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TRUMENBA® (Meningococcal Group B Vaccine) Clinical Studies

14 CLINICAL STUDIES

The immunogenicity of Trumenba following the three-dose schedule (0, 2, and 6 months) was evaluated in individuals 10 to 25 years of age in the U.S., Canada, and Europe (Studies 1 and 2) and following the two-dose (0 and 6 months) and three-dose schedules (0, 1–2, and 6 months) in individuals 11 to 18 years of age in Europe (Study 3). Serum bactericidal antibodies were measured with hSBA assays that used each of four meningococcal serogroup B strains. These four primary test strains express fHBP variants representing the two subfamilies (A and B) and, when taken together, are representative of meningococcal serogroup B strains causing invasive disease in the U.S. and Europe. The studies assessed the proportions of subjects with a 4-fold or greater increase in hSBA titer for each of the four primary strains. The studies also assessed the composite response to the four primary strains combined (proportion of subjects who achieved a hSBA titer greater than or equal to 1:8 (three strains) or 1:16 (one strain). To assess the effectiveness of the three-dose schedule of Trumenba against diverse meningococcal serogroup B strains, the proportion of subjects achieving a defined hSBA titer post-dose 3 was evaluated against a panel of 10 additional strains, each expressing a different fHBP variant.

14.1 Immunogenicity

The hSBA responses to each of the primary strains observed in U.S. subjects after the third dose of Trumenba are presented for Study 1 and Study 2 in Table 5.

Table 5: Percentages of U.S. Individuals 10 to 25 Years of Age With ≥4-fold rise in hSBA Titer and Composite Response Following Administration of Trumenba on a 0-, 2-, and 6-Month Schedule for Four Primary Strains (Studies 1 and 2)*,,,§
Study 1Study 2
(10 to 18 Years of Age)(18 to 25 Years of Age)
n%
(95% CI)
n%
(95% CI)
Subfamily/Subgroup
  fHBP Variant#,Þ
Abbreviations: CI=confidence interval; fHBP=factor H binding protein; hSBA=serum bactericidal assay using human complement; LLOQ=lower limit of quantitation; LOD=limit of detection.
Note: LLOQ = 1:16 for A22; 1:8 for A56, B24, and B44.
Note: The 4-fold increase is defined as follows: (1) For subjects with a baseline hSBA titer <1:4, a response is defined as an hSBA titer ≥1:16. (2) For subjects with a baseline hSBA titer ≥1:4, a response is defined as an hSBA titer ≥4 times the LLOQ or ≥4 times the baseline titer, whichever was higher.
Note: Pre-specified criteria for assessment of hSBA responses (4-fold rise in titer to each primary test strain, and titer above LLOQ for all four primary test strains) among U.S. subjects were met in these studies.
*
Evaluable immunogenicity population.
Study 1 = NCT01830855 and Study 2 = NCT01352845.
Study 1: Group 1 (0, 2, and 6 months).
§
Study 2: Group 1 (0, 2, and 6 months).
Exact 2-sided confidence interval (Clopper-Pearson method) based upon the observed proportion of subjects.
#
The strains expressing variants A22, A56, B24, and B44 correspond to strains PMB80, PMB2001, PMB2948, and PMB2707, respectively.
Þ
For the third dose, serum was obtained approximately 1 month after vaccination.
ß
Composite response = hSBA ≥ LLOQ for all 4 primary meningococcal B strains.
≥4-Fold Increase
PMB80 (A22)Dose 358786.2
(83.1, 88.9)
64481.1
(77.8, 84.0)
PMB2001 (A56)Dose 352692.0
(89.4, 94.2)
62190.7
(88.1, 92.8)
PMB2948 (B24)Dose 358581.9
(78.5, 84.9)
63483.9
(80.8, 86.7)
PMB2707 (B44)Dose 355588.3
(85.3, 90.8)
64379.3
(76.0, 82.4)
Composite hSBA responseß
Before Dose 15070.6
(0.1, 1.7)
6103.3
(2.0, 5.0)
Dose 353785.7
(82.4, 88.5)
62582.4
(79.2, 85.3)

The hSBA responses against a panel of 10 additional strains observed in U.S. subjects after the third dose of Trumenba are presented for Study 1 and Study 2 in Table 6.

Table 6. Percentages of U.S. Individuals 10 to 25 Years of Age With a hSBA Titer ≥ LLOQ Against 10 Additional Strains Following Administration of Trumenba on a 0-, 2-, and 6-Month Schedule (Study 1 and Study 2)- *,
Study 1Study 2
(10 to 18 Years of Age)(18 to 25 Years of Age)
n%
(95% CI)
n%
(95% CI)
Subfamily/Subgroup
  fHBP Variant§,
Abbreviations: CI=confidence interval; fHBP=factor H binding protein; hSBA=serum bactericidal assay using human complement; LLOQ=lower limit of quantitation.
Note: LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16.
*
The evaluable immunogenicity population was used for the analysis.
Study 1 = NCT01830855 and Study 2 = NCT01352845.
Exact 2-sided confidence interval (Clopper and Pearson) based upon the observed proportion of subjects.
§
The strains expressing variants A06, A12, A19, A07, A15, A29, B03, B09, B15, and B16 correspond to strains PMB3010, PMB824, PMB1989, PMB3040, PMB1672, PMB3175, PMB1256, PMB866, PMB431, and PMB648, respectively.
For the third dose, serum was obtained approximately 1 month after vaccination.
A/N1C1
  PMB3175 (A29)
Before Dose 116911.2
(6.9, 17.0)
16023.8
(17.4, 31.1)
Dose 317698.9
(96.0, 99.9)
16298.8
(95.6, 99.9)
A/N1C2
  PMB3010 (A06)
Before Dose 11787.9
(4.4, 12.8)
16610.8
(6.6, 16.6)
Dose 317997.8
(94.4, 99.4)
16489.0
(83.2, 93.4)
A/N2C1
  PMB3040 (A07)
Before Dose 117037.6
(30.3, 45.4)
16555.8
(47.8, 63.5)
Dose 317896.1
(92.1, 98.4)
16595.2
(90.7, 97.9)
  PMB824 (A12)Before Dose 11805.0
(2.3, 9.3)
1664.8
(2.1, 9.3)
Dose 318076.1
(69.2, 82.1)
16566.7
(58.9, 73.8)
  PMB1672 (A15)Before Dose 117015.9
(10.7, 22.3)
15930.2
(23.2, 38.0)
Dose 316686.7
(80.6, 91.5)
15989.9
(84.2, 94.1)
A/N2C2
  PMB1989 (A19)
Before Dose 11745.7
(2.8, 10.3)
15823.4
(17.1, 30.8)
Dose 317391.9
(86.8, 95.5)
16394.5
(89.8, 97.4)
B/N6
  PMB1256 (B03)
Before Dose 11832.2
(0.6, 5.5)
1645.5
(2.5, 10.2)
Dose 318192.3
(87.4, 95.7)
16184.5
(77.9, 89.7)
  PMB866 (B09)Before Dose 118012.2
(7.8, 17.9)
16513.9
(9.0, 20.2)
Dose 318285.7
(79.8, 90.5)
16272.2
(64.7, 79.0)
  PMB431 (B15)Before Dose 118027.8
(21.4, 34.9)
16333.1
(26.0, 40.9)
Dose 318397.3
(93.7, 99.1)
16395.7
(91.4, 98.3)
  PMB648 (B16)Before Dose 11806.7
(3.5, 11.4)
16111.8
(7.3, 17.8)
Dose 318083.9
(77.7, 88.9)
15972.3
(64.7, 79.1)

In Study 3, Trumenba was administered according to different schedules, including Group 1 (0, 1, and 6 months), Group 2 (0, 2, and 6 months) and Group 3 (0 and 6 months). The hSBA responses observed after the second dose in Groups 1, 2, and 3 and completion of the three-dose series in Group 1 and 2 are presented in Table 7.

Table 7: Percentages of European Individuals 11 to 18 Years of Age With a ≥4-Fold Increase in hSBA Titer and Composite Response*,
Group 1Group 2Group 3
3-Dose Schedule
(0, 1, and 6 Months)
3-Dose Schedule
(0, 2, and 6 Months)§
2-Dose Schedule
(0 and 6 Months)
fHBP Variant#,Þ%
(95% CI)ß
%
(95% CI)ß
%
(95% CI)ß
Abbreviations: CI=confidence interval; fHBP=factor H binding protein; hSBA=serum bactericidal assay using human complement; LLOQ=lower limit of quantitation; NA=not applicable.
Note: LLOQ = 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).
Note: The ≥4-fold increase is defined as follows: (1) For subjects with a baseline hSBA titer <1:4, a ≥4-fold increase was defined as an hSBA titer ≥1:16. (2) For subjects with a baseline hSBA titer ≥1:4, a ≥4-fold increase was defined as an hSBA titer ≥4 times the LLOQ or ≥4 times the baseline titer, whichever was higher.
*
Per-schedule Evaluable populations. Dose 2 data include subjects who received two doses, irrespective of whether they received the third dose.
Study 3: NCT01299480.
Group 1 (0, 1, and 6 months). The denominators ranged from 173 to 187 after Dose 2 and 178 to 188 after Dose 3, depending on the strain.
§
Group 2 (0, 2, and 6 months). The denominators ranged from 229 to 240 after Dose 2 and 159 to 162 after Dose 3, depending on the strain.
Group 3 (0 and 6 months). The denominators ranged from 188 to 203 after Dose 2, depending on the strain.
#
The strains expressing variant A22, A56, B24, and B44 correspond to strains PMB80, PMB2001, PMB2948, and PMB2707, respectively.
Þ
For the second and third doses, serum was obtained approximately 1 month after vaccination.
ß
Exact 2-sided confidence interval (Clopper and Pearson) based upon the observed proportion of subjects.
à
Composite response = hSBA ≥LLOQ for all 4 primary meningococcal B strains.
≥4-Fold Increase
PMB80 (A22)
  Dose 258.8
(51.4, 66.0)
72.5
(66.4, 78.0)
82.3
(76.3, 87.3)
  Dose 377.6
(70.9, 83.4)
87.7
(81.6, 92.3)
NA
PMB2001 (A56)
  Dose 287.8
(82.2, 92.2)
90.7
(86.2, 94.1)
90.1
(85.1, 93.8)
  Dose 391.2
(86.1, 94.9)
93.8
(88.8, 97.0)
NA
PMB2948 (B24)
  Dose 251.1
(43.6, 58.5)
54.2
(47.7, 60.7)
64.5
(57.4, 71.1)
  Dose 374.1
(67.1, 80.2)
78.3
(71.1, 84.4)
NA
PMB2707 (B44)
  Dose 248.1
(40.7, 55.6)
53.4
(46.8, 59.9)
66.0
(58.9, 72.6)
  Dose 380.9
(74.5, 86.2)
78.6
(71.4, 84.7)
NA
Composite ResponseÞ,à
  Before Dose 14.6
(2.0, 8.8)
2.2
(0.7, 5.0)
1.5
(0.3, 4.4)
  Dose 252.0
(44.3, 59.7)
52.0
(45.3, 58.6)
72.9
(65.9, 79.1)
  Dose 380.3
(73.7, 85.9)
81.8
(74.9, 87.4)
NA

14.2 Concomitant Vaccine Administration

Study 4 evaluated the immunogenicity of concomitantly administered Trumenba and Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant (HPV4) (Merck & Co, Inc.). U.S. subjects 11 to <18 years of age were randomized into three groups: Group 1 received Trumenba and HPV4 (N=992), Group 2 received Trumenba and saline (N=990), and Group 3 received saline and HPV4 (N=501). All vaccines were administered according to a 0, 2 and 6 month schedule. Immune responses were evaluated by comparisons of geometric mean titer [GMT] for each HPV type at 1 month after the third HPV4 vaccination (Group 1 vs. Group 3), and hSBA GMTs using two meningococcal serogroup B strains [variants A22 and B24] 1 month after the third Trumenba vaccination (Group 1 vs. Group 2). The noninferiority criteria for the comparisons of GMTs [lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio (Group 1/Group 3 for HPV and Group 1/Group 2 for meningococcal serogroup B strains) >0.67] were met for three HPV types (6, 11 and 16) and for the meningococcal serogroup B strains tested. For HPV-18, the lower bound of the 95% CI for the GMT ratio was 0.62 at one month after the third HPV4 vaccination.

Study 5 evaluated the immunogenicity of concomitantly administered Trumenba and Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine (MCV4) (Sanofi Pasteur Inc.) and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) (Sanofi Pasteur Ltd.) vaccines. U.S. subjects 10 to <13 years of age were randomized into three groups: Group 1 received Trumenba at 0, 2, and 6 months, and MCV4 and Tdap were coadministered with the first Trumenba dose (N=883). Group 2 received saline at 0, 2 and 6 months, and MCV4 and Tdap were coadministered with the first saline injection (N=870). Group 3 received Trumenba at 0, 2 and 6 months, and saline was coadministered with the first Trumenba dose (N=875). Immune responses were evaluated by comparisons of GMTs for each of the MCV4 and Tdap antigens 1 month after the first Trumenba vaccination, and hSBA GMTs using two meningococcal serogroup B strains [variants A22 and B24] 1 month after the third Trumenba vaccination. The noninferiority criteria for the comparisons of GMTs [lower limit of the 2-sided 95% CI of the GMT ratio (Group 1/Group 3 for meningococcal serogroup B strains and Group 1/Group 2 for MCV4 and Tdap) >0.67] were met for all antigens.

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