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| ID | Type | Description | Link |
|---|---|---|---|
| V72_75 | Other Identifier | Novartis | |
| 2017-000093-11 | EudraCT Number |
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The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in adolescents [who previously participated in parent studies V72_41 (NCT0142384) and V72P10 (NCT00661713)] and 2) the kinetics of immune response following booster vaccination with rMenB+OMV NZ
After all subjects (Groups A and B) from Canada and Australia have completed the study, an interim analysis for the primary and secondary immunogenicity objectives will be performed. Follow on subjects (Group A) from parent study V72_41 (NCT0142384) will be analyzed for i) antibody persistence at approximately 4 years following a 2 dose primary series and ii) the immune response at 3, 7 and 30 days after a third dose (booster) of rMenB+OMV NZ. Canadian and Australian vaccine naïve subjects (Group B) will be analyzed for the immune response at 30 days after the first dose, and 3, 7 and 30 days after the second dose of rMenB+OMV NZ.
Subjects in Group B (naïve subjects) will be randomized into two different blood draw schedules according to a 1:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 3B | Experimental | Subjects who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during studies V72P10 (NCT00661713) or V72_41(NCT0142384), and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster. |
|
| Group B_0_1 | Active Comparator | Subjects who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine) | Biological | One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Human Serum Bactericidal Activity (hSBA)≥1:4 | Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254. | Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose). |
| Percentage of Subjects With hSBA≥1:5 | Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. This outcome measure was assessed only for strains H44/76 and M10713. | Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose). |
| Percentage of Subjects With hSBA Titers≥1:5 in Parent Studies-V72P10 and V72_41 | Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713 | At one month after last vaccination in parent studies- V72P10 (Month 7) and V72_41 (Month 2) |
| Percentage of Subjects With hSBA≥1:8 | Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 | Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose). |
| Percentage of Subjects With hSBA≥1:16 | Bactericidal activity was measured against each of the N. meningitidis group B Indicator strains H44/76,5/99,NZ98/254 and M10713 | Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose). |
| hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With hSBA ≥1:4 After Booster Dose/First Vaccination of rMenB+OMV NZ. | Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254. | Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination. |
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Inclusion Criteria:
Inclusion Criterion for naïve subjects:
Inclusion Criteria for all subjects:
Exclusion Criteria for all subjects
Exclusion Criterion for follow-on subjects:
• Received a third dose of a Meningococcal group B vaccine prior to enrolment in this study.
Exclusion Criterion for naïve subjects:
• Received any other Meningococcal group B vaccines prior to enrolment in this study.
Exclusion Criteria for all subjects:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Sherwood | Queensland | 4075 | Australia | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30691980 | Derived | Nolan T, Santolaya ME, de Looze F, Marshall H, Richmond P, Henein S, Rheault P, Heaton K, Perrett KP, Garfield H, Gupta A, Ferguson M, D'Agostino D, Toneatto D, O'Ryan M. Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine. Vaccine. 2019 Feb 21;37(9):1209-1218. doi: 10.1016/j.vaccine.2018.12.059. Epub 2019 Jan 26. |
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All enrolled subjects were included in the study. Only groups 3B & B_0_1 were accounted for enrollment number as subjects from parent studies are included in the group 3B.
Subjects were recruited from 4 sites in Australia,6 sites in Canada & 2 sites in Chile.Analysis were performed on the study population (Groups 3B and B_0_1), but also repeated & stratified by parent study (i.e., V72_41 subjects using naïve subjects in Australia and Canada as controls, and V72P10 subjects using naïve subjects in Chile as controls)
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 3B | Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 and at 0,1 month schedule in study V72_41, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster. |
| FG001 | Group B_0_1 | Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 3B | Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 and at 0,1 month schedule in study V72_41, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Human Serum Bactericidal Activity (hSBA)≥1:4 | Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254. | Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set,& all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1,for at least one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose). |
|
Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only).
Serious Adverse Events (SAEs) were collected until study termination (1 month for group 3B subjects/ 2 months for group B_0_1 subjects)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 3B | Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 month schedule in studies V72_41 or V72P10, and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99, NZ98/254 a nd M10713.
| Group 3B: 1 month after the last rMenB+OMV NZ vaccination in parent study and Day 1(prior to booster dose); Group B_0_1: Day 1(prior to first dose) |
| Geometric Mean Ratios (GMRs) of GMTs After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study Versus Day 1. | The GMRs of GMTs at Day 1 versus one month after the last dose of rMenB+OMV NZ vaccination in the parent study were calculated. Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713. | Group 3B: 1 month after the last vaccination in parent study and Day 1 (prior to booster dose) |
| Number of Subjects With Solicited Local and Systemic AEs. | Solicited adverse events are signs and symptoms derived from organized data collection systems, such as Subject Diaries or interview. The percentage and frequencies of subjects reporting solicited local and systemic AEs were tabulated. Threshold for any Erythema, Swelling and Induration: >= 25 mm Note:Vaccination 2 was performed only on group B_0_1 subjects. Threshold for any Erythema, Swelling and Induration: >= 25 mm | 7 days (including the day of vaccination) after each vaccination |
| Number of Subjects With Any Unsolicited Adverse Events (AEs). | An unsolicited adverse event is an adverse event that was not solicited using a subject Diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. Note : Vaccination 2 was performed only on group B_0_1 subjects. | 30 days (including the day of vaccination) after each vaccination. |
| Number of Subjects With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs. | A serious adverse event is any untoward medical occurrence that at any dose results in death or is life threatening or requires prolonged hospitalization, leads to Persistent or significant disability/incapacity. | Group 3B: from Day 1 to Day 31 (study termination visit) and Group B_0_1: from Day 1 to Day 61 (study termination visit) |
| Percentage of Subjects With hSBA ≥1:5 After Booster Dose/First Vaccination of rMenB+OMV NZ. | Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. This outcome measure was assessed only for strains H44/76 and M10713. | Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination. |
| Percentage of Subjects With hSBA ≥1:8 After Booster Dose/First Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. | Group 3B : 30 days after booster dose, Group B_0_1 : 30 days after first vaccination. |
| Percentage of Subjects With hSBA ≥1:16 After Booster Dose/First Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76, 5/99, NZ98/254 & M10713. | Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination. |
| hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination. | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713. | Group 3B subjects: Day 1(pre-booster dose) and 30 days post-booster dose. Group B_0_1: Day 1 (pre-first dose) and 30 days post-first dose. |
| Geometric Mean Ratio (GMRs) of GMTs After Booster Dose/First rMenB+OMV NZ Vaccination Versus Day 1. | Bactericidal activity was measured against each of the fout N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 by calculating the GMRs of GMTs one month post-vaccination of a booster dose versus pre-booster dose (follow-on subjects) or first dose of rMenB+OMV NZ versus prefirst dose (naïve subjects) to each N. meningitidis group B indicator strain. | At Day 31 (30 days post booster dose/first dose of vaccination) versus Day 1 (prior to booster dose/first dose of vaccination). |
| Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Pre Vaccination Compared to One Month Post-booster/First rMenB+OMV NZ Vaccination | The percentage of subjects with 4-fold rise at one month post-vaccination with a booster dose (follow-on subjects) /first dose (naive subjects) of rMenB+OMV NZ with respect to day 1 (follow-on subjects) / pre-first dose of rMenB+OMV NZ (naïve subjects). Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as: • for a pre-vaccination titer < 4, a post-vaccination titer of at least 16; • for a pre-vaccination titer ≥ 4 but \ | Group 3B: 1 month after booster dose; Group B_0_1: 1 month after first vaccination |
| Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points: Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose. This outcome measure was assessed only for strains 5/99 and NZ98/254. | Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose. |
| Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points: Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose. This outcome measure was assessed only for strains H44/76 and M10713. | Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose." |
| Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points: Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose. | Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose. |
| Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points: Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose | Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose |
| hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points: Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose. | Group 3B: Day 1 (pre-booster dose) and 3, 7 and 30 days after third dose booster; Group B_0_1: Pre 2nd dose and at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose. |
| Geometric Mean Ratios (GMRs) of GMTs After Booster/Second Vaccination Versus Before Booster/Second Vaccination. | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 by calculating the GMRs of GMTs post-vaccination with a booster dose (Group 3B) versus pre-booster dose or second dose (Group B_0_1) of vaccination versus pre second dose. | Group 3B: Day 1 and 30 days after third dose booster; Group B_0_1: 30 days post-first dose and at 30 days post-second dose |
| Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination | The percentage of subjects with 4-fold rise at 3, 7, 30 days post-vaccination with a booster dose (follow-on subjects) /second dose (naive subjects) of rMenB+OMV NZ with respect to day 1 (follow-on subjects) / pre-second dose of rMenB+OMV NZ (naïve subjects). Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as: • for a pre-vaccination titer < 4, a post-vaccination titer of at least 16; • for a pre-vaccination titer ≥ 4 but \ | Group 3B: at 3, 7 and 30 days after third dose booster; Group B_0_1: at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose |
| Percentage of Subjects With hSBA ≥1:4 After Second Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure. | At Day 61 (30 days post second dose of vaccination.) |
| Percentage of Subjects With hSBA ≥1:5 After Second Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure. | At Day 61 (30 days post second dose of vaccination.) |
| Percentage of Subjects With hSBA ≥1:8 After Second Vaccination of rMenB+OMV NZ. | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure. | At Day 61 (30 days post second vaccination) |
| Percentage of Subjects With hSBA ≥1:16 After Second Vaccination of rMenB+OMV NZ. | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure. | At Day 61 (30 days post second vaccination) |
| hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ. | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure. | At Day 1 & Day 61 (30 days post second dose of vaccination) |
| Geometric Mean Ratio (GMRs) of GMTs One Month Post Second Vaccination Versus Pre Vaccination at Day 1 | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure. | At Day 1 & Day 61 (30 days post 2nd vaccination) |
| Percentages of Subjects With at Least Four-fold Increase in hSBA Titers at Pre-First Vaccination Compared to One Month Post-Second Vaccination | The percentage of subjects with 4-fold rise at one month post-vaccination with a second dose (naïve subjects) of rMenB+OMV NZ with respect to day 1, to each and any one, two, three or all 4 indicator strains. Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as:
| At Day 61 (30 days post second dose of vaccination) |
| North Adelaide |
| South Australia |
| 5006 |
| Australia |
| GSK Investigational Site | Carlton | Victoria | 3010 | Australia |
| GSK Investigational Site | Subiaco | Western Australia | 6008 | Australia |
| GSK Investigational Site | Truro | Nova Scotia | B2N1L2 | Canada |
| GSK Investigational Site | Greater Sudbury | Ontario | P3E1H5 | Canada |
| GSK Investigational Site | Newmarket | Ontario | L3Y5G8 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G1N8 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9V 4B4 | Canada |
| GSK Investigational Site | Woodstock | Ontario | N4S5P5 | Canada |
| GSK Investigational Site | Santiago | 7500092 | Chile |
| GSK Investigational Site | Santiago | 8380453 | Chile |
| Adverse Event |
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| Other |
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| BG001 | Group B_0_1 | Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | Group 3B (V72P10) | Subjects who received two doses of rMenB+OMV NZ administered at 0,1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during study V72P10, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster. |
| OG002 | Group 3B | Subjects who received two doses of rMenB+OMV NZ administered at 0, 1 or 0,2 or 0,6 month schedule in study V72P10 (NCT00661713) and at 0,1 month schedule in study V72_41(NCT0142384), and who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during parent studies, and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster. |
| OG003 | Group B_0_1 (V72_41) | Naive subjects from Australia and Canada, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose. |
| OG004 | Group B_0_1 (V72P10) | Naive subjects from Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule in this study and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose. |
| OG005 | Group B_0_1 | Naive subjects from Australia,Canada and Chile, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose |
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| Primary | Percentage of Subjects With hSBA≥1:5 | Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. This outcome measure was assessed only for strains H44/76 and M10713. | Analysis was performed on the Full analysis set (FAS) persistence.The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose). |
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| Primary | Percentage of Subjects With hSBA Titers≥1:5 in Parent Studies-V72P10 and V72_41 | Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713 | Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At one month after last vaccination in parent studies- V72P10 (Month 7) and V72_41 (Month 2) |
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| Primary | Percentage of Subjects With hSBA≥1:8 | Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 | Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose). |
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| Primary | Percentage of Subjects With hSBA≥1:16 | Bactericidal activity was measured against each of the N. meningitidis group B Indicator strains H44/76,5/99,NZ98/254 and M10713 | Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose). |
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| Primary | hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study. | Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99, NZ98/254 a nd M10713. | Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Group 3B: 1 month after the last rMenB+OMV NZ vaccination in parent study and Day 1(prior to booster dose); Group B_0_1: Day 1(prior to first dose) |
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| Primary | Geometric Mean Ratios (GMRs) of GMTs After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study Versus Day 1. | The GMRs of GMTs at Day 1 versus one month after the last dose of rMenB+OMV NZ vaccination in the parent study were calculated. Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713. | Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Group 3B: 1 month after the last vaccination in parent study and Day 1 (prior to booster dose) |
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| Primary | Number of Subjects With Solicited Local and Systemic AEs. | Solicited adverse events are signs and symptoms derived from organized data collection systems, such as Subject Diaries or interview. The percentage and frequencies of subjects reporting solicited local and systemic AEs were tabulated. Threshold for any Erythema, Swelling and Induration: >= 25 mm Note:Vaccination 2 was performed only on group B_0_1 subjects. Threshold for any Erythema, Swelling and Induration: >= 25 mm | The analysis was done on the Solicited Safety Set. The solicited safety set included all subjects in the exposed set with any solicited adverse event data and/indicators of solicited adverse events. | Posted | Number | Subjects | 7 days (including the day of vaccination) after each vaccination |
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| Primary | Number of Subjects With Any Unsolicited Adverse Events (AEs). | An unsolicited adverse event is an adverse event that was not solicited using a subject Diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. Note : Vaccination 2 was performed only on group B_0_1 subjects. | Analysis was performed on the unsolicited safety set. The unsolicited safety set included all subjects who received a study vaccination with unsolicited adverse event data. | Posted | Number | Subjects | 30 days (including the day of vaccination) after each vaccination. |
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| Primary | Number of Subjects With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs. | A serious adverse event is any untoward medical occurrence that at any dose results in death or is life threatening or requires prolonged hospitalization, leads to Persistent or significant disability/incapacity. | Analysis was performed on the Overall safety set. The overall safety set included all screened subjects in the solicited and unsolicited safety set who provided informed consent and provided demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study and received a Subject ID. | Posted | Number | Subjects | Group 3B: from Day 1 to Day 31 (study termination visit) and Group B_0_1: from Day 1 to Day 61 (study termination visit) |
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| Secondary | Percentage of Subjects With hSBA ≥1:4 After Booster Dose/First Vaccination of rMenB+OMV NZ. | Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254. | Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination. |
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| Secondary | Percentage of Subjects With hSBA ≥1:5 After Booster Dose/First Vaccination of rMenB+OMV NZ. | Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. This outcome measure was assessed only for strains H44/76 and M10713. | Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination. |
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| Secondary | Percentage of Subjects With hSBA ≥1:8 After Booster Dose/First Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. | Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B : 30 days after booster dose, Group B_0_1 : 30 days after first vaccination. |
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| Secondary | Percentage of Subjects With hSBA ≥1:16 After Booster Dose/First Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76, 5/99, NZ98/254 & M10713. | Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination. |
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| Secondary | hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination. | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713. | Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Group 3B subjects: Day 1(pre-booster dose) and 30 days post-booster dose. Group B_0_1: Day 1 (pre-first dose) and 30 days post-first dose. |
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| Secondary | Geometric Mean Ratio (GMRs) of GMTs After Booster Dose/First rMenB+OMV NZ Vaccination Versus Day 1. | Bactericidal activity was measured against each of the fout N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 by calculating the GMRs of GMTs one month post-vaccination of a booster dose versus pre-booster dose (follow-on subjects) or first dose of rMenB+OMV NZ versus prefirst dose (naïve subjects) to each N. meningitidis group B indicator strain. | Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Day 31 (30 days post booster dose/first dose of vaccination) versus Day 1 (prior to booster dose/first dose of vaccination). |
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| Secondary | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Pre Vaccination Compared to One Month Post-booster/First rMenB+OMV NZ Vaccination | The percentage of subjects with 4-fold rise at one month post-vaccination with a booster dose (follow-on subjects) /first dose (naive subjects) of rMenB+OMV NZ with respect to day 1 (follow-on subjects) / pre-first dose of rMenB+OMV NZ (naïve subjects). Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as: • for a pre-vaccination titer < 4, a post-vaccination titer of at least 16; • for a pre-vaccination titer ≥ 4 but \ | Analysis was performed on the Full Analysis set (FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for atleast one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: 1 month after booster dose; Group B_0_1: 1 month after first vaccination |
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| Secondary | Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points: Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose. This outcome measure was assessed only for strains 5/99 and NZ98/254. | Analysis was performed on PPS kinetics which included all subjects who correctly received the vaccination at day 1/ day 1 & day 31 (naive subjects) & provided evaluable immunogenicity result at all of days 4, 8 & 31 (for follow-on subjects) or at all of days 34,38 and 61 (naive subjects). | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose. |
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| Secondary | Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points: Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose. This outcome measure was assessed only for strains H44/76 and M10713. | Analysis was performed on the PPS kinetics which included all subjects who correctly received the vaccination at day 1/ day 1 & day 31 (naive subjects) & provided evaluable immunogenicity result at all of days 4, 8 & 31 (for follow-on subjects) or at all of days 34,38 & 61 (naive subjects). | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose." |
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| Secondary | Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points: Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose. | Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34, 38 & 61(naive) | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose. |
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| Secondary | Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points: Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose | Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34, 38 & 61(naive) | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose |
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| Secondary | hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination. | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points: Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose. | Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34, 38 & 61(naive) | Posted | Geometric Mean | 95% Confidence Interval | Titers | Group 3B: Day 1 (pre-booster dose) and 3, 7 and 30 days after third dose booster; Group B_0_1: Pre 2nd dose and at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose. |
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| Secondary | Geometric Mean Ratios (GMRs) of GMTs After Booster/Second Vaccination Versus Before Booster/Second Vaccination. | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 by calculating the GMRs of GMTs post-vaccination with a booster dose (Group 3B) versus pre-booster dose or second dose (Group B_0_1) of vaccination versus pre second dose. | Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34, 38 & 61(naive) | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Group 3B: Day 1 and 30 days after third dose booster; Group B_0_1: 30 days post-first dose and at 30 days post-second dose |
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| Secondary | Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination | The percentage of subjects with 4-fold rise at 3, 7, 30 days post-vaccination with a booster dose (follow-on subjects) /second dose (naive subjects) of rMenB+OMV NZ with respect to day 1 (follow-on subjects) / pre-second dose of rMenB+OMV NZ (naïve subjects). Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as: • for a pre-vaccination titer < 4, a post-vaccination titer of at least 16; • for a pre-vaccination titer ≥ 4 but \ | Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34/38 & 61(naive) | Posted | Number | 95% Confidence Interval | Percentage of subjects | Group 3B: at 3, 7 and 30 days after third dose booster; Group B_0_1: at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose |
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| Secondary | Percentage of Subjects With hSBA ≥1:4 After Second Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure. | Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain. The analysis was performed only on strains 5/99 and NZ98/254 | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 61 (30 days post second dose of vaccination.) |
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| Secondary | Percentage of Subjects With hSBA ≥1:5 After Second Vaccination of rMenB+OMV NZ | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure. | Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain. The analysis was performed only on strains H44/76 and M10713 | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 61 (30 days post second dose of vaccination.) |
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| Secondary | Percentage of Subjects With hSBA ≥1:8 After Second Vaccination of rMenB+OMV NZ. | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure. | Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 61 (30 days post second vaccination) |
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| Secondary | Percentage of Subjects With hSBA ≥1:16 After Second Vaccination of rMenB+OMV NZ. | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure. | Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 61 (30 days post second vaccination) |
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| Secondary | hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ. | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure. | Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 & Day 61 (30 days post second dose of vaccination) |
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| Secondary | Geometric Mean Ratio (GMRs) of GMTs One Month Post Second Vaccination Versus Pre Vaccination at Day 1 | Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure. | Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Day 1 & Day 61 (30 days post 2nd vaccination) |
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| Secondary | Percentages of Subjects With at Least Four-fold Increase in hSBA Titers at Pre-First Vaccination Compared to One Month Post-Second Vaccination | The percentage of subjects with 4-fold rise at one month post-vaccination with a second dose (naïve subjects) of rMenB+OMV NZ with respect to day 1, to each and any one, two, three or all 4 indicator strains. Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as:
| Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain. | Posted | Number | 95% Confidence Interval | Percentage of Subjects | At Day 61 (30 days post second dose of vaccination) |
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| 0 |
| 275 |
| 0 |
| 275 |
| 266 |
| 275 |
| EG001 | Group B_0_1 | Naive subjects from V72_41 or V72P10 studies, who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose. | 0 | 255 | 1 | 255 | 253 | 255 |
| Injectioon site pain | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
| D000090862 | Neuroinflammatory Diseases |
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| M10713 |
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| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine groups difference | 22 | 2-Sided | 95 | 13.2 | 30.1 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [(Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 30 | 2-Sided | 95 | 20.0 | 39.6 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 4 | 2-Sided | 95 | -3.4 | 11.9 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group differences | 12 | 2-Sided | 95 | 0.33 | 24.2 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1(V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 0 | 2-Sided | 95 | -10.0 | 9.5 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1(V72P10)] |
| H44/76- 1 month after last vacc in Parent study |
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| M10713- Baseline in Parent study |
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| M10713- 1 month after last vacc in Parent study |
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| 5/99 |
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| NZ98/254 |
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| M10713 |
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| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 21 | 2-Sided | 95 | 14.6 | 28.9 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 26 | 2-Sided | 95 | 16.4 | 35.3 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 68 | 2-Sided | 95 | 60.8 | 73.7 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 74 | 2-Sided | 95 | 65.3 | 81.3 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 64 | 2-Sided | 95 | 53.6 | 72.3 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 9 | 2-Sided | 95 | 3.7 | 14.0 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 7 | 2-Sided | 95 | 3.3 | 12.3 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 13 | 2-Sided | 95 | 4.5 | 22.0 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 5 | 2-Sided | 95 | -3.4 | 12.8 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 9 | 2-Sided | 95 | -3.3 | 21.4 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 4 | 2-Sided | 95 | -6.4 | 14.5 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
|
| 5/99 |
|
|
| NZ98/254 |
|
|
| M10713 |
|
|
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 12 | 2-Sided | 95 | 7.5 | 18.1 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 21 | 2-Sided | 95 | 12.3 | 29.9 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 66 | 2-Sided | 95 | 59.6 | 72.4 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 70 | 2-Sided | 95 | 60.8 | 77.0 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 65 | 2-Sided | 95 | 55.2 | 73.7 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 9 | 2-Sided | 95 | 4.9 | 13.6 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 5 | 2-Sided | 95 | 1.2 | 9.7 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 15 | 2-Sided | 95 | 7.5 | 22.6 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 2 | 2-Sided | 95 | -6.8 | 10.0 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 3 | 2-Sided | 95 | -9.8 | 15.2 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 4 | 2-Sided | 95 | -7.8 | 14.7 | Other | Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
|
| H44/76( Day 1) |
|
|
| 5/99(1 month post last vacc in parent study) |
|
|
| 5/99 (Day 1) |
|
|
| NZ98/254(1 month post last vacc in parent study) |
|
|
| NZ98/254( Day 1) |
|
|
| M10713(1 month post last vacc in parent study) |
|
|
| M10713(Day 1) |
|
|
| Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Adjusted by vaccine group and country | vaccine group ratio of GMTs | 2.13 | 2-Sided | 95 | 1.66 | 2.72 | Other | Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Adjusted by vaccine group and country | vaccine group ratio of GMTs | 2.96 | 2-Sided | 95 | 2.15 | 4.07 | Other | Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Adjusted by vaccine group and country | Vaccine group ratio of GMTs | 16 | 2-Sided | 95 | 12 | 21 | Other | Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 (Group 3B vs. Group B_0_1) |
| Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Adjusted by vaccine group and country | vaccine group ratio of GMTs | 20 | 2-Sided | 95 | 14 | 28 | Other | Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Adjusted by vaccine group and country | vaccine group ratio of GMTs | 14 | 2-Sided | 95 | 9.05 | 20 | Other | Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Adjusted by vaccine group and country | Vaccine group ratio of GMTs | 1.50 | 2-Sided | 95 | 1.26 | 1.78 | Other | Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 (Group 3B vs. Group B_0_1) |
| Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Adjusted by vaccine group and country | vaccine group ratio of GMTs | 1.30 | 2-Sided | 95 | 1.11 | 1.51 | Other | Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Adjusted by vaccine group and country | vaccine group ratio of GMTs | 1.70 | 2-Sided | 95 | 1.27 | 2.28 | Other | Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Adjusted by vaccine group and country | Vaccine group ratio of GMTs | 1.26 | 2-Sided | 95 | 0.94 | 1.68 | Other | Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 (Group 3B vs. Group B_0_1) |
| Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Adjusted by vaccine group and country | vaccine group ratio of GMTs | 1.32 | 2-Sided | 95 | 0.85 | 2.05 | Other | Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Adjusted by vaccine group and country | vaccine group ratio of GMTs | 1.20 | 2-Sided | 95 | 0.81 | 1.78 | Other | Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| 5/99 |
|
|
| NZ98/254 |
|
|
| M10713 |
|
|
| Any Local (vaccination 1) |
|
|
| Injection site pain (vaccination 1) |
|
|
| Erythema (vaccination 1) |
|
|
| Swelling (vaccination 1) |
|
|
| Induration (vaccination 1) |
|
|
| Any systemic (vaccination 1) |
|
|
| Fever (≥ 38.0°C) (vaccination 1) |
|
|
| High fever (≥ 39.5°C) (vaccination 1) |
|
|
| Nausea (vaccination 1) |
|
|
| Fatigue (vaccination 1) |
|
|
| Myalgia (vaccination 1) |
|
|
| Arthralgia (vaccination 1) |
|
|
| Headache (vaccination 1) |
|
|
| Any Local (vaccination 2) |
|
|
| Injection site pain (vaccination 2) |
|
|
| Erythema (vaccination 2) |
|
|
| Swelling (vaccination 2) |
|
|
| Induration (vaccination 2) |
|
|
| Any systemic (vaccination 2) |
|
|
| Fever (≥ 38.0°C) (vaccination 2) |
|
|
| High fever (≥ 39.5°C) (vaccination 2) |
|
|
| Nausea (vaccination 2) |
|
|
| Fatigue (vaccination 2) |
|
|
| Myalgia (vaccination 2) |
|
|
| Arthralgia (vaccination 2) |
|
|
| Headache (vaccination 2) |
|
|
| Any unsolicited AEs ( vaccination 1) |
|
|
| Any unsolicited AEs (vaccination 2) |
|
|
| Any AEs leading to premature withdrawal |
|
|
| NZ98/254 |
|
|
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 16 | 2-Sided | 95 | 10.8 | 23.1 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 15 | 2-Sided | 95 | 11.0 | 20.1 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 54 | 2-Sided | 95 | 43.0 | 63.3 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 31 | 2-Sided | 95 | 22.0 | 40.1 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 41 | 2-Sided | 95 | 33.6 | 47.2 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1) |
|
| M10713 |
|
|
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 18 | 2-Sided | 95 | 10.7 | 27.0 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 21 | 2-Sided | 95 | 15.6 | 28.8 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 12 | 2-Sided | 95 | 8.0 | 16.8 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 20 | 2-Sided | 95 | 12.8 | 28.6 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 6 | 2-Sided | 95 | 1.5 | 12.2 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
|
| 5/99 |
|
|
| NZ98/254 |
|
|
| M10713 |
|
|
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 31 | 2-Sided | 95 | 21.8 | 40.3 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 26 | 2-Sided | 95 | 19.2 | 33.1 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 19 | 2-Sided | 95 | 14.3 | 24.3 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 19 | 2-Sided | 95 | 12.1 | 27.5 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 19 | 2-Sided | 95 | 13.3 | 26.4 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 43 | 2-Sided | 95 | 35.2 | 49.9 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 58 | 2-Sided | 95 | 46.6 | 67.3 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 33 | 2-Sided | 95 | 23.0 | 42.5 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 13 | 2-Sided | 95 | 8.8 | 18.3 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 20 | 2-Sided | 95 | 12.6 | 29.0 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 8 | 2-Sided | 95 | 2.7 | 14.7 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
|
| 5/99 |
|
|
| NZ98/254 |
|
|
| M10713 |
|
|
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 49 | 2-Sided | 95 | 38.9 | 58.5 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 34 | 2-Sided | 95 | 26.6 | 42.2 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 27 | 2-Sided | 95 | 21.6 | 33.0 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 23 | 2-Sided | 95 | 15.5 | 32.0 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 30 | 2-Sided | 95 | 22.9 | 38.1 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 43 | 2-Sided | 95 | 35.1 | 50.6 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 51 | 2-Sided | 95 | 39.3 | 60.9 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 41 | 2-Sided | 95 | 29.9 | 50.2 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 19 | 2-Sided | 95 | 12.9 | 24.6 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 28 | 2-Sided | 95 | 17.9 | 37.8 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 13 | 2-Sided | 95 | 6.4 | 20.1 | Other | Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
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| H44/76-1 month post booster/first dose |
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| 5/99- pre booster/ pre first dose |
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| 5/99-1 month post booster/first dose |
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| NZ98/254-pre booster/ pre first dose |
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| NZ98/254-1 month post booster/first dose |
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| M10713-pre booster/ pre first dose |
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| M10713-1 month post booster/first dose |
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| Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 11 | 2-Sided | 95 | 8.85 | 15 | Other | Vaccine comparison Post-booster or post-1st dose in V72_75 (Group 3B vs. Group B _0_1) |
| Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 2.18 | 2-Sided | 95 | 1.70 | 2.79 | Other | Vaccine comparison-Pre-booster or pre-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 12 | 2-Sided | 95 | 8.22 | 17 | Other | Vaccine comparison-post-booster or post-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 3.04 | 2-Sided | 95 | 2.20 | 4.20 | Other | Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 11 | 2-Sided | 95 | 7.75 | 16 | Other | Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 16 | 2-Sided | 95 | 12 | 21 | Other | Vaccine comparison Pre-booster or pre-1st dose in V72_75 (Group 3B vs. Group B _0_1) |
| Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 68 | 2-Sided | 95 | 51 | 90 | Other | Vaccine comparison Post-booster or post-1st dose in V72_75 (Group 3B vs. Group B _0_1) |
| Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 18 | 2-Sided | 95 | 13 | 26 | Other | Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 74 | 2-Sided | 95 | 51 | 107 | Other | Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 14 | 2-Sided | 95 | 8.99 | 22 | Other | Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 63 | 2-Sided | 95 | 41 | 95 | Other | Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 1.48 | 2-Sided | 95 | 1.24 | 1.75 | Other | Vaccine comparison Pre-booster or pre-1st dose in V72_75 (Group 3B vs. Group B _0_1) |
| Post booster dose/ post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 5.90 | 2-Sided | 95 | 4.49 | 7.76 | Other | Vaccine comparison Post-booster or post-1st dose in V72_75 (Group 3B vs. Group B _0_1) |
| Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 1.32 | 2-Sided | 95 | 1.13 | 1.54 | Other | Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 8.27 | 2-Sided | 95 | 5.83 | 12 | Other | Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 1.64 | 2-Sided | 95 | 1.22 | 2.20 | Other | Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 4.36 | 2-Sided | 95 | 2.88 | 6.58 | Other | Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 1.30 | 2-Sided | 95 | 0.97 | 1.75 | Other | Vaccine comparison Pre-booster or pre-1st dose in V72_75 (Group 3B vs. Group B _0_1) |
| Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 2.60 | 2-Sided | 95 | 2.08 | 3.25 | Other | Vaccine comparison Post-booster or post-1st dose in V72_75 (Group 3B vs. Group B _0_1) |
| Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 1.40 | 2-Sided | 95 | 0.90 | 2.18 | Other | Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 2.79 | 2-Sided | 95 | 2.04 | 3.81 | Other | Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] |
| Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 1.23 | 2-Sided | 95 | 0.82 | 1.82 | Other | Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
| Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 2.45 | 2-Sided | 95 | 1.79 | 3.36 | Other | Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] |
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| 5/99 |
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| NZ98/254 |
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| M10713 |
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| 5/99 |
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| NZ98/254 |
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| M10713 |
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| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 29 | 2-Sided | 95 | 19.3 | 38.7 | Other | 1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41) Difference](streamdown:incomplete-link) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 26 | 2-Sided | 95 | 18.3 | 33.9 | Other | 1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10) Difference](streamdown:incomplete-link) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval or the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 22 | 2-Sided | 95 | 15.9 | 27.9 | Other | 1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 19 | 2-Sided | 95 | 11.5 | 28.5 | Other | 1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41) Difference](streamdown:incomplete-link) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 23 | 2-Sided | 95 | 14.6 | 31.9 | Other | 1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10) Difference](streamdown:incomplete-link) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 38 | 2-Sided | 95 | 29.8 | 45.4 | Other | 1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 55 | 2-Sided | 95 | 43.5 | 64.7 | Other | 1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41) Difference](streamdown:incomplete-link) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 24 | 2-Sided | 95 | 12.9 | 35.1 | Other | 1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10) Difference](streamdown:incomplete-link) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 23 | 2-Sided | 95 | 14.7 | 30.8 | Other | 1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 24 | 2-Sided | 95 | 12.2 | 35.5 | Other | 1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41) Difference](streamdown:incomplete-link) |
| The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 22 | 2-Sided | 95 | 10.6 | 32.9 | Other | 1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10) Difference](streamdown:incomplete-link) |
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| 5/99- 7 days post vaccination |
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| 5/99- 1 month post vaccination |
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| NZ98/254- 3 days post vaccination |
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| NZ98/254- 7 days post vaccination |
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| NZ98/254- 1 month post vaccination |
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| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | -4 | 2-Sided | 95 | -17.0 | 11.4 | Other | Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | -8 | 2-Sided | 95 | -20.0 | 7.3 | Other | Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 1 | 2-Sided | 95 | -0.9 | 6.2 | Other | Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 0 | 2-Sided | 95 | -3.6 | 8.8 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 2 | 2-Sided | 95 | -2.5 | 11.0 | Other | Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 0 | 2-Sided | 95 | -3.6 | 4.4 | Other | Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1(V72_41) (1 month after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 2 | 2-Sided | 95 | -2.3 | 7.8 | Other | Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 1 | 2-Sided | 95 | -0.9 | 4.1 | Other | Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | -20 | 2-Sided | 95 | -35.2 | -7.5 | Other | Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | -32 | 2-Sided | 95 | -46.5 | -15.7 | Other | Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | -28 | 2-Sided | 95 | -38.4 | -17.1 | Other | Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | -6 | 2-Sided | 95 | -19.2 | 9.2 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | -2 | 2-Sided | 95 | -14.1 | 12.3 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | -5 | 2-Sided | 95 | -13.6 | 5.6 | Other | Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 12 | 2-Sided | 95 | 3.6 | 21.6 | Other | Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 15 | 2-Sided | 95 | 6.4 | 24.6 | Other | Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 14 | 2-Sided | 95 | 7.6 | 20.3 | Other | Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose) |
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| H44/76 7 days post vaccination |
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| H44/76 1 month post vaccination |
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| M10713- 3 days post-vaccination |
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| M10713- 7 days post-vaccination |
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| M10713- 1 month post-vaccination |
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| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -1 | 2-Sided | 95 | -3.9 | 3.6 | Other | Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -2.7 | 2.4 | Other | Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -46 | 2-Sided | 95 | -58.4 | -29.8 | Other | Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -3 | 2-Sided | 95 | -7.7 | 5.1 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -1 | 2-Sided | 95 | -5.7 | 3.7 | Other | Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | -40 | 2-Sided | 95 | -51.8 | -25.4 | Other | Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 1 | 2-Sided | 95 | -3.3 | 9.0 | Other | Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 1 | 2-Sided | 95 | -2.4 | 5.0 | Other | Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -4 | 2-Sided | 95 | -12.4 | 5.8 | Other | Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 2 | 2-Sided | 95 | -2.2 | 7.7 | Other | Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 6 | 2-Sided | 95 | 2.8 | 10.5 | Other | Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -5 | 2-Sided | 95 | -17.8 | 10.6 | Other | Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 2 | 2-Sided | 95 | -3.2 | 13.0 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 9 | 2-Sided | 95 | 3.7 | 16.5 | Other | Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -2 | 2-Sided | 95 | -11.8 | 11.0 | Other | Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 1 | 2-Sided | 95 | -4.6 | 10.1 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 4 | 2-Sided | 95 | -0.8 | 9.5 | Other | Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month days after booster or 2nd dose) |
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| H44/76 7 days post vaccination |
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| H44/76 1 month post vaccination |
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| 5/99- 3 days post-vaccination |
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| 5/99- 7 days post-vaccination |
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| 5/99- 1 month post-vaccination |
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| NZ98/254- 3 days post-vaccination |
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| NZ98/254- 7 days post-vaccination |
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| NZ98/254- 1 month post-vaccination |
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| M10713- 3 days post-vaccination |
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| M10713- 7 days post-vaccination |
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| M10713- 1 month post-vaccination |
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| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -1 | 2-Sided | 95 | -4.5 | 5.2 | Other | Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 1 | 2-Sided | 95 | -1.9 | 3.9 | Other | Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -48 | 2-Sided | 95 | -60.8 | -32.0 | Other | Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -1 | 2-Sided | 95 | -7.3 | 10.1 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -1 | 2-Sided | 95 | -5.7 | 3.7 | Other | Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -41 | 2-Sided | 95 | -53.3 | -25.5 | Other | Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -4.8 | 8.1 | Other | Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score methodx | vaccine group difference | 3 | 2-Sided | 95 | -0.6 | 7.8 | Other | Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month days after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -6 | 2-Sided | 95 | -15.9 | 4.6 | Other | Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 1 | 2-Sided | 95 | -0.9 | 6.2 | Other | Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 1 | 2-Sided | 95 | -0.9 | 4.1 | Other | Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -6 | 2-Sided | 95 | -19.2 | 10.3 | Other | Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -3.6 | 8.8 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -3.6 | 4.4 | Other | Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -6 | 2-Sided | 95 | -19.4 | 9.1 | Other | Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 2 | 2-Sided | 95 | -2.5 | 11.0 | Other | Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 2 | 2-Sided | 95 | -2.3 | 7.8 | Other | Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month days after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -26 | 2-Sided | 95 | -36.6 | -15.7 | Other | Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -3 | 2-Sided | 95 | -13.3 | 8.5 | Other | Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 21 | 2-Sided | 95 | 12.8 | 28.3 | Other | Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -18 | 2-Sided | 95 | -32.5 | -5.8 | Other | Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -7 | 2-Sided | 95 | -22.3 | 9.5 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 20 | 2-Sided | 95 | 8.4 | 31.3 | Other | Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -31 | 2-Sided | 95 | -46.0 | -15.5 | Other | Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 3 | 2-Sided | 95 | -10.8 | 18.8 | Other | Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 22 | 2-Sided | 95 | 12.1 | 32.8 | Other | Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month days after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -4 | 2-Sided | 95 | -13.4 | 7.1 | Other | Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 2 | 2-Sided | 95 | -3.2 | 8.5 | Other | Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 8 | 2-Sided | 95 | 4.2 | 13.2 | Other | Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -15.1 | 16.1 | Other | Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 2 | 2-Sided | 95 | -4.7 | 13.9 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 12 | 2-Sided | 95 | 5.9 | 20.9 | Other | Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -5 | 2-Sided | 95 | -16.7 | 8.6 | Other | Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 1 | 2-Sided | 95 | -5.7 | 11.1 | Other | Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | vaccine group difference | 5 | 2-Sided | 95 | -0.7 | 11.1 | Other | Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose) |
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| H44/76 7 days post vaccination |
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| H44/76 1 month post vaccination |
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| 5/99- 3 days post-vaccination |
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| 5/99- 7 days post-vaccination |
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| 5/99- 1 month post-vaccination |
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| NZ98/254- 3 days post-vaccination |
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| NZ98/254- 7 days post-vaccination |
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| NZ98/254- 1 month post-vaccination |
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| M10713- 3 days post-vaccination |
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| M10713- 7 days post-vaccination |
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| M10713- 1 month post-vaccination |
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| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 3 | 2-Sided | 95 | -2.6 | 10.3 | Other | Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 8 | 2-Sided | 95 | 3.9 | 12.5 | Other | Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -27 | 2-Sided | 95 | -41.8 | -12.9 | Other | Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 3 | 2-Sided | 95 | -6.0 | 16.2 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 7 | 2-Sided | 95 | 1.4 | 15.2 | Other | Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -31 | 2-Sided | 95 | -45.1 | -14.6 | Other | Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 4 | 2-Sided | 95 | 1.9 | 13.5 | Other | Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 8 | 2-Sided | 95 | 4.4 | 15.0 | Other | Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -5 | 2-Sided | 95 | -16.0 | 6.5 | Other | Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 1 | 2-Sided | 95 | -0.9 | 6.2 | Other | Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 2 | 2-Sided | 95 | -0.33 | 5.0 | Other | Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -6 | 2-Sided | 95 | -20.5 | 10.6 | Other | Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -3.6 | 8.8 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -3.6 | 4.4 | Other | Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -4 | 2-Sided | 95 | -19.4 | 13.0 | Other | Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 2 | 2-Sided | 95 | -2.5 | 11.0 | Other | Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 3 | 2-Sided | 95 | -1.2 | 9.4 | Other | Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -20 | 2-Sided | 95 | -30.0 | -11.1 | Other | Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 4 | 2-Sided | 95 | -7.6 | 15.7 | Other | Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 32 | 2-Sided | 95 | 23.2 | 40.2 | Other | Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -13 | 2-Sided | 95 | -25.9 | -3.0 | Other | Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -17.1 | 15.9 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 33 | 2-Sided | 95 | 20.5 | 45.3 | Other | Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -25 | 2-Sided | 95 | -40.1 | -11.2 | Other | Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 12 | 2-Sided | 95 | -3.9 | 28.1 | Other | Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 33 | 2-Sided | 95 | 22.0 | 44.1 | Other | Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -5 | 2-Sided | 95 | -16.0 | 6.0 | Other | Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -6.8 | 8.9 | Other | Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 11 | 2-Sided | 95 | 5.3 | 16.9 | Other | Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -2 | 2-Sided | 95 | -18.0 | 14.1 | Other | Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 1 | 2-Sided | 95 | -9.7 | 15.7 | Other | Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 17 | 2-Sided | 95 | 8.2 | 27.8 | Other | Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -6 | 2-Sided | 95 | -19.1 | 9.1 | Other | Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose) |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -8.4 | 11.8 | Other | Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose) |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 6 | 2-Sided | 95 | -0.47 | 12.6 | Other | Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose) |
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| H44/76 - 3 days post-vacc |
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| H44/76 - 7 days post-vacc |
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| H44/76 - 1 month post-vacc. |
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| 5/99- pre-vaccination |
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| 5/99- 3 days post-vacc |
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| 5/99- 7 days post-vacc |
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| 5/99- 1 month post-vacc. |
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| NZ98/254- pre-vaccination |
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| NZ98/254- 3 days post-vacc |
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| NZ98/254- 7 days post-vacc |
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| NZ98/254- 1 month post-vacc. |
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| M10713- pre-vaccination |
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| M10713- 3 days post-vacc |
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| M10713- 7 days post-vacc |
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| M10713- 1 month post-vacc. |
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| Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 2.73 | 2-Sided | 95 | 2.02 | 3.69 | Other | Vaccine Comparison Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 4.46 | 2-Sided | 95 | 3.38 | 5.88 | Other | Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose) |
| Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 8.18 | 2-Sided | 95 | 6.51 | 10 | Other | Vaccine Comparison Day 31 Group 3B vs Day 61 Group B_0_1(1 month after booster or 2nd dose) |
| Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 9.58 | 2-Sided | 95 | 7.17 | 13 | Other | Vaccine Comparison Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 6.90 | 2-Sided | 95 | 4.82 | 9.87 | Other | Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose) |
| Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 2.58 | 2-Sided | 95 | 1.98 | 3.36 | Other | Vaccine Comparison Day 31 Group 3B vs Day 61 Group B_0_1(1 month after booster or 2nd dose) |
| Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 2.65 | 2-Sided | 95 | 1.89 | 3.73 | Other | Vaccine Comparison Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 2.51 | 2-Sided | 95 | 1.67 | 3.78 | Other | Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose) |
| Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country | ANOVA | Ratio of GMTs | 1.90 | 2-Sided | 95 | 1.52 | 2.36 | Other | Vaccine Comparison Day 31 Group 3B vs Day 61 Group B_0_1(1 month after booster or 2nd dose) |
| Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 1.88 | 2-Sided | 95 | 1.37 | 2.59 | Other | Vaccine Comparison Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose) |
| Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country. | ANOVA | Ratio of GMTs | 1.91 | 2-Sided | 95 | 1.41 | 2.58 | Other | Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose) |
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| 5/99 |
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| NZ98/25 |
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| M10713 |
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| H44/76 - 7 days post-vacc |
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| H44/76 - 1 month post-vacc. |
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| 5/99- 3 days post-vacc |
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| 5/99- 7 days post-vacc |
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| 5/99- 1 month post-vacc. |
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| NZ98/254- 3 days post-vacc |
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| NZ98/254- 7 days post-vacc |
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| NZ98/254- 1 month post-vacc. |
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| M10713- 3 days post-vacc |
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| M10713- 7 days post-vacc |
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| M10713- 1 month post-vacc. |
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| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | 53 | 2-Sided | 95 | 42.1 | 62.5 | Other | 7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | 58 | 2-Sided | 95 | 50.5 | 64.7 | Other | 1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -4 | 2-Sided | 95 | -14.1 | 2.0 | Other | 3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 44 | 2-Sided | 95 | 28.1 | 58.5 | Other | 7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 44 | 2-Sided | 95 | 32.7 | 54.1 | Other | 1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -8.0 | 4.8 | Other | 3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 60 | 2-Sided | 95 | 45.0 | 71.5 | Other | 7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 71 | 2-Sided | 95 | 61.2 | 78.5 | Other | 1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | -1 | 2-Sided | 95 | -9.1 | 4 | Other | 3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 37 | 2-Sided | 95 | 27.0 | 48.1 | Other | 7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 33 | 2-Sided | 95 | 25.2 | 40.4 | Other | 1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 2 | 2-Sided | 95 | -8.7 | 10.2 | Other | 3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 43 | 2-Sided | 95 | 27.7 | 58.6 | Other | 7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 42 | 2-Sided | 95 | 31.1 | 53.0 | Other | 1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | -6 | 2-Sided | 95 | -19.2 | 0.9 | Other | 3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 32 | 2-Sided | 95 | 18.2 | 47.0 | Other | 7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 24 | 2-Sided | 95 | 13.2 | 34.4 | Other | 1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -4.7 | 3.4 | Other | 3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | Vaccine group difference | 36 | 2-Sided | 95 | 25.6 | 45.7 | Other | 7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | 54 | 2-Sided | 95 | 45.2 | 61.1 | Other | 1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 0 | 2-Sided | 95 | -8.4 | 5.0 | Other | 3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 29 | 2-Sided | 95 | 12.1 | 43.0 | Other | 7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/154 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 46 | 2-Sided | 95 | 33.6 | 57.1 | Other | 1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 0 | 2-Sided | 95 | -8.0 | 5.4 | Other | 3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 42 | 2-Sided | 95 | 27.8 | 54.5 | Other | 7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 60 | 2-Sided | 95 | 47.9 | 69.6 | Other | 1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 3 | 2-Sided | 95 | -1.1 | 5.4 | Other | 3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen score method | vaccine group difference | 28 | 2-Sided | 95 | 19.1 | 34.9 | Other | 7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | vaccine group difference | 39 | 2-Sided | 95 | 31.6 | 46.6 | Other | 1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 2 | 2-Sided | 95 | -4.9 | 6.7 | Other | 3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 25 | 2-Sided | 95 | 9.7 | 37.1 | Other | 7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 37 | 2-Sided | 95 | 25.1 | 47.0 | Other | 1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference |
| 3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 3 | 2-Sided | 95 | -3.9 | 7.6 | Other | 3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference |
| 7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 28 | 2-Sided | 95 | 20.2 | 36.6 | Other | 7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference |
| 1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen | Miettinen and Nurminen score method | Vaccine group difference | 42 | 2-Sided | 95 | 31.0 | 51.9 | Other | 1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference |
| NZ98/254 |
|
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| M10713 |
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| 5/99 |
|
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| NZ98/254 |
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| M10713 |
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| 5/99 |
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|
| NZ98/254 |
|
|
| M10713 |
|
|
| H44/76 1 month post 2nd vaccination |
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|
| 5/99 Day 1 |
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| 5/99 1 month post 2nd vaccination |
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| NZ98/254 Day 1 |
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| NZ98/254 1 month post 2nd vaccination |
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| M10713 Day 1 |
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| M10713 1 month post 2nd vaccination |
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| 5/99 |
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|
| NZ98/254 |
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| M10713 |
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| 5/99 |
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|
| NZ98/254 |
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| M10713 |
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|