Meningococcal Disease
Conditions
Keywords
Meningitis, adolescents, Meningococcal B
Brief summary
The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged between 11 to 17 years.
Interventions
BIOLOGICALMeningococcal B Recombinant vaccine rMenB+OMV NZ
Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months.
BIOLOGICALPlacebo
Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
BIOLOGICALMeningococcal ACWY-CRM conjugate vaccine
Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
Sponsors
Novartis
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adolescents 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment; 2. 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 the outcome of medical history, physical examination and clinical judgment of the investigator; 4. With a negative urine pregnancy test (for female subjects only).
Exclusion criteria
1. History of any meningococcal vaccine administration; 2. Current or previous, confirmed or suspected disease caused by N. meningitidis; 3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment; 4. Pregnancy or nursing (breastfeeding) mothers; 5. Female subjects who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study; 6. Any serious chronic or progressive disease; 7. Family members and household members of research staff; 8. Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives; 9. Significant acute or chronic infection within the previous 7 days or fever within 3 days prior to enrolment; 10. Antibiotics within 6 days prior to enrollment; 11. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy; 12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days; 13. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component; 14. Receipt of or intent to immunize with any other vaccine(s) within 30 days prior and throughout the study period; 15. Participation in another clinical trial within the last 90 days or planned for during study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | Day 1 and Day 61 | Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | Day 61/ Day 1 | The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group. |
| The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | Day 61 | Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group. |
| The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group. | Day 1 and Day 61 | The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group. |
| The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | Day 1 and Day 61 | The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group. |
| The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Day 1 through day 7 after each vaccination | The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported. |
| The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | Day 1 through Day 61 | The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported. |
| The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups. | Day 61/Day 1 | The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group. |
Countries
South Korea
Participant flow
Recruitment details
Subjects were recruited from 7 study sites in Korea.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| rMENB Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study | 176 |
| Placebo/MenACWY Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study | 88 |
| Total | 264 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | rMENB | Placebo/MenACWY | Total |
|---|---|---|---|
| Age, Continuous | 13.5 years STANDARD_DEVIATION 1.8 | 13.4 years STANDARD_DEVIATION 1.8 | 13.5 years STANDARD_DEVIATION 1.8 |
| Sex: Female, Male Female | 77 Participants | 36 Participants | 113 Participants |
| Sex: Female, Male Male | 99 Participants | 52 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 167 / 175 | 63 / 88 | 230 / 263 |
| serious Total, serious adverse events | 2 / 174 | 0 / 88 | 2 / 262 |
Outcome results
Primary
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.
Time frame: Day 1 and Day 61
Population: Analysis was done on the Full Analysis Set (FAS) i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenb | Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | 5/99 strain (Day 61) | 97 percentage of subjects |
| rMenb | Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | H44/76 strain (Day 61) | 98 percentage of subjects |
| rMenb | Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | NZ98/254 strain (Day 1) | 16 percentage of subjects |
| rMenb | Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | 5/99 strain (Day 1) | 12 percentage of subjects |
| rMenb | Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | NZ98/254 strain (Day 61) | 97 percentage of subjects |
| rMenb | Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | H44/76 strain (Day 1) | 26 percentage of subjects |
| Placebo/MenACWY | Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | NZ98/254 strain (Day 61) | 17 percentage of subjects |
| Placebo/MenACWY | Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | H44/76 strain (Day 61) | 27 percentage of subjects |
| Placebo/MenACWY | Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | 5/99 strain (Day 1) | 10 percentage of subjects |
| Placebo/MenACWY | Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | 5/99 strain (Day 61) | 16 percentage of subjects |
| Placebo/MenACWY | Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | H44/76 strain (Day 1) | 24 percentage of subjects |
| Placebo/MenACWY | Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. | NZ98/254 strain (Day 1) | 15 percentage of subjects |
Secondary
The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.
The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group.
Time frame: Day 1 and Day 61
Population: Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenb | The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group. | Day1 | 23 IU/mL |
| rMenb | The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group. | Day61 | 1208 IU/mL |
| Placebo/MenACWY | The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group. | Day1 | 26 IU/mL |
| Placebo/MenACWY | The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group. | Day61 | 27 IU/mL |
Secondary
The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group.
Time frame: Day 61/ Day 1
Population: Analysis was done on the FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenb | The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | H44/76 strain | 40 Ratio |
| rMenb | The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | 5/99 strain | 234 Ratio |
| rMenb | The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | NZ98/254 strain | 19 Ratio |
| Placebo/MenACWY | The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | H44/76 strain | 1.18 Ratio |
| Placebo/MenACWY | The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | 5/99 strain | 1.34 Ratio |
| Placebo/MenACWY | The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | NZ98/254 strain | 1.11 Ratio |
Secondary
The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.
The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group.
Time frame: Day 61/Day 1
Population: Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| rMenb | The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups. | 52 Ratio |
| Placebo/MenACWY | The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups. | 1.05 Ratio |
Secondary
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.
Time frame: Day 1 through day 7 after each vaccination
Population: Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Nausea (2nd vacc; N=173,88) | 15 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Nausea (1st vacc; N=174,88) | 20 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Malaise (2nd vacc; N=173,88) | 47 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site induration II (1st vacc; N=174,87) | 29 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Myalgia (2nd vacc; N=173,88) | 29 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Malaise (1st vacc; N=174,87) | 51 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Arthralgia (2nd vacc; N=173,88) | 15 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site erythema II (1st vacc; N=174,87) | 14 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Headache (2nd vacc; N=173,88) | 50 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Myalgia (1st vacc; N=174,87) | 45 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Treatment of pain/fever (2nd vacc;N=173,88) | 12 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Any Local (2nd vacc; N=173,88) | 145 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Any Local (1st vacc; N=174, 87) | 160 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Arthralgia (1st vacc; N=174,87) | 14 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site pain (1st vacc; N=174,87) | 158 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site pain (2nd vacc; N=173,88) | 142 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site erythema II (2nd vacc; N=173,88) | 11 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site swelling II (1st vacc; N=174,87) | 19 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site swelling I (2nd vacc; N=173,88) | 47 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Prevention of pain/fever (1st vacc;N=174,87) | 1 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site swelling II (2nd vacc; N=173,88) | 16 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site erythema I (1st vacc; N=174,87) | 62 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site induration I (2nd vacc; N=172,88) | 54 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Treatment of pain/fever (1st vacc;N=174,87) | 11 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Any Systemic (1st vacc; N=174,87) | 89 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site erythema I (2nd vacc; N=173,88) | 49 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Loss of appetite (1st vacc; N=174,87) | 15 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Medically attended fever (1st vacc;N=174,86) | 1 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Headache (1st vacc; N=174,87) | 42 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site induration I (1st vacc; N=174,87) | 55 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Body Temperature (≥38°C) (1st vacc; N=174,87) | 6 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Any Systemic (2nd vacc; N=173,88) | 74 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site induration II (2nd vacc; N=172,88) | 26 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Body Temperature (≥38°C) (2nd vacc; N=173,88) | 9 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Loss of appetite (2nd vacc; N=173,88) | 21 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Prevention of pain/fever (2nd vacc;N=173,88) | 1 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Medically attended fever (2nd vacc;N=171,88) | 2 Number of subjects |
| rMenb | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site swelling I (1st vacc; N=174,87) | 57 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Medically attended fever (2nd vacc;N=171,88) | 0 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site erythema I (1st vacc; N=174,87) | 5 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site erythema II (1st vacc; N=174,87) | 0 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site swelling I (1st vacc; N=174,87) | 0 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site swelling II (1st vacc; N=174,87) | 0 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site induration I (1st vacc; N=174,87) | 3 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site induration II (1st vacc; N=174,87) | 0 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Any Local (2nd vacc; N=173,88) | 36 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site pain (2nd vacc; N=173,88) | 33 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site erythema I (2nd vacc; N=173,88) | 17 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site induration II (2nd vacc; N=172,88) | 7 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Nausea (1st vacc; N=174,88) | 7 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Malaise (1st vacc; N=174,87) | 13 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Myalgia (1st vacc; N=174,87) | 10 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Arthralgia (1st vacc; N=174,87) | 4 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Prevention of pain/fever (1st vacc;N=174,87) | 0 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Treatment of pain/fever (1st vacc;N=174,87) | 1 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Medically attended fever (1st vacc;N=174,86) | 0 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Any Systemic (2nd vacc; N=173,88) | 21 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Loss of appetite (2nd vacc; N=173,88) | 4 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Nausea (2nd vacc; N=173,88) | 5 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Malaise (2nd vacc; N=173,88) | 10 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Myalgia (2nd vacc; N=173,88) | 9 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Arthralgia (2nd vacc; N=173,88) | 7 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Prevention of pain/fever (2nd vacc;N=173,88) | 0 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Treatment of pain/fever (2nd vacc;N=173,88) | 1 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Any Local (1st vacc; N=174, 87) | 22 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site erythema II (2nd vacc; N=173,88) | 7 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site swelling I (2nd vacc; N=173,88) | 16 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site swelling II (2nd vacc; N=173,88) | 3 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site induration I (2nd vacc; N=172,88) | 17 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Any Systemic (1st vacc; N=174,87) | 31 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Loss of appetite (1st vacc; N=174,87) | 8 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Headache (1st vacc; N=174,87) | 19 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Body Temperature (≥38°C) (1st vacc; N=174,87) | 1 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Headache (2nd vacc; N=173,88) | 16 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Body Temperature (≥38°C) (2nd vacc; N=173,88) | 1 Number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. | Injec site pain (1st vacc; N=174,87) | 18 Number of subjects |
Secondary
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.
Time frame: Day 1 through Day 61
Population: Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenb | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | Any AE | 45 number of subjects |
| rMenb | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | Possibly or Probably Related AES | 30 number of subjects |
| rMenb | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | SAEs | 2 number of subjects |
| rMenb | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | At least possibly related SAEs | 0 number of subjects |
| rMenb | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | Deaths | 0 number of subjects |
| rMenb | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | Medically attended AEs | 45 number of subjects |
| rMenb | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | AEs resulting in premature withdrawal | 1 number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | At least possibly related SAEs | 0 number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | Any AE | 10 number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | AEs resulting in premature withdrawal | 0 number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | Possibly or Probably Related AES | 3 number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | Deaths | 0 number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | SAEs | 0 number of subjects |
| Placebo/MenACWY | The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. | Medically attended AEs | 20 number of subjects |
Secondary
The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group.
Time frame: Day 61
Population: Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenb | The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | H44/76 strain | 93 percentage of subjects |
| rMenb | The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | 5/99 strain | 97 percentage of subjects |
| rMenb | The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | NZ98/254 strain | 83 percentage of subjects |
| Placebo/MenACWY | The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | H44/76 strain | 8 percentage of subjects |
| Placebo/MenACWY | The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | 5/99 strain | 6 percentage of subjects |
| Placebo/MenACWY | The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group. | NZ98/254 strain | 6 percentage of subjects |
Secondary
The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.
The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group.
Time frame: Day 1 and Day 61
Population: Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenb | The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | 5/99 strain (Day 1) | 1.5 Titers |
| rMenb | The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | NZ98/254 strain (Day 1) | 1.71 Titers |
| rMenb | The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | 5/99 strain (Day 61) | 351 Titers |
| rMenb | The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | H44/76 strain (Day 61) | 91 Titers |
| rMenb | The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | NZ98/254 strain (Day 61) | 32 Titers |
| rMenb | The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | H44/76 strain (Day 1) | 2.31 Titers |
| Placebo/MenACWY | The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | NZ98/254 strain (Day 61) | 1.77 Titers |
| Placebo/MenACWY | The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | H44/76 strain (Day 1) | 2.18 Titers |
| Placebo/MenACWY | The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | H44/76 strain (Day 61) | 2.56 Titers |
| Placebo/MenACWY | The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | 5/99 strain (Day 1) | 1.37 Titers |
| Placebo/MenACWY | The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | NZ98/254 strain (Day 1) | 1.59 Titers |
| Placebo/MenACWY | The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. | 5/99 strain (Day 61) | 1.84 Titers |