Meningococcal Disease, Meningococcal Meningitis
Conditions
Keywords
Meningococcal Meningitis, prevention, vaccination, adolescents
Brief summary
The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.
Detailed description
Novartis will consider this study a success if, at one month following the second vaccination, the two-sided 95% CI of the ratio of the hSBA GMTs for each of 3 serogroup B reference strains (H44/76, 5/99, and NZ98/254) and the two-sided 95% CI of the ratio of the ELISA GMCs against vaccine antigen 287-953 are contained within the interval (0.5, 2.0).
Interventions
BIOLOGICALSerogroup B meningococcal vaccine
All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or two doses of rMenB+OMV NZ Lot 2. A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination
Sponsors
Novartis Vaccines
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects (11-17 years of age inclusive) who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment * 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) * in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Exclusion criteria
* History of any serogroup B meningococcal vaccination * Current or previous, confirmed or suspected disease caused by N. meningitidis * Exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment * Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥ 38.0 °C) within the previous day * Antibiotic use within 3 days (72 hours) prior to enrollment * Pregnancy or nursing (breastfeeding) mothers * Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry * Any serious chronic or progressive disease, Known or suspected impairment/alteration of the immune system * Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days * History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains. | One month after the second vaccination (day 61) | Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0). |
| ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953 | One month after the second vaccination (day 61) | The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953 | One month after the second vaccination (day 61) | The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline). |
| hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | Two weeks after the second vaccination (day 45) | The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination. |
| GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | Two weeks after the second vaccination (day 45) | The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of GMRs of GMT against 3 N. meningitidis serogroup B reference strains at two weeks after last vaccination. |
| Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45. | Two weeks after the second vaccination (day 45) | The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA ≥1:5 two weeks after the last vaccination. |
| Percentage of Subjects in Each Lot With hSBA ≥ 1:5 | One month after the second vaccination (day 61) | The percentage of subjects in each lot with hSBA ≥ 1:5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group |
| GMR of ELISA GMCs Against Antigen 287-953 at Day 45. | Two weeks after the second vaccination (day 45) | The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 45 vs baseline). |
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | From day 1 to day 7 after any vaccination | Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination. |
| Number of Subjects Reporting Unsolicited AEs | From day 1 to day 7 after any vaccination. | Number of subjects reporting any Unsolicited AEs after any vaccination. |
| Number of Subjects Reporting SAEs and AE Leading to Withdrawal | Throughout the study period. | Number of subjects reporting any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject's withdrawal from the study after any vaccination. |
| ELISA GMCs Against Vaccine Antigen 287-953 at Day 45. | Two weeks after the second vaccination (day 45) | The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953. |
| Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains. | One month after the second vaccination (day 61) | The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after the second vaccination vs baseline). |
Countries
Australia, Canada
Participant flow
Recruitment details
Actual start date of recruiting was 30 August 2011. Subjects were recruited from 7 centres in Canada and 6 centres in Australia.
Pre-assignment details
All subjects were enrolled in the trial.
Participants by arm
| Arm | Count |
|---|---|
| 4CMenB_Rosia Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility. | 170 |
| 4CMenB_Siena Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility. | 174 |
| Total | 344 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | 4CMenB_Rosia | 4CMenB_Siena | Total |
|---|---|---|---|
| Age, Continuous | 13.6 years STANDARD_DEVIATION 1.9 | 13.8 years STANDARD_DEVIATION 1.8 | 13.7 years STANDARD_DEVIATION 1.9 |
| Sex: Female, Male Female | 72 Participants | 82 Participants | 154 Participants |
| Sex: Female, Male Male | 98 Participants | 92 Participants | 190 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 165 / 169 | 171 / 173 |
| serious Total, serious adverse events | 0 / 169 | 0 / 173 |
Outcome results
Primary
ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953
The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
Time frame: One month after the second vaccination (day 61)
Population: Per Protocol Set population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 4CMenB_Rosia | ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953 | 2729 IU/ml |
| 4CMenB_Siena | ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953 | 3291 IU/ml |
Comparison: Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs95% CI: [0.67, 1.02]
Primary
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains.
Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).
Time frame: One month after the second vaccination (day 61)
Population: Per Protocol Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 4CMenB_Rosia | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains. | H44/76 strain | 111 Titers |
| 4CMenB_Rosia | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains. | NZ98/254 strain | 9.27 Titers |
| 4CMenB_Rosia | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains. | 5/99 strain (N=152) | 183 Titers |
| 4CMenB_Siena | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains. | H44/76 strain | 111 Titers |
| 4CMenB_Siena | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains. | NZ98/254 strain | 11 Titers |
| 4CMenB_Siena | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains. | 5/99 strain (N=152) | 199 Titers |
Comparison: Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against H44/76 strain95% CI: [0.82, 1.23]
Comparison: Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against 5/99 strain95% CI: [0.77, 1.1]
Comparison: Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against NZ98/254 strain95% CI: [0.6, 1.09]
Secondary
ELISA GMCs Against Vaccine Antigen 287-953 at Day 45.
The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
Time frame: Two weeks after the second vaccination (day 45)
Population: Per Protocol Set, immunogenicity subset.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 4CMenB_Rosia | ELISA GMCs Against Vaccine Antigen 287-953 at Day 45. | 3742 IU/ml |
| 4CMenB_Siena | ELISA GMCs Against Vaccine Antigen 287-953 at Day 45. | 4798 IU/ml |
Secondary
Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953
The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline).
Time frame: One month after the second vaccination (day 61)
Population: Per Protocol Set Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 4CMenB_Rosia | Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953 | 122 Ratio of GMTs |
| 4CMenB_Siena | Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953 | 153 Ratio of GMTs |
Secondary
Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains.
The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after the second vaccination vs baseline).
Time frame: One month after the second vaccination (day 61)
Population: Per Protocol Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 4CMenB_Rosia | Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains. | H44/76 strain (N=151) | 104 Ratio of GMTs |
| 4CMenB_Rosia | Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains. | NZ98/254 strain (N=151) | 8.63 Ratio of GMTs |
| 4CMenB_Rosia | Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains. | 5/99 | 156 Ratio of GMTs |
| 4CMenB_Siena | Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains. | H44/76 strain (N=151) | 107 Ratio of GMTs |
| 4CMenB_Siena | Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains. | NZ98/254 strain (N=151) | 11 Ratio of GMTs |
| 4CMenB_Siena | Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains. | 5/99 | 167 Ratio of GMTs |
Secondary
GMR of ELISA GMCs Against Antigen 287-953 at Day 45.
The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 45 vs baseline).
Time frame: Two weeks after the second vaccination (day 45)
Population: Per Protocol Set, immunogenicity subset
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 4CMenB_Rosia | GMR of ELISA GMCs Against Antigen 287-953 at Day 45. | 166 Ratio of GMTs |
| 4CMenB_Siena | GMR of ELISA GMCs Against Antigen 287-953 at Day 45. | 217 Ratio of GMTs |
Secondary
GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.
The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of GMRs of GMT against 3 N. meningitidis serogroup B reference strains at two weeks after last vaccination.
Time frame: Two weeks after the second vaccination (day 45)
Population: Per Protocol Set, Immunogenicity subset
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 4CMenB_Rosia | GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | H44/76 strain | 174 Ratio of GMTs |
| 4CMenB_Rosia | GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | NZ98/254 | 13 Ratio of GMTs |
| 4CMenB_Rosia | GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | 5/99 strain | 214 Ratio of GMTs |
| 4CMenB_Siena | GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | H44/76 strain | 157 Ratio of GMTs |
| 4CMenB_Siena | GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | NZ98/254 | 20 Ratio of GMTs |
| 4CMenB_Siena | GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | 5/99 strain | 243 Ratio of GMTs |
Secondary
hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.
The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination.
Time frame: Two weeks after the second vaccination (day 45)
Population: Per Protocol Set, immunogenicity subset
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 4CMenB_Rosia | hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | H44/76 strain | 187 Titers |
| 4CMenB_Rosia | hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | NZ98/254 strain | 14 Titers |
| 4CMenB_Rosia | hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | 5/99 strain | 254 Titers |
| 4CMenB_Siena | hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | H44/76 strain | 171 Titers |
| 4CMenB_Siena | hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | NZ98/254 strain | 20 Titers |
| 4CMenB_Siena | hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. | 5/99 strain | 339 Titers |
Secondary
Number of Subjects Reporting SAEs and AE Leading to Withdrawal
Number of subjects reporting any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject's withdrawal from the study after any vaccination.
Time frame: Throughout the study period.
Population: Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4CMenB_Rosia | Number of Subjects Reporting SAEs and AE Leading to Withdrawal | Serious Adverse Events | 0 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting SAEs and AE Leading to Withdrawal | Adverse Events | 0 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting SAEs and AE Leading to Withdrawal | Serious Adverse Events | 0 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting SAEs and AE Leading to Withdrawal | Adverse Events | 1 Number of subjects |
Secondary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination.
Time frame: From day 1 to day 7 after any vaccination
Population: Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Any systemic | 136 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Any local | 163 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Nausea | 49 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Myalgia | 99 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Pain | 162 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Arthralgia | 28 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Induration | 65 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Headache | 75 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Erythema | 111 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Fever (>= 38C) | 8 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Use of analgesics | 82 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Rash | 11 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Swelling | 80 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Any other | 87 Number of subjects |
| 4CMenB_Rosia | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 75 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Any other | 96 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Induration | 75 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Nausea | 56 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 85 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Use of analgesics | 92 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Pain | 170 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Erythema | 111 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Swelling | 74 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Any systemic | 150 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Myalgia | 118 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Arthralgia | 44 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Headache | 89 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Fever (>= 38C) | 5 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Rash | 16 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Any local | 170 Number of subjects |
Secondary
Number of Subjects Reporting Unsolicited AEs
Number of subjects reporting any Unsolicited AEs after any vaccination.
Time frame: From day 1 to day 7 after any vaccination.
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4CMenB_Rosia | Number of Subjects Reporting Unsolicited AEs | 56 Number of subjects |
| 4CMenB_Siena | Number of Subjects Reporting Unsolicited AEs | 55 Number of subjects |
Secondary
Percentage of Subjects in Each Lot With hSBA ≥ 1:5
The percentage of subjects in each lot with hSBA ≥ 1:5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group
Time frame: One month after the second vaccination (day 61)
Population: Per Protocol Set population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4CMenB_Rosia | Percentage of Subjects in Each Lot With hSBA ≥ 1:5 | H44/76 strain (N=151) | 99 Percentage of subjects |
| 4CMenB_Rosia | Percentage of Subjects in Each Lot With hSBA ≥ 1:5 | NZ98/254 strain (N=151) | 70 Percentage of subjects |
| 4CMenB_Rosia | Percentage of Subjects in Each Lot With hSBA ≥ 1:5 | 5/99 strain | 100 Percentage of subjects |
| 4CMenB_Siena | Percentage of Subjects in Each Lot With hSBA ≥ 1:5 | H44/76 strain (N=151) | 99 Percentage of subjects |
| 4CMenB_Siena | Percentage of Subjects in Each Lot With hSBA ≥ 1:5 | NZ98/254 strain (N=151) | 79 Percentage of subjects |
| 4CMenB_Siena | Percentage of Subjects in Each Lot With hSBA ≥ 1:5 | 5/99 strain | 100 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45.
The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA ≥1:5 two weeks after the last vaccination.
Time frame: Two weeks after the second vaccination (day 45)
Population: Per Protocol Population, immunogenicity subset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4CMenB_Rosia | Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45. | H44/76 strain | 100 Percentage of subjects |
| 4CMenB_Rosia | Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45. | NZ98/254 strain | 84 Percentage of subjects |
| 4CMenB_Rosia | Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45. | 5/99 strain | 100 Percentage of subjects |
| 4CMenB_Siena | Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45. | H44/76 strain | 100 Percentage of subjects |
| 4CMenB_Siena | Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45. | NZ98/254 strain | 96 Percentage of subjects |
| 4CMenB_Siena | Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45. | 5/99 strain | 100 Percentage of subjects |