Serogroup B Meningococcal Meningitis
Conditions
Keywords
infant, Meningococcal disease, prevention, vaccination
Brief summary
The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.
Interventions
BIOLOGICALSerogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
BIOLOGICALSerogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
One dose of rMenB concomitantly with the routinely administered infant vaccines
BIOLOGICALSerogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
One dose of rMenB concomitantly with the routinely administered infant vaccines
BIOLOGICALInfanrix Hexa
Routine vaccination
BIOLOGICALMenjugate
One dose of the routinely administered infant vaccines + MenC vaccine
BIOLOGICALPrevenar
Routine vaccination
Sponsors
GlaxoSmithKline
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Days to 89 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy 2-month old infants (55-89 days, inclusive)
Exclusion criteria
* Prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens) * Previous ascertained or suspected disease caused by N. meningitidis * History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; * Any serious chronic or progressive disease * Known or suspected impairment or alteration of the immune system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | one month after the third vaccination | The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs). |
| The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | one month after the third vaccination | The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | 1 month after third vaccination | The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination. |
| Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | 1 month after third vaccination | Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination. |
| Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month after third vaccination | The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(\>=1:8). Diptheria and Tetanus: primary endpoint ELISA \>=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA\>=1.0 IU/mL. HepB (HBV):primary endpoint ELISA \>=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC \>=0.35 mcg/ml |
| The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 1 month after the third vaccination | The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination. |
| Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | 1 Month after third vaccination | Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age. |
| Percentage of Subjects With hSBA Titers ≥1:8 | 1 month after third vaccination | Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains. |
| Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | upto 7 days after any vaccination | The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events. |
| Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens | 5 months | Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid). |
| Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | 1 Month after the third vaccination | The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ. |
Countries
Austria, Czechia, Finland, Germany, Italy
Participant flow
Recruitment details
16 sites in Finland, 28 sites in the Czech Republic, 13 sites in Germany, 6 sites in Austria, 7 sites in Italy.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| rMenB Lot1 Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. | 833 |
| rMenB Lot2 Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. | 828 |
| rMenB Lot3 Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. | 820 |
| Routine Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. | 659 |
| MenC+ Routine Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age. | 490 |
| Total | 3,630 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | AE or Death | 7 | 7 | 6 | 7 | 1 |
| Overall Study | Lost to Follow-up | 9 | 9 | 7 | 1 | 21 |
| Overall Study | Protocol Violation | 0 | 2 | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 7 | 15 | 15 | 5 | 9 |
Baseline characteristics
| Characteristic | rMenB Lot1 | rMenB Lot2 | rMenB Lot3 | Routine | MenC+ Routine | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 73.8 Days STANDARD_DEVIATION 9.5 | 74.1 Days STANDARD_DEVIATION 9.6 | 73.3 Days STANDARD_DEVIATION 9.4 | 74.7 Days STANDARD_DEVIATION 9.3 | 70.6 Days STANDARD_DEVIATION 9.7 | 73.5 Days STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 403 Participants | 400 Participants | 416 Participants | 318 Participants | 234 Participants | 1771 Participants |
| Sex: Female, Male Male | 430 Participants | 428 Participants | 404 Participants | 341 Participants | 256 Participants | 1859 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 827 / 832 | 825 / 828 | 817 / 820 | 652 / 659 | 482 / 490 |
| serious Total, serious adverse events | 70 / 832 | 80 / 828 | 60 / 820 | 51 / 659 | 28 / 490 |
Outcome results
Primary
The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
Time frame: one month after the third vaccination
Population: Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB Lot1 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | 44/76-SL strain (Baseline) | 1.21 Titers |
| rMenB Lot1 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | 44/76-SL strain one month after 3rd vaccination | 87 Titers |
| rMenB Lot1 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | 5/99 strain (Baseline) | 1.21 Titers |
| rMenB Lot1 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | 5/99 strain one month after 3rd vaccination | 598 Titers |
| rMenB Lot1 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | NZ98/254 strain (Baseline) | 1.03 Titers |
| rMenB Lot1 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | one month after 3rd vaccination | 15 Titers |
| rMenB Lot2 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | one month after 3rd vaccination | 14 Titers |
| rMenB Lot2 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | 44/76-SL strain (Baseline) | 1.19 Titers |
| rMenB Lot2 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | 5/99 strain one month after 3rd vaccination | 681 Titers |
| rMenB Lot2 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | NZ98/254 strain (Baseline) | 1.06 Titers |
| rMenB Lot2 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | 44/76-SL strain one month after 3rd vaccination | 98 Titers |
| rMenB Lot2 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | 5/99 strain (Baseline) | 1.2 Titers |
| rMenB Lot3 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | 44/76-SL strain one month after 3rd vaccination | 85 Titers |
| rMenB Lot3 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | 5/99 strain (Baseline) | 1.21 Titers |
| rMenB Lot3 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | one month after 3rd vaccination | 15 Titers |
| rMenB Lot3 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | 5/99 strain one month after 3rd vaccination | 607 Titers |
| rMenB Lot3 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | 44/76-SL strain (Baseline) | 1.19 Titers |
| rMenB Lot3 | The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | NZ98/254 strain (Baseline) | 1.04 Titers |
Comparison: The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).95% CI: [0.81, 0.99]ANOVA
Comparison: The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).95% CI: [0.93, 1.13]ANOVA
Comparison: The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).95% CI: [1.03, 1.27]ANOVA
Comparison: The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).95% CI: [0.78, 0.98]ANOVA
Comparison: The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).95% CI: [0.88, 1.1]ANOVA
Comparison: The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).95% CI: [1, 1.26]ANOVA
Comparison: The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).95% CI: [0.88, 1.23]ANOVA
Comparison: The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).95% CI: [0.81, 1.13]ANOVA
Comparison: The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for NZ98~/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).95% CI: [0.78, 1.08]ANOVA
Primary
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.
Time frame: one month after the third vaccination
Population: Analysis was done on PP population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB Lot1 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | 44/76-SL strain (Baseline) | 3 Percentages of subjects |
| rMenB Lot1 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | 44/76-SL strain-1 Month after 3rd vaccination | 100 Percentages of subjects |
| rMenB Lot1 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | 5/99 strain (Baseline) | 4 Percentages of subjects |
| rMenB Lot1 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | 5/99 strain-1 Month after 3rd vaccination | 100 Percentages of subjects |
| rMenB Lot1 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | NZ98/254 strain (Baseline) | 1 Percentages of subjects |
| rMenB Lot1 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | 1 Month after 3rd vaccination | 84 Percentages of subjects |
| rMenB Lot2 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | NZ98/254 strain (Baseline) | 1 Percentages of subjects |
| rMenB Lot2 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | 44/76-SL strain (Baseline) | 3 Percentages of subjects |
| rMenB Lot2 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | 5/99 strain-1 Month after 3rd vaccination | 2 Percentages of subjects |
| rMenB Lot2 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | 44/76-SL strain-1 Month after 3rd vaccination | 3 Percentages of subjects |
| rMenB Lot2 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | 1 Month after 3rd vaccination | 2 Percentages of subjects |
| rMenB Lot2 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | 5/99 strain (Baseline) | 7 Percentages of subjects |
Secondary
Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)
The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination.
Time frame: 1 month after third vaccination
Population: Analysis was done on PP dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB Lot1 | Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | Baseline | 22 IU/mL |
| rMenB Lot1 | Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | 1 Month after 3rd vaccination | 3149 IU/mL |
| rMenB Lot2 | Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | Baseline | 22 IU/mL |
| rMenB Lot2 | Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | 1 Month after 3rd vaccination | 3484 IU/mL |
| rMenB Lot3 | Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | Baseline | 22 IU/mL |
| rMenB Lot3 | Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | 1 Month after 3rd vaccination | 3103 IU/mL |
| Routine | Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | 1 Month after 3rd vaccination | 3370 IU/mL |
| Routine | Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | Baseline | 22 IU/mL |
| Routine | Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | Baseline | 21 IU/mL |
| Routine | Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | 1 Month after 3rd vaccination | 22 IU/mL |
Secondary
Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations
Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination.
Time frame: 1 month after third vaccination
Population: Analysis was done on Immunogenicity Routine PP (Pertussis Antigens)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB Lot1 | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | Pertactin (Baseline) | 6.3 IU/mL |
| rMenB Lot1 | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | 1 Month post 3rd vaccination; FHA | 123 IU/mL |
| rMenB Lot1 | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | 1 Month post 3rd vaccination; PT | 41 IU/mL |
| rMenB Lot1 | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | 1 Month post 3rd vaccination; Pertactin | 107 IU/mL |
| rMenB Lot1 | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | FHA (Baseline) | 9.98 IU/mL |
| rMenB Lot1 | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | PT (Baseline) | 2.82 IU/mL |
| rMenB Lot2 | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | FHA (Baseline) | 9.28 IU/mL |
| rMenB Lot2 | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | 1 Month post 3rd vaccination; FHA | 147 IU/mL |
| rMenB Lot2 | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | Pertactin (Baseline) | 5.36 IU/mL |
| rMenB Lot2 | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | 1 Month post 3rd vaccination; Pertactin | 139 IU/mL |
| rMenB Lot2 | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | PT (Baseline) | 2.82 IU/mL |
| rMenB Lot2 | Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | 1 Month post 3rd vaccination; PT | 51 IU/mL |
Comparison: Immunogenicity of the pertussis components (FHA) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.95% CI: [0.76, 0.94]ANOVA
Comparison: Immunogenicity of the pertussis component (Pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.95% CI: [0.67, 0.89]ANOVA
Comparison: Immunogenicity of the pertussis components (PT) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.95% CI: [0.71, 0.91]ANOVA
Secondary
Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ
The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ.
Time frame: 1 Month after the third vaccination
Population: Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB Lot1 | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | 44/76 Strain (Baseline) | 1.15 Titers |
| rMenB Lot1 | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | 44/76 Strain-1 Month after third vaccination | 91 Titers |
| rMenB Lot1 | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | 5/99 Strain (Baseline) | 1.18 Titers |
| rMenB Lot1 | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | 5/99 Strain-1 Month after third vaccination | 635 Titers |
| rMenB Lot1 | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | NZ98/254 (Baseline) | 1.05 Titers |
| rMenB Lot1 | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | 1 Month after third vaccination | 14 Titers |
| rMenB Lot2 | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | NZ98/254 (Baseline) | 1.01 Titers |
| rMenB Lot2 | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | 44/76 Strain (Baseline) | 1.12 Titers |
| rMenB Lot2 | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | 5/99 Strain-1 Month after third vaccination | 1.06 Titers |
| rMenB Lot2 | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | 44/76 Strain-1 Month after third vaccination | 1.2 Titers |
| rMenB Lot2 | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | 1 Month after third vaccination | 1.04 Titers |
| rMenB Lot2 | Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | 5/99 Strain (Baseline) | 1.21 Titers |
Secondary
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events.
Time frame: upto 7 days after any vaccination
Population: The analysis was done on safety subset population - all subjects enrolled who received study vaccination and provided post-baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Injection site swelling | 1174 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Diarrhea | 1086 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Injection site erythema | 2049 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Irritability | 2296 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Any Systemic | 2450 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Unusual Crying | 2109 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Injection site tenderness | 2147 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Rash | 318 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Change in Eating Habits | 1787 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Fever >= 38.5C | 1912 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Injection site induration | 1908 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Others | 2302 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Sleepiness | 2159 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Medical Attend. Fever | 57 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Any Local | 2388 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Analg. Antipyretic Med.Used | 2302 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Vomiting | 662 Participants |
| rMenB Lot1 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Antipyretic Med.Used | 2240 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Vomiting | 116 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Any Local | 443 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Injection site tenderness | 266 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Injection site erythema | 261 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Injection site induration | 227 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Injection site swelling | 84 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Any Systemic | 459 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Change in Eating Habits | 257 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Sleepiness | 353 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Antipyretic Med.Used | 314 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Diarrhea | 164 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Irritability | 370 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Unusual Crying | 352 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Rash | 43 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Fever >= 38.5C | 228 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Others | 325 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Medical Attend. Fever | 16 Participants |
| rMenB Lot2 | Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | Analg. Antipyretic Med.Used | 325 Participants |
Secondary
Percentage of Subjects With hSBA Titers ≥1:8
Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains.
Time frame: 1 month after third vaccination
Population: Analysis was done on PP population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB Lot1 | Percentage of Subjects With hSBA Titers ≥1:8 | 5/99 (Baseline) | 3 Percentages of subjects |
| rMenB Lot1 | Percentage of Subjects With hSBA Titers ≥1:8 | NZ98/254 (Baseline) | 1 Percentages of subjects |
| rMenB Lot1 | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination-44/76-SL | 100 Percentages of subjects |
| rMenB Lot1 | Percentage of Subjects With hSBA Titers ≥1:8 | 44/76-SL (Baseline) | 2 Percentages of subjects |
| rMenB Lot1 | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination | 70 Percentages of subjects |
| rMenB Lot1 | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination-5/99 | 100 Percentages of subjects |
| rMenB Lot2 | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination-5/99 | 100 Percentages of subjects |
| rMenB Lot2 | Percentage of Subjects With hSBA Titers ≥1:8 | 5/99 (Baseline) | 3 Percentages of subjects |
| rMenB Lot2 | Percentage of Subjects With hSBA Titers ≥1:8 | 44/76-SL (Baseline) | 2 Percentages of subjects |
| rMenB Lot2 | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination | 70 Percentages of subjects |
| rMenB Lot2 | Percentage of Subjects With hSBA Titers ≥1:8 | NZ98/254 (Baseline) | 1 Percentages of subjects |
| rMenB Lot2 | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination-44/76-SL | 100 Percentages of subjects |
| rMenB Lot3 | Percentage of Subjects With hSBA Titers ≥1:8 | 5/99 (Baseline) | 2 Percentages of subjects |
| rMenB Lot3 | Percentage of Subjects With hSBA Titers ≥1:8 | 44/76-SL (Baseline) | 2 Percentages of subjects |
| rMenB Lot3 | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination-44/76-SL | 99 Percentages of subjects |
| rMenB Lot3 | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination | 75 Percentages of subjects |
| rMenB Lot3 | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination-5/99 | 99 Percentages of subjects |
| rMenB Lot3 | Percentage of Subjects With hSBA Titers ≥1:8 | NZ98/254 (Baseline) | 0 Percentages of subjects |
| Routine | Percentage of Subjects With hSBA Titers ≥1:8 | 44/76-SL (Baseline) | 2 Percentages of subjects |
| Routine | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination | 72 Percentages of subjects |
| Routine | Percentage of Subjects With hSBA Titers ≥1:8 | NZ98/254 (Baseline) | 1 Percentages of subjects |
| Routine | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination-44/76-SL | 100 Percentages of subjects |
| Routine | Percentage of Subjects With hSBA Titers ≥1:8 | 5/99 (Baseline) | 3 Percentages of subjects |
| Routine | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination-5/99 | 100 Percentages of subjects |
| Routine | Percentage of Subjects With hSBA Titers ≥1:8 | 5/99 (Baseline) | 2 Percentages of subjects |
| Routine | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination | 1 Percentages of subjects |
| Routine | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination-5/99 | 2 Percentages of subjects |
| Routine | Percentage of Subjects With hSBA Titers ≥1:8 | 44/76-SL (Baseline) | 2 Percentages of subjects |
| Routine | Percentage of Subjects With hSBA Titers ≥1:8 | NZ98/254 (Baseline) | 0 Percentages of subjects |
| Routine | Percentage of Subjects With hSBA Titers ≥1:8 | 1 Month after 3rd vaccination-44/76-SL | 1 Percentages of subjects |
Secondary
Percentages of Subjects With Antibody Response Against the Routine Antigens
The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(\>=1:8). Diptheria and Tetanus: primary endpoint ELISA \>=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA\>=1.0 IU/mL. HepB (HBV):primary endpoint ELISA \>=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC \>=0.35 mcg/ml
Time frame: 1 Month after third vaccination
Population: Analysis was done on PP population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;Polio 3 | 97 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC4 ≥0.35μg/mL (Baseline) | 2 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Anti-DiphtheriaToxin ≥0.1IU/mL(Baseline) | 38 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;anti-D | 100 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Anti-DiphtheriaToxin ≥1.0 IU/mL(Baseline) | 2 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post 3rd vaccination;PnC 23F | 92 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination, anti-D≥1.0 IU/mL | 80 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Anti-TetanusToxin ≥0.1 IU/mL(Baseline) | 93 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;anti-T | 100 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Anti-Tetanus Toxin ≥1.0 IU/mL(Baseline) | 24 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month after third vaccination,anti-T≥1.0 IU/mL | 91 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Polio 1 ≥1:8 (Baseline) | 75 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;Polio 1 | 95 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post 3rd vaccination;anti-PRP ≥ 0.15 | 99 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Polio 2 (Baseline) | 68 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;Polio 2 | 88 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Polio 3 (Baseline) | 48 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC 19F ≥0.35μg/mL (Baseline) | 20 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;PnC 19 | 96 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | HBV ≥10 mIU/mL (Baseline) | 22 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;HBV | 98 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Anti-PRP (HIB) ≥ 0.15 μg/mL(Baseline) | 54 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Anti-PRP (HIB) ≥ 1.0 μg/mL (Baseline) | 12 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;anti-PRP ≥ 1.0 | 79 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;PnC4 | 98 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC 6B ≥0.35μg/mL (Baseline) | 14 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;PnC 6B | 90 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC 9V ≥0.35μg/mL (Baseline) | 4 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;PnC 9V | 100 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC 14 ≥0.35μg/mL (Baseline) | 33 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;PnC 14 | 96 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC 18C ≥0.35μg/mL (Baseline) | 10 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;PnC 18 | 98 Percentages Of Subjects |
| rMenB Lot1 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC 23F ≥0.35μg/mL (Baseline) | 16 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;PnC 18 | 99 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;PnC 14 | 97 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC 9V ≥0.35μg/mL (Baseline) | 3 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;PnC 9V | 100 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Anti-TetanusToxin ≥0.1 IU/mL(Baseline) | 95 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC 19F ≥0.35μg/mL (Baseline) | 21 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Anti-DiphtheriaToxin ≥0.1IU/mL(Baseline) | 38 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;PnC4 | 100 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;anti-D | 100 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Polio 3 (Baseline) | 49 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Anti-DiphtheriaToxin ≥1.0 IU/mL(Baseline) | 2 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC 23F ≥0.35μg/mL (Baseline) | 22 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;Polio 3 | 98 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;PnC 19 | 96 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination, anti-D≥1.0 IU/mL | 86 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | HBV ≥10 mIU/mL (Baseline) | 15 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC 6B ≥0.35μg/mL (Baseline) | 16 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;HBV | 100 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Anti-Tetanus Toxin ≥1.0 IU/mL(Baseline) | 27 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post 3rd vaccination;PnC 23F | 95 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC 14 ≥0.35μg/mL (Baseline) | 38 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;anti-T | 100 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month after third vaccination,anti-T≥1.0 IU/mL | 95 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post 3rd vaccination;anti-PRP ≥ 0.15 | 100 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Polio 1 ≥1:8 (Baseline) | 72 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;PnC 6B | 88 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;Polio 1 | 97 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Anti-PRP (HIB) ≥ 0.15 μg/mL(Baseline) | 55 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Anti-PRP (HIB) ≥ 1.0 μg/mL (Baseline) | 10 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC 18C ≥0.35μg/mL (Baseline) | 17 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | Polio 2 (Baseline) | 69 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;anti-PRP ≥ 1.0 | 79 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | 1 Month post third vaccination;Polio 2 | 94 Percentages Of Subjects |
| rMenB Lot2 | Percentages of Subjects With Antibody Response Against the Routine Antigens | PnC4 ≥0.35μg/mL (Baseline) | 2 Percentages Of Subjects |
Comparison: Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age,would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.95% CI: [-1, 2]Miettinen and Nurminen
Comparison: Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.95% CI: [-12, 1]Miettinen and Nurminen
Comparison: Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.95% CI: [-2, 2]Miettinen and Nurminen
Comparison: Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.95% CI: [-9, 1]Miettinen and Nurminen
Comparison: Immunogenicity of the polio type 1 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBV-IPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.95% CI: [-5, 2]Miettinen and Nurminen
Comparison: Immunogenicity of the polio type 2 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBVIPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.95% CI: [-11, -1]Miettinen and Nurminen
Comparison: Immunogenicity of the polio type 3 of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2,4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.95% CI: [-4, 2]Miettinen and Nurminen
Comparison: Immunogenicity of the hepatitis B surface antigen component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT ≥10.0 mIU/ml was greater than -10%95% CI: [-5, -1]Miettinen and Nurminen
Comparison: Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferiority that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥0.15 μg/mL was greater than -10%.95% CI: [-3, 1]Miettinen and Nurminen
Comparison: Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥1.0 μg/mL was greater than -10%.95% CI: [-7, 7]Miettinen and Nurminen
Comparison: Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% confidence interval for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL was, for the pneumococcal antigen PnC4.95% CI: [-4, 0]Miettinen and Nurminen
Comparison: Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 6B antigen greater than -10%.95% CI: [-4, 8]Miettinen and Nurminen
Comparison: Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa\_HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 9V, greater than -10%.95% CI: [-2, 1]Miettinen and Nurminen
Comparison: Immunogenicity of the 7 components of PCV7 vaccine when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC14 antigen, greater than -10%.95% CI: [-4, 3]Miettinen and Nurminen
Comparison: Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 18C antigen greater than -10%.95% CI: [-3, 1]Miettinen and Nurminen
Comparison: Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 19F antigen, greater than -10%.95% CI: [-3, 4]Miettinen and Nurminen
Comparison: Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 23F antigen, greater than -10%.95% CI: [-8, 2]Miettinen and Nurminen
Secondary
Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens
Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid).
Time frame: 5 months
Population: Analysis was done on PP dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB Lot1 | Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens | FHA | 84 Percentages of Subjects |
| rMenB Lot1 | Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens | Pertactin | 79 Percentages of Subjects |
| rMenB Lot1 | Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens | PT | 92 Percentages of Subjects |
| rMenB Lot2 | Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens | FHA | 87 Percentages of Subjects |
| rMenB Lot2 | Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens | Pertactin | 88 Percentages of Subjects |
| rMenB Lot2 | Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens | PT | 95 Percentages of Subjects |
Comparison: Immunogenicity of the FHA antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.95% CI: [-9, 4]Miettinen and Nurminen
Comparison: Immunogenicity of the Pertactin antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.95% CI: [-16, -3]Miettinen and Nurminen
Comparison: Immunogenicity of the PT antigen of DTPa-HBV-IPV vaccine given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.95% CI: [-7, 2]Miettinen and Nurminen
Secondary
Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination
Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age.
Time frame: 1 Month after third vaccination
Population: Analysis was done on PP dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB Lot1 | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | 44/76-SL | 99 Percentages of Subjects |
| rMenB Lot1 | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | NZ98/254 | 70 Percentages of Subjects |
| rMenB Lot1 | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | 5/99 | 100 Percentages of Subjects |
| rMenB Lot2 | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | 5/99 | 100 Percentages of Subjects |
| rMenB Lot2 | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | 44/76-SL | 100 Percentages of Subjects |
| rMenB Lot2 | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | NZ98/254 | 69 Percentages of Subjects |
| rMenB Lot3 | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | 5/99 | 99 Percentages of Subjects |
| rMenB Lot3 | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | 44/76-SL | 98 Percentages of Subjects |
| rMenB Lot3 | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | NZ98/254 | 75 Percentages of Subjects |
| Routine | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | 44/76-SL | 99 Percentages of Subjects |
| Routine | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | NZ98/254 | 71 Percentages of Subjects |
| Routine | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | 5/99 | 100 Percentages of Subjects |
| Routine | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | 5/99 | 2 Percentages of Subjects |
| Routine | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | 44/76-SL | 1 Percentages of Subjects |
| Routine | Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | NZ98/254 | 1 Percentages of Subjects |
Secondary
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)
The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination.
Time frame: 1 month after the third vaccination
Population: Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB Lot1 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 44/76-SL Baseline | 4 Percentages of subjects |
| rMenB Lot1 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 44/76-SL-1 Month after 3rd vaccination | 100 Percentages of subjects |
| rMenB Lot1 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 5/99 Baseline | 3 Percentages of subjects |
| rMenB Lot1 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 5/99-1 Month after 3rd vaccination | 100 Percentages of subjects |
| rMenB Lot1 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | NZ 98/254 Baseline | 1 Percentages of subjects |
| rMenB Lot1 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 1 Month after 3rd vaccination | 84 Percentages of subjects |
| rMenB Lot2 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 1 Month after 3rd vaccination | 81 Percentages of subjects |
| rMenB Lot2 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 5/99-1 Month after 3rd vaccination | 100 Percentages of subjects |
| rMenB Lot2 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 44/76-SL Baseline | 2 Percentages of subjects |
| rMenB Lot2 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 5/99 Baseline | 4 Percentages of subjects |
| rMenB Lot2 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 44/76-SL-1 Month after 3rd vaccination | 100 Percentages of subjects |
| rMenB Lot2 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | NZ 98/254 Baseline | 2 Percentages of subjects |
| rMenB Lot3 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 44/76-SL-1 Month after 3rd vaccination | 99 Percentages of subjects |
| rMenB Lot3 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 5/99 Baseline | 4 Percentages of subjects |
| rMenB Lot3 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 5/99-1 Month after 3rd vaccination | 99 Percentages of subjects |
| rMenB Lot3 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 1 Month after 3rd vaccination | 85 Percentages of subjects |
| rMenB Lot3 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | NZ 98/254 Baseline | 1 Percentages of subjects |
| rMenB Lot3 | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 44/76-SL Baseline | 3 Percentages of subjects |
| Routine | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | NZ 98/254 Baseline | 1 Percentages of subjects |
| Routine | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 1 Month after 3rd vaccination | 2 Percentages of subjects |
| Routine | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 44/76-SL-1 Month after 3rd vaccination | 3 Percentages of subjects |
| Routine | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 5/99-1 Month after 3rd vaccination | 2 Percentages of subjects |
| Routine | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 44/76-SL Baseline | 3 Percentages of subjects |
| Routine | The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | 5/99 Baseline | 7 Percentages of subjects |
Comparison: The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third vaccination, were entirely within the interval \[-10%, 10%\].95% CI: [-1, 1]Miettinen and Nurminen
Comparison: The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].95% CI: [0, 2]Miettinen and Nurminen
Comparison: The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].95% CI: [0, 2]Miettinen and Nurminen
Comparison: The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].95% CI: [-1, 1]Miettinen and Nurminen
Comparison: The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].95% CI: [0, 2]Miettinen and Nurminen
Comparison: The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].95% CI: [0, 2]Miettinen and Nurminen
Comparison: The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentages of subjects with hSBA titers ≥ 1:5 at 1 month after the third dose, were entirely within the interval \[-10%, 10%\].95% CI: [-2, 8]Miettinen and Nurminen
Comparison: The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1 month after the third dise, were entirely within the interval \[-10%, 10%\].95% CI: [-6, 4]Miettinen and Nurminen
Comparison: The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third dose, were entirely within the interval \[-10%, 10%\].95% CI: [-9, 1]Miettinen and Nurminen