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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
531
One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm.
GSK Investigational Site
Sherwood, Queensland, Australia
GSK Investigational Site
North Adelaide, South Australia, Australia
GSK Investigational Site
Carlton, Victoria, Australia
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99, NZ98/254 a nd M10713.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Subiaco, Western Australia, Australia
GSK Investigational Site
Truro, Nova Scotia, Canada
GSK Investigational Site
Greater Sudbury, Ontario, Canada
GSK Investigational Site
Newmarket, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Woodstock, Ontario, Canada
...and 2 more locations
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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 ≥1:4 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.
Time frame: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 \<LLOQ, a post vaccination titer of at least fourfold the LLOQ; • for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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 \<LLOQ, a post vaccination titer of at least fourfold the LLOQ; • for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: * for a pre-vaccination titer \< 4, a post-vaccination titer of at least 16; * for a pre-vaccination titer ≥ 4 but \<LLOQ, a post vaccination titer of at least fourfold the LLOQ; * for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer. Only subjects receiving the second dose of vaccination(group B\_0\_1) were considered for this outcome measure.
Time frame: At Day 61 (30 days post second dose of vaccination)