N. Meningitidis Carriage
Conditions
Keywords
Meningococcal vaccines, Meningococcal B, Meningococcal ACWY serogroups
Brief summary
The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal vaccines on carriage of Neisseria meningitidis in a young adult population.
Interventions
BIOLOGICALMeningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)
BIOLOGICALMenACWY-CRM conjugate vaccine
BIOLOGICALJapanese Encephalitis vaccine
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects, 18-24 years of age who provided written informed consent at the time of enrollment; * Subjects who were available for all the visits scheduled in the study; * Subjects who were 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 vaccine administration; * Current or previous, confirmed or suspected disease caused by N. meningitidis; * Household contact with and/or intimate 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 oral temperature ≥38ºC) within the previous day; * Antibiotics within 3 days (72 hours) prior to enrollment; * Pregnancy or nursing (breastfeeding) mothers; * Females of childbearing age who had not used or did not plan to use acceptable birth control measures, for the 12 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence were 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 30 days prior to study entry; * Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); * Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. \[Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body were allowed\]; use of immunostimulants; * 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; * Participation in another clinical trial within the last 90 days or planned for during study; * Family members and household members of research staff; * Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination | 61 days (31 days after receiving the second injection) | Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported. Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010. |
| Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination | 31 days after MenACWY-CRM injection | The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | Percentage of subjects with carriage of nonvirulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported. |
| Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | Percentage of subjects with carriage of all N.meningitidis strains combined in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported. |
| Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | Percentages of subjects with carriage of N.meningitidis ABCWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported. |
| Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | Percentages of subjects with carriage of N.meningitidis ACWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported |
| Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | Percentages of subjects with carriage of N.meningitidis serogroups A,C,W or Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported. |
| Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | Percentages of subjects with carriage of N.meningitidis genogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported. |
| Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | Percentages of subjects with carriage of N.meningitidis serogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported. |
| Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | Up to 361 days after vaccination | Percentages of subject with carriage of N. meningitidis genogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported. |
| Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | Up to 361 days after vaccination | Percentages of subjects with carriage of N. meningitidis serogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported. |
| Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | Up to 361 days after vaccination | Percentages of subjects with carriage of N. meningitidis genogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported. |
| Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | Up to 361 days after vaccination | Percentages of subjects with carriage of N. meningitidis serogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported. |
| Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | The percentages of subjects with newly acquired pharyngeal carriage of all ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported. |
| Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | The percentages of subjects with newly acquired pharyngeal carriage of virulent ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported. |
| Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | The percentages of subjects with newly acquired pharyngeal carriage of all N. meningitidis in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported. |
| Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | The percentages of subjects with newly acquired pharyngeal carriage of N. meningitidis genogroups ABCWY in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported. |
| Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | The percentage of subjects with carriage of all (virulent + non-virulent) ST types of N. meningitidis B (genogroupable) in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported. |
| Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | Up to 361 days after vaccination | The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroup Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported. |
| The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage) | The duration of carriage of any N.meningitidis strains after receiving two doses of rMenB+OMV compared to that in the control group is reported. |
| The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM | Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage) | The duration of carriage of any N meningitidis strain after receiving one dose MenACWY-CRM as compared to that in control group is reported. |
| The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage) | The duration of carriage after new acquisition of N.meningitidis strains after receiving two doses of rMenB+OMV vaccine compared to that in the control group is reported. |
| The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine | Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage) | The duration of carriage after new acquisition of N.meningitidis strains after receiving one dose of MenACWY-CRM vaccine compared to that in the control group is reported. |
| Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | The percentages of subjects with N. meningitidis Virulent ST of serogroup B, at different time points of the study, in subjects stratified by pre-vaccination hSBA (\<4 and ≥4) titers after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported. The serum bactericidal antibodies directed against N.meningitides serogroups, are measured by Serum Bactericidal Assay using human complement (hSBA). H44/76, 5/99 and NZ98/254 are strains in serogroup B. |
| Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | Up to 12 months after vaccination | The prevalence of carriage of N. meningitidis serogroup Y, at different time points of the study, in subjects stratified by pre-vaccination hSBA (\<8 and ≥8) titers, after administration of one dose of MenACWY-CRM vaccine as compared to the control group is reported. |
| Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | Up to 361 days after vaccination | The percentages of subjects with hSBA titers ≥1:4 against the three strains of N. meningitidis B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported. |
| The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Up to 361 days after vaccination | The hSBA Geometric Mean Titers (GMTs) against the three strains of N. meningitidis serogroup B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported. |
| Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Up to 361 days after vaccination | The percentages of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported. As serogroup A and W strains were not detected in substantial proportion of subjects during pharyngeal carriage analysis, these serogroups were not tested. |
| The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Up to 361 days after vaccination | The hSBA antibody titers against N. meningitidis serogroups C and Y after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group, are reported as GMTs. Serogroups A and W were not analysed. |
| Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group. | 61 days | The percentages of subjects with hSBA seroresponse against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination as compared to the control group are reported. Seroresponse to N. meningitidis serogroups Cand Y is defined as :(1)for subjects with a pre-vaccination hSBA titer \< 1:4 to a post-vaccination hSBA titer ≥ 1:8 or (2) for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer. Analysis was not done for serogroups A and W. |
| The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | Up to 361 days after vaccination | The hSBA geometric mean titers against the N. meningitidis serogroups C and Y in subjects (who have received a prior dose of MenC vaccine) after MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported. Analysis was not done for serogroups A and W. |
| Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | Up to 361 days after vaccination | The percentages of subjects (who have received a prior dose of MenC vaccine) with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y after receiving MenACWY-CRM vaccination in this study as compared to the control group are reported. Analysis was not done for serogroups A and W. |
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Day 1 through day 7 after any vaccination | The safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group rMenB+OMV) and one dose of MenACWY-CRM vaccine (Group MenACWY) was assessed in terms of number of subjects with solicited local and systemic adverse events and other adverse events, following vaccination and compared to that of the control group. |
| Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | Up to 361 days after vaccination | The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroups A,C, W or Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported. |
| Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | Up to 361 days after vaccination | Percentage of subjects with carriage of virulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported. |
Countries
United Kingdom
Participant flow
Recruitment details
Subjects were enrolled from 10 sites in United Kingdom
Pre-assignment details
Total 2968 subjects were enrolled of which 14 subjects were not randomized and were therefore removed from the study (2 subjects withdrew consent and 11 subjects were withdrawn due to inappropriate enrollment and 1 withdrawn due to protocol violation).
Participants by arm
| Arm | Count |
|---|---|
| rMenB+OMV Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart | 979 |
| MenACWY Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart | 988 |
| Control Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart | 987 |
| Total | 2,954 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative reason | 1 | 0 | 0 |
| Overall Study | Adverse event or death | 11 | 8 | 3 |
| Overall Study | Inappropriate enrollment | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 124 | 98 | 123 |
| Overall Study | Protocol Violation | 5 | 5 | 6 |
| Overall Study | Unable to classify | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 38 | 31 | 28 |
Baseline characteristics
| Characteristic | rMenB+OMV | MenACWY | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 19.9 years STANDARD_DEVIATION 1.6 | 19.9 years STANDARD_DEVIATION 1.6 | 19.8 years STANDARD_DEVIATION 1.6 | 19.9 years STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 516 Participants | 533 Participants | 547 Participants | 1596 Participants |
| Sex: Female, Male Male | 463 Participants | 455 Participants | 440 Participants | 1358 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 | 200 / 974 | 186 / 984 | 172 / 985 |
| serious Total, serious adverse events | 31 / 974 | 26 / 984 | 20 / 985 |
Outcome results
Primary
Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination
Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported. Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010.
Time frame: 61 days (31 days after receiving the second injection)
Population: Analysis was done on the modified-intention to treat (MITT) dataset (Pharyngeal carriage), i.e subjects who actually received a study vaccination and provided at least one evaluable swab sample at baseline and after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination | Baseline | 8 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination | Month 2 (N= 916, 928) | 9 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination | Baseline | 7 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination | Month 2 (N= 916, 928) | 8 Percentages of subjects |
Comparison: Vaccine Group Odds Ratios for carriage of virulent ST strain of N. meningitidis group B in 4CMenB group as compared to the control group at 1 month after receiving the 2nd rMenB+OMV NZ vaccinationp-value: 0.382895% CI: [0.809, 1.737]Regression, Logistic
Primary
Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination
The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Time frame: 31 days after MenACWY-CRM injection
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination | Baseline | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination | Month 1 (N=956, 947) | 6 Percentages of subjects |
| Control | Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination | Baseline | 5 Percentages of subjects |
| Control | Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination | Month 1 (N=956, 947) | 6 Percentages of subjects |
Comparison: Vaccine Group Odds Ratios for carriage of combined N. meningitidis serogroups A, C, W, Y in the MenACWY-CRM group compared to Control group at 1 month after receiving 1 injection of MenACWY vaccine95% CI: [0.555, 1.273]Regression, Logistic
Secondary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group
The safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group rMenB+OMV) and one dose of MenACWY-CRM vaccine (Group MenACWY) was assessed in terms of number of subjects with solicited local and systemic adverse events and other adverse events, following vaccination and compared to that of the control group.
Time frame: Day 1 through day 7 after any vaccination
Population: Analysis was done on the Immunogenicity Subset, Safety Population i.e. all subjects in the exposed population who provided postvaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Rash (N=190, 186, 191) | 9 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Arthralgia (N=190, 186, 191) | 38 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Injection site pain (N=190, 186,191) | 181 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Any local | 184 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Nausea (N=190, 186, 191) | 36 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Temperature (≥40°C) (N= 190, 186, 191) | 0 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Headache (N=190, 186, 191) | 71 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Malaise (N=190, 186, 191) | 57 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Injection site induration (N=190, 186, 191) | 68 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Myalgia (N=190, 186, 191) | 155 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Antipyretic treatment med. used (N=190, 186, 191) | 55 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Any Other | 64 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Injection site swelling (N=190, 186, 191) | 68 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Antipyretic preventive med. used (N=190, 186, 191) | 20 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Fever (≥38°C) (N= 190, 186,191) | 7 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Any systemic | 169 number of subjects |
| rMenB+OMV | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Injection site erythema (N=190, 186, 191) | 100 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Headache (N=190, 186, 191) | 56 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Any local | 158 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Injection site pain (N=190, 186,191) | 143 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Injection site erythema (N=190, 186, 191) | 71 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Injection site induration (N=190, 186, 191) | 41 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Injection site swelling (N=190, 186, 191) | 31 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Any systemic | 133 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Arthralgia (N=190, 186, 191) | 27 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Nausea (N=190, 186, 191) | 23 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Malaise (N=190, 186, 191) | 41 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Myalgia (N=190, 186, 191) | 117 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Rash (N=190, 186, 191) | 9 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Fever (≥38°C) (N= 190, 186,191) | 5 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Any Other | 22 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Temperature (≥40°C) (N= 190, 186, 191) | 0 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Antipyretic preventive med. used (N=190, 186, 191) | 7 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Antipyretic treatment med. used (N=190, 186, 191) | 17 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Injection site pain (N=190, 186,191) | 117 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Rash (N=190, 186, 191) | 12 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Injection site swelling (N=190, 186, 191) | 23 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Antipyretic treatment med. used (N=190, 186, 191) | 22 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Fever (≥38°C) (N= 190, 186,191) | 7 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Injection site induration (N=190, 186, 191) | 21 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Antipyretic preventive med. used (N=190, 186, 191) | 3 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Any Other | 25 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Injection site erythema (N=190, 186, 191) | 61 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Any local | 139 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Malaise (N=190, 186, 191) | 46 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Temperature (≥40°C) (N= 190, 186, 191) | 0 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Myalgia (N=190, 186, 191) | 112 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Nausea (N=190, 186, 191) | 24 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Arthralgia (N=190, 186, 191) | 29 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Headache (N=190, 186, 191) | 75 number of subjects |
| Control | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group | Any systemic | 140 number of subjects |
Secondary
Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group.
The percentages of subjects (who have received a prior dose of MenC vaccine) with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y after receiving MenACWY-CRM vaccination in this study as compared to the control group are reported. Analysis was not done for serogroups A and W.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Immunogenicity subset)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | Baseline (Men C) (N=46,6) | 93 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | 1 month post 2nd vaccination (Men C) (N=45, 6) | 100 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | 11 months post 2nd vaccination (Men C) (N=45, 6) | 100 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | Baseline (Men Y) | 80 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | 1 month post 2nd vaccination (Men Y) (N=45, 26) | 96 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | 3 months post 2nd vaccination (Men Y) (N=42, 25) | 95 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | 5 months post 2nd vaccination (Men Y) (N=45, 26) | 96 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | 11 months post 2nd vaccination (Men Y) (N=45, 26) | 91 Percentages of subjects |
| Control | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | 11 months post 2nd vaccination (Men Y) (N=45, 26) | 77 Percentages of subjects |
| Control | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | Baseline (Men C) (N=46,6) | 100 Percentages of subjects |
| Control | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | 1 month post 2nd vaccination (Men Y) (N=45, 26) | 77 Percentages of subjects |
| Control | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | 1 month post 2nd vaccination (Men C) (N=45, 6) | 100 Percentages of subjects |
| Control | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | 5 months post 2nd vaccination (Men Y) (N=45, 26) | 77 Percentages of subjects |
| Control | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | 11 months post 2nd vaccination (Men C) (N=45, 6) | 100 Percentages of subjects |
| Control | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | 3 months post 2nd vaccination (Men Y) (N=42, 25) | 80 Percentages of subjects |
| Control | Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group. | Baseline (Men Y) | 81 Percentages of subjects |
Secondary
Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination
Percentage of subjects with carriage of all N.meningitidis strains combined in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | Baseline | 33 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931, 947) | 34 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916, 928) | 38 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860, 885) | 35 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832, 864) | 34 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797, 827) | 27 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832, 864) | 36 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | Baseline | 31 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860, 885) | 36 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931, 947) | 32 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797, 827) | 30 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916, 928) | 36 Percentages of subjects |
Secondary
Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination
The percentage of subjects with carriage of all (virulent + non-virulent) ST types of N. meningitidis B (genogroupable) in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | Baseline | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (Day 31) N=931, 947 | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (Day 61) N=916, 928 | 11 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (Day 121) N=860, 885 | 10 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (Day 181) N=832, 864 | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (Day 361) N=797,827 | 8 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (Day 181) N=832, 864 | 10 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | Baseline | 9 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (Day 121) N=860, 885 | 10 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (Day 31) N=931, 947 | 9 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (Day 361) N=797,827 | 10 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (Day 61) N=916, 928 | 10 Percentages of subjects |
Secondary
Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination
Percentages of subjects with carriage of N.meningitidis ABCWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | Baseline | 19 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931, 947) | 19 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916, 928) | 22 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860, 885) | 20 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832, 864) | 19 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797, 827) | 15 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832, 864) | 23 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | Baseline | 17 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860, 885) | 22 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931, 947) | 19 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797, 827) | 18 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916, 928) | 22 Percentages of subjects |
Secondary
Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination
Percentages of subjects with carriage of N.meningitidis ACWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931, 947) | 11 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860, 885) | 10 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | Baseline | 10 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832, 864) | 10 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916, 928) | 11 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797, 827) | 7 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797, 827) | 8 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | Baseline | 8 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931, 947) | 10 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916, 928) | 12 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860, 885) | 12 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832, 864) | 13 Percentages of subjects |
Secondary
Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination
Percentages of subjects with carriage of N. meningitidis genogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | Baseline | 7 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | 1 month post 1 dose (N=956, 947) | 7 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | 2 months post 1 dose (N=929, 928) | 7 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | 4 months post 1 dose (N=884, 885) | 8 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | 6 months post 1 dose (N=867, 864) | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | 12 months post 1 dose (N=845, 827) | 6 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | 6 months post 1 dose (N=867, 864) | 10 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | Baseline | 7 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | 4 months post 1 dose (N=884, 885) | 10 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | 1 month post 1 dose (N=956, 947) | 8 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | 12 months post 1 dose (N=845, 827) | 6 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination | 2 months post 1 dose (N=929, 928) | 10 Percentages of subjects |
Secondary
Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination
Percentages of subjects with carriage of N.meningitidis genogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MIIT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | Baseline | 7 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931, 947) | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916, 928) | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860, 885) | 8 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832, 864) | 8 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797, 827) | 5 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832, 864) | 10 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | Baseline | 7 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860, 885) | 10 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931, 947) | 8 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797, 827) | 6 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916, 928) | 10 Percentages of subjects |
Secondary
Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination
Percentages of subjects with carriage of N.meningitidis serogroups A,C,W or Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | Baseline | 7 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931, 947) | 7 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916, 928) | 7 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860, 885) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832, 864) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797, 827) | 5 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832, 864) | 9 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | Baseline | 5 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860, 885) | 8 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931, 947) | 6 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797, 827) | 5 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916, 928) | 8 Percentages of subjects |
Secondary
Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination
Percentages of subjects with carriage of N. meningitidis serogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | Baseline (Day 1) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 1 month post 1 dose (N=956, 947) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 2 months post 1 dose (N=929, 928) | 5 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 4 months post 1 dose (N=884, 885) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 6 months post 1 dose (N=867, 864) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 12 months post 1 dose (N=845, 827) | 4 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 6 months post 1 dose (N=867, 864) | 9 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | Baseline (Day 1) | 5 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 4 months post 1 dose (N=884, 885) | 8 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 1 month post 1 dose (N=956, 947) | 6 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 12 months post 1 dose (N=845, 827) | 5 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 2 months post 1 dose (N=929, 928) | 8 Percentages of subjects |
Secondary
Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination
Percentages of subjects with carriage of N. meningitidis serogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | Baseline | 4 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | 1 month post 1 dose (N=956, 947) | 5 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | 2 months post 1 dose (N=929, 928) | 4 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | 4 months post 1 dose (N=884, 885) | 5 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | 6 months post 1 dose (N=867, 864) | 5 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | 12 months post 1 dose (N=845, 827) | 4 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | 6 months post 1 dose (N=867, 864) | 7 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | Baseline | 5 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | 4 months post 1 dose (N=884, 885) | 7 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | 1 month post 1 dose (N=956, 947) | 5 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | 12 months post 1 dose (N=845, 827) | 4 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination | 2 months post 1 dose (N=929, 928) | 7 Percentages of subjects |
Secondary
Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination
Percentages of subjects with carriage of N.meningitidis serogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | Baseline | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931, 947) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916, 928) | 5 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860, 885) | 5 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832, 864) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797, 827) | 4 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832, 864) | 7 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | Baseline | 5 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860, 885) | 7 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931, 947) | 5 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797, 827) | 4 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916, 928) | 7 Percentages of subjects |
Secondary
Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination
Percentage of subjects with carriage of nonvirulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | Baseline | 1 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931,947) | 1 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916,928) | 1 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860,885) | 1 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832,864) | 1 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797,827) | 1 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=832,864) | 1 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | Baseline | 1 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=860,885) | 1 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=931,947) | 1 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=797,827) | 1 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=916,928) | 2 Percentages of subjects |
Secondary
Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination
Percentage of subjects with carriage of virulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | Baseline | 8 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (Day 31) N=931,947 | 8 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (Day 61) N=916, 928 | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (Day 121) N=860, 885 | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (Day 181) N=832,864 | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (Day 361) N=797,827 | 8 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (Day 181) N=832,864 | 9 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | Baseline | 7 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (Day 121) N=860, 885 | 9 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (Day 31) N=931,947 | 8 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (Day 361) N=797,827 | 9 Percentages of subjects |
| Control | Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (Day 61) N=916, 928 | 8 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group.
The percentages of subjects with hSBA seroresponse against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination as compared to the control group are reported. Seroresponse to N. meningitidis serogroups Cand Y is defined as :(1)for subjects with a pre-vaccination hSBA titer \< 1:4 to a post-vaccination hSBA titer ≥ 1:8 or (2) for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer. Analysis was not done for serogroups A and W.
Time frame: 61 days
Population: Analysis was done on the MITT dataset (Immunogenicity subset)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group. | 1 month post 2nd dose from day 1(Men C)N=48,181,48 | 8 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group. | 1 month post 2nd dose from day 1(Men Y) | 12 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group. | 1 month post 2nd dose from day 1(Men C)N=48,181,48 | 81 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group. | 1 month post 2nd dose from day 1(Men Y) | 44 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group. | 1 month post 2nd dose from day 1(Men C)N=48,181,48 | 4 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group. | 1 month post 2nd dose from day 1(Men Y) | 7 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group
The percentages of subjects with hSBA titers ≥1:4 against the three strains of N. meningitidis B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Immunogenicity subset) i.e all enrolled subjects who actually received a study vaccination, provided at least one evaluable serum sample after vaccination and whose assay result was available for at least one serogroup.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | Baseline 5/99 | 60 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 3 months post 2nd dose (H44/76) (N=173, 40, 46) | 99 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | Baseline NZ98/254 | 57 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 1 month post 2nd dose (5/99) (N=189, 45, 48) | 100 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 1 month post 2nd dose (H44/76) (N=189, 45, 48) | 100 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 11 months post 2nd dose (5/99) (N=177, 41, 46) | 97 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 3 months post 2nd dose (5/99) (N=173, 40, 46) | 99 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 3 months post 2nd dose (NZ98/254) (N=173, 40, 46) | 93 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 5 months post 2nd dose (5/99) (N=169, 43, 45) | 99 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 5 months post 2nd dose (H44/76) (N=169, 43, 45) | 100 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 11 months post 2nd dose (NZ98/254) (N=177, 41, 46) | 85 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | Baseline H44/76 | 69 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 11 months post 2nd dose (H44/76) (N=177, 41, 46) | 95 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 5 months post 2nd dose (NZ98/254) (N=169, 43, 45) | 91 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 1 month post 2nd dose (NZ98/254) (N=189, 45, 48) | 99 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 1 month post 2nd dose (NZ98/254) (N=189, 45, 48) | 53 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | Baseline H44/76 | 71 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 1 month post 2nd dose (H44/76) (N=189, 45, 48) | 76 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 3 months post 2nd dose (H44/76) (N=173, 40, 46) | 73 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 5 months post 2nd dose (H44/76) (N=169, 43, 45) | 74 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 11 months post 2nd dose (H44/76) (N=177, 41, 46) | 76 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | Baseline 5/99 | 45 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 1 month post 2nd dose (5/99) (N=189, 45, 48) | 40 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 3 months post 2nd dose (5/99) (N=173, 40, 46) | 49 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 5 months post 2nd dose (5/99) (N=169, 43, 45) | 49 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 11 months post 2nd dose (5/99) (N=177, 41, 46) | 51 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | Baseline NZ98/254 | 53 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 3 months post 2nd dose (NZ98/254) (N=173, 40, 46) | 48 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 5 months post 2nd dose (NZ98/254) (N=169, 43, 45) | 58 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 11 months post 2nd dose (NZ98/254) (N=177, 41, 46) | 66 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | Baseline 5/99 | 54 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 5 months post 2nd dose (NZ98/254) (N=169, 43, 45) | 42 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | Baseline NZ98/254 | 38 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 11 months post 2nd dose (H44/76) (N=177, 41, 46) | 70 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 5 months post 2nd dose (H44/76) (N=169, 43, 45) | 67 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 1 month post 2nd dose (NZ98/254) (N=189, 45, 48) | 44 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 3 months post 2nd dose (H44/76) (N=173, 40, 46) | 65 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | Baseline H44/76 | 62 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 3 months post 2nd dose (NZ98/254) (N=173, 40, 46) | 48 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 3 months post 2nd dose (5/99) (N=173, 40, 46) | 53 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 1 month post 2nd dose (H44/76) (N=189, 45, 48) | 63 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 5 months post 2nd dose (5/99) (N=169, 43, 45) | 53 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 1 month post 2nd dose (5/99) (N=189, 45, 48) | 58 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 11 months post 2nd dose (NZ98/254) (N=177, 41, 46) | 43 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group | 11 months post 2nd dose (5/99) (N=177, 41, 46) | 63 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
The percentages of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported. As serogroup A and W strains were not detected in substantial proportion of subjects during pharyngeal carriage analysis, these serogroups were not tested.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Immunogenicity subset)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (Men C) (N=48, 158, 41) | 94 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline Men C (N= 49, 194,50) | 90 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (Men C) (N=48, 182, 48) | 98 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline Men Y | 72 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (Men Y) (N=187, 182, 188) | 81 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (Men Y) (N=173,164,175) | 79 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (Men Y) (N=170, 165, 170) | 78 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (Men Y) (N=177, 158, 165) | 77 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (Men C) (N=48, 158, 41) | 97 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (Men Y) (N=170, 165, 170) | 92 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline Men Y | 78 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (Men Y) (N=187, 182, 188) | 95 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (Men Y) (N=173,164,175) | 95 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline Men C (N= 49, 194,50) | 87 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (Men Y) (N=177, 158, 165) | 91 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (Men C) (N=48, 182, 48) | 99 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (Men C) (N=48, 182, 48) | 88 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (Men Y) (N=173,164,175) | 82 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (Men C) (N=48, 158, 41) | 88 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline Men Y | 78 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (Men Y) (N=170, 165, 170) | 84 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline Men C (N= 49, 194,50) | 80 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (Men Y) (N=187, 182, 188) | 82 Percentages of subjects |
| Control | Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (Men Y) (N=177, 158, 165) | 81 Percentages of subjects |
Secondary
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination
The percentages of subjects with newly acquired pharyngeal carriage of all N. meningitidis in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=479, 513) | 14 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=374, 395) | 8 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=578, 627) | 17 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=344, 361) | 11 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=410, 452) | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | At 3,5, 11 months post 2nd vaccination (N=410,452) | 26 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | Baseline non-carrier | 77 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | At 3,5, 11 months post 2nd vaccination (N=410,452) | 31 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | Baseline non-carrier | 80 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=578, 627) | 18 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=479, 513) | 12 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=410, 452) | 13 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=374, 395) | 9 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=344, 361) | 14 Percentages of subjects |
Secondary
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination
The percentages of subjects with newly acquired pharyngeal carriage of all ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=614, 642) | 3 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | At 3,5,11 months post 2nd vaccination (N=628,674) | 5 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | Baseline non-carrier | 90 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=671, 715) | 3 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=650, 687) | 3 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=628, 674) | 1 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=623, 656) | 1 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=614, 642) | 3 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=650, 687) | 2 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | At 3,5,11 months post 2nd vaccination (N=628,674) | 7 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=623, 656) | 2 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | Baseline non-carrier | 91 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=628, 674) | 3 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=671, 715) | 4 Percentages of subjects |
Secondary
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination
The percentages of subjects with newly acquired pharyngeal carriage of N. meningitidis genogroups ABCWY in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=553, 592) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=497, 515) | 5 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=611, 663) | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=472, 491) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=519, 551) | 4 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | At 3,5, 11 months post 2nd vaccination (N=519,551) | 14 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | Baseline non-carrier | 82 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | At 3,5, 11 months post 2nd vaccination (N=519,551) | 17 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | Baseline non-carrier | 84 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=611, 663) | 10 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=553, 592) | 7 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=519, 551) | 7 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=497, 515) | 5 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=472, 491) | 6 Percentages of subjects |
Secondary
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination
The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroups A,C, W or Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | 1 month post 2nd vaccination (N=712, 709) | 2 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | 5 months post 2nd vaccination (N=685, 660) | 3 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | 1 month post 1st vaccination (N=746, 745) | 4 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | 11 months post 2nd vaccination (N=666, 650) | 2 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | 3 months post 2nd vaccination (N=701, 680) | 2 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | 1,3,5, 11 months post 2nd vaccination (N=712, 709) | 8 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | Baseline non-carrier | 94 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | 1,3,5, 11 months post 2nd vaccination (N=712, 709) | 10 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | Baseline non-carrier | 95 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | 1 month post 1st vaccination (N=746, 745) | 5 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | 1 month post 2nd vaccination (N=712, 709) | 4 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | 3 months post 2nd vaccination (N=701, 680) | 3 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | 5 months post 2nd vaccination (N=685, 660) | 2 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination | 11 months post 2nd vaccination (N=666, 650) | 1 Percentages of subjects |
Secondary
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination
The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroup Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | 1 month post 1st vaccination (N=758, 749) | 4 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | 5 months post 2nd vaccination (N=709, 678) | 2 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | 1 month post 2nd vaccination (N=730, 719) | 1 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | 11 months post 2nd vaccination (N=694, 669) | 2 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | 3 months post 2nd vaccination (N=719, 693) | 1 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | 1,3,5, 11 months post 2nd vaccination (N=730, 719) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | Baseline non-carrier | 95 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | 1,3,5, 11 months post 2nd vaccination (N=730, 719) | 8 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | Baseline non-carrier | 95 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | 1 month post 2nd vaccination (N=730, 719) | 4 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | 1 month post 1st vaccination (N=758, 749) | 4 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | 3 months post 2nd vaccination (N=719, 693) | 2 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | 5 months post 2nd vaccination (N=709, 678) | 1 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination | 11 months post 2nd vaccination (N=694, 669) | 1 Percentages of subjects |
Secondary
Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination
The percentages of subjects with newly acquired pharyngeal carriage of virulent ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=659, 699) | 3 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=632, 670) | 1 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=682, 726) | 3 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=623, 656) | 3 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=638, 686) | 1 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | At 3,5, 11 months post 2nd vaccination (N=638,686) | 5 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | Baseline non-carrier | 91 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | At 3,5, 11 months post 2nd vaccination (N=638,686) | 6 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | Baseline non-carrier | 92 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 1st vaccination (N=682, 726) | 3 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 1 month post 2nd vaccination (N=659, 699) | 2 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 3 months post 2nd vaccination (N=638, 686) | 2 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 5 months post 2nd vaccination (N=632, 670) | 2 Percentages of subjects |
| Control | Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination | 11 months post 2nd vaccination (N=623, 656) | 2 Percentages of subjects |
Secondary
Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers
The prevalence of carriage of N. meningitidis serogroup Y, at different time points of the study, in subjects stratified by pre-vaccination hSBA (\<8 and ≥8) titers, after administration of one dose of MenACWY-CRM vaccine as compared to the control group is reported.
Time frame: Up to 12 months after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | Baseline hSBA <8 (MenY) (N=42, 44) | 0 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 1month post 1st dose; hSBA <8 (MenY) (N=39, 40) | 0 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 1 month post 2nd dose;hSBA <8 (MenY) (N=39, 40) | 0 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 3 months post 2nd dose;hSBA <8 (MenY) (N=36, 37) | 0 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 5 months post 2nd dose;hSBA <8 (MenY) (N=36, 36) | 0 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 11 months post 2nd dose;hSBA <8 (MenY) (N=34, 35) | 3 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | Baseline hSBA ≥8 (MenY) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 1month post 1st dose; hSBA ≥8 (MenY) (N=146,151) | 6 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 1 month post 2nd dose;hSBA ≥8 (MenY) (N=143, 149) | 5 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 3 months post 2nd dose;hSBA ≥8 (MenY) (N=131, 139) | 8 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 5 months post 2nd dose;hSBA ≥8 (MenY) (N=130, 134) | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 11 months post 2nd dose;hSBA ≥8 (MenY) (N=129,135) | 4 Percentages of subjects |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 5 months post 2nd dose;hSBA ≥8 (MenY) (N=130, 134) | 5 Percentages of subjects |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | Baseline hSBA <8 (MenY) (N=42, 44) | 0 Percentages of subjects |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | Baseline hSBA ≥8 (MenY) | 6 Percentages of subjects |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 1month post 1st dose; hSBA <8 (MenY) (N=39, 40) | 3 Percentages of subjects |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 3 months post 2nd dose;hSBA ≥8 (MenY) (N=131, 139) | 7 Percentages of subjects |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 1 month post 2nd dose;hSBA <8 (MenY) (N=39, 40) | 0 Percentages of subjects |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 1month post 1st dose; hSBA ≥8 (MenY) (N=146,151) | 5 Percentages of subjects |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 3 months post 2nd dose;hSBA <8 (MenY) (N=36, 37) | 3 Percentages of subjects |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 11 months post 2nd dose;hSBA ≥8 (MenY) (N=129,135) | 3 Percentages of subjects |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 5 months post 2nd dose;hSBA <8 (MenY) (N=36, 36) | 6 Percentages of subjects |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 1 month post 2nd dose;hSBA ≥8 (MenY) (N=143, 149) | 5 Percentages of subjects |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers | 11 months post 2nd dose;hSBA <8 (MenY) (N=34, 35) | 6 Percentages of subjects |
Secondary
Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination
The percentages of subjects with N. meningitidis Virulent ST of serogroup B, at different time points of the study, in subjects stratified by pre-vaccination hSBA (\<4 and ≥4) titers after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported. The serum bactericidal antibodies directed against N.meningitides serogroups, are measured by Serum Bactericidal Assay using human complement (hSBA). H44/76, 5/99 and NZ98/254 are strains in serogroup B.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Baseline hSBA ≥4 (5/99) (N=116, 27) | 8 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 11 months post 2nd dose;hSBA <4(H44/76) (N=56, 16) | 11 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 1st dose; hSBA ≥4 (5/99) (N=113, 26) | 5 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 5 months post 2nd dose;hSBA ≥4 (H44/76) (N=115,28) | 5 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1 month post 2nd dose;hSBA ≥4 (5/99) (N=113, 26) | 8 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 3months post 2nd dose; hSBA<4(H44/76) (N=56, 17) | 4 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 3 months post 2nd dose;hSBA ≥4 (5/99) (N=105, 25) | 10 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 11 months post 2nd dose;hSBA ≥4 (H44/76)(N=123,30) | 5 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 5 months post 2nd dose;hSBA ≥4 (5/99) (N=103, 24) | 8 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Baseline hSBA ≥4 (H44/76) | 10 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 11 months post 2nd dose;hSBA ≥4(5/99) (N=108, 26) | 6 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Baseline hSBA < 4 (5/99) (N=77, 23) | 5 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Baseline hSBA < 4 (NZ98/254) (N=83, 31) | 2 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 2nd dose; hSBA<4(H44/76) (N=60, 18) | 7 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 1st dose; hSBA<4(NZ98/254) (N=81, 30) | 4 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 1st dose; hSBA<4 (5/99) (N=77, 22) | 4 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 2nd dose; hSBA<4 (NZ98/254) (N=81, 30) | 4 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 1st dose; hSBA ≥4 (H44/76) (N=130, 30) | 5 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 3 months post 2nd dose;hSBA <4 (NZ98/254)(N=75,29) | 3 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1 month post 2nd dose;hSBA <4 (5/99) (N=77, 22) | 6 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 5 months post 2nd dose;hSBA <4 (NZ98/254)(N=70,29) | 3 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 5 months post 2nd dose; hSBA <4(H44/76) (N=56, 17) | 7 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 11 months post 2nd dose;hSBA <4(NZ98/254)(N=75,28) | 11 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 3 months post 2nd dose;hSBA <4 (5/99) (N=71, 21) | 4 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Baseline hSBA ≥4 (NZ98/254) (N=110, 19) | 10 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1 month post 2nd dose;hSBA ≥4 (H44/76) (N=130, 30) | 8 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 1st dose; hSBA ≥4 (NZ98/254)(N=109,18) | 6 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 5 months post 2nd dose;hSBA <4 (5/99) (N=68, 21) | 3 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1 month post 2nd dose;hSBA ≥4 (NZ98/254)(N=109,18) | 10 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 1st dose; hSBA<4(H44/76) (N=60, 18) | 3 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 3 months post 2nd dose;hSBA ≥4(NZ98/254)(N=101,17) | 11 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 11 months post 2nd dose;hSBA <4(5/99) (N=71, 20) | 7 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 5 months post 2nd dose;hSBA ≥4(NZ98/254)(N=101,16) | 8 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 3 months post 2nd dose;hSBA ≥4 (H44/76) (N=120,29) | 9 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 11 months post 2nd dose;hSBA≥4(NZ98/254)(N=104,18) | 4 Percentage |
| rMenB+OMV | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Baseline hSBA < 4 (H44/76) (N=60,19) | 0 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 11 months post 2nd dose;hSBA≥4(NZ98/254)(N=104,18) | 6 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Baseline hSBA < 4 (H44/76) (N=60,19) | 0 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 1st dose; hSBA<4(H44/76) (N=60, 18) | 0 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 2nd dose; hSBA<4(H44/76) (N=60, 18) | 0 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 3months post 2nd dose; hSBA<4(H44/76) (N=56, 17) | 0 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 5 months post 2nd dose; hSBA <4(H44/76) (N=56, 17) | 0 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 11 months post 2nd dose;hSBA <4(H44/76) (N=56, 16) | 0 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Baseline hSBA ≥4 (H44/76) | 6 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 1st dose; hSBA ≥4 (H44/76) (N=130, 30) | 10 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1 month post 2nd dose;hSBA ≥4 (H44/76) (N=130, 30) | 7 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 3 months post 2nd dose;hSBA ≥4 (H44/76) (N=120,29) | 14 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 5 months post 2nd dose;hSBA ≥4 (H44/76) (N=115,28) | 11 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 11 months post 2nd dose;hSBA ≥4 (H44/76)(N=123,30) | 7 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Baseline hSBA < 4 (5/99) (N=77, 23) | 9 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 1st dose; hSBA<4 (5/99) (N=77, 22) | 9 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1 month post 2nd dose;hSBA <4 (5/99) (N=77, 22) | 0 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 3 months post 2nd dose;hSBA <4 (5/99) (N=71, 21) | 10 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 5 months post 2nd dose;hSBA <4 (5/99) (N=68, 21) | 10 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 11 months post 2nd dose;hSBA <4(5/99) (N=71, 20) | 5 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Baseline hSBA ≥4 (5/99) (N=116, 27) | 0 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 1st dose; hSBA ≥4 (5/99) (N=113, 26) | 4 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1 month post 2nd dose;hSBA ≥4 (5/99) (N=113, 26) | 8 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 3 months post 2nd dose;hSBA ≥4 (5/99) (N=105, 25) | 8 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 5 months post 2nd dose;hSBA ≥4 (5/99) (N=103, 24) | 4 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 11 months post 2nd dose;hSBA ≥4(5/99) (N=108, 26) | 4 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Baseline hSBA < 4 (NZ98/254) (N=83, 31) | 6 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 1st dose; hSBA<4(NZ98/254) (N=81, 30) | 7 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 2nd dose; hSBA<4 (NZ98/254) (N=81, 30) | 0 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 3 months post 2nd dose;hSBA <4 (NZ98/254)(N=75,29) | 3 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 5 months post 2nd dose;hSBA <4 (NZ98/254)(N=70,29) | 3 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 11 months post 2nd dose;hSBA <4(NZ98/254)(N=75,28) | 4 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | Baseline hSBA ≥4 (NZ98/254) (N=110, 19) | 0 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1month post 1st dose; hSBA ≥4 (NZ98/254)(N=109,18) | 6 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 1 month post 2nd dose;hSBA ≥4 (NZ98/254)(N=109,18) | 11 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 3 months post 2nd dose;hSBA ≥4(NZ98/254)(N=101,17) | 18 Percentage |
| Control | Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination | 5 months post 2nd dose;hSBA ≥4(NZ98/254)(N=101,16) | 13 Percentage |
Secondary
Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination
Percentages of subject with carriage of N. meningitidis genogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+OMV | Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | Baseline | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 1 month post 1 dose (N=956, 947) | 10 Percentages of subjects |
| rMenB+OMV | Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 2 months post 1 dose (N=929, 928) | 9 Percentages of subjects |
| rMenB+OMV | Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 4 months post 1 dose (N=884, 885) | 10 Percentages of subjects |
| rMenB+OMV | Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 6 months post 1 dose (N=867, 864) | 11 Percentages of subjects |
| rMenB+OMV | Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 12 months post 1 dose (N=845, 827) | 8 Percentages of subjects |
| Control | Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 6 months post 1 dose (N=867, 864) | 13 Percentages of subjects |
| Control | Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | Baseline | 8 Percentages of subjects |
| Control | Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 4 months post 1 dose (N=884, 885) | 12 Percentages of subjects |
| Control | Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 1 month post 1 dose (N=956, 947) | 10 Percentages of subjects |
| Control | Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 12 months post 1 dose (N=845, 827) | 8 Percentages of subjects |
| Control | Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination | 2 months post 1 dose (N=929, 928) | 12 Percentages of subjects |
Secondary
The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV
The duration of carriage of any N.meningitidis strains after receiving two doses of rMenB+OMV compared to that in the control group is reported.
Time frame: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| rMenB+OMV | The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | Genogroup B All STs (N=152, 160) | 127 Number of days |
| rMenB+OMV | The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | Genogroup B virulent STs (N=142, 142) | 122 Number of days |
| rMenB+OMV | The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | All N meningitidis | 193 Number of days |
| rMenB+OMV | The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | Genogroups ABCWY (N=300, 323) | 143 Number of days |
| rMenB+OMV | The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | Serogroups ACWY (N=131, 142) | 104 Number of days |
| rMenB+OMV | The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | Serogroup Y (N=106, 123) | 106 Number of days |
| Control | The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | Serogroups ACWY (N=131, 142) | 113 Number of days |
| Control | The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | Genogroup B All STs (N=152, 160) | 146 Number of days |
| Control | The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | Genogroups ABCWY (N=300, 323) | 162 Number of days |
| Control | The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | Genogroup B virulent STs (N=142, 142) | 147 Number of days |
| Control | The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | Serogroup Y (N=106, 123) | 117 Number of days |
| Control | The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV | All N meningitidis | 202 Number of days |
Secondary
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine
The duration of carriage after new acquisition of N.meningitidis strains after receiving one dose of MenACWY-CRM vaccine compared to that in the control group is reported.
Time frame: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| rMenB+OMV | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine | Serogroups ACWY | 90 Number of days |
| rMenB+OMV | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine | Serogroup Y (N=74, 87) | 87 Number of days |
| Control | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine | Serogroups ACWY | 120 Number of days |
| Control | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine | Serogroup Y (N=74, 87) | 120 Number of days |
Secondary
The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine
The duration of carriage after new acquisition of N.meningitidis strains after receiving two doses of rMenB+OMV vaccine compared to that in the control group is reported.
Time frame: Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| rMenB+OMV | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | Genogroup B All STs (N=76, 89) | 82 Number of days |
| rMenB+OMV | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | Genogroup B virulent STs (N=77, 82) | 80 Number of days |
| rMenB+OMV | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | All N meningitidis | 158 Number of days |
| rMenB+OMV | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | Genogroups ABCWY (N=165, 201) | 121 Number of days |
| rMenB+OMV | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | Serogroups ACWY (N=75, 102) | 111 Number of days |
| rMenB+OMV | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | Serogroup Y (N=61, 87) | 111 Number of days |
| Control | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | Serogroups ACWY (N=75, 102) | 120 Number of days |
| Control | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | Genogroup B All STs (N=76, 89) | 107 Number of days |
| Control | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | Genogroups ABCWY (N=165, 201) | 146 Number of days |
| Control | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | Genogroup B virulent STs (N=77, 82) | 107 Number of days |
| Control | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | Serogroup Y (N=61, 87) | 120 Number of days |
| Control | The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine | All N meningitidis | 165 Number of days |
Secondary
The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM
The duration of carriage of any N meningitidis strain after receiving one dose MenACWY-CRM as compared to that in control group is reported.
Time frame: Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage)
Population: Analysis was done on the MITT dataset (Pharyngeal carriage)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| rMenB+OMV | The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM | Serogroups ACWY | 88 Number of days |
| rMenB+OMV | The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM | Serogroup Y (N=110, 123) | 86 Number of days |
| Control | The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM | Serogroups ACWY | 113 Number of days |
| Control | The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM | Serogroup Y (N=110, 123) | 117 Number of days |
Secondary
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
The hSBA Geometric Mean Titers (GMTs) against the three strains of N. meningitidis serogroup B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Immunogenicity subset)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline NZ98/254 | 6.15 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline 5/99 | 6.44 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (NZ98/254) (N=169, 43, 45) | 50 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (5/99) (N=177, 41, 46) | 55 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (5/99) (N=189, 45, 48) | 424 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (H44/76) (N=173, 40, 46) | 144 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (5/99) (N=169, 43, 45) | 105 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (5/99) (N=173, 40, 46) | 169 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (NZ98/254) (N=176, 41, 44) | 34 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (NZ98/254) (N=172, 40, 46) | 56 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (H44/76) (N=169, 43, 45) | 111 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (H44/76) (N=189, 45, 48) | 229 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (NZ98/254) (N=188, 45, 48) | 99 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (H44/76) (N=177, 40, 46) | 68 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline H44/76 | 11 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (NZ98/254) (N=176, 41, 44) | 7.77 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline H44/76 | 11 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (H44/76) (N=189, 45, 48) | 11 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (H44/76) (N=173, 40, 46) | 9.07 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (H44/76) (N=169, 43, 45) | 12 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (H44/76) (N=177, 40, 46) | 14 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline 5/99 | 3.12 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (5/99) (N=189, 45, 48) | 2.63 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (5/99) (N=173, 40, 46) | 2.95 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (5/99) (N=169, 43, 45) | 3.36 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (5/99) (N=177, 41, 46) | 3.58 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline NZ98/254 | 4.32 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (NZ98/254) (N=188, 45, 48) | 4.82 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (NZ98/254) (N=172, 40, 46) | 4.93 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (NZ98/254) (N=169, 43, 45) | 6.5 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (5/99) (N=177, 41, 46) | 5.98 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (H44/76) (N=177, 40, 46) | 14 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (NZ98/254) (N=176, 41, 44) | 6.93 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline NZ98/254 | 4.16 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (H44/76) (N=169, 43, 45) | 12 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (NZ98/254) (N=169, 43, 45) | 4.67 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (NZ98/254) (N=188, 45, 48) | 3.88 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (H44/76) (N=173, 40, 46) | 11 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline H44/76 | 9.42 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (5/99) (N=173, 40, 46) | 5.6 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (5/99) (N=189, 45, 48) | 5.62 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (NZ98/254) (N=172, 40, 46) | 4.72 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (5/99) (N=169, 43, 45) | 5.32 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline 5/99 | 5.49 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (H44/76) (N=189, 45, 48) | 10 Titers |
Secondary
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.
The hSBA antibody titers against N. meningitidis serogroups C and Y after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group, are reported as GMTs. Serogroups A and W were not analysed.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Immunogenicity subset)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (MenC) (N=48, 158, 41) | 59 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline Men C (N=49, 194, 50) | 43 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline Men Y | 18 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (Men Y) (N=177, 158, 165) | 21 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (Men C) (N=48, 182, 48) | 83 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (Men Y) (N=187, 182, 188) | 26 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (Men Y (N=170, 165, 170) | 23 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (Men Y) (N=173, 164, 175) | 24 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (Men C) (N=48, 182, 48) | 1302 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (Men Y) (N=173, 164, 175) | 69 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline Men C (N=49, 194, 50) | 50 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (Men Y (N=170, 165, 170) | 63 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (Men Y) (N=177, 158, 165) | 49 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (MenC) (N=48, 158, 41) | 438 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline Men Y | 19 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (Men Y) (N=187, 182, 188) | 83 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline Men Y | 19 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | Baseline Men C (N=49, 194, 50) | 32 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (Men C) (N=48, 182, 48) | 37 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (MenC) (N=48, 158, 41) | 41 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 11 months post 2nd dose (Men Y) (N=177, 158, 165) | 22 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 1 month post 2nd dose (Men Y) (N=187, 182, 188) | 23 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 3 months post 2nd dose (Men Y) (N=173, 164, 175) | 22 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group. | 5 months post 2nd dose (Men Y (N=170, 165, 170) | 22 Titers |
Secondary
The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group
The hSBA geometric mean titers against the N. meningitidis serogroups C and Y in subjects (who have received a prior dose of MenC vaccine) after MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported. Analysis was not done for serogroups A and W.
Time frame: Up to 361 days after vaccination
Population: Analysis was done on the MITT dataset (Immunogenicity subset)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | 3 months post 2nd vaccination (Men Y) (N=42, 25) | 67 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | 1 month post 2nd vaccination (Men Y) (N=45, 26) | 89 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | Baseline (Men C) (N=46, 6) | 91 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | 1 month post 2nd vaccination (Men C) (N=45, 6) | 1905 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | 5 months post 2nd vaccination (Men Y) (N=45, 26) | 65 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | 11 months post 2nd vaccination (Men C) (N=45, 6) | 691 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | 11 months post 2nd vaccination (Men Y) (N=45, 26) | 48 Titers |
| rMenB+OMV | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | Baseline (Men Y) | 21 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | 11 months post 2nd vaccination (Men Y) (N=45, 26) | 22 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | 1 month post 2nd vaccination (Men C) (N=45, 6) | 154 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | 11 months post 2nd vaccination (Men C) (N=45, 6) | 125 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | Baseline (Men Y) | 23 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | 1 month post 2nd vaccination (Men Y) (N=45, 26) | 19 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | 3 months post 2nd vaccination (Men Y) (N=42, 25) | 20 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | 5 months post 2nd vaccination (Men Y) (N=45, 26) | 20 Titers |
| Control | The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group | Baseline (Men C) (N=46, 6) | 157 Titers |