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Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines

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ClinicalTrials.gov Identifier: NCT01367158
Recruitment Status : Completed
First Posted : June 6, 2011
Results First Posted : November 19, 2014
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Care Provider);   Primary Purpose: Prevention
Conditions Meningococcal Disease
Meningococcal Meningitis
Interventions Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine
Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine
Biological: Tdap
Enrollment 440
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV 3 B 2 B 1ACWY
Hide Arm/Group Description Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
Period Title: Overall Study
Started 25 49 24 49 25 48 25 49 23 50 73
Completed 25 46 23 48 23 46 25 47 23 50 72
Not Completed 0 3 1 1 2 2 0 2 0 0 1
Reason Not Completed
Withdrew consent             0             2             1             0             2             0             0             1             0             0             0
Lost to Follow-up             0             0             0             1             0             2             0             1             0             0             1
Protocol Violation             0             1             0             0             0             0             0             0             0             0             0
Arm/Group Title 3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV 3 B 2 B 1ACWY Total
Hide Arm/Group Description Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study Total of all reporting groups
Overall Number of Baseline Participants 25 49 24 49 25 48 25 49 23 50 73 440
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 49 participants 24 participants 49 participants 25 participants 48 participants 25 participants 49 participants 23 participants 50 participants 73 participants 440 participants
14.3  (2.2) 14.2  (2.0) 14.4  (2.1) 14.4  (2.1) 14.9  (2.6) 14.2  (2.1) 14.3  (2.0) 14.4  (2.1) 14.8  (2.5) 15.0  (2.0) 14.8  (2.1) 14.5  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 49 participants 24 participants 49 participants 25 participants 48 participants 25 participants 49 participants 23 participants 50 participants 73 participants 440 participants
Female
16
  64.0%
29
  59.2%
14
  58.3%
27
  55.1%
12
  48.0%
26
  54.2%
14
  56.0%
19
  38.8%
11
  47.8%
25
  50.0%
39
  53.4%
232
  52.7%
Male
9
  36.0%
20
  40.8%
10
  41.7%
22
  44.9%
13
  52.0%
22
  45.8%
11
  44.0%
30
  61.2%
12
  52.2%
25
  50.0%
34
  46.6%
208
  47.3%
1.Primary Outcome
Title Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Hide Description Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).
Time Frame At month 6 and month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by Modified Intention-To-Treat (MITT) Month 7 Set. MITT is defined as all subjects in the enrolled set who received a study vaccination at Month 6 and provided one evaluable serum sample at Month 7.
Arm/Group Title 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV 3 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 25 24 25 25 23 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Ser. A - month 6 (n=23,24,24,25,23,69)
52
(31 to 73)
79
(58 to 93)
75
(53 to 90)
68
(46 to 85)
35
(16 to 57)
55
(43 to 67)
Ser. A - month 7 (n=24,24,21,25,22,71)
100
(86 to 100)
100
(86 to 100)
100
(84 to 100)
100
(86 to 100)
91
(71 to 99)
58
(45 to 69)
Ser. C - month 6 (n=22,24,24,24,21,70)
100
(85 to 100)
96
(79 to 100)
100
(86 to 100)
100
(86 to 100)
33
(15 to 57)
76
(64 to 85)
Ser. C - month 7 (n=23,24,23,25,22,72)
100
(85 to 100)
100
(86 to 100)
100
(85 to 100)
100
(86 to 100)
73
(50 to 89)
68
(56 to 79)
Ser. W - month 6 (n=24,24,25,24,22,69)
100
(86 to 100)
96
(79 to 100)
100
(86 to 100)
100
(86 to 100)
55
(32 to 76)
97
(90 to 100)
Ser. W - month 7 (n=23,24,21,25,21,72)
100
(85 to 100)
100
(86 to 100)
100
(84 to 100)
100
(86 to 100)
90
(70 to 99)
96
(88 to 99)
Ser. Y - month 6 (n=24,24,24,25,23,72)
96
(79 to 100)
100
(86 to 100)
96
(79 to 100)
92
(74 to 99)
4
(0 to 22)
85
(74 to 92)
Ser. Y - month 7 (n=25,24,24,25,22,72)
100
(86 to 100)
96
(79 to 100)
100
(86 to 100)
100
(86 to 100)
14
(3 to 35)
85
(74 to 92)
2.Primary Outcome
Title Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Hide Description Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)
Time Frame At month 6 and month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT Month 7 Set.
Arm/Group Title 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV 3 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 25 24 25 25 23 73
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
H44/76 (fHbp) - month 6 (n=25,24,25,24,23,72)
40
(21 to 61)
46
(26 to 67)
52
(31 to 72)
29
(13 to 51)
35
(16 to 57)
3
(0 to 10)
H44/76 (fHbp) - month 7 (n=25,24,24,24,25,22,73)
92
(74 to 99)
96
(79 to 100)
96
(79 to 100)
92
(74 to 99)
91
(71 to 99)
4
(1 to 12)
5/99 (NadA) - month 6 (n=25,24,24,25,23,72)
96
(80 to 100)
100
(86 to 100)
96
(79 to 100)
100
(86 to 100)
100
(85 to 100)
15
(8 to 26)
5/99 (NadA) - month 7 (n=25,24,24,25,23,73)
100
(86 to 100)
100
(86 to 100)
100
(86 to 100)
100
(86 to 100)
100
(85 to 100)
16
(9 to 27)
NZ98/254(PorA) - month 6 (n=25,24,24,25,23,72)
12
(3 to 31)
8
(1 to 27)
29
(13 to 51)
12
(3 to 31)
9
(1 to 28)
0
(0 to 5)
NZ98/254(PorA) - month 7 (n=25,24,24,25,23,73)
20
(7 to 41)
29
(13 to 51)
88
(68 to 97)
76
(55 to 91)
17
(5 to 39)
1
(0.035 to 7)
M14459(fHBP) - month 6 (n=25,24,25,25,23,71)
24
(9 to 45)
25
(10 to 47)
32
(15 to 54)
16
(5 to 36)
17
(5 to 39)
6
(2 to 14)
M14459(fHBP) - month 7 (n=25,24,23,25,22,73)
80
(59 to 93)
79
(58 to 93)
87
(66 to 97)
88
(69 to 97)
64
(41 to 83)
8
(3 to 17)
M07-0241084(NHBA) - month 6 (n=25,23,23,25,23,70)
20
(7 to 41)
35
(16 to 57)
39
(20 to 61)
52
(31 to 72)
30
(13 to 53)
30
(20 to 42)
M07-0241084(NHBA) - month 7 (n=25,23,22,25,21,72)
68
(46 to 85)
61
(39 to 80)
95
(77 to 100)
92
(74 to 99)
62
(38 to 82)
29
(19 to 41)
M01-0240364(NadA) - month 6 (n=25,21,24,24,21,71)
16
(5 to 36)
38
(18 to 62)
25
(10 to 47)
33
(16 to 55)
33
(15 to 57)
4
(1 to 12)
M01-0240364(NadA) - month 7 (n=24,23,24,25,23,71)
96
(79 to 100)
100
(85 to 100)
100
(86 to 100)
96
(80 to 100)
96
(78 to 100)
4
(1 to 12)
3.Secondary Outcome
Title Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Hide Description Antibody response was measured as Geometric Mean hSBA Titers against N meningitidis Serogroups A, C, W and Y at One of Four MenABCWY Formulations or rMenB at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)
Time Frame At month 6 and month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT Month 7 Set.
Arm/Group Title 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV 3 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 25 24 25 25 23 72
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Ser. A - month 6 (n=23,24,24,25,23,69)
15
(6.66 to 33)
44
(20 to 96)
31
(14 to 68)
21
(9.53 to 44)
4.52
(2.02 to 10)
21
(13 to 34)
Ser. A - month 7 (n=24,24,21,25,22,71)
247
(120 to 509)
322
(157 to 659)
242
(113 to 521)
274
(136 to 553)
135
(64 to 287)
22
(14 to 33)
Ser. C - month 6 (n=22,24,24,24,21,70)
211
(125 to 355)
153
(93 to 251)
168
(102 to 278)
137
(83 to 224)
4.54
(2.66 to 7.75)
25
(18 to 34)
Ser. C - month 7 (n=23,24,23,25,22,72)
796
(472 to 1343)
716
(430 to 1193)
670
(397 to 1130)
634
(385 to 1044)
31
(18 to 53)
19
(14 to 26)
Ser. W - month 6 (n=24,24,25,24,22,69)
189
(116 to 305)
184
(144 to 296)
202
(127 to 324)
164
(102 to 263)
11
(6.67 to 18)
128
(95 to 173)
Ser. W - month 7 (n=23,24,21,25,21,72)
710
(442 to 1143)
695
(441 to 1096)
929
(570 to 1512)
684
(438 to 1069)
126
(77 to 207)
130
(98 to 172)
Ser. Y - month 6 (n=24,24,24,25,23,72)
203
(111 to 372)
233
(128 to 425)
158
(86 to 289)
129
(72 to 233)
1.72
(0.93 to 3.18)
97
(67 to 140)
Ser. Y - month 7 (n=25,24,24,25,22,72)
695
(385 to 1255)
629
(346 to 1144)
619
(339 to 1129)
432
(241 to 776)
2.64
(1.41 to 4.96)
85
(59 to 122)
4.Secondary Outcome
Title Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Hide Description Antibody response was measured as Geometric Mean Ratio (95% CI), against N meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination (month 7) With One of Four MenABCWY Formulations or rMenB
Time Frame At month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT Month 7 Set.
Arm/Group Title 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV 3 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 25 24 25 25 23 72
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Ser. A (n=22,24,21,25,22,68)
15
(8.88 to 25)
7.53
(4.58 to 12)
10
(6.1 to 18)
14
(8.37 to 22)
34
(20 to 57)
1.05
(0.77 to 1.43)
Ser. C (n=21,24,22,24,20,70)
3.43
(2.59 to 4.54)
4.63
(3.56 to 6.02)
3.85
(2.92 to 5.06)
5.01
(3.85 to 6.5)
8.41
(6.31 to 11)
0.75
(0.64 to 0.89)
Ser. W (n=23,24,21,24,20,69)
3.42
(2.41 to 4.85)
3.66
(2.62 to 5.12)
3.98
(2.78 to 5.69)
4.05
(2.9 to 5.66)
11
(7.55 to 16)
1.01
(0.82 to 1.24)
Ser. Y (n=24,24,23,25,22,71)
3.33
(2.31 to 4.79)
2.68
(1.87 to 3.85)
4.45
(3.06 to 6.45)
3.32
(2.33 to 4.73)
1.46
(1 to 2.14)
0.81
(0.65 to 1.02)
5.Secondary Outcome
Title GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Hide Description Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Time Frame At month 6 and month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT Month 7 Set.
Arm/Group Title 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV 3 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 25 24 25 25 23 73
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H44/76 (fHbp) - month 6 (n=25,24,25,24,23,72)
5.9
(3.07 to 11)
6.88
(3.56 to 13)
12
(6.14 to 23)
5.25
(2.71 to 10)
6.42
(3.27 to 13)
1.18
(1.01 to 1.37)
H44/76 (fHbp) - month 7 (n= 25,24,24,25,22,73)
109
(60 to 201)
154
(83 to 285)
181
(97 to 336)
114
(62 to 208)
109
(57 to 209)
1.21
(1.04 to 1.4)
5/99 (NadA) - month 6 (n=25,24,24,25,23,72)
78
(52 to 118)
122
(80 to 186)
46
(30 to 71)
84
(56 to 127)
152
(99 to 234)
1.74
(1.36 to 2.22)
5/99 (NadA) - month 7 (n=25,24,24,25,23,73)
546
(365 to 817)
740
(492 to 1112)
665
(441 to 1002)
527
(354 to 786)
832
(548 to 1263)
1.93
(1.5 to 2.48)
NZ98/254(PorA) - month 6 (n=25,24,24,25,23,72)
1.96
(1.29 to 3)
1.85
(1.21 to 2.85)
3.47
(2.26 to 5.35)
1.89
(1.24 to 2.88)
1.81
(1.17 to 2.81)
1.15
(1.05 to 1.25)
NZ98/254(PorA) - month 7 (n=25,24,24,25,23,72)
2.37
(1.5 to 3.74)
3.26
(2.06 to 5.17)
24
(15 to 37)
12
(7.57 to 19)
2.64
(1.65 to 4.23)
1.2
(1.07 to 1.33)
M14459(fHBP) - month 6 (n=25,24,25,25,23,71)
2.71
(1.72 to 4.27)
3.29
(2.08 to 5.21)
4.49
(2.85 to 7.06)
2.34
(1.49 to 3.67)
2.48
(1.55 to 3.97)
1.28
(1.11 to 1.49)
M14459(fHBP) - month 7 (n=25,24,23,25,22,73)
16
(10 to 27)
27
(17 to 44)
45
(27 to 75)
20
(13 to 33)
12
(7.07 to 20)
1.28
(1.1 to 1.49)
M07-0241084(NHBA) - month 6 (n=25,23,23,25,23,70)
3.37
(1.98 to 5.73)
3.66
(2.12 to 6.34)
6.92
(3.99 to 12)
6.45
(3.81 to 11)
3.32
(1.91 to 5.75)
2.99
(2.16 to 4.14)
M07-0241084(NHBA) - month 7 (n=25,23,22,25,21,72)
12
(7.07 to 21)
9.48
(5.37 to 17)
38
(21 to 69)
25
(15 to 44)
9.73
(5.33 to 18)
3.03
(2.22 to 4.15)
M01-0240364 (NadA) - month 6 (n=25,21,23,24,21,71)
4.62
(2.15 to 9.95)
9.98
(4.37 to 23)
6.95
(3.19 to 15)
7.44
(3.44 to 16)
7.21
(3.15 to 17)
1.18
(1 to 1.39)
M01-0240364 (NadA) - month 7 (n=24,23,23,25,23,71)
311
(152 to 637)
533
(259 to 1098)
385
(188 to 786)
286
(143 to 573)
474
(229 to 980)
1.18
(1 to 1.39)
6.Secondary Outcome
Title GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Hide Description Antibody response was measured as Geometric Mean Ratio (95% CI), against Serogroup B Test Strains at One Month After the Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Time Frame At month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT Month 7 Set.
Arm/Group Title 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV 3 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 25 24 25 25 23 73
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
H44/76 (fHbp) (n=25,24,24,24,22,72)
18
(12 to 29)
22
(14 to 36)
14
(8.88 to 23)
22
(14 to 36)
16
(9.83 to 26)
1.03
(0.98 to 1.08)
5/99 (NadA) (n=25,24,23,25,23,72)
6.96
(5.15 to 9.42)
6.04
(4.45 to 8.21)
14
(11 to 20)
6.25
(4.63 to 8.44)
5.47
(4 to 7.48)
1.12
(0.93 to 1.36)
NZ98/254 (PorA) (n=25,24,23,25,23,72)
1.21
(0.87 to 1.67)
1.76
(1.26 to 2.45)
6.56
(4.67 to 9.2)
6.29
(4.55 to 8.69)
1.45
(1.04 to 2.04)
1.05
(0.95 to 1.15)
M14459 (fHBP) (n=25,24,23,25,22,71)
5.99
(4.11 to 8.73)
8.1
(5.54 to 12)
9.08
(6.14 to 13)
8.58
(5.91 to 12)
4.37
(2.93 to 6.53)
1.01
(0.91 to 1.11)
M07-0241084 (NHBA) (n=25,22,20,25,21,69)
3.61
(2.57 to 5.09)
2.46
(1.71 to 3.54)
5.18
(3.53 to 7.58)
3.92
(2.8 to 5.51)
2.75
(1.89 to 4.01)
1.01
(0.91 to 1.12)
M01-0240364 (NadA) (n=24,20,23,24,21,69)
65
(37 to 114)
50
(27 to 92)
65
(37 to 116)
40
(23 to 71)
66
(36 to 120)
1
(0.97 to 1.04)
7.Secondary Outcome
Title Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Hide Description Antibody response was measured as the percentage of subjects with seroresponse Against N meningitidis Serogroups A, C, W and Y, after pre and post vaccination at month 6 and after the third vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo. Seroresponse to N meningitidis serogroups A, C, W and Y is defined as: For subjects with a prevaccination hSBA <1:4, a postvaccination hSBA ≥1:8;For subjects with a prevaccination hSBA ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Time Frame At month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT month 7 Set.
Arm/Group Title 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV 3 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 24 24 23 25 22 71
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Ser. A (n=22,24,21,25,22,68)
59
(36 to 79)
67
(45 to 84)
67
(43 to 85)
72
(51 to 88)
82
(60 to 95)
3
(0 to 10)
Ser. C (n=21,24,22,24,20,70)
48
(26 to 70)
54
(33 to 74)
59
(36 to 79)
67
(45 to 84)
60
(36 to 81)
0
(0 to 5)
Ser. W (n=23,24,21,24,20,69)
35
(16 to 57)
38
(19 to 59)
48
(26 to 70)
58
(37 to 78)
60
(36 to 81)
3
(0 to 10)
Ser. Y (n=24,24,23,25,22,71)
29
(13 to 51)
38
(19 to 59)
43
(23 to 66)
32
(15 to 54)
5
(0 to 23)
0
(0 to 5)
8.Secondary Outcome
Title Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Hide Description Antibody response was measured as the percentage of subjects with 4-fold Increase in human serum bactericidal assay (hSBA) titers and associated 95% CI, Against Serogroup B Test Strains at One Month After Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Time Frame At month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT month 7 Set.
Arm/Group Title 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV 3 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 25 24 24 25 23 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
H44/76 (fHbp) (n=25,24,24,24,22,72)
80
(59 to 93)
88
(68 to 97)
83
(63 to 95)
88
(68 to 97)
73
(50 to 89)
0
(0 to 5)
5/99 (NadA) (n=25,24,23,25,23,72)
80
(59 to 93)
67
(45 to 84)
83
(61 to 95)
76
(55 to 91)
57
(34 to 77)
3
(0 to 10)
NZ98/254 (PorA) (n=25,24,23,25,23,72)
4
(0 to 20)
17
(5 to 37)
61
(39 to 80)
44
(24 to 65)
17
(5 to 39)
1
(0.035 to 7)
M14459 (fHBP) (n=25,24,23,25,22,71)
56
(35 to 76)
54
(33 to 74)
65
(43 to 84)
52
(31 to 72)
50
(28 to 72)
1
(0.036 to 8)
M07-0241084 (NHBA) (n=25,22,20,25,21,69)
36
(18 to 57)
23
(8 to 45)
60
(36 to 81)
44
(24 to 65)
29
(11 to 52)
0
(0 to 5)
M01-0240364 (NadA) (n=24,20,23,24,21,69)
88
(68 to 97)
80
(56 to 94)
83
(61 to 95)
79
(58 to 93)
90
(70 to 99)
0
(0 to 5)
9.Secondary Outcome
Title GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Hide Description Antibody response was measured as Geometric Mean hSBA Titers Against N meningitidis Serogroups A, C, W and Y after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.
Time Frame At month 1, 3, 6, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT Set.
Arm/Group Title 2ABCWY 2ABx2CWY 2ABCWY+OMV 2ABCWYqOMV 2 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 49 48 48 49 50 73
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Ser. A - month 1 (n=48,48,47,49,50,70)
61
(35 to 107)
61
(35 to 107)
49
(28 to 86)
37
(21 to 65)
2.96
(1.71 to 5.13)
107
(66 to 172)
Ser. A - month 3 (n=49,48,47,48,50,72)
162
(106 to 249)
206
(134 to 316)
183
(118 to 282)
169
(109 to 262)
44
(29 to 68)
36
(25 to 52)
Ser. A - month 6 (n=46,46,48,44,49,69)
28
(16 to 49)
44
(25 to 78)
21
(12 to 36)
24
(14 to 44)
4.22
(2.43 to 7.33)
20
(12 to 32)
Ser. A - month 7 (n=48,47,46,49,50,71)
24
(14 to 39)
28
(17 to 46)
17
(9.94 to 28)
17
(10 to 29)
3.18
(1.95 to 5.19)
21
(13 to 31)
Ser. A - month 12 (n=43,44,45,46,50,71)
10
(5.69 to 18)
9.73
(5.6 to 17)
8.88
(5.09 to 15)
8.08
(4.64 to 14)
2.21
(1.31 to 3.75)
14
(9.03 to 22)
Ser. C - month 1 (n=48,48,48,48,50,71)
51
(33 to 80)
116
(75 to 180)
99
(64 to 155)
101
(64 to 159)
8.76
(5.63 to 14)
75
(51 to 109)
Ser. C - month 3 (n=49,47,46,48,50,71)
340
(252 to 460)
501
(370 to 680)
338
(248 to 461)
380
(278 to 520)
17
(12 to 22)
45
(35 to 58)
Ser. C - month 6 (n=46,48,47,48,49,70)
133
(94 to 189)
186
(133 to 261)
117
(83 to 165)
157
(111 to 223)
6.77
(4.82 to 9.52)
23
(17 to 31)
Ser. C - month 7 (n=48,47,46,49,50,72)
110
(78 to 156)
153
(108 to 217)
88
(61 to 126)
128
(90 to 183)
5.53
(3.9 to 7.84)
18
(13 to 24)
Ser. C - month 12 (n=44,46,46,46,50,72)
55
(38 to 81)
66
(45 to 95)
45
(31 to 65)
72
(49 to 105)
6.03
(4.19 to 8.69)
14
(10 to 19)
Ser. W - month 1 (n=48,48,47,48,49,72)
163
(113 to 237)
243
(168 to 352)
173
(119 to 252)
233
(160 to 341)
29
(20 to 42)
210
(154 to 287)
Ser. W - month 3 (n=49,46,47,48,50,72)
370
(290 to 472)
514
(400 to 661)
349
(272 to 448)
435
(338 to 559)
140
(110 to 179)
166
(135 to 204)
Ser. W - month 6 (n=44,47,45,45,43,69)
202
(144 to 284)
196
(141 to 272)
143
(102 to 200)
194
(138 to 274)
15
(11 to 21)
117
(88 to 154)
Ser. W - month 7 (n=46,47,45,47,45,72)
173
(125 to 240)
167
(121 to 230)
118
(85 to 164)
168
(121 to 234)
13
(9.72 to 19)
121
(93 to 159)
Ser. W - month 12 (n=45,45,45,43,46,69)
119
(82 to 174)
113
(77 to 164)
83
(57 to 120)
109
(73 to 161)
11
(7.81 to 17)
75
(55 to 103)
Ser. Y - month 1 (n=48,48,48,49,49,73)
98
(66 to 145)
119
(80 to 177)
76
(51 to 113)
92
(62 to 136)
5.6
(3.77 to 8.32)
92
(66 to 128)
Ser. Y - month 3 (n=49,48,47,49,50,73)
214
(162 to 281)
283
(215 to 374)
195
(147 to 258)
226
(172 to 298)
4.7
(3.58 to 6.18)
72
(57 to 91)
Ser. Y - month 6 (n=48,48,48,48,49,72)
206
(134 to 315)
249
(162 to 382)
138
(90 to 212)
154
(100 to 237)
1.93
(1.26 to 2.95)
84
(58 to 120)
Ser. Y - month 7 (n=46,48,46,49,50,72)
180
(116 to 278)
213
(139 to 327)
100
(65 to 155)
127
(83 to 194)
2.05
(1.34 to 3.13)
75
(52 to 108)
Ser. Y - month 12 (n=45,47,45,46,50,70)
88
(55 to 141)
112
(71 to 178)
55
(34 to 88)
75
(47 to 121)
1.59
(1.01 to 2.5)
47
(31 to 69)
10.Secondary Outcome
Title GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Hide Description Antibody response was measured as Geometric Mean Ratios (95%CI) Against N meningitidis Serogroups A, C, W and Y after after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time Frame At month 1, 3, 6, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by Per MITT Set.
Arm/Group Title 2ABCWY 2ABx2CWY 2ABCWY+OMV 2ABCWYqOMV 2 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 49 48 48 49 50 73
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Ser. A - month 1 (n=48,48,47,48,50,70)
41
(23 to 73)
45
(26 to 80)
36
(20 to 65)
30
(17 to 53)
2.25
(1.28 to 3.93)
78
(48 to 127)
Ser. A - month 3 (n=49,48,47,47,50,72)
107
(68 to 168)
150
(95 to 235)
135
(85 to 214)
137
(86 to 217)
34
(21 to 52)
26
(18 to 38)
Ser. A - month 6 (n=46,46,48,44,49,69)
19
(11 to 34)
32
(18 to 57)
15
(8.77 to 27)
20
(11 to 35)
3.19
(1.85 to 5.59)
15
(9.12 to 24)
Ser. A - month 7 (n=48,47,46,48,50,71)
16
(9.83 to 27)
21
(12 to 34)
12
(7.36 to 21)
14
(8.22 to 23)
2.41
(1.47 to 3.97)
15
(9.87 to 23)
Ser. A - month 12 (n=43,44,45,45,50,71)
6.97
(3.93 to 12)
7.18
(4.11 to 13)
6.61
(3.77 to 12)
6.42
(3.67 to 11)
1.68
(0.99 to 2.85)
11
(6.65 to 17)
Ser. C - month 1 (n=48,48,48,47,50,70)
11
(6.83 to 19)
26
(16 to 43)
19
(12 to 31)
20
(12 to 33)
1.42
(0.87 to 2.32)
16
(11 to 25)
Ser. C - month 3 (n=49,47,46,46,50,70)
72
(47 to 110)
114
(74 to 175)
60
(39 to 93)
71
(45 to 110)
2.36
(1.54 to 3.59)
9.54
(6.61 to 14)
Ser. C - month 6 (n=46,48,47,46,49,69)
29
(19 to 45)
41
(27 to 63)
22
(14 to 34)
31
(20 to 47)
1.07
(0.7 to 1.63)
5.14
(3.57 to 7.39)
Ser. C - month 7 (n=48,47,46,47,50,71)
24
(16 to 37)
33
(21 to 51)
16
(10 to 25)
25
(16 to 38)
0.85
(0.55 to 1.3)
3.9
(2.7 to 5.64)
Ser. C - month 12 (n=44,46,46,44,50,71)
12
(7.82 to 19)
16
(10 to 24)
8.88
(5.7 to 14)
15
(9.57 to 24)
0.99
(0.65 to 1.52)
3.06
(2.12 to 4.4)
Ser. W - month 1 (n=48,47,47,46,49,72)
9.2
(5.41 to 16)
13
(7.42 to 21)
7.41
(4.34 to 13)
10
(6.1 to 18)
1.15
(0.68 to 1.95)
10
(6.49 to 16)
Ser. W - month 3 (n=49,45,47,46,50,72)
20
(11 to 34)
27
(15 to 48)
12
(6.7 to 21)
19
(11 to 35)
4.83
(2.76 to 8.46)
7.32
(4.53 to 12)
Ser. W - month 6 (n=44,46,45,43,43,69)
11
(6.33 to 20)
9.75
(5.64 to 17)
5.44
(3.11 to 9.52)
9.75
(5.51 to 17)
0.58
(0.33 to 1.02)
5.17
(3.25 to 8.24)
Ser. W - month 7 (n=46,46,45,45,45,72)
9.21
(5.2 to 16)
8.17
(4.64 to 14)
4.84
(2.72 to 8.62)
7.94
(4.44 to 14)
0.55
(0.31 to 0.97)
5.47
(3.4 to 8.8)
Ser. W - month 12 (n=45,44,45,42,46,69)
7.33
(4.08 to 13)
6.54
(3.62 to 12)
3.52
(1.95 to 6.33)
4.83
(2.62 to 8.92)
0.49
(0.27 to 0.89)
3.62
(2.21 to 5.94)
Ser. Y - month 1 (n=48,47,48,49,49,73)
21
(13 to 32)
26
(17 to 40)
15
(9.89 to 24)
20
(13 to 31)
1.02
(0.66 to 1.58)
16
(11 to 23)
Ser. Y - month 3 (n=49,47,47,49,50,73)
44
(30 to 63)
59
(41 to 85)
37
(25 to 54)
47
(33 to 68)
0.8
(0.56 to 1.15)
12
(8.54 to 16)
Ser. Y - month 6 (n=48,47,48,48,49,72)
44
(27 to 71)
56
(34 to 91)
27
(16 to 44)
33
(20 to 54)
0.35
(0.21 to 0.56)
14
(9.04 to 21)
Ser. Y - month 7 (n=46,47,46,49,50,72)
37
(22 to 61)
45
(27 to 74)
19
(11 to 31)
26
(16 to 43)
0.35
(0.21 to 0.56)
12
(7.76 to 18)
Ser. Y - month 12 (n=45,46,45,46,50,70)
18
(11 to 31)
25
(15 to 42)
10
(6.14 to 18)
16
(9.64 to 28)
0.27
(0.16 to 0.45)
7.27
(4.68 to 11)
11.Secondary Outcome
Title GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Hide Description Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, After Third Vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time Frame At month 1, 3, 6, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT Set.
Arm/Group Title 2ABCWY 2ABx2CWY 2ABCWY+OMV 2ABCWYqOMV 2 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study.
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 49 49 48 49 50 73
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H44/76 (fHbp) - month 1 (n=48,48,48,49,50,73)
5.56
(3.44 to 8.99)
10
(6.38 to 17)
15
(9.5 to 25)
11
(6.93 to 18)
4.56
(2.84 to 7.3)
1.51
(1.19 to 1.92)
H44/76 (fHbp) - month 3 (n=49,48,46,48,50,72)
74
(53 to 102)
114
(82 to 158)
114
(81 to 159)
133
(96 to 186)
44
(32 to 61)
1.27
(1.07 to 1.5)
H44/76 (fHbp) - month 6 (n=47,48,48,48,50,72)
7.87
(5.04 to 12)
7.76
(4.98 to 12)
9.44
(6.04 to 15)
14
(9.2 to 23)
4.34
(2.81 to 6.71)
1.18
(1.01 to 1.37)
H44/76 (fHbp) - month 7 (n=48,48,47,49,49,73)
4.62
(3.04 to 7.02)
5.75
(3.79 to 8.73)
6.12
(4 to 9.37)
11
(7.15 to 17)
3.55
(2.35 to 5.37)
1.21
(1.04 to 1.4)
H44/76 (fHbp) - month 12 (n=45,47,45,46,50,71)
3.24
(2.18 to 4.8)
2.31
(1.57 to 3.39)
4
(2.69 to 5.97)
4.31
(2.91 to 6.4)
2.42
(1.66 to 3.52)
1.13
(1 to 1.29)
5/99 (NadA) - month 1 (n=48,48,47,49,50,72)
44
(29 to 65)
91
(62 to 135)
23
(15 to 34)
34
(23 to 51)
58
(39 to 85)
2.27
(1.82 to 2.85)
5/99 (NadA) - month 3 (n=49,48,47,47,50,71)
257
(203 to 324)
401
(318 to 507)
337
(266 to 427)
363
(285 to 462)
322
(255 to 406)
2.11
(1.65 to 2.7)
5/99 (NadA) - month 6 (n=47,49,48,48,48,72)
69
(51 to 93)
122
(91 to 163)
55
(41 to 74)
72
(53 to 97)
73
(54 to 98)
1.74
(1.36 to 2.22)
5/99 (NadA) - month 7 (n=47,48,47,49,50,73)
55
(42 to 73)
96
(72 to 127)
44
(33 to 58)
59
(45 to 79)
68
(51 to 90)
1.93
(1.5 to 2.48)
5/99 (NadA) - month 12 (n=45,47,46,46,50,72)
31
(22 to 44)
46
(33 to 64)
30
(21 to 42)
35
(25 to 49)
32
(23 to 44)
1.53
(1.25 to 1.88)
NZ98/254 (PorA) - month 1 (n=48,48,48,49,50,72)
2.14
(1.58 to 2.9)
2.42
(1.8 to 3.26)
4.95
(3.66 to 6.7)
4.26
(3.15 to 5.77)
2.01
(1.49 to 2.71)
1.51
(1.32 to 1.74)
NZ98/254 (PorA) - month 3 (n=49,48,47,48,50,72)
2.98
(2.18 to 4.06)
3.86
(2.83 to 5.26)
14
(10 to 19)
12
(8.96 to 17)
2.81
(2.06 to 3.84)
1.49
(1.29 to 1.72)
NZ98/254 (PorA) - month 6 (n=48,49,48,48,49,72)
1.7
(1.28 to 2.26)
1.88
(1.42 to 2.48)
3.19
(2.4 to 4.25)
3.09
(2.31 to 4.13)
1.47
(1.1 to 1.95)
1.15
(1.05 to 1.25)
NZ98/254 (PorA) - month 7 (n=47,48,47,49,50,73)
1.45
(1.05 to 2)
1.76
(1.29 to 2.41)
2.62
(1.9 to 3.62)
2.49
(1.81 to 3.43)
1.45
(1.06 to 2)
1.2
(1.07 to 1.33)
NZ98/254 (PorA) - month 12 (n=45,47,46,46,50,72)
1.57
(1.2 to 2.06)
1.6
(1.23 to 2.09)
2.47
(1.89 to 3.24)
2.18
(1.66 to 2.86)
1.21
(0.93 to 1.57)
1.15
(1.05 to 1.25)
M14459 (fHBP) - month 1 (n=48,48,47,49,50,72)
1.99
(1.44 to 2.75)
2.66
(1.92 to 3.68)
4.59
(3.28 to 6.44)
3.47
(2.47 to 4.89)
2.02
(1.46 to 2.8)
1.26
(1.08 to 1.47)
M14459 (fHBP) - month 3 (n=49,48,45,43,50,70)
6.31
(4.28 to 9.32)
13
(8.91 to 20)
17
(11 to 26)
20
(13 to 30)
5.04
(3.39 to 7.47)
1.29
(1.1 to 1.51)
M14459 (fHBP) - month 6 (n=47,47,48,48,50,71)
2.1
(1.59 to 2.79)
2.63
(1.99 to 3.49)
3.33
(2.49 to 4.44)
3.15
(2.35 to 4.24)
2.05
(1.55 to 2.71)
1.28
(1.11 to 1.49)
M14459 (fHBP) - month 7 (n=47,48,47,49,50,73)
1.79
(1.29 to 2.49)
2.4
(1.74 to 3.33)
2.75
(1.96 to 3.86)
3.59
(2.55 to 5.06)
1.87
(1.35 to 2.59)
1.28
(1.1 to 1.49)
M14459 (fHBP) - month 12 ( n=45,47,45,47,50,72)
1.73
(1.31 to 2.27)
1.64
(1.25 to 2.14)
2.43
(1.83 to 3.23)
2.53
(1.91 to 3.36)
1.44
(1.1 to 1.87)
1.37
(1.15 to 1.64)
M07-0241084 (NHBA) - month 1 (n=48,48,48,48,50,72)
2.88
(2.17 to 3.81)
3.17
(2.39 to 4.21)
7.11
(5.18 to 9.76)
5.51
(4.12 to 7.36)
3.76
(2.85 to 4.97)
2.68
(1.93 to 3.7)
M07-0241084 (NHBA) - month 3 (n=48,48,42,45,49,68)
4.34
(3.27 to 5.75)
6.27
(4.71 to 8.33)
12
(8.71 to 17)
14
(10 to 19)
6.25
(4.71 to 8.28)
2.85
(2.08 to 3.91)
M07-0241084 (NHBA) - month 6 (n=47,48,48,48,49,70)
3.78
(2.88 to 4.95)
3.3
(2.51 to 4.34)
5.43
(4 to 7.37)
6.93
(5.23 to 9.19)
3.36
(2.56 to 4.4)
2.99
(2.16 to 4.14)
M07-0241084 (NHBA) - month 7 (n=47,48,47,48,50,72)
3.51
(2.54 to 4.85)
3.19
(2.3 to 4.41)
5.18
(3.58 to 7.48)
6.58
(4.7 to 9.22)
3.78
(2.74 to 5.2)
3.03
(2.22 to 4.15)
M07-0241084(NHBA) - month 12 (n=45,46,45,47,50,70)
3.71
(2.74 to 5.03)
2.82
(2.08 to 3.83)
4.92
(3.51 to 6.89)
6.16
(4.53 to 8.38)
3.09
(2.31 to 4.14)
2.91
(2.06 to 4.12)
M01-0240364 (NadA) - month 1 (n=48,44,46,48,50,72)
5.46
(3.1 to 9.61)
6.42
(3.54 to 12)
4.7
(2.58 to 8.58)
4.24
(2.33 to 7.71)
4.25
(2.44 to 7.41)
1.12
(0.98 to 1.29)
M01-0240364 (NadA) - month 3 (n=48,48,44,42,49,70)
67
(38 to 118)
192
(109 to 339)
133
(72 to 245)
125
(67 to 233)
88
(50 to 154)
1.41
(1.07 to 1.85)
M01-0240364 (NadA) - month 6 (n=46,48,48,48,48,71)
8.59
(4.95 to 15)
17
(9.65 to 29)
11
(6.48 to 20)
6.27
(3.52 to 11)
7.02
(4.07 to 12)
1.18
(1 to 1.39)
M01-0240364 (NadA) - month 7 (n=44,48,48,48,50,71)
5.38
(3.2 to 9.03)
9.65
(5.83 to 16)
7.51
(4.45 to 13)
4.13
(2.43 to 7.01)
5.72
(3.49 to 9.35)
1.18
(1 to 1.39)
M01-0240364 (NadA) - month12 (n=43,45,44,44,50,72)
3.85
(2.16 to 6.84)
4.79
(2.72 to 8.44)
5.76
(3.19 to 10)
3.23
(1.78 to 5.87)
2.88
(1.68 to 4.92)
1.15
(0.97 to 1.37)
12.Secondary Outcome
Title GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Hide Description Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (month 6) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time Frame At month 1, 3, 6, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT Set.
Arm/Group Title 2ABCWY 2ABx2CWY 2ABCWY+OMV 2ABCWYqOMV 2 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 49 49 48 49 50 73
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
H44/76 (fHbp) - month 1 (n=48,47,47,48,50,73)
4.42
(2.73 to 7.16)
7.99
(4.95 to 13)
12
(7.44 to 20)
8.82
(5.43 to 14)
3.53
(2.2 to 5.65)
1.15
(0.98 to 1.35)
H44/76 (fHbp) - month 3 (n=49,47,45,47,50,72)
61
(42 to 87)
84
(58 to 121)
87
(60 to 127)
103
(71 to 150)
32
(22 to 46)
1.05
(0.89 to 1.24)
H44/76 (fHbp) - month 6 (n=47,47,47,47,50,72)
6.3
(4.01 to 9.9)
5.94
(3.79 to 9.3)
7.37
(4.69 to 12)
11
(7.14 to 18)
3.31
(2.13 to 5.14)
0.89
(0.78 to 1.02)
H44/76 (fHbp) - month 7 (n=48,47,46,48,49,73)
3.73
(2.43 to 5.75)
4.34
(2.82 to 6.68)
4.75
(3.06 to 7.37)
8.48
(5.49 to 13)
2.66
(1.73 to 4.08)
0.92
(0.79 to 1.06)
H44/76 (fHbp) - month 12 (n=45,46,44,45,50,71)
2.58
(1.73 to 3.84)
1.77
(1.2 to 2.61)
3.11
(2.08 to 4.66)
3.41
(2.29 to 5.09)
1.85
(1.27 to 2.71)
0.86
(0.73 to 1.01)
5/99 (NadA) - month 1 (n=48,48,47,48,50,72)
18
(12 to 29)
42
(27 to 65)
12
(7.41 to 18)
16
(10 to 26)
21
(13 to 33)
1
(0.85 to 1.18)
5/99 (NadA) - month 3 (n=49,48,47,46,50,71)
106
(74 to 151)
184
(129 to 263)
176
(122 to 253)
174
(120 to 252)
107
(75 to 153)
1
(0.8 to 1.26)
5/99 (NadA) - month 6 (n=47,49,48,47,48,72)
28
(19 to 41)
56
(39 to 82)
29
(20 to 42)
35
(24 to 51)
25
(17 to 37)
0.78
(0.61 to 0.99)
5/99 (NadA) - month 7 (n=47,48,47,48,50,73)
23
(16 to 34)
44
(30 to 63)
23
(16 to 33)
29
(20 to 42)
23
(16 to 34)
0.86
(0.68 to 1.08)
5/99 (NadA) - month 12 (n=45,47,46,45,50,72)
13
(8.78 to 20)
21
(14 to 31)
15
(10 to 23)
18
(12 to 28)
11
(7.48 to 16)
0.7
(0.59 to 0.83)
NZ98/254(PorA) - month 1 (n=48,48,48,48,50,72)
1.27
(0.93 to 1.73)
1.46
(1.07 to 1.98)
2.91
(2.14 to 3.96)
2.51
(1.84 to 3.42)
1.08
(0.8 to 1.46)
1
(0.87 to 1.16)
NZ98/254(PorA) - month 3 (n=49,48,47,47,50,72)
1.74
(1.26 to 2.4)
2.33
(1.69 to 3.21)
8.25
(5.95 to 11)
7.17
(5.16 to 9.96)
1.46
(1.06 to 2.01)
0.99
(0.83 to 1.17)
NZ98/254(PorA) - month 6 (n=48,49,48,47,49,72)
0.99
(0.73 to 1.33)
1.14
(0.85 to 1.53)
1.86
(1.38 to 2.52)
1.79
(1.32 to 2.44)
0.75
(0.56 to 1.02)
0.76
(0.65 to 0.89)
NZ98/254(PorA) - month 7 (n=47,48,47,48,50,73)
0.85
(0.61 to 1.19)
1.07
(0.76 to 1.49)
1.53
(1.09 to 2.15)
1.45
(1.03 to 2.03)
0.73
(0.52 to 1.01)
0.8
(0.67 to 0.94)
NZ98/254(PorA) - month 12 (n=45,47,46,45,50,72)
0.91
(0.68 to 1.22)
0.97
(0.73 to 1.29)
1.41
(1.05 to 1.88)
1.25
(0.93 to 1.68)
0.6
(0.46 to 0.8)
0.77
(0.66 to 0.9)
M14459(fHBP) - month 1 (n=48,47,44,45,50,71)
1.57
(1.13 to 2.17)
2.09
(1.51 to 2.89)
3.61
(2.58 to 5.06)
2.73
(1.95 to 3.84)
1.57
(1.14 to 2.16)
0.95
(0.87 to 1.03)
M14459(fHBP) - month 3 (n=49,47,42,41,50,69)
4.96
(3.35 to 7.36)
10
(6.77 to 15)
13
(8.66 to 20)
15
(9.83 to 23)
3.54
(2.4 to 5.23)
1.04
(0.9 to 1.2)
M14459(fHBP) - month 6 (n=47,46,45,44,50,70)
1.65
(1.25 to 2.19)
2.04
(1.54 to 2.71)
2.58
(1.94 to 3.45)
2.46
(1.83 to 3.31)
1.53
(1.16 to 2.02)
0.99
(0.87 to 1.12)
M14459(fHBP) - month 7 (n=47,47,44,45,50,72)
1.4
(1 to 1.96)
1.82
(1.31 to 2.54)
2.08
(1.48 to 2.94)
2.75
(1.95 to 3.9)
1.3
(0.94 to 1.8)
0.97
(0.83 to 1.13)
M14459(fHBP) - month 12 (n=45,46,42,43,50,71)
1.35
(1.02 to 1.77)
1.26
(0.96 to 1.65)
1.86
(1.4 to 2.47)
1.96
(1.48 to 2.61)
1.05
(0.81 to 1.37)
1.03
(0.87 to 1.24)
M07-0241084(NHBA) - month 1 (n=47,45,37,44,50,66)
1.07
(0.81 to 1.42)
1.14
(0.86 to 1.52)
2.6
(1.89 to 3.57)
2.03
(1.52 to 2.73)
1.31
(1 to 1.72)
1.02
(0.87 to 1.19)
M07-0241084(NHBA) - month 3 (n=47,45,33,40,49,65)
1.62
(1.19 to 2.19)
2.1
(1.55 to 2.85)
4.46
(3.11 to 6.39)
4.94
(3.56 to 6.84)
1.91
(1.42 to 2.56)
1.13
(0.89 to 1.44)
M07-0241084(NHBA) - month 6 (n=46,45,37,43,49,65)
1.39
(1.04 to 1.85)
1.13
(0.85 to 1.5)
1.91
(1.39 to 2.64)
2.53
(1.88 to 3.4)
1.07
(0.81 to 1.42)
1.2
(0.97 to 1.49)
M07-0241084(NHBA) - month 7(n=46,45,36,43,50,66)
1.29
(0.91 to 1.82)
1.05
(0.74 to 1.48)
1.81
(1.22 to 2.68)
2.41
(1.68 to 3.46)
1.12
(0.8 to 1.57)
1.21
(0.96 to 1.51)
M07-0241084(NHBA) - month 12 (n=44,43,36,43,50,64)
1.38
(0.99 to 1.9)
0.94
(0.68 to 1.3)
1.7
(1.18 to 2.43)
2.24
(1.61 to 3.12)
0.94
(0.69 to 1.28)
1.19
(0.9 to 1.58)
M01-0240364(NadA) - month 1 (n=48,42,42,44,50,71)
4.42
(2.51 to 7.77)
5.08
(2.8 to 9.2)
3.77
(2.07 to 6.88)
3.35
(1.84 to 6.08)
3.35
(1.93 to 5.83)
1
(0.86 to 1.16)
M01-0240364(NadA) - month 3 (n=48,46,40,40,49,69)
57
(32 to 102)
145
(80 to 261)
105
(56 to 199)
89
(47 to 170)
64
(36 to 113)
1.28
(1.01 to 1.63)
M01-0240364(NadA) - month 6 (n=46,46,44,44,48,70)
7.07
(4.05 to 12)
13
(7.46 to 22)
9.18
(5.17 to 16)
4.78
(2.68 to 8.54)
5.32
(3.08 to 9.19)
1.05
(0.9 to 1.23)
M01-0240364(NadA) - month 7 (n=44,46,44,44,50,70)
4.46
(2.63 to 7.56)
7.43
(4.45 to 12)
6.03
(3.54 to 10)
3.11
(1.81 to 5.33)
4.29
(2.6 to 7.08)
1.07
(0.92 to 1.25)
M01-0240364(NadA) - month 12 (n=43,43,41,40,50,71)
3.17
(1.77 to 5.69)
3.77
(2.12 to 6.69)
4.65
(2.55 to 8.47)
2.52
(1.38 to 4.62)
2.17
(1.26 to 3.72)
1.03
(0.87 to 1.22)
13.Secondary Outcome
Title GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Hide Description Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time Frame At month 1, 3, 6, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT Set.
Arm/Group Title 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV 3 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 25 24 25 25 23 73
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Ser. A - month 1 (n=24,24,24,25,23,70)
42
(19 to 92)
98
(45 to 213)
44
(20 to 95)
46
(21 to 98)
4.35
(1.97 to 9.6)
107
(66 to 172)
Ser. A - month 3 (n=25,24,25,25,23,72)
132
(73 to 237)
252
(139 to 456)
185
(103 to 333)
153
(86 to 275)
98
(53 to 181)
36
(25 to 52)
Ser. A - month 6 (n=23,24,24,25,23,69)
14
(6.54 to 32)
40
(19 to 86)
32
(15 to 69)
19
(8.99 to 41)
4.65
(2.12 to 10)
20
(12 to 32)
Ser. A - month 7 (n=24,24,21,25,22,71)
247
(124 to 495)
296
(149 to 591)
253
(121 to 530)
256
(130 to 503)
140
(68 to 289)
21
(13 to 31)
Ser. A - month 12 (n=25,23,21,25,22,71)
33
(16 to 68)
58
(27 to 123)
47
(21 to 103)
38
(18 to 78)
11
(5.1 to 24)
14
(9.03 to 22)
Ser. C - month 1 (n=25,24,24,25,23,71)
125
(68 to 230)
87
(47 to 161)
112
(61 to 208)
74
(41 to 136)
5.93
(3.16 to 11)
75
(51 to 109)
Ser. C - month 3 (n=25,24,25,24,23,71)
482
(318 to 731)
384
(252 to 585)
346
(228 to 523)
381
(250 to 580)
20
(13 to 31)
45
(35 to 58)
Ser. C - month 6 (n=22,24,24,24,21,70)
182
(111 to 297)
143
(90 to 229)
157
(98 to 251)
118
(74 to 189)
4.58
(2.77 to 7.57)
23
(17 to 31)
Ser. C - month 7 (n=23,24,23,25,22,72)
676
(410 to 1114)
676
(416 to 1097)
636
(387 to 1046)
553
(344 to 891)
33
(20 to 55)
18
(13 to 24)
Ser. C - month 12 (n=25,23,21,25,23,72)
202
(123 to 334)
185
(110 to 309)
153
(89 to 263)
157
(96 to 258)
7.8
(4.65 to 13)
14
(10 to 19)
Ser. W - month 1 (n=25,24,24,25,23,72)
152
(92 to 253)
180
(108 to 300)
237
(141 to 396)
144
(87 to 238)
19
(11 to 32)
210
(154 to 287)
Ser. W - month 3 (n=25,24,25,24,23,72)
398
(285 to 557)
455
(324 to 639)
499
(357 to 697)
406
(289 to 570)
139
(98 to 197)
166
(135 to 204)
Ser. W - month 6 (n=24,24,25,24,22,69)
166
(105 to 261)
176
(112 to 275)
191
(123 to 297)
148
(94 to 231)
10
(6.28 to 16)
117
(88 to 154)
Ser. W - month 7 (n=23,24,21,25,21,72)
640
(405 to 1014)
670
(432 to 1039)
876
(548 to 1402)
627
(407 to 965)
116
(72 to 187)
121
(93 to 159)
Ser. W - month 12(n=24,22,19,24,23,69)
264
(159 to 438)
258
(153 to 433)
257
(147 to 449)
212
(128 to 349)
17
(10 to 29)
75
(55 to 103)
Ser. Y - month 1 (n=25,24,23,25,23,73)
75
(44 to 129)
48
(28 to 82)
62
(36 to 109)
71
(42 to 121)
4.38
(2.51 to 7.67)
92
(66 to 128)
Ser. Y - month 3 (n=25,24,25,25,23,73)
225
(154 to 328)
179
(122 to 262)
214
(147 to 312)
170
(117 to 247)
4.91
(3.32 to 7.26)
72
(57 to 91)
Ser. Y - month 6 (n=24,24,24,25,23,72)
185
(102 to 336)
216
(119 to 390)
147
(81 to 267)
121
(68 to 216)
1.69
(0.92 to 3.09)
84
(58 to 120)
Ser. Y - month 7 (n=25,24,24,25,22,72)
648
(362 to 1162)
590
(327 to 1066)
599
(331 to 1085)
408
(229 to 728)
2.56
(1.38 to 4.77)
75
(52 to 108)
Ser. Y - month 12 (n=25,23,21,25,23,70)
295
(158 to 550)
351
(184 to 670)
210
(107 to 413)
205
(110 to 381)
1.46
(0.76 to 2.78)
47
(31 to 69)
14.Secondary Outcome
Title GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Hide Description Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time Frame At month 1, 3, 6, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT Set.
Arm/Group Title 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV 3 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 25 24 25 25 23 73
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Ser. A - month 1 (n=24,24,24,25,23,70)
32
(15 to 71)
71
(32 to 155)
35
(16 to 77)
33
(15 to 72)
3.45
(1.54 to 7.73)
78
(48 to 127)
Ser. A - month 3 (n=25,24,25,25,23,72)
99
(53 to 185)
176
(94 to 330)
150
(81 to 280)
109
(59 to 202)
79
(42 to 150)
26
(18 to 38)
Ser. A - month 6 (n=23,24,24,25,23,69)
11
(4.86 to 24)
29
(13 to 63)
25
(12 to 56)
14
(6.47 to 30)
3.69
(1.66 to 8.2)
15
(9.12 to 24)
Ser. A - month 7 (n=24,24,21,25,22,71)
190
(94 to 385)
214
(106 to 432)
201
(95 to 425)
187
(94 to 372)
110
(53 to 230)
15
(9.87 to 23)
Ser. A - month 12 (n=25,23,21,25,22,71)
25
(12 to 52)
42
(20 to 90)
36
(16 to 81)
28
(13 to 57)
8.75
(4.01 to 19)
11
(6.65 to 17)
Ser. C - month 1 (n=25,24,24,25,23,70)
23
(11 to 45)
19
(9.55 to 38)
26
(13 to 52)
14
(7.09 to 28)
1.51
(0.74 to 3.07)
16
(11 to 25)
Ser. C - month 3 (n=25,24,25,24,23,70)
80
(44 to 143)
81
(45 to 148)
75
(42 to 135)
63
(35 to 114)
5.17
(2.81 to 9.52)
9.54
(6.61 to 14)
Ser. C - month 6 (n=22,24,24,24,21,69)
33
(18 to 61)
31
(17 to 56)
33
(19 to 60)
22
(12 to 39)
1.16
(0.62 to 2.18)
5.14
(3.57 to 7.39)
Ser. C - month 7 (n=23,24,23,25,22,71)
115
(62 to 214)
146
(80 to 266)
139
(75 to 258)
100
(56 to 181)
9.09
(4.84 to 17)
3.9
(2.7 to 5.64)
Ser. C - month 12 (n=25,23,21,25,23,71)
37
(21 to 67)
41
(22 to 75)
33
(18 to 63)
30
(17 to 53)
2.01
(1.09 to 3.69)
3.06
(2.12 to 4.4)
Ser. W - month 1 (n=25,24,24,25,23,72)
6.44
(3.12 to 13)
9.65
(4.64 to 20)
13
(6.09 to 27)
6.3
(3.07 to 13)
0.81
(0.38 to 1.72)
10
(6.49 to 16)
Ser. W - month 3 (n=25,24,25,24,23,72)
15
(6.85 to 33)
24
(11 to 52)
24
(11 to 53)
14
(6.51 to 31)
5.42
(2.42 to 12)
7.32
(4.53 to 12)
Ser. W - month 6 (n=24,24,25,24,22,69)
6.45
(3.03 to 14)
9.27
(4.4 to 20)
9.6
(4.6 to 20)
6.36
(3.02 to 13)
0.45
(0.21 to 0.98)
5.17
(3.25 to 8.24)
Ser. W - month 7 (n=23,24,21,25,21,72)
24
(11 to 54)
35
(16 to 76)
41
(18 to 94)
26
(12 to 55)
4.78
(2.08 to 11)
5.47
(3.4 to 8.8)
Ser. W - month 12 (n=24,22,19,24,23,69)
11
(4.99 to 24)
15
(6.76 to 34)
15
(6.38 to 37)
9.44
(4.32 to 21)
0.75
(0.34 to 1.67)
3.62
(2.21 to 5.94)
Ser. Y - month 1 (n=25,24,23,25,23,73)
15
(8.32 to 28)
9.78
(5.33 to 18)
13
(6.88 to 24)
15
(8.2 to 27)
1.02
(0.55 to 1.9)
16
(11 to 23)
Ser. Y - month 3 (n=25,24,25,25,23,73)
43
(26 to 71)
35
(21 to 58)
43
(26 to 72)
34
(21 to 56)
1.13
(0.67 to 1.9)
12
(8.54 to 16)
Ser. Y - month 6 (n=24,24,24,25,23,72)
36
(18 to 70)
43
(22 to 84)
30
(15 to 59)
25
(13 to 48)
0.39
(0.2 to 0.78)
14
(9.04 to 21)
Ser. Y - month 7 (n=25,24,24,25,22,72)
123
(63 to 242)
115
(58 to 227)
129
(65 to 257)
81
(42 to 159)
0.55
(0.27 to 1.14)
12
(7.76 to 18)
Ser. Y - month 12 (n=25,23,21,25,23,70)
56
(28 to 114)
67
(32 to 139)
43
(20 to 93)
41
(20 to 83)
0.33
(0.16 to 0.69)
7.27
(4.68 to 11)
15.Secondary Outcome
Title GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Hide Description Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time Frame At month 1, 3, 6, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT Set.
Arm/Group Title 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV 3 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 25 24 25 25 23 73
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H44/76 (fHbp) - month 1 (n=25,24,24,24,23,73)
4.84
(2.52 to 9.3)
14
(7 to 26)
22
(11 to 42)
11
(5.83 to 22)
5.03
(2.55 to 9.9)
1.51
(1.19 to 1.92)
H44/76 (fHbp) - month 3 (n=25,24,24,25,23,72)
62
(40 to 97)
115
(73 to 180)
153
(97 to 241)
110
(71 to 171)
71
(45 to 112)
1.27
(1.07 to 1.5)
H44/76 (fHbp) - month 6 (n=25,24,25,24,23,72)
5.75
(3.15 to 11)
6.56
(3.56 to 12)
11
(5.95 to 20)
5.41
(2.93 to 9.98)
6.1
(3.27 to 11)
1.18
(1.01 to 1.37)
H44/76 (fHbp) - month 7 (n=25,24,24,25,22,73)
108
(61 to 190)
149
(84 to 264)
169
(95 to 302)
118
(67 to 208)
104
(57 to 191)
1.21
(1.04 to 1.4)
H44/76 (fHbp) - month 12 (n=25,23,21,25,23,71)
5.42
(3.22 to 9.11)
9.63
(5.64 to 16)
22
(12 to 38)
8.09
(4.84 to 14)
9.02
(5.26 to 15)
1.13
(1 to 1.29)
5/99 (NadA) - month 1 (n=25,24,24,25,23,72)
54
(31 to 93)
128
(74 to 222)
29
(17 to 51)
42
(24 to 71)
157
(90 to 276)
2.27
(1.82 to 2.85)
5/99 (NadA) - month 3 (n=24,24,25,24,23,71)
328
(237 to 455)
426
(308 to 589)
367
(267 to 506)
382
(277 to 528)
454
(326 to 632)
2.11
(1.65 to 2.7)
5/99 (NadA) - month 6 (n=25,24,24,25,23,72)
75
(50 to 112)
122
(81 to 183)
48
(32 to 72)
84
(56 to 125)
156
(103 to 237)
1.74
(1.36 to 2.22)
5/99 (NadA) - month 7 (n=25,24,24,25,23,73)
530
(361 to 779)
741
(502 to 1092)
674
(456 to 996)
527
(360 to 771)
856
(575 to 1274)
1.93
(1.5 to 2.48)
5/99 (NadA) - month 12 (n=25,23,21,25,23,72)
140
(89 to 220)
202
(127 to 322)
126
(77 to 206)
127
(81 to 199)
274
(172 to 439)
1.53
(1.25 to 1.88)
NZ98/254 (PorA) - month 1 (n=25,24,24,25,23,72)
2.13
(1.41 to 3.21)
2.22
(1.46 to 3.36)
6.22
(4.09 to 9.45)
2.92
(1.95 to 4.39)
1.76
(1.15 to 2.7)
1.51
(1.32 to 1.74)
NZ98/254 (PorA) - month 3 (n=25,24,25,24,23,72)
2.87
(1.87 to 4.4)
3.14
(2.04 to 4.83)
18
(12 to 27)
8.95
(5.85 to 14)
2.75
(1.77 to 4.28)
1.49
(1.29 to 1.72)
NZ98/254 (PorA) - month 6 (n=25,24,24,25,23,72)
1.9
(1.29 to 2.81)
1.85
(1.25 to 2.74)
3.33
(2.24 to 4.96)
1.83
(1.24 to 2.69)
1.83
(1.22 to 2.73)
1.15
(1.05 to 1.25)
NZ98/254 (PorA) - month 7 (n=25,24,24,25,23,73)
2.3
(1.49 to 3.54)
3.24
(2.09 to 5.02)
23
(15 to 35)
12
(7.5 to 18)
2.65
(1.69 to 4.14)
1.2
(1.07 to 1.33)
NZ98/254 (PorA) - month 12 (n=25,23,21,25,23,72)
1.41
(0.98 to 2.02)
1.94
(1.34 to 2.81)
5.01
(3.4 to 7.39)
2.39
(1.68 to 3.42)
1.79
(1.23 to 2.59)
1.15
(1.05 to 1.25)
M14459 (fHBP) - month 1 (n=25,24,24,25,23,72)
1.87
(1.2 to 2.91)
2.78
(1.78 to 4.36)
4.4
(2.8 to 6.91)
2.69
(1.69 to 4.29)
2.08
(1.32 to 3.3)
1.26
(1.08 to 1.47)
M14459 (fHBP) - month 3 (n=25,24,25,24,23,70)
5.94
(3.47 to 10)
15
(8.59 to 25)
22
(13 to 38)
11
(6.03 to 19)
9.66
(5.55 to 17)
1.29
(1.1 to 1.51)
M14459 (fHBP) - month 6 (n=25,24,25,25,23,71)
2.25
(1.54 to 3.3)
2.64
(1.8 to 3.89)
4
(2.73 to 5.86)
2.11
(1.42 to 3.15)
2.27
(1.53 to 3.37)
1.28
(1.11 to 1.49)
M14459 (fHBP) - month 7 (n=25,24,23,25,22,73)
14
(9.12 to 22)
23
(14 to 36)
41
(26 to 65)
17
(11 to 27)
11
(6.77 to 17)
1.28
(1.1 to 1.49)
M14459 (fHBP) - month 12 (n=25,23,21,25,23,72)
1.79
(1.25 to 2.57)
2.63
(1.81 to 3.81)
5.99
(4.06 to 8.85)
2.35
(1.61 to 3.43)
2.8
(1.93 to 4.07)
1.37
(1.15 to 1.64)
M07-0241084(NHBA) - month 1 (n=25,24,23,23,23,72)
3.42
(2.33 to 5.02)
3.23
(2.19 to 4.75)
6.8
(4.57 to 10)
5.73
(3.76 to 8.71)
4.07
(2.76 to 6.01)
2.68
(1.93 to 3.7)
M07-0241084 (NHBA) - month 3 (n=25,24,22,21,22,68)
4.04
(2.75 to 5.93)
5.1
(3.46 to 7.53)
12
(8.04 to 19)
8.09
(5.18 to 13)
6.48
(4.35 to 9.66)
2.85
(2.08 to 3.91)
M07-0241084 (NHBA) - month 6 (n=25,23,23,25,23,70)
3.27
(2.26 to 4.73)
3.21
(2.19 to 4.69)
5.91
(3.99 to 8.74)
4.57
(3.08 to 6.78)
3.67
(2.52 to 5.34)
2.99
(2.16 to 4.14)
M07-0241084 (NHBA) - month 7 (n=25,23,22,25,21,72)
12
(7.85 to 19)
8.91
(5.64 to 14)
33
(20 to 53)
22
(14 to 35)
11
(6.65 to 17)
3.03
(2.22 to 4.15)
M07-0241084(NHBA) - month 12 (n=25,23,21,25,23,70)
2.77
(1.85 to 4.13)
3.05
(2.01 to 4.61)
9.99
(6.39 to 16)
4.92
(3.2 to 7.56)
5.74
(3.82 to 8.64)
2.91
(2.06 to 4.12)
M01-0240364 (NadA) - month 1 (n=23,24,24,25,23,72)
2.94
(1.32 to 6.58)
10
(4.75 to 22)
6
(2.71 to 13)
5.52
(2.46 to 12)
3.84
(1.74 to 8.52)
1.12
(0.98 to 1.29)
M01-0240364 (NadA) - month 3 (n=25,24,24,24,23,70)
41
(19 to 88)
245
(113 to 532)
126
(57 to 280)
205
(91 to 459)
226
(102 to 501)
1.41
(1.07 to 1.85)
M01-0240364 (NadA) - month 6 (n=25,21,24,24,21,71)
4.39
(2.09 to 9.19)
9.54
(4.3 to 21)
7.3
(3.44 to 15)
9.08
(4.1 to 20)
7.87
(3.54 to 18)
1.18
(1 to 1.39)
M01-0240364 (NadA) - month 7 (n=24,23,24,25,23,71)
294
(147 to 589)
513
(255 to 1035)
409
(202 to 829)
280
(137 to 572)
507
(251 to 1027)
1.18
(1 to 1.39)
M01-0240364(NadA) - month 12 (n=23,21,20,25,22,72)
7.32
(3.4 to 16)
24
(11 to 54)
17
(7.37 to 38)
19
(8.71 to 41)
41
(19 to 88)
1.15
(0.97 to 1.37)
16.Secondary Outcome
Title GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Hide Description Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time Frame At month 1, 3, 6, 7 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done by MITT Set.
Arm/Group Title 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV 3 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 25 24 25 25 23 73
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
H44/76 (fHbp) - month 1 (n=25,24,24,24,23,73)
3.79
(1.97 to 7.29)
11
(5.45 to 20)
17
(8.59 to 33)
8.95
(4.62 to 17)
3.92
(1.99 to 7.72)
1.15
(0.98 to 1.35)
H44/76 (fHbp) - month 3 (n=25,24,24,25,23,72)
48
(29 to 78)
86
(52 to 143)
111
(67 to 185)
90
(55 to 147)
53
(32 to 89)
1.05
(0.89 to 1.24)
H44/76 (fHbp) - month 6 (n=25,24,25,24,23,72)
4.47
(2.43 to 8.23)
5.06
(2.73 to 9.37)
8.28
(4.5 to 15)
4.31
(2.32 to 8.01)
4.7
(2.5 to 8.85)
0.89
(0.78 to 1.02)
H44/76 (fHbp) - month 7 (n=25,24,24,25,22,73)
83
(46 to 150)
113
(63 to 206)
126
(69 to 229)
95
(53 to 170)
79
(42 to 147)
0.92
(0.79 to 1.06)
H44/76 (fHbp) - month 12 (n=25,23,21,25,23,71)
4.22
(2.49 to 7.14)
7.44
(4.33 to 13)
16
(9.28 to 29)
6.45
(3.83 to 11)
6.97
(4.04 to 12)
0.86
(0.73 to 1.01)
5/99 (NadA) - month 1 (n=25,24,24,25,23,72)
23
(12 to 42)
60
(32 to 110)
14
(7.59 to 26)
19
(11 to 35)
79
(42 to 148)
1
(0.85 to 1.18)
5/99 (NadA) - month 3 (n=24,24,25,24,23,71)
131
(79 to 216)
197
(120 to 324)
182
(112 to 298)
182
(111 to 299)
233
(140 to 387)
1
(0.8 to 1.26)
5/99 (NadA) - month 6 (n=25,24,24,25,23,72)
31
(19 to 53)
56
(34 to 95)
24
(14 to 41)
39
(23 to 64)
79
(46 to 134)
0.78
(0.61 to 0.99)
5/99 (NadA) - month 7 (n=25,24,24,25,23,73)
221
(133 to 368)
344
(206 to 574)
325
(194 to 545)
244
(147 to 403)
435
(257 to 736)
0.86
(0.68 to 1.08)
5/99 (NadA) - month 12 (n=25,23,21,25,23,72)
58
(34 to 101)
95
(54 to 167)
62
(34 to 111)
58
(34 to 100)
138
(78 to 243)
0.7
(0.59 to 0.83)
NZ98/254 (PorA) - month 1 (n=25,24,24,25,23,72)
1.25
(0.82 to 1.9)
1.32
(0.86 to 2.02)
3.63
(2.37 to 5.57)
1.71
(1.13 to 2.6)
1.06
(0.68 to 1.63)
1
(0.87 to 1.16)
NZ98/254 (PorA) - month 3 (n=25,24,25,24,23,72)
1.67
(1.07 to 2.6)
1.86
(1.19 to 2.91)
10
(6.67 to 16)
5.16
(3.31 to 8.06)
1.64
(1.04 to 2.6)
0.99
(0.83 to 1.17)
NZ98/254 (PorA) - month 6 (n=25,24,24,25,23,72)
1.11
(0.73 to 1.67)
1.1
(0.73 to 1.67)
1.93
(1.27 to 2.92)
1.06
(0.71 to 1.59)
1.09
(0.71 to 1.67)
0.76
(0.65 to 0.89)
NZ98/254 (PorA) - month 7 (n=25,24,24,25,23,73)
1.33
(0.84 to 2.1)
1.93
(1.21 to 3.07)
13
(8.14 to 21)
6.66
(4.23 to 10)
1.59
(0.99 to 2.55)
0.8
(0.67 to 0.94)
NZ98/254 (PorA) - month 12 (n=25,23,21,25,23,72)
0.81
(0.55 to 1.19)
1.13
(0.76 to 1.69)
2.81
(1.85 to 4.27)
1.37
(0.94 to 2.02)
1.06
(0.71 to 1.58)
0.77
(0.66 to 0.9)
M14459 (fHBP) - month 1 (n=25,24,24,22,23,71)
1.46
(0.94 to 2.27)
2.18
(1.39 to 3.4)
3.46
(2.2 to 5.42)
2.12
(1.33 to 3.38)
1.64
(1.04 to 2.59)
0.95
(0.87 to 1.03)
M14459 (fHBP) - month 3 (n=25,24,25,22,23,69)
4.41
(2.57 to 7.57)
11
(6.28 to 19)
17
(9.77 to 29)
8.26
(4.68 to 15)
7.4
(4.22 to 13)
1.04
(0.9 to 1.2)
M14459 (fHBP) - month 6 (n=25,24,25,22,23,70)
1.73
(1.18 to 2.53)
2.02
(1.37 to 2.96)
3.1
(2.12 to 4.54)
1.66
(1.11 to 2.48)
1.77
(1.19 to 2.63)
0.99
(0.87 to 1.12)
M14459 (fHBP) - month 7 (n=25,24,23,22,22,72)
10
(6.66 to 16)
16
(10 to 26)
31
(19 to 49)
13
(8.26 to 21)
8.18
(5.06 to 13)
0.97
(0.83 to 1.13)
M14459 (fHBP) - month 12 (n=25,23,21,22,23,71)
1.35
(0.94 to 1.94)
1.97
(1.35 to 2.86)
4.57
(3.09 to 6.77)
1.83
(1.25 to 2.68)
2.16
(1.48 to 3.14)
1.03
(0.87 to 1.24)
M07-0241084 (NHBA) - month 1 (n=24,23,22,20,23,66)
1.28
(0.87 to 1.89)
1.19
(0.8 to 1.75)
2.5
(1.67 to 3.74)
2.1
(1.38 to 3.21)
1.55
(1.05 to 2.29)
1.02
(0.87 to 1.19)
M07-0241084 (NHBA) - month 3 (n=24,23,20,18,22,65)
1.52
(1 to 2.3)
1.82
(1.2 to 2.77)
4.54
(2.89 to 7.11)
2.81
(1.74 to 4.54)
2.56
(1.67 to 3.93)
1.13
(0.89 to 1.44)
M07-0241084 (NHBA) - month 6 (n=24,22,21,21,23,65)
1.22
(0.83 to 1.8)
1.14
(0.76 to 1.7)
2.14
(1.42 to 3.23)
1.62
(1.07 to 2.46)
1.42
(0.95 to 2.1)
1.2
(0.97 to 1.49)
M07-0241084 (NHBA) - month 7 (n=24,22,20,21,21,66)
4.55
(2.84 to 7.29)
3.1
(1.9 to 5.05)
12
(6.98 to 20)
7.7
(4.65 to 13)
4.15
(2.49 to 6.9)
1.21
(0.96 to 1.51)
M07-0241084 (NHBA) - month 12(n=24,22,19,21,23,64)
1.03
(0.67 to 1.59)
1.07
(0.68 to 1.66)
3.56
(2.21 to 5.75)
1.73
(1.09 to 2.74)
2.24
(1.44 to 3.46)
1.19
(0.9 to 1.58)
M01-0240364 (NadA) - month 1 (n=23,24,23,22,23,71)
2.33
(1.04 to 5.2)
8.23
(3.79 to 18)
4.84
(2.19 to 11)
4.48
(2 to 10)
3.12
(1.41 to 6.91)
1
(0.86 to 1.16)
M01-0240364 (NadA) - month 3 (n=25,24,23,22,23,69)
31
(14 to 68)
190
(85 to 424)
105
(46 to 239)
177
(77 to 408)
196
(86 to 446)
1.28
(1.01 to 1.63)
M01-0240364 (NadA) - month 6 (n=25,21,24,21,21,70)
3.41
(1.62 to 7.2)
7.46
(3.33 to 17)
5.97
(2.79 to 13)
7.56
(3.39 to 17)
6.57
(2.93 to 15)
1.05
(0.9 to 1.23)
M01-0240364 (NadA) - month 7 (n=24,23,23,22,23,70)
226
(111 to 459)
401
(196 to 820)
336
(164 to 690)
236
(114 to 488)
428
(209 to 879)
1.07
(0.92 to 1.25)
M01-0240364 (NadA) - month 12(n=23,21,20,22,22,71)
5.61
(2.58 to 12)
19
(8.45 to 42)
14
(6.13 to 32)
16
(7.28 to 35)
34
(16 to 76)
1.03
(0.87 to 1.22)
17.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
Hide Description Unsolicited AEs were collected with onset from Day 1 through Day 7 After Vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
Time Frame From Day 1 to Day 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).
Arm/Group Title 3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV 3 B 2 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 24 49 24 49 25 48 24 50 23 50 73
Measure Type: Number
Unit of Measure: Number of Subjects
Any AEs 3 6 1 4 2 3 3 2 2 6 6
At least possibly related AEs 1 4 0 2 1 1 3 0 1 3 3
Serious AEs 0 0 0 0 0 0 1 0 0 0 0
At least possibly related SAEs 0 0 0 0 0 0 1 0 0 0 0
18.Secondary Outcome
Title Numbers of Subjects With Other Unsolicited AEs
Hide Description Unsolicited AEs were collected from Day 8 After vaccination Through Study Termination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
Time Frame Day 8 After vaccination Through Study Termination, up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).
Arm/Group Title 3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV 3 B 2 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 24 48 24 49 25 48 24 50 23 50 73
Measure Type: Number
Unit of Measure: Number of Subjects
Medically attended AEs 5 7 4 10 6 7 2 5 4 14 15
AEs leading to Withdrawal 0 0 0 0 0 0 0 0 0 0 0
At least possibly related AEs 0 0 0 0 0 0 0 0 0 0 1
SAEs 0 0 1 1 0 0 0 1 0 1 0
At least possibly related SAEs 0 0 0 0 0 0 0 0 0 0 0
19.Secondary Outcome
Title Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Hide Description Solicited local and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
Time Frame From Day 1 to Day 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Safety Set (all subjects in the exposed set who provided post-vaccination solicited AE data).
Arm/Group Title 3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV 3 B 2 B 1ACWY
Hide Arm/Group Description:
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
Overall Number of Participants Analyzed 24 48 24 49 25 48 24 50 23 50 73
Measure Type: Number
Unit of Measure: Number of Subjects
Any Solicited Local AEs 18 33 18 35 23 36 20 30 17 38 53
Injection site erythema 5 13 7 12 12 11 13 3 9 13 19
Injection site induration 7 14 11 12 10 17 11 6 7 14 18
Injection site pain 18 33 15 35 23 35 19 30 17 36 52
Swelling 5 11 9 10 10 14 13 5 7 14 14
Any Solicited Systemic AEs 10 33 14 25 20 23 18 24 14 34 43
Chills 3 10 4 2 7 7 4 5 5 5 8
Malaise 6 12 7 14 8 9 7 8 5 13 13
Myalgia 6 23 9 20 15 18 14 19 9 21 32
Arthralgia 2 6 5 7 6 5 8 3 2 8 9
Headache 5 20 6 17 9 11 10 15 6 18 27
Fatigue 3 9 3 9 5 11 4 7 3 10 9
Nausea 4 6 2 3 4 6 6 3 2 4 6
Rash 1 2 2 1 0 1 1 0 1 1 2
Fever (≥38°C) 3 5 0 3 3 0 3 1 2 2 4
Any other indicators of reactogenicity 4 8 3 5 6 3 7 4 3 5 11
Stay home 0 5 0 2 1 0 3 1 0 0 3
Time Frame Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
Adverse Event Reporting Description The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
 
Arm/Group Title 3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV 3 B 2 B 1ACWY
Hide Arm/Group Description Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
All-Cause Mortality
3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV 3 B 2 B 1ACWY
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV 3 B 2 B 1ACWY
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/49 (0.00%)   1/24 (4.17%)   1/49 (2.04%)   0/25 (0.00%)   0/48 (0.00%)   1/24 (4.17%)   1/50 (2.00%)   0/23 (0.00%)   1/50 (2.00%)   0/73 (0.00%) 
Infections and infestations                       
Appendiceal Abscess * 1  0/24 (0.00%)  0/49 (0.00%)  1/24 (4.17%)  0/49 (0.00%)  0/25 (0.00%)  0/48 (0.00%)  0/24 (0.00%)  0/50 (0.00%)  0/23 (0.00%)  0/50 (0.00%)  0/73 (0.00%) 
Gastroenteritis * 1  0/24 (0.00%)  0/49 (0.00%)  0/24 (0.00%)  0/49 (0.00%)  0/25 (0.00%)  0/48 (0.00%)  0/24 (0.00%)  1/50 (2.00%)  0/23 (0.00%)  0/50 (0.00%)  0/73 (0.00%) 
Peritonsillar Abscess * 1  0/24 (0.00%)  0/49 (0.00%)  0/24 (0.00%)  1/49 (2.04%)  0/25 (0.00%)  0/48 (0.00%)  0/24 (0.00%)  0/50 (0.00%)  0/23 (0.00%)  0/50 (0.00%)  0/73 (0.00%) 
Injury, poisoning and procedural complications                       
Burns Second Degree * 1  0/24 (0.00%)  0/49 (0.00%)  0/24 (0.00%)  0/49 (0.00%)  0/25 (0.00%)  0/48 (0.00%)  0/24 (0.00%)  0/50 (0.00%)  0/23 (0.00%)  1/50 (2.00%)  0/73 (0.00%) 
Vaccination Complication * 1  0/24 (0.00%)  0/49 (0.00%)  0/24 (0.00%)  0/49 (0.00%)  0/25 (0.00%)  0/48 (0.00%)  1/24 (4.17%)  0/50 (0.00%)  0/23 (0.00%)  0/50 (0.00%)  0/73 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV 3 B 2 B 1ACWY
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/24 (83.33%)   38/49 (77.55%)   20/24 (83.33%)   36/49 (73.47%)   23/25 (92.00%)   37/48 (77.08%)   22/24 (91.67%)   38/50 (76.00%)   19/23 (82.61%)   40/50 (80.00%)   56/73 (76.71%) 
Gastrointestinal disorders                       
Nausea  1  4/24 (16.67%)  6/49 (12.24%)  2/24 (8.33%)  3/49 (6.12%)  4/25 (16.00%)  7/48 (14.58%)  6/24 (25.00%)  3/50 (6.00%)  2/23 (8.70%)  4/50 (8.00%)  6/73 (8.22%) 
General disorders                       
Chills  1  3/24 (12.50%)  10/49 (20.41%)  4/24 (16.67%)  2/49 (4.08%)  7/25 (28.00%)  8/48 (16.67%)  4/24 (16.67%)  5/50 (10.00%)  5/23 (21.74%)  5/50 (10.00%)  8/73 (10.96%) 
Fatigue  1  3/24 (12.50%)  9/49 (18.37%)  3/24 (12.50%)  9/49 (18.37%)  5/25 (20.00%)  11/48 (22.92%)  4/24 (16.67%)  7/50 (14.00%)  3/23 (13.04%)  10/50 (20.00%)  9/73 (12.33%) 
Injection Site Erythema  1  5/24 (20.83%)  16/49 (32.65%)  7/24 (29.17%)  14/49 (28.57%)  13/25 (52.00%)  12/48 (25.00%)  16/24 (66.67%)  5/50 (10.00%)  10/23 (43.48%)  14/50 (28.00%)  20/73 (27.40%) 
Injection Site Induration  1  7/24 (29.17%)  16/49 (32.65%)  11/24 (45.83%)  13/49 (26.53%)  12/25 (48.00%)  17/48 (35.42%)  13/24 (54.17%)  8/50 (16.00%)  8/23 (34.78%)  15/50 (30.00%)  19/73 (26.03%) 
Injection Site Pain  1  18/24 (75.00%)  33/49 (67.35%)  15/24 (62.50%)  35/49 (71.43%)  23/25 (92.00%)  35/48 (72.92%)  19/24 (79.17%)  31/50 (62.00%)  17/23 (73.91%)  36/50 (72.00%)  52/73 (71.23%) 
Injection Site Swelling  1  5/24 (20.83%)  11/49 (22.45%)  9/24 (37.50%)  11/49 (22.45%)  11/25 (44.00%)  14/48 (29.17%)  14/24 (58.33%)  6/50 (12.00%)  8/23 (34.78%)  14/50 (28.00%)  16/73 (21.92%) 
Malaise  1  6/24 (25.00%)  12/49 (24.49%)  7/24 (29.17%)  14/49 (28.57%)  8/25 (32.00%)  9/48 (18.75%)  8/24 (33.33%)  8/50 (16.00%)  5/23 (21.74%)  13/50 (26.00%)  13/73 (17.81%) 
Pyrexia  1  3/24 (12.50%)  6/49 (12.24%)  0/24 (0.00%)  3/49 (6.12%)  3/25 (12.00%)  0/48 (0.00%)  5/24 (20.83%)  1/50 (2.00%)  2/23 (8.70%)  3/50 (6.00%)  4/73 (5.48%) 
Infections and infestations                       
Nasopharyngitis * 1  2/24 (8.33%)  2/49 (4.08%)  0/24 (0.00%)  4/49 (8.16%)  1/25 (4.00%)  1/48 (2.08%)  1/24 (4.17%)  2/50 (4.00%)  1/23 (4.35%)  3/50 (6.00%)  4/73 (5.48%) 
Musculoskeletal and connective tissue disorders                       
Athralgia  1  2/24 (8.33%)  6/49 (12.24%)  5/24 (20.83%)  7/49 (14.29%)  6/25 (24.00%)  5/48 (10.42%)  8/24 (33.33%)  3/50 (6.00%)  2/23 (8.70%)  8/50 (16.00%)  9/73 (12.33%) 
Myalgia  1  6/24 (25.00%)  23/49 (46.94%)  9/24 (37.50%)  20/49 (40.82%)  15/25 (60.00%)  18/48 (37.50%)  14/24 (58.33%)  19/50 (38.00%)  9/23 (39.13%)  21/50 (42.00%)  32/73 (43.84%) 
Nervous system disorders                       
Headache  1  5/24 (20.83%)  20/49 (40.82%)  6/24 (25.00%)  17/49 (34.69%)  9/25 (36.00%)  11/48 (22.92%)  10/24 (41.67%)  15/50 (30.00%)  7/23 (30.43%)  18/50 (36.00%)  27/73 (36.99%) 
Skin and subcutaneous tissue disorders                       
Rash  1  1/24 (4.17%)  2/49 (4.08%)  2/24 (8.33%)  1/49 (2.04%)  0/25 (0.00%)  1/48 (2.08%)  0/24 (0.00%)  0/50 (0.00%)  0/23 (0.00%)  0/50 (0.00%)  0/73 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines
EMail: RegistryContactVaccineUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01367158     History of Changes
Other Study ID Numbers: V102_02E1
First Submitted: June 3, 2011
First Posted: June 6, 2011
Results First Submitted: February 11, 2014
Results First Posted: November 19, 2014
Last Update Posted: November 19, 2014