1) | 31 Percentages of subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | After 2nd vaccination (Day 91)(N=12) | 100 Percentages of subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | NZ98/254 Prevaccination (Day 1) | 0 Percentages of subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | Post 2nd vaccination (Day 91)(N=12) | 75 Percentages of subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | M10713 Prevaccination (Day 1) | 92 Percentages of subjects |
Primary
Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.
The immunogenicity was assessed to evaluate the human serum bactericidal activity titers ≥ 1:8 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.
Time frame: Day1 and Day91
Population: Analysis was done on Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | H44/76 Prevaccination (Day 1) | 0 Percentage of Subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | Post 2nd vaccination (Day 91) | 100 Percentage of Subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | 5/99 Prevaccination (Day 1) | 8 Percentage of Subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | After 2nd vaccination (Day 91)(N=12) | 92 Percentage of Subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | NZ98/254 Prevaccination (Day 1) | 0 Percentage of Subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | Post 2nd vaccination (Day 91)(N=12) | 75 Percentage of Subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | M10713 Prevaccination (Day 1) | 85 Percentage of Subjects |
| rMenB+OMV NZ | Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule. | Post second vaccination (Day 91)(N=12) | 92 Percentage of Subjects |