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Trial record 1 of 1 for:    NCT01992536
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Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992536
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : October 25, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Meningococcal Disease
Interventions Biological: MenABCWY+OMV
Biological: MenABCWY+¼OMV
Biological: Placebo
Enrollment 194
Recruitment Details Subjects were recruited from 5 study sites in Poland and from 8 study sites in United States.
Pre-assignment Details All enrolled subjects were included in the study.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 2B_Pbo 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study. Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study. Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study. Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study. Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study. Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study. Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study. Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study. Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study. Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Period Title: Overall Study
Started 26 25 17 24 11 21 7 21 19 19
Completed 22 22 16 22 11 20 0 21 18 18
Not Completed 4 3 1 2 0 1 7 0 1 1
Reason Not Completed
Administrative Reason             0             0             0             0             0             0             7             0             0             0
Lost to Follow-up             4             2             1             0             0             1             0             0             1             1
Withdrawal by Subject             0             1             0             2             0             0             0             0             0             0
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 2B_Pbo 1M_OMV 1M_qOMV 1M_Pbo Total
Hide Arm/Group Description Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study. Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study. Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study. Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study. Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study. Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study. Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study. Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study. Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study. Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study. Total of all reporting groups
Overall Number of Baseline Participants 26 25 17 24 11 21 7 21 19 19 190
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 25 participants 17 participants 24 participants 11 participants 21 participants 7 participants 21 participants 19 participants 19 participants 190 participants
18.8  (5.19) 17.1  (4.31) 18  (5.05) 19  (5.4) 20.9  (3.99) 19.7  (5.36) 17.9  (4.67) 16.8  (4.65) 19.2  (6.1) 17.6  (5.19) 18.4  (5.08)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 17 participants 24 participants 11 participants 21 participants 7 participants 21 participants 19 participants 19 participants 190 participants
Female 8 13 9 14 2 15 3 12 12 11 99
Male 18 12 8 10 9 6 4 9 7 8 91
1.Primary Outcome
Title 1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.
Hide Description Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Arm/Group Title 2OMV_OMV 2qOMV_qOMV
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Overall Number of Participants Analyzed 25 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
Men A
96
(79.6 to 99.9)
94
(69.8 to 99.84)
Men C (N=20,10)
85
(62.1 to 96.8)
100
(69.2 to 100)
Men W (N=20,13)
85
(62.1 to 96.8)
85
(54.6 to 98.1)
Men Y (N=25,14)
96
(79.6 to 99.9)
100
(76.8 to 100)
2.Primary Outcome
Title 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
Hide Description Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180).
Time Frame Day 1 and Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Arm/Group Title 2OMV_OMV 2qOMV_qOMV
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Overall Number of Participants Analyzed 25 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
5/99 (Day 1, N= 25,15)
76
(54.9 to 90.6)
87
(59.5 to 98.3)
5/99 (Day 30, N=25,17)
100
(86.3 to 100.0)
100
(80.5 to 100.0)
H44/76 (Day 1, N=25,16)
16
(4.5 to 36.1)
13
(1.6 to 38.3)
H44/76 (Day 30, N=25,17)
96
(79.6 to 99.90)
100
(80.5 to 100.0)
M01-0240364 (Day 1, N=24,15)
25
(9.8 to 46.7)
20
(4.3 to 48.1)
M01-0240364 (Day 30, N=25,17)
100
(86.3 to 100.0)
100
(80.5 to 100.0)
M07-0241084 (Day 1,N=25,15)
36
(18.0 to 57.5)
27
(7.8 to 55.1)
M07-0241084 (Day 30, N=25,17)
100
(86.3 to 100.0)
88
(63.6 to 98.5)
M14459 (Day 1, N=25,15)
24
(9.4 to 45.1)
7
(0.17 to 31.9)
M14459 (Day 30, N=25,17)
92
(74.0 to 99.0)
88
(63.6 to 98.5)
NZ98/254 (Day 1, N=25,15)
16
(4.5 to 36.1)
7
(0.17 to 31.9)
NZ98/254 (Day 30, N=25,17)
92
(74.0 to 99.0)
71
(44.0 to 89.7)
3.Secondary Outcome
Title 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.
Hide Description

Percentage of subjects with HT-hSBA titer ≥ 1:8 in serogroups A, C, W, Y against N. meningitides assessed prior to the administration of MenABCWY booster vaccination or placebo.

Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).

Time Frame Day 1 (Pre vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB+OMV Menveo
Hide Arm/Group Description:
Subjects received two doses of MenABCWY + OMV administered two months apart.
Subjects received two doses of MenABCWY + qOMV administered two months apart.
Subjects received two doses of rMenB + OMV, administered two months apart.
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
Overall Number of Participants Analyzed 51 40 38 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
Men A (N=51,40,38,58)
27
(15.9 to 41.7)
28
(14.6 to 43.9)
29
(15.4 to 45.9)
31
(19.5 to 44.5)
Men C (N=48,38,38,58)
67
(51.6 to 79.6)
68
(51.3 to 82.5)
45
(28.6 to 61.7)
57
(43.2 to 69.8)
Men W (N=50,36,38,56)
92
(80.8 to 97.8)
75
(57.8 to 87.9)
76
(59.8 to 88.6)
68
(54 to 79.7)
Men Y (N=51,38,38,59)
65
(50.1 to 77.6)
50
(33.4 to 66.6)
16
(6 to 31.3)
46
(32.7 to 59.2)
4.Secondary Outcome
Title 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Hide Description

Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B assessed prior to the administration of MenABCWY booster vaccination or placebo.

Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).

Time Frame Day 1 (Pre vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB+OMV Menveo
Hide Arm/Group Description:
Subjects received two doses of MenABCWY + OMV administered two months apart.
Subjects received two doses of MenABCWY + qOMV administered two months apart.
Subjects received two doses of rMenB + OMV, administered two months apart.
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
Overall Number of Participants Analyzed 51 39 38 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
5/99 (N=51,38,36,59)
76
(62.5 to 87.2)
87
(71.9 to 95.6)
94
(81.3 to 99.3)
19
(9.7 to 30.9)
H44/76 (N=51,39,38,59)
22
(11.3 to 35.3)
18
(7.5 to 33.5)
34
(19.6 to 51.4)
3
(0.41 to 11.7)
M01-0240364 (N=50,37,37,58)
24
(13.1 to 38.2)
16
(6.2 to 32.0)
35
(20.2 to 52.5)
7
(1.9 to 16.7)
M07-0241084 (N=51,38,38,59)
37
(24.1 to 51.9)
29
(15.4 to 45.9)
50
(33.4 to 66.6)
22
(12.3 to 34.7)
M14459 (N=51,39,38,59)
29
(17.5 to 43.8)
13
(4.3 to 27.4)
26
(13.4 to 43.1)
14
(6.0 to 25.0)
NZ98/254 (N=51,39,38,59)
24
(12.8 to 37.5)
8
(1.6 to 20.9)
16
(6.0 to 31.3)
3
(0.41 to 11.7)
5.Secondary Outcome
Title 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.
Hide Description

The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y prior the administration of MenABCWY booster vaccination or placebo.

Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).

Time Frame Day 1 (Pre-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB+OMV Menveo
Hide Arm/Group Description:
Subjects received two doses of MenABCWY + OMV administered two months apart.
Subjects received two doses of MenABCWY + qOMV administered two months apart.
Subjects received two doses of rMenB + OMV, administered two months apart.
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
Overall Number of Participants Analyzed 51 40 38 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Men A (N=51,40,38,58)
3.34
(2.19 to 5.08)
3.3
(1.95 to 5.60)
2.96
(1.70 to 5.17)
4.14
(2.75 to 6.23)
Men C (N=48,38,38,58)
18
(11 to 30)
13
(8.00 to 20)
6.05
(4.28 to 8.55)
10
(6.36 to 17)
Men W (N=50,36,38,56)
35
(24 to 52)
23
(12 to 45)
20
(11 to 34)
17
(9.65 to 29)
Men Y (N=51,38,38,59)
13
(7.01 to 23)
8.85
(4.24 to 18)
1.8
(1.25 to 2.60)
6.49
(3.72 to 11)
6.Secondary Outcome
Title 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
Hide Description

The HT-hSBA GMTs against N. meningitidis strains of serogroup B prior the administration of MenABCWY booster vaccination or placebo.

Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).

Time Frame Day 1 (Pre-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
Arm/Group Title ABCWY+OMV ABCWY+qOMV rMenB+OMV Menveo
Hide Arm/Group Description:
Subjects received two doses of MenABCWY + OMV administered two months apart.
Subjects received two doses of MenABCWY + qOMV administered two months apart.
Subjects received two doses of rMenB + OMV, administered two months apart.
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
Overall Number of Participants Analyzed 50 38 36 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
5/99 (N=51,38,36,59)
16
(11 to 24)
33
(19 to 54)
39
(25 to 62)
2.46
(1.73 to 3.51)
H44/76 (N=51,39,38,59)
2.54
(1.69 to 3.82)
1.78
(1.26 to 2.53)
3.22
(2.18 to 4.76)
1.32
(1.06 to 1.65)
M01-0240364 (N=50,37,37,58)
2.67
(1.70 to 4.20)
2.1
(1.21 to 3.65)
4.72
(2.44 to 9.13)
1.37
(1.06 to 1.78)
M07-0241084 (N=51,38,38,59)
3.76
(2.55 to 5.56)
2.42
(1.70 to 3.45)
4.56
(2.97 to 7.01)
2.35
(1.68 to 3.28)
M14459 (N=51,39,38,59)
2.67
(1.92 to 3.70)
1.94
(1.48 to 2.56)
2.82
(2.00 to 3.96)
1.87
(1.43 to 2.43)
NZ98/254 (N=51,39,38,59)
2.03
(1.43 to 2.89)
1.46
(1.15 to 1.85)
1.75
(1.24 to 2.47)
1.16
(1.00 to 1.34)
7.Secondary Outcome
Title 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Hide Description The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.
Time Frame Day 1 and Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 25 25 16 23 11 21 21 18 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Men A (Day 1, N=25,25,16,22,11,21,19,16,18)
3.41
(1.87 to 6.22)
2.92
(1.59 to 5.36)
2.86
(1.23 to 6.63)
2.73
(1.41 to 5.27)
2.26
(0.96 to 5.31)
3.94
(1.58 to 9.85)
6.62
(2.85 to 15)
2.09
(1.28 to 3.41)
5.02
(2.06 to 12)
Men A (Day 30, N=25,25,16,22,11,21,19,17,18)
259
(174 to 383)
4.28
(2.03 to 9.03)
333
(199 to 559)
3.07
(1.51 to 6.25)
438
(287 to 670)
416
(198 to 871)
138
(84 to 229)
46
(24 to 87)
4.91
(2.00 to 12)
Men C (Day 1, N=20,23,10,22,7,16,21,18,17)
23
(9.45 to 57)
16
(7.06 to 36)
17
(5.98 to 51)
11
(6.24 to 19)
5.45
(2.41 to 12)
9.02
(5.24 to 16)
7.75
(4.19 to 14)
7.53
(2.38 to 24)
17
(6.60 to 44)
Men C (Day 30, N=21,24,11,23,7,16,21,18,18)
660
(401 to 1084)
17
(7.60 to 38)
612
(245 to 1524)
11
(5.51 to 22)
292
(75 to 1142)
135
(69 to 261)
338
(205 to 558)
304
(124 to 742)
20
(7.20 to 56)
Men W (Day 1, N=20,24,13,21,11,19,18,17,15)
34
(20 to 59)
33
(17 to 65)
30
(8.90 to 101)
18
(7.30 to 46)
25
(7.98 to 79)
29
(13 to 64)
28
(12 to 66)
9.37
(2.85 to 31)
9.42
(3.03 to 29)
Men W (Day 30, N=20,24,16,22,11,19,19,17,16)
792
(516 to 1216)
34
(16 to 71)
880
(671 to 1154)
26
(11 to 59)
392
(252 to 610)
363
(278 to 473)
629
(384 to 1032)
364
(180 to 736)
16
(4.87 to 53)
Men Y (Day 1, N=25,25,14,22,11,21,21,18,18)
10
(4.89 to 21)
15
(5.50 to 43)
15
(4.33 to 53)
5.66
(2.25 to 14)
2.4
(1.05 to 5.47)
1.84
(1.07 to 3.14)
6.43
(2.86 to 14)
5.79
(1.77 to 19)
5.32
(1.81 to 16)
Men Y (Day 30, N=25,25,16,23,11,21,21,18,18)
464
(294 to 734)
16
(5.65 to 48)
697
(435 to 1116)
5.17
(2.16 to 12)
48
(14 to 157)
39
(13 to 120)
658
(431 to 1003)
419
(217 to 809)
6.36
(1.91 to 21)
8.Secondary Outcome
Title 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
Hide Description The HT-hSBA GMTs against N. meningitidis strains of serogroups B at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.
Time Frame Day 1 and Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 25 25 17 23 11 21 21 19 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
5/99 (Day 1, N=25,25,15,22,9,21,21,19,18)
17
(9.56 to 29)
16
(8.32 to 30)
35
(14 to 92)
30
(15 to 60)
27
(8.61 to 86)
43
(24 to 77)
2.97
(1.58 to 5.59)
1.74
(1.01 to 3.03)
2.81
(1.30 to 6.06)
5/99 (Day 30, N=25,25,17,23,11,21,21,19,18)
1131
(716 to 1787)
20
(10 to 42)
1598
(900 to 2840)
34
(20 to 59)
2205
(1560 to 3117)
2576
(1716 to 3867)
28
(11 to 67)
30
(11 to 78)
3.41
(1.20 to 9.73)
H44/76 (Day 1, N= 25,25,16,22,11,21,19,19,18)
2.92
(1.50 to 5.67)
2.03
(1.23 to 3.34)
1.46
(0.96 to 2.21)
1.92
(1.11 to 3.32)
3.45
(1.81 to 6.57)
3.24
(1.76 to 5.94)
1.09
(0.96 to 1.22)
1.47
(0.92 to 2.36)
1.18
(0.97 to 1.44)
H44/76 (Day 30, 25,25,17,23,11,21,19,19,18)
97
(60 to 157)
2.36
(1.39 to 4.01)
56
(32 to 97)
2.54
(1.42 to 4.53)
132
(64 to 271)
79
(42 to 149)
5.27
(2.54 to 11)
3.85
(1.85 to 8.02)
1.63
(0.75 to 3.52)
M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18)
2.28
(1.3 to 3.98)
3.11
(1.44 to 6.68)
2.67
(0.87 to 8.24)
1.36
(0.83 to 2.23)
2.46
(0.72 to 8.4)
6.81
(2.47 to 19)
1.34
(0.84 to 2.13)
1.23
(0.88 to 1.71)
1.63
(0.86 to 3.11)
M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18)
685
(397 to 1182)
3.21
(1.4 to 7.37)
856
(454 to 1614)
1.94
(1.02 to 3.69)
1336
(810 to 2202)
1275
(794 to 2048)
3.5
(1.32 to 9.3)
3.42
(1.19 to 9.8)
1.76
(0.75 to 4.09)
M07-0241084 (Day 1, N= 25,25,15,22,11,21,21,19,18)
3.53
(2.09 to 5.95)
3.54
(1.98 to 6.31)
2.16
(1.15 to 4.08)
2.52
(1.58 to 4.03)
4.10
(1.89 to 8.90)
6.08
(3.18 to 12)
2.08
(1.26 to 3.42)
2.06
(1.13 to 3.77)
3.01
(1.38 to 6.56)
M07-0241084 (Day 30, N=25,25,17,23,11,21,21,19,18)
50
(31 to 79)
3.66
(2.02 to 6.64)
29
(14 to 58)
2.48
(1.55 to 3.96)
68
(33 to 142)
69
(36 to 129)
3.26
(1.75 to 6.06)
2.15
(1.13 to 4.07)
3.86
(1.40 to 11)
M14459 (Day 1, N=25,25,15,23,11,21,20,19,18)
2.57
(1.57 to 4.22)
2.58
(1.62 to 4.12)
1.6
(0.97 to 2.65)
2.27
(1.61 to 3.2)
3.11
(1.74 to 5.56)
3.18
(1.87 to 5.41)
1.91
(1.14 to 3.2)
1.45
(1.03 to 2.05)
2.37
(1.31 to 4.29)
M14459 (Day 30, N=25,25,17,23,11,21,20,19,18)
31
(18 to 54)
2.18
(1.39 to 3.42)
20
(11 to 37)
2.33
(1.62 to 3.35)
56
(27 to 117)
35
(21 to 58)
3.44
(2.05 to 5.75)
2.57
(1.51 to 4.37)
2.93
(1.14 to 7.53)
NZ98/254 (Day 1, N= 25,25,15,23,11,21,21,19,18)
1.65
(1.09 to 2.48)
2.11
(1.28 to 3.49)
1.32
(0.94 to 1.84)
1.58
(1.11 to 2.27)
1.72
(0.99 to 2.98)
2.07
(1.17 to 3.66)
1.18
(0.84 to 1.66)
1.18
(0.90 to 1.54)
1.12
(0.94 to 1.34)
NZ98/254 (Day 30, N= 25,25,17,23,11,21,21,19,18)
29
(18 to 47)
2.03
(1.21 to 3.40)
12
(5.04 to 31)
1.87
(1.11 to 3.16)
17
(6.22 to 45)
28
(17 to 44)
2.48
(1.31 to 4.69)
1.58
(0.96 to 2.59)
1.71
(0.84 to 3.50)
9.Secondary Outcome
Title 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
Hide Description

Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, from Day 1 (baseline) to Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.

Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase.

Time Frame Day 1 and Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 25 25 16 22 11 21 21 19 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
5/99 (Day 1, N= 24,24,16,22,11,20,6,5,5)
96
(78.9 to 99.89)
100
(85.8 to 100.0)
94
(69.8 to 99.84)
100
(84.6 to 100.0)
91
(58.7 to 99.77)
95
(75.1 to 99.87)
0
(0 to 45.9)
0
(0.0 to 52.2)
0
(0.0 to 52.2)
5/99 (Day 30, N=25,25,15,22,9,21,21,19,18)
100
(86.3 to 100.0)
4
(0.10 to 20.4)
93
(68.1 to 99.83)
0
(0.0 to 15.4)
100
(66.4 to 100.0)
95
(76.2 to 99.88)
57
(34.0 to 78.2)
79
(54.4 to 93.9)
6
(0.14 to 27.3)
H44/76 (Day 1, N=24,25,16,23,11,20,6,5,5)
100
(85.8 to 100.0)
96
(79.6 to 99.90)
100
(79.4 to 100.0)
96
(78.1 to 99.89)
91
(58.7 to 99.77)
90
(68.3 to 98.8)
0
(0.0 to 45.9)
0
(0.0 to 52.2)
0
(0.0 to 52.2)
H44/76 (Day 30, N=25,25,16,22,11,21,19,19,18)
84
(63.9 to 95.5)
4
(0.10 to 20.4)
94
(69.8 to 99.84)
0
(0.0 to 15.4)
100
(71.5 to 100.0)
76
(52.8 to 91.8)
37
(16.3 to 61.6)
26
(9.1 to 51.2)
6
(0.14 to 27.3)
M01-0240364 (Day 1, N=23,23,16,20,11,20,6,5,4)
78
(56.3 to 92.5)
74
(51.6 to 89.8)
63
(35.4 to 84.8)
75
(50.9 to 91.3)
82
(48.2 to 97.7)
85
(62.1 to 96.8)
0
(0.0 to 45.9)
0
(0.0 to 52.2)
0
(0.0 to 60.2)
M01-0240364 (Day30,N=24,25,15,20,10,21,20,18,18)
100
(85.8 to 100.0)
4
(0.10 to 20.4)
93
(68.1 to 99.83)
5
(0.13 to 24.9)
100
(69.2 to 100.0)
90
(69.6 to 98.8)
20
(5.7 to 43.7)
22
(6.4 to 47.6)
6
(0.14 to 27.3)
M07-0241084 (Day 1, N=24,23,16,21,11,20,6,5,4)
25
(9.8 to 46.7)
17
(5.0 to 38.8)
31
(11.0 to 58.7)
19
(5.4 to 41.9)
45
(16.7 to 76.6)
55
(31.5 to 76.9)
0
(0.0 to 45.9)
0
(0.0 to 52.2)
0
(0.0 to 60.2)
M07-0241084 (Day 30,N=25,25,15,22,11,21,21,19,18)
76
(54.9 to 90.6)
0
(0.0 to 13.7)
87
(59.5 to 98.3)
0
(0.0 to 15.4)
82
(48.2 to 97.7)
62
(38.4 to 81.9)
14
(3.0 to 36.3)
0
(0.0 to 17.6)
6
(0.14 to 27.3)
M14459 (Day 1, N=24,25,16,22,11,20,6,5,5)
54
(32.8 to 74.4)
48
(27.8 to 68.7)
63
(35.4 to 84.8)
59
(36.4 to 79.3)
91
(58.7 to 99.77)
60
(36.1 to 80.9)
0
(0.0 to 45.9)
0
(0.0 to 52.2)
0
(0.0 to 52.2)
M14459 (Day 30, N=25,25,15,23,11,21,5,20,19,18)
72
(50.6 to 87.9)
0
(0.0 to 13.7)
87
(59.5 to 98.3)
0
(0.0 to 14.8)
100
(71.5 to 100.0)
76
(52.8 to 91.8)
15
(3.2 to 37.9)
5
(0.13 to 26.0)
6
(0.14 to 27.3)
NZ98/254 (Day 1, N=24,24,16,22,11,20,6,5,5)
50
(29.1 to 70.9)
46
(25.6 to 67.2)
50
(24.7 to 75.3)
59
(36.4 to 79.3)
55
(23.4 to 83.3)
70
(45.7 to 88.1)
0
(0.0 to 45.9)
0
(0.0 to 52.2)
0
(0.0 to 52.2)
NZ98/254 (Day 30, N=25,25,15,23,11,21,21,19,18)
76
(54.9 to 90.6)
0
(0.0 to 13.7)
67
(38.4 to 88.2)
4
(0.11 to 21.9)
82
(48.2 to 97.7)
67
(43.0 to 85.4)
19
(5.4 to 41.9)
5
(0.13 to 26.0)
6
(0.14 to 27.3)
10.Secondary Outcome
Title 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Hide Description Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.
Time Frame Day 1 and Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 25 25 16 23 11 21 21 18 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
Men A (Day 1, N=25,25,16,22,11,21,19,16,18)
32
(14.9 to 53.5)
20
(6.8 to 40.7)
19
(4.0 to 45.6)
27
(10.7 to 50.2)
27
(6.0 to 61.0)
33
(14.6 to 57.0)
47
(24.4 to 71.1)
6
(0.16 to 30.2)
39
(17.3 to 64.3)
Men A (Day 30, N=25,25,16,22,11,21,19,17,18)
100
(86.3 to 100)
36
(18 to 57.5)
100
(79.4 to 100)
27
(10.7 to 50.2)
100
(71.5 to 100)
95
(76.2 to 99.88)
100
(82.4 to 100)
94
(71.3 to 99.85)
39
(17.3 to 64.3)
Men C (Day 1, N=20,23,10,22,7,16,21,18,17)
70
(45.7 to 88.1)
65
(42.7 to 83.6)
70
(34.8 to 93.3)
68
(45.1 to 86.1)
43
(9.9 to 81.6)
63
(35.4 to 84.8)
57
(34 to 78.2)
44
(21.5 to 69.2)
65
(38.3 to 85.8)
Men C (Day 30, N=21,24,11,23,7,16,21,18,18)
100
(83.9 to 100)
63
(40.6 to 81.2)
100
(71.5 to 100)
61
(38.5 to 80.3)
100
(59 to 100)
100
(79.4 to 100)
100
(83.9 to 100)
89
(65.3 to 98.6)
61
(35.7 to 82.7)
Men W (Day 1, N=20,24,13,21,11,19,18,17,15)
95
(75.1 to 99.87)
88
(67.6 to 97.3)
77
(46.2 to 95)
71
(47.8 to 88.7)
82
(48.2 to 97.7)
79
(54.4 to 93.9)
83
(58.6 to 96.4)
53
(27.8 to 77)
53
(26.6 to 78.7)
Men W (Day 30, N=20,24,16,22,11,19,19,17,16)
100
(83.2 to 100)
79
(57.8 to 92.9)
100
(79.4 to 100)
77
(54.6 to 92.9)
100
(71.5 to 100)
100
(82.4 to 100)
100
(82.4 to 100)
100
(80.5 to 100)
63
(35.4 to 84.8)
Men Y (Day 1, N=25,25,14,22,11,21,21,18,18)
64
(42.5 to 82)
64
(42.5 to 82)
64
(35.1 to 87.2)
41
(20.7 to 63.6)
36
(10.9 to 69.2)
10
(1.2 to 30.4)
52
(29.8 to 74.3)
39
(17.3 to 64.3)
39
(17.3 to 64.3)
Men Y (Day 30, N=25,25,16,23,11,21,21,18,18)
100
(86.3 to 100)
60
(38.7 to 78.9)
100
(79.4 to 100)
39
(19.7 to 61.5)
82
(48.2 to 97.7)
76
(52.8 to 91.8)
100
(83.9 to 100)
100
(81.5 to 100)
39
(17.3 to 64.3)
11.Secondary Outcome
Title 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
Hide Description Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.
Time Frame Day 1 and Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 25 25 17 23 11 21 21 19 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
5/99 (Day 1, N=25,25,15,22,9,21,21,19,18)
76
(54.9 to 90.6)
76
(54.9 to 90.6)
87
(59.5 to 98.3)
86
(65.1 to 97.1)
89
(51.8 to 99.72)
95
(76.2 to 99.88)
19
(5.4 to 41.9)
16
(3.4 to 39.6)
22
(6.4 to 47.6)
5/99 (Day 30, N=25,25,17,23,11,21,21,19,18)
100
(86.3 to 100)
84
(63.9 to 95.5)
100
(80.5 to 100)
91
(72 to 98.6)
100
(71.5 to 100)
100
(83.9 to 100)
76
(52.8 to 91.8)
84
(60.4 to 96.6)
22
(6.4 to 47.6)
H44/76 (Day 1, N=25,25,16,22,11,21,19,19,18)
16
(4.5 to 36.1)
24
(9.4 to 45.1)
13
(1.6 to 38.3)
18
(5.2 to 40.3)
45
(16.7 to 76.6)
29
(11.3 to 52.2)
0
(0 to 17.6)
5
(0.13 to 26.0)
0
(0 to 18.5)
H44/76 (Day 30, N=25,25,17,23,11,21,19,19,18)
96
(79.6 to 99.90)
24
(9.4 to 45.1)
100
(80.5 to 100)
26
(10.2 to 48.4)
100
(71.5 to 100)
100
(83.9 to 100)
58
(33.5 to 79.7)
32
(12.6 to 56.6)
6
(0.14 to 27.3)
M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18)
25
(9.8 to 46.7)
24
(9.4 to 45.1)
20
(4.3 to 48.1)
5
(0.13 to 24.9)
20
(2.5 to 55.6)
43
(21.8 to 66)
5
(0.13 to 24.9)
6
(0.14 to 27.3)
11
(1.4 to 34.7)
M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18)
100
(86.3 to 100)
24
(9.4 to 45.1)
100
(80.5 to 100)
18
(5.2 to 40.3)
100
(71.5 to 100)
100
(83.9 to 100)
25
(8.7 to 49.1)
26
(9.1 to 51.2)
11
(1.4 to 34.7)
M07-0241084 (Day 1,N=25,25,15,22,11,21,21,19,18)
36
(18.0 to 57.5)
36
(18.0 to 57.5)
27
(7.8 to 55.1)
27
(10.7 to 50.2)
64
(30.8 to 89.1)
52
(29.8 to 74.3)
19
(5.4 to 41.9)
16
(3.4 to 39.6)
33
(13.3 to 59.0)
M07-0241084 (Day 30,N=25,25,17,23,11,21,21,19,18)
100
(86.3 to 100)
40
(21.1 to 61.3)
88
(63.6 to 98.5)
30
(13.2 to 52.9)
91
(58.7 to 99.77)
95
(76.2 to 99.88)
33
(14.6 to 57.0)
21
(6.1 to 45.6)
33
(13.3 to 59.0)
M14459 (Day 1, N=25,25,15,23,11,21,20,19,18)
24
(9.4 to 45.1)
32
(14.9 to 53.5)
7
(0.17 to 31.9)
17
(5.0 to 38.8)
36
(10.9 to 69.2)
29
(11.3 to 52.2)
10
(1.2 to 31.7)
11
(1.3 to 33.1)
22
(6.4 to 47.6)
M14459 (Day 30, N=25,25,17,23,11,21,20,19,18)
92
(74 to 99)
28
(12.1 to 49.4)
88
(63.6 to 98.5)
30
(13.2 to 52.9)
100
(71.5 to 100)
95
(76.2 to 99.88)
35
(15.4 to 59.2)
32
(12.6 to 56.6)
22
(6.4 to 47.6)
NZ98/254 (Day 1, N=25,25,15,23,11,21,21,19,18)
16
(4.5 to 36.1)
28
(12.1 to 49.4)
7
(0.17 to 31.9)
9
(1.1 to 28)
9
(0.23 to 41.3)
24
(8.2 to 47.2)
5
(0.12 to 23.8)
5
(0.13 to 26)
0
(0 to 18.5)
NZ98/254 (Day 30, N=25,25,17,23,11,21,21,19,18)
92
(74 to 99)
20
(6.8 to 40.7)
71
(44 to 89.7)
13
(2.8 to 33.6)
82
(48.2 to 97.7)
95
(76.2 to 99.88)
19
(5.4 to 41.9)
16
(3.4 to 39.6)
6
(0.14 to 27.3)
12.Secondary Outcome
Title 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.
Hide Description Percentage of subjects with seroresponse to N. meningitidis serogroup A, C, W and Y, at Day 30 after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 25 25 16 22 11 21 21 18 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
Men A Overall
96
(79.6 to 99.90)
12
(2.5 to 31.2)
94
(69.8 to 99.84)
0
(0 to 15.4)
100
(71.5 to 100.0)
86
(63.7 to 97)
84
(60.4 to 96.6)
94
(69.8 to 99.84)
0
(0 to 18.5)
Men C Overall
85
(62.1 to 96.8)
4
(0.11 to 21.9)
100
(69.2 to 100.0)
0
(0 to 15.4)
100
(59.0 to 100.0)
81
(54.4 to 96.0)
95
(76.2 to 99.88)
78
(52.4 to 93.6)
6
(0.15 to 28.7)
Men W Overall
85
(62.1 to 96.8)
4
(0.11 to 21.1)
85
(54.6 to 98.1)
5
(0.12 to 23.8)
82
(48.2 to 97.7)
68
(43.4 to 87.4)
83
(58.6 to 96.4)
76
(50.1 to 93.2)
20
(4.3 to 48.1)
Men Y Overall
96
(79.6 to 99.9)
4
(0.1 to 20.4)
100
(76.8 to 100.0)
0
(0 to 15.4)
73
(39 to 94)
62
(38.4 to 81.9)
95
(76.2 to 99.88)
89
(65.3 to 98.6)
6
(0.14 to 27.3)
13.Secondary Outcome
Title 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Hide Description Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y, at 24 and 36 months after the primary vaccination.
Time Frame Day 1 and Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 21 22 16 20 11 20 20 18 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
Men A (Day 1, N= 21,22,15,20,10,20,20,17,17)
38
(18.1 to 61.6)
18
(5.2 to 40.3)
20
(4.3 to 48.1)
30
(11.9 to 54.3)
30
(6.7 to 65.2)
35
(15.4 to 59.2)
45
(23.1 to 68.5)
12
(1.5 to 36.4)
41
(18.4 to 67.1)
Men A (Day 365, N= 21,22,16,20,10,20,20,18,17)
67
(43.0 to 85.4)
23
(7.8 to 45.4)
88
(61.7 to 98.4)
25
(8.7 to 49.1)
90
(55.5 to 99.75)
85
(62.1 to 96.8)
85
(62.1 to 96.8)
50
(26.0 to 74.0)
35
(14.2 to 61.7)
Men C (Day 1, N= 20,19,14,20,11,19,19,18,16)
65
(40.8 to 84.6)
68
(43.4 to 87.4)
71
(41.9 to 91.6)
65
(40.8 to 84.6)
36
(10.9 to 69.2)
58
(33.5 to 79.7)
58
(33.5 to 79.7)
50
(26 to 74)
75
(47.6 to 92.7)
Men C (Day 365, N= 21,21,16,20,11,19,19,18,17)
100
(83.9 to 100)
62
(38.4 to 81.9)
100
(79.4 to 100)
50
(27.2 to 72.8)
82
(48.2 to 97.7)
95
(74 to 99.87)
100
(82.4 to 100)
89
(65.3 to 98.6)
65
(38.3 to 85.8)
Men W (Day 1, N= 20,22,12,20,11,20,17,18,16)
95
(75.1 to 99.87)
95
(77.2 to 99.88)
75
(42.8 to 94.5)
70
(45.7 to 88.1)
82
(48.2 to 97.7)
75
(50.9 to 91.3)
82
(56.6 to 96.2)
61
(35.7 to 82.7)
56
(29.9 to 80.2)
Men W (Day 365, N= 21,22,16,20,11,20,19,18,17)
100
(83.9 to 100)
82
(59.7 to 94.8)
100
(79.4 to 100)
65
(40.8 to 84.6)
91
(58.7 to 99.77)
100
(83.2 to 100)
100
(82.4 to 100)
100
(81.5 to 100)
65
(38.3 to 85.8)
Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17)
62
(38.4 to 81.9)
62
(38.4 to 81.9)
71
(41.9 to 91.6)
40
(19.1 to 63.9)
36
(10.9 to 69.2)
11
(1.4 to 34.7)
55
(31.5 to 76.9)
44
(21.5 to 69.2)
41
(18.4 to 67.1)
Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17)
95
(76.2 to 99.88)
52
(29.8 to 74.3)
100
(79.4 to 100)
40
(19.1 to 63.9)
45
(16.7 to 76.6)
72
(46.5 to 90.3)
100
(83.2 to 100)
89
(65.3 to 98.6)
47
(23 to 72.2)
14.Secondary Outcome
Title 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
Hide Description Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B, at 24 and 36 months after the primary vaccination.
Time Frame Day 1, Day 30 and Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 21 22 16 20 11 20 21 18 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
5/99 (Day 1, N=21,22,14,20,9,19,21,18,17)
76
(52.8 to 91.8)
82
(59.7 to 94.8)
86
(57.2 to 98.2)
85
(62.1 to 96.8)
89
(51.8 to 99.72)
95
(74.0 to 99.87)
19
(5.4 to 41.9)
17
(3.6 to 41.4)
24
(6.8 to 49.9)
5/99 (Day 30, N=21,22,16,20,11,19,21,18,16)
100
(83.9 to 100.0)
86
(65.1 to 97.1)
100
(79.4 to 100.0)
90
(68.3 to 98.8)
100
(71.5 to 100.0)
100
(82.4 to 100.0)
76
(52.8 to 91.8)
83
(58.6 to 96.4)
25
(7.3 to 52.4)
5/99 (Day 365, N=21,22,16,20,11,19,21,18,17)
95
(76.2 to 99.88)
77
(54.6 to 92.2)
100
(79.4 to 100.0)
80
(56.3 to 94.3)
100
(71.5 to 100.0)
100
(82.4 to 100.0)
43
(21.8 to 66.0)
33
(13.3 to 59.0)
18
(3.8 to 43.4)
H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17)
19
(5.4 to 41.9)
27
(10.7 to 50.2)
13
(1.7 to 40.5)
15
(3.2 to 37.9)
45
(16.7 to 76.6)
30
(11.9 to 54.3)
5
(0.12 to 23.8)
6
(0.14 to 27.3)
0
(0.0 to 19.5)
H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16)
95
(76.2 to 99.88)
27
(10.7 to 50.2)
100
(79.4 to 100.0)
15
(3.2 to 37.9)
100
(71.5 to 100.0)
100
(83.2 to 100.0)
58
(33.5 to 79.7)
33
(13.3 to 59.0)
6
(0.16 to 30.2)
H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17)
76
(52.8 to 91.8)
18
(5.2 to 40.3)
44
(19.8 to 70.1)
10
(1.2 to 31.7)
82
(48.2 to 97.7)
65
(40.8 to 84.6)
19
(5.4 to 41.9)
11
(1.4 to 34.7)
6
(0.15 to 28.7)
M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17)
24
(8.2 to 47.2)
27
(10.7 to 50.2)
21
(4.7 to 50.8)
6
(0.14 to 27.3)
20
(2.5 to 55.6)
42
(20.3 to 66.5)
5
(0.13 to 24.9)
6
(0.15 to 28.7)
12
(1.5 to 36.4)
M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16)
100
(83.9 to 100.0)
27
(10.7 to 50.2)
100
(79.4 to 100.0)
6
(0.15 to 28.7)
100
(71.5 to 100.0)
100
(82.4 to 100.0)
21
(6.1 to 45.6)
28
(9.7 to 53.5)
13
(1.6 to 38.3)
M01-0240364(Day 365, N=21,22,16,18,11,19,20,18,17)
71
(47.8 to 88.7)
32
(13.9 to 54.9)
75
(47.6 to 92.7)
6
(0.14 to 27.3)
100
(71.5 to 100.0)
95
(74.0 to 99.87)
15
(3.2 to 37.9)
11
(1.4 to 34.7)
18
(3.8 to 43.4)
M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17)
38
(18.1 to 61.6)
41
(20.7 to 63.6)
29
(8.4 to 58.1)
25
(8.7 to 49.1)
64
(30.8 to 89.1)
58
(33.5 to 79.7)
19
(5.4 to 41.9)
17
(3.6 to 41.4)
35
(14.2 to 61.7)
M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16)
100
(83.9 to 100.0)
45
(24.4 to 67.8)
94
(69.8 to 99.84)
25
(8.7 to 49.1)
91
(58.7 to 99.77)
95
(74.0 to 99.87)
33
(14.6 to 57.0)
22
(6.4 to 47.6)
38
(15.2 to 64.6)
M07-0241084(Day 365, N=21,22,16,20,11,19,21,18,17)
62
(38.4 to 81.9)
32
(13.9 to 54.9)
50
(24.7 to 75.3)
20
(5.7 to 43.7)
82
(48.2 to 97.7)
74
(48.8 to 90.9)
29
(11.3 to 52.2)
17
(3.6 to 41.4)
35
(14.2 to 61.7)
M14459 (Day 1, N=21,22,14,20,11,20,21,18,17)
24
(8.2 to 47.2)
36
(17.2 to 59.3)
7
(0.18 to 33.9)
15
(3.2 to 37.9)
36
(10.9 to 69.2)
30
(11.9 to 54.3)
10
(1.2 to 30.4)
11
(1.4 to 34.7)
24
(6.8 to 49.9)
M14459 (Day 30, N=21,22,16,20,11,20,20,18,16)
95
(76.2 to 99.88)
32
(13.9 to 54.9)
88
(61.7 to 98.4)
20
(5.7 to 43.7)
100
(71.5 to 100.0)
95
(75.1 to 99.87)
35
(15.4 to 59.2)
33
(13.3 to 59.0)
25
(7.3 to 52.4)
M14459 (Day 365, N=21,22,16,20,11,20,21,18,17)
57
(34.0 to 78.2)
18
(5.2 to 40.3)
38
(15.2 to 64.6)
5
(0.13 to 24.9)
82
(48.2 to 97.7)
60
(36.1 to 80.9)
14
(3.0 to 36.3)
11
(1.4 to 34.7)
24
(6.8 to 49.9)
NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17)
19
(5.4 to 41.9)
32
(13.9 to 54.9)
7
(0.18 to 33.9)
5
(0.13 to 24.9)
9
(0.23 to 41.3)
26
(9.1 to 51.2)
5
(0.12 to 23.8)
6
(0.14 to 27.3)
0
(0.0 to 19.5)
NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16)
95
(76.2 to 99.88)
23
(7.8 to 45.4)
75
(47.6 to 92.7)
10
(1.2 to 31.7)
82
(48.2 to 97.7)
95
(74.0 to 99.87)
19
(5.4 to 41.9)
17
(3.6 to 41.4)
6
(0.16 to 30.2)
NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17)
29
(11.3 to 52.2)
14
(2.9 to 34.9)
31
(11.0 to 58.7)
5
(0.13 to 24.9)
45
(16.7 to 76.6)
42
(20.3 to 66.5)
19
(5.4 to 41.9)
6
(0.14 to 27.3)
6
(0.15 to 28.7)
15.Secondary Outcome
Title 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
Hide Description

Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, at 24 and 36 months after the primary vaccination.

Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase.

Time Frame Day 1, Day 30 and Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 21 22 15 20 11 19 21 18 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
5/99 (Day 1, N= 20,21,15,19,11,18,6,4,5)
95
(75.1 to 99.87)
100
(83.9 to 100.0)
100
(78.2 to 100.0)
100
(82.4 to 100.0)
91
(58.7 to 99.77)
94
(72.7 to 99.86)
0
(0.0 to 45.9)
0
(0.0 to 60.2)
0
(0.0 to 52.2)
5/99 (Day 30, N=21,22,14,20,9,19,21,18,16)
100
(83.9 to 100.0)
5
(0.12 to 22.8)
93
(66.1 to 99.82)
0
(0.0 to 16.8)
100
(66.4 to 100.0)
100
(82.4 to 100.0)
57
(34.0 to 78.2)
78
(52.4 to 93.6)
6
(0.16 to 30.2)
5/99 (Day 365, N=21,22,14,20,9,19,21,18,17)
67
(43.0 to 85.4)
5
(0.12 to 22.8)
86
(57.2 to 98.2)
0
(0.0 to 16.8)
89
(51.8 to 99.72)
74
(48.8 to 90.9)
29
(11.3 to 52.2)
28
(9.7 to 53.5)
6
(0.15 to 28.7)
H44/76 (Day 1, N=20,22,15,20,11,19,6,4,5)
100
(83.2 to 100.0)
95
(77.2 to 99.88)
100
(78.2 to 100.0)
95
(75.1 to 99.87)
91
(58.7 to 99.77)
89
(66.9 to 98.7)
0
(0.0 to 45.9)
0
(0.0 to 60.2)
0
(0.0 to 52.2)
H44/76 (Day 30, N=21,22,15,20,11,20,19,18,16)
81
(58.1 to 94.6)
5
(0.12 to 22.8)
93
(68.1 to 99.83)
0
(0.0 to 16.8)
100
(71.5 to 100.0)
75
(50.9 to 91.3)
37
(16.3 to 61.6)
28
(9.7 to 53.5)
6
(0.16 to 30.2)
H44/76 (Day 365, N=21,22,15,20,11,20,21,18,17)
38
(18.1 to 61.6)
0
(0.0 to 15.4)
20
(4.3 to 48.1)
0
(0.0 to 16.8)
64
(30.8 to 89.1)
30
(11.9 to 54.3)
10
(1.2 to 30.4)
0
(0.0 to 18.5)
6
(0.15 to 28.7)
M01-0240364 (Day 1, N=19,21,15,15,11,18,6,4,4)
79
(54.4 to 93.9)
76
(52.8 to 91.8)
67
(38.4 to 88.2)
67
(38.4 to 88.2)
82
(48.2 to 97.7)
89
(65.3 to 98.6)
0
(0.0 to 45.9)
0
(0.0 to 60.2)
0
(0.0 to 60.2)
M01-0240364 (Day 30, N=21,22,14,17,10,19,19,17,16)
100
(83.9 to 100.0)
5
(0.12 to 22.8)
93
(66.1 to 99.82)
6
(0.15 to 28.7)
100
(69.2 to 100.0)
89
(66.9 to 98.7)
16
(3.4 to 39.6)
24
(6.8 to 49.9)
6
(0.16 to 30.2)
M01-0240364 (Day 365,N=21,22,14,18,10,19,20,17,17)
62
(38.4 to 81.9)
5
(0.12 to 22.8)
64
(35.1 to 87.2)
6
(0.14 to 27.3)
90
(55.5 to 99.75)
79
(54.4 to 93.9)
15
(3.2 to 37.9)
6
(0.15 to 28.7)
6
(0.15 to 28.7)
M07-0241084 (Day 1, N=20,20,15,18,11,18,6,4,4)
30
(11.9 to 54.3)
20
(5.7 to 43.7)
33
(11.8 to 61.6)
17
(3.6 to 41.4)
45
(16.7 to 76.6)
56
(30.8 to 78.5)
0
(0.0 to 45.9)
0
(0.0 to 60.2)
0
(0.0 to 60.2)
M07-0241084 (Day 30, N=21,22,14,20,11,19,21,18,16)
81
(58.1 to 94.6)
0
(0.0 to 15.4)
93
(66.1 to 99.82)
0
(0.0 to 16.8)
82
(48.2 to 97.7)
58
(33.5 to 79.7)
14
(3.0 to 36.3)
0
(0.0 to 18.5)
6
(0.16 to 30.2)
M07-0241084 (Day 365,N=21,22,14,20,11,19,21,18,17)
19
(5.4 to 41.9)
0
(0.0 to 15.4)
0
(0.0 to 23.2)
0
(0.0 to 16.8)
27
(6.0 to 61.0)
5
(0.13 to 26.0)
0
(0.0 to 16.1)
0
(0.0 to 18.5)
6
(0.15 to 28.7)
M14459 (Day 1, N=20,22,15,19,11,19,6,4,5)
55
(31.5 to 76.9)
55
(32.2 to 75.6)
67
(38.4 to 88.2)
58
(33.5 to 79.7)
91
(58.7 to 99.77)
63
(38.4 to 83.7)
0
(0.0 to 45.9)
0
(0.0 to 60.2)
0
(0.0 to 52.2)
M14459 (Day 30, N=21,22,14,20,11,20,20,18,16)
76
(52.8 to 91.8)
0
(0.0 to 15.4)
86
(57.2 to 98.2)
0
(0.0 to 16.8)
100
(71.5 to 100.0)
75
(50.9 to 91.3)
15
(3.2 to 37.9)
6
(0.14 to 27.3)
6
(0.16 to 30.2)
M14459 (Day 365, N=21,22,14,20,11,20,21,18,17)
24
(8.2 to 47.2)
0
(0.0 to 15.4)
0
(0.0 to 23.2)
0
(0.0 to 16.8)
36
(10.9 to 69.2)
25
(8.7 to 49.1)
10
(1.2 to 30.4)
0
(0.0 to 18.5)
6
(0.15 to 28.7)
NZ98/254 (Day 1, N=20,21,15,19,11,18,6,4,5)
60
(36.1 to 80.9)
52
(29.8 to 74.3)
53
(26.6 to 78.7)
58
(33.5 to 79.7)
55
(23.4 to 83.3)
67
(41.0 to 86.7)
0
(0.0 to 45.9)
0
(0.0 to 60.2)
0
(0.0 to 52.2)
NZ98/254 (Day 30, N=21,22,14,20,11,19,21,18,16)
81
(58.1 to 94.6)
0
(0.0 to 15.4)
71
(41.9 to 91.6)
5
(0.13 to 24.9)
82
(48.2 to 97.7)
63
(38.4 to 83.7)
19
(5.4 to 41.9)
6
(0.14 to 27.3)
6
(0.16 to 30.2)
NZ98/254 (Day 365, N=21,22,14,20,11,19,21,18,17)
10
(1.2 to 30.4)
0
(0.0 to 15.4)
14
(1.8 to 42.8)
0
(0.0 to 16.8)
9
(0.23 to 41.3)
5
(0.13 to 26.0)
10
(1.2 to 30.4)
0
(0.0 to 18.5)
6
(0.15 to 28.7)
16.Secondary Outcome
Title 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Hide Description The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y, at 24 and 36 months after the primary vaccination.
Time Frame Day 1 and Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 21 22 16 20 11 20 20 18 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Men A (Day 1, N=21,22,15,20,10,20,20,17,17)
3.98
(1.98 to 8)
2.73
(1.44 to 5.15)
3.07
(1.26 to 7.47)
2.98
(1.38 to 6.42)
2.27
(0.87 to 5.94)
4.22
(1.63 to 11)
6.31
(2.82 to 14)
2.49
(1.52 to 4.09)
5.48
(2.18 to 14)
Men A (Day 365, N=21,22,16,20,10,20,20,18,17)
25
(11 to 59)
2.62
(1.39 to 4.94)
44
(18 to 105)
3.03
(1.30 to 7.06)
54
(17 to 174)
53
(22 to 130)
34
(16 to 69)
6.52
(2.71 to 16)
3.54
(1.40 to 8.92)
Men C (Day 1, N=20,19,14,20,11,19,19,18,16)
18
(8.21 to 39)
19
(7.54 to 49)
19
(8.13 to 44)
10
(5.52 to 19)
5.20
(2.80 to 9.65)
7.83
(4.51 to 14)
7.89
(4.26 to 15)
8.45
(2.64 to 27)
24
(9.34 to 61)
Men C (Day 365, N=21,21,16,20,11,19,19,18,17)
128
(75 to 217)
15
(5.82 to 39)
177
(102 to 305)
9.14
(4.07 to 21)
29
(10 to 82)
32
(16 to 67)
81
(46 to 141)
72
(27 to 191)
24
(8.98 to 66)
Men W (Day 1, N=20,22,12,20,11,20,17,18,16)
36
(21 to 62)
43
(24 to 79)
30
(7.82 to 112)
17
(6.88 to 43)
25
(7.98 to 79)
23
(9.81 to 52)
28
(11 to 70)
15
(4.54 to 47)
10
(3.53 to 30)
Men W (Day 365, N=21,22,16,20,11,20,19,18,17)
190
(133 to 272)
28
(13 to 59)
213
(135 to 337)
16
(5.58 to 47)
80
(26 to 246)
96
(72 to 127)
172
(97 to 306)
104
(49 to 221)
16
(5.27 to 49)
Men Y (Day 1, N=21,21,14,20,11,18,20,18,17)
10
(4.39 to 24)
16
(4.85 to 54)
24
(6.62 to 90)
5.39
(2.06 to 14)
2.40
(1.05 to 5.47)
1.90
(1.02 to 3.55)
7.05
(3.08 to 16)
6.83
(2.11 to 22)
7.03
(1.99 to 25)
Men Y (Day 365, N=21,21,16,20,11,18,20,18,17)
116
(58 to 231)
18
(5.05 to 62)
235
(147 to 376)
5.93
(1.97 to 18)
7.17
(1.91 to 27)
20
(6.92 to 58)
193
(123 to 301)
101
(36 to 280)
9.56
(2.44 to 37)
17.Secondary Outcome
Title 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
Hide Description The HT-hSBA GMTs against N. meningitidis strains of serogroups B, at 24 and 36 months after the primary vaccination.
Time Frame Day 1 and Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 21 22 16 20 11 20 21 18 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
5/99 (Day 1, N= 21,22,14,20,9,19,21,18,17)
18
(9.47 to 34)
18
(9.50 to 34)
31
(12 to 85)
31
(15 to 65)
27
(8.61 to 86)
39
(21 to 74)
2.97
(1.58 to 5.59)
1.80
(1.01 to 3.22)
3.20
(1.44 to 7.09)
5/99 (Day 365, N= 21,22,16,20,11,19,21,18,17)
175
(79 to 385)
13
(6.07 to 29)
305
(149 to 625)
23
(11 to 47)
587
(351 to 983)
491
(258 to 936)
6.05
(3.10 to 12)
4.23
(1.48 to 12)
2.45
(1 to 5.99)
H44/76 (Day 1, N= 21,22,15,20,11,20,21,18,17)
3.58
(1.66 to 7.71)
2.23
(1.28 to 3.90)
1.49
(0.96 to 2.33)
1.73
(0.97 to 3.10)
3.45
(1.81 to 6.57)
3.43
(1.83 to 6.43)
1.34
(0.85 to 2.13)
1.51
(0.91 to 2.48)
1.19
(0.97 to 1.47)
H44/76 (Day 365, N= 21,22,16,20,11,20,21,18,17)
12
(5.18 to 26)
1.93
(1.20 to 3.10)
4.19
(1.93 to 9.11)
1.83
(1.07 to 3.15)
21
(6.00 to 71)
11
(4.68 to 25)
1.96
(1.21 to 3.19)
1.92
(1.17 to 3.17)
1.49
(0.90 to 2.48)
M01-0240364 (Day 1, N= 21,22,14,18,10,19,20,17,17)
2.33
(1.25 to 4.36)
3.39
(1.43 to 8.05)
2.87
(0.86 to 9.59)
1.26
(0.89 to 1.80)
2.46
(0.72 to 8.40)
6.29
(2.22 to 18)
1.24
(0.79 to 1.94)
1.24
(0.88 to 1.77)
1.68
(0.85 to 3.33)
M01-0240364(Day 365,N= 21,22,16,18,11,19,20,18,17)
30
(9.54 to 93)
3.55
(1.56 to 8.07)
74
(18 to 300)
1.23
(0.91 to 1.68)
303
(174 to 527)
155
(69 to 350)
1.61
(0.99 to 2.63)
1.71
(0.86 to 3.42)
2.03
(0.90 to 4.58)
M07-0241084 (Day 1, N= 21,22,14,20,11,19,21,18,17)
3.68
(2.07 to 6.54)
4.20
(2.25 to 7.85)
2.28
(1.16 to 4.48)
2.36
(1.51 to 3.70)
4.10
(1.89 to 8.90)
7.35
(3.82 to 14)
2.08
(1.26 to 3.42)
2.15
(1.14 to 4.05)
3.50
(1.57 to 7.80)
M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17)
7.96
(4.60 to 14)
3.28
(2.16 to 4.97)
4.09
(2.30 to 7.25)
2.04
(1.43 to 2.92)
10
(4.51 to 24)
11
(6.35 to 18)
2.45
(1.59 to 3.79)
1.91
(1.14 to 3.23)
3.92
(1.90 to 8.07)
M14459 (Day 1, N= 21,22,14,20,11,20,21,18,16)
2.69
(1.51 to 4.78)
2.94
(1.77 to 4.89)
1.54
(0.90 to 2.63)
2.01
(1.40 to 2.88)
3.11
(1.74 to 5.56)
3.37
(1.95 to 5.81)
1.85
(1.13 to 3.04)
1.48
(1.03 to 2.13)
2.55
(1.37 to 4.77)
M14459 (Day 365, N= 21,22,16,20,11,20,21,18,17)
7.19
(3.89 to 13)
1.67
(1.07 to 2.60)
2.94
(1.49 to 5.80)
1.47
(1.07 to 2.03)
11
(4.41 to 28)
7.12
(3.59 to 14)
2.09
(1.33 to 3.29)
1.38
(0.98 to 1.93)
2.17
(1.07 to 4.41)
NZ98/254 (Day 1, N= 21,22,14,20,11,19,21,18,17)
1.73
(1.06 to 2.81)
2.34
(1.33 to 4.10)
1.34
(0.94 to 1.93)
1.48
(1.01 to 2.17)
1.72
(0.99 to 2.98)
2.24
(1.20 to 4.17)
1.18
(0.84 to 1.66)
1.19
(0.90 to 1.58)
1.13
(0.94 to 1.37)
NZ98/254 (Day 365, N= 21,22,16,20,11,19,21,18,17)
3.49
(2.12 to 5.74)
1.71
(1.41 to 2.57)
2.67
(1.27 to 5.61)
1.23
(0.90 to 1.69)
3.28
(1.66 to 6.49)
3.77
(1.98 to 7.18)
1.65
(1.04 to 2.61)
1.19
(0.91 to 1.54)
1.28
(0.85 to 1.92)
18.Secondary Outcome
Title 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Hide Description Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Time Frame Day 1, Day 30 and Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 21 22 16 20 11 20 20 18 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
Men A (Day 1,N=21,22,15,20,10,20,20,17,17)
38
(18.1 to 61.6)
18
(5.2 to 40.3)
20
(4.3 to 48.1)
30
(11.9 to 54.3)
30
(6.7 to 65.2)
35
(15.4 to 59.2)
45
(23.1 to 68.5)
12
(1.5 to 36.4)
41
(18.4 to 67.1)
Men A (Day 30, N=21,22,15,19,10,20,18,16,16)
100
(83.9 to 100.0)
32
(13.9 to 54.9)
100
(78.2 to 100.0)
26
(9.1 to 51.2)
100
(69.2 to 100.0)
95
(75.1 to 99.87)
100
(81.5 to 100.0)
94
(69.8 to 99.84)
44
(19.8 to 70.1)
Men A (Day 365, N=21,22,16,20,10,20,20,18,17)
67
(43.0 to 85.4)
23
(7.8 to 45.4)
88
(61.7 to 98.4)
25
(8.7 to 49.1)
90
(55.5 to 99.75)
85
(62.1 to 96.8)
85
(62.1 to 96.8)
50
(26.0 to 74.0)
35
(14.2 to 61.7)
Men C (Day 1, N=20,19,14,20,11,19,19,18,16)
65
(40.8 to 84.6)
68
(43.4 to 87.4)
71
(41.9 to 91.6)
65
(40.8 to 84.6)
36
(10.9 to 69.2)
58
(33.5 to 79.7)
58
(33.5 to 79.7)
50
(26.0 to 74.0)
75
(47.6 to 92.7)
Men C (Day 30, N=17,20,10,20,7,14,19,17,16)
100
(80.5 to 100.0)
65
(40.8 to 84.6)
100
(69.2 to 100.0)
55
(31.5 to 76.9)
100
(59.0 to 100.0)
100
(76.8 to 100.0)
100
(82.4 to 100.0)
88
(63.6 to 98.5)
69
(41.3 to 89.0)
Men C (Day 365, N=21,21,16,20,11,19,19,18,17)
100
(83.9 to 100.0)
62
(38.4 to 81.9)
100
(79.4 to 100.0)
50
(27.2 to 72.8)
82
(48.2 to 97.7)
95
(74.0 to 99.87)
100
(82.4 to 100.0)
89
(65.3 to 98.6)
65
(38.3 to 85.8)
Men W (Day 1,N=20,22,12,20,11,20,17,18,16)
95
(75.1 to 99.87)
95
(77.2 to 99.88)
75
(42.8 to 94.5)
70
(45.7 to 88.1)
82
(48.2 to 97.7)
75
(50.9 to 91.3)
82
(56.6 to 96.2)
61
(35.7 to 82.7)
56
(29.9 to 80.2)
Men W (Day 30, N=18,22,15,19,11,18,17,16,14)
100
(81.5 to 100.0)
86
(65.1 to 97.1)
100
(78.2 to 100.0)
74
(48.8 to 90.9)
100
(71.5 to 100.0)
100
(81.5 to 100.0)
100
(80.5 to 100.0)
100
(79.4 to 100.0)
57
(28.9 to 82.3)
Men W (Day 365, N=21,22,16,20,11,20,19,18,17)
100
(83.9 to 100.0)
82
(59.7 to 94.8)
100
(79.4 to 100.0)
65
(40.8 to 84.6)
91
(58.7 to 99.77)
100
(83.2 to 100.0)
100
(82.4 to 100.0)
100
(81.5 to 100.0)
65
(38.3 to 85.8)
Men Y (Day 1, N=21,21,14,20,11,18,20,18,17)
62
(38.4 to 81.9)
62
(38.4 to 81.9)
71
(41.9 to 91.6)
40
(19.1 to 63.9)
36
(10.9 to 69.2)
11
(1.4 to 34.7)
55
(31.5 to 76.9)
44
(21.5 to 69.2)
41
(18.4 to 67.1)
Men Y (Day 30, N=21,21,15,20,11,18,20,17,16)
100
(83.9 to 100.0)
57
(34.0 to 78.2)
100
(78.2 to 100.0)
40
(19.1 to 63.9)
82
(48.2 to 97.7)
83
(58.6 to 96.4)
100
(83.2 to 100.0)
100
(80.5 to 100.0)
38
(15.2 to 64.6)
Men Y (Day 365, N=21,21,16,20,11,18,20,18,17)
95
(76.2 to 99.88)
52
(29.8 to 74.3)
100
(79.4 to 100.0)
40
(19.1 to 63.9)
45
(16.7 to 76.6)
72
(46.5 to 90.3)
100
(83.2 to 100.0)
89
(65.3 to 98.6)
47
(23.0 to 72.2)
19.Secondary Outcome
Title 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Hide Description Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitides strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Time Frame Day 1, Day 30 and Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Arm/Group Title 2OMV_OMV 2qOMV_qOMV 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Overall Number of Participants Analyzed 21 16 11 20 21 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
5/99 (Day 1,N= 21,14,9,19,21,18)
76
(52.8 to 91.8)
86
(57.2 to 98.2)
89
(51.8 to 99.72)
95
(74 to 99.87)
19
(5.4 to 41.9)
17
(3.6 to 41.4)
5/99 (Day 30, N= 21,16,11,19,21,18)
100
(83.9 to 100)
100
(79.4 to 100)
100
(71.5 to 100)
100
(82.4 to 100)
76
(52.8 to 91.8)
83
(58.6 to 96.4)
5/99 (Day 365, 21,16,11,19,21,18)
95
(76.2 to 99.88)
100
(79.4 to 100)
100
(71.5 to 100)
100
(82.4 to 100)
43
(21.8 to 66)
33
(13.3 to 59)
H44/76 (Day 1, N= 21,15,11,20,21,18)
19
(5.4 to 41.9)
13
(1.7 to 40.5)
45
(16.7 to 76.6)
30
(11.9 to 54.3)
5
(0.12 to 23.8)
6
(0.14 to 27.3)
H44/76 (Day 30, N= 21,16,11,20,19,18)
95
(76.2 to 99.88)
100
(79.4 to 100)
100
(71.5 to 100)
100
(83.2 to 100)
58
(33.5 to 79.7)
33
(13.3 to 59)
H44/76 (Day 365, N= 21,16,11,20,21,18)
76
(52.8 to 91.8)
44
(19.8 to 70.1)
82
(48.2 to 97.7)
65
(40.8 to 84.6)
19
(5.4 to 41.9)
11
(1.4 to 34.7)
M01-0240364 (Day 1, N= 21,14,10,19,20,17)
24
(8.2 to 47.2)
21
(4.7 to 50.8)
20
(2.5 to 55.6)
42
(20.3 to 66.5)
5
(0.13 to 24.9)
6
(0.15 to 28.7)
M01-0240364(Day 30, N= 21,16,11,19,19,18)
100
(83.9 to 100)
100
(79.4 to 100)
100
(71.5 to 100)
100
(82.4 to 100)
21
(6.1 to 45.6)
28
(9.7 to 53.5)
M01-0240364 (Day 365, N= 21,16,11,19,20,18)
71
(47.8 to 88.7)
75
(47.6 to 92.7)
100
(71.5 to 100)
95
(74 to 99.87)
15
(3.2 to 37.9)
11
(1.4 to 34.7)
M07-0241084 (Day 1, N= 21,14,11,19,21,18)
38
(18.1 to 61.6)
29
(8.4 to 58.1)
64
(30.8 to 89.1)
58
(33.5 to 79.7)
19
(5.4 to 41.9)
17
(3.6 to 41.4)
M07-0241084 (Day 30, N= 21,16,11,19,21,18)
100
(83.9 to 100)
94
(69.8 to 99.84)
91
(58.7 to 99.77)
95
(74 to 99.87)
33
(14.6 to 57)
22
(6.4 to 47.6)
M07-0241084(Day 365, N=21,16,11,19,21,18)
62
(38.4 to 81.9)
50
(24.7 to 75.3)
82
(48.2 to 97.7)
74
(48.8 to 90.9)
29
(11.3 to 52.2)
17
(3.6 to 41.4)
M14459 (Day 1, N= 21,14,11,20,21,18)
24
(8.2 to 47.2)
7
(0.18 to 33.9)
36
(10.9 to 69.2)
30
(11.9 to 54.3)
10
(1.2 to 30.4)
11
(1.4 to 34.7)
M14459 (Day 30, N= 21,16,11,20,20,18)
95
(76.2 to 99.88)
88
(61.7 to 98.4)
100
(71.5 to 100)
95
(75.1 to 99.87)
35
(15.4 to 59.2)
33
(13.3 to 59)
M14459 (Day 365, N= 21,16,11,20,21,18)
57
(34 to 78.2)
38
(15.2 to 64.6)
82
(48.2 to 97.7)
60
(36.1 to 80.9)
14
(3 to 36.3)
11
(1.4 to 34.7)
NZ98/254 (Day 1,N= 21,14,11,19,21,18)
19
(5.4 to 41.9)
7
(0.18 to 33.9)
9
(0.23 to 41.3)
26
(9.1 to 51.2)
5
(0.12 to 23.8)
6
(0.14 to 27.3)
NZ98/254 (Day 30, N= 21,16,11,19,21,18)
95
(76.2 to 99.88)
75
(47.6 to 92.7)
82
(48.2 to 97.7)
95
(74 to 99.87)
19
(5.4 to 41.9)
17
(3.6 to 41.4)
NZ98/254 (Day 365, N= 21,16,11,19,21,18)
29
(11.3 to 52.2)
31
(11 to 58.7)
45
(16.7 to 76.6)
42
(20.3 to 66.5)
19
(5.4 to 41.9)
6
(0.14 to 27.3)
20.Secondary Outcome
Title 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Hide Description The HT-hSBA GMTs against Neisseria meningitidis serogroup A, C, W, Y and strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Time Frame Day 1, Day 30 and Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 21 22 16 20 11 20 20 18 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Men A (Day 1, N= 21,22,15,20,10,20,20,17,17)
3.98
(1.98 to 8)
2.73
(1.44 to 5.15)
3.07
(1.26 to 7.47)
2.98
(1.38 to 6.42)
2.27
(0.87 to 5.94)
4.22
(1.63 to 11)
6.31
(2.82 to 14)
2.49
(1.52 to 4.09)
5.48
(2.18 to 14)
Men A (Day 30, N= 21,22,15,19,10,20,18,16,16)
275
(174 to 435)
3.88
(1.74 to 8.66)
348
(202 to 601)
2.95
(1.41 to 6.17)
445
(277 to 715)
428
(196 to 931)
140
(82 to 239)
46
(23 to 91)
5.99
(2.27 to 16)
Men A (Day 365, N= 21,22,16,20,10,20,20,18,17)
25
(11 to 59)
2.62
(1.39 to 4.94)
44
(18 to 105)
3.03
(1.30 to 7.06)
54
(17 to 174)
53
(22 to 130)
34
(16 to 69)
6.52
(2.71 to 16)
3.54
(1.40 to 8.92)
Men C (Day 1, N= 20,19,14,20,11,19,19,18,16)
18
(8.21 to 39)
19
(7.54 to 49)
19
(8.13 to 44)
10
(5.52 to 19)
5.20
(2.80 to 9.65)
7.83
(4.51 to 14)
7.89
(4.26 to 15)
8.45
(2.64 to 27)
24
(9.34 to 61)
Men C (Day 30, N= 17,20,10,20,7,14,19,17,16)
737
(459 to 1183)
21
(8.38 to 52)
766
(325 to 1804)
8.43
(4.37 to 16)
292
(75 to 1142)
102
(57 to 181)
322
(186 to 556)
307
(118 to 795)
27
(9.15 to 78)
Men C (Day 365, N= 21,21,16,20,11,19,19,18,17)
128
(75 to 217)
15
(5.82 to 39)
177
(102 to 305)
9.14
(4.07 to 21)
29
(10 to 82)
32
(16 to 67)
81
(46 to 141)
72
(27 to 191)
24
(8.98 to 66)
Men W (Day 1, N= 20,22,12,20,11,20,17,18,16)
36
(21 to 62)
43
(24 to 79)
30
(7.82 to 112)
17
(6.88 to 43)
25
(7.98 to 79)
23
(9.81 to 52)
28
(11 to 70)
15
(4.54 to 47)
10
(3.53 to 30)
Men W (Day 30, N= 18,22,15,19,11,18,17,16,14)
844
(535 to 1333)
46
(23 to 89)
890
(665 to 1190)
22
(8.89 to 52)
392
(252 to 610)
395
(321 to 487)
620
(354 to 1085)
360
(169 to 765)
13
(3.50 to 52)
Men W (Day 365, N= 21,22,16,20,11,20,19,18,17)
190
(133 to 272)
28
(13 to 59)
213
(135 to 337)
16
(5.58 to 47)
80
(26 to 246)
96
(72 to 127)
172
(97 to 306)
104
(49 to 221)
16
(5.27 to 49)
Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17)
10
(4.39 to 24)
16
(4.85 to 54)
24
(6.62 to 90)
5.39
(2.06 to 14)
2.40
(1.05 to 5.47)
1.90
(1.02 to 3.55)
7.05
(3.08 to 16)
6.83
(2.11 to 22)
7.03
(1.99 to 25)
Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16)
444
(257 to 768)
17
(4.77 to 57)
748
(463 to 1208)
4.86
(1.86 to 13)
48
(14 to 157)
54
(17 to 171)
662
(424 to 1032)
404
(201 to 811)
6.84
(1.78 to 26)
Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17)
116
(58 to 231)
18
(5.05 to 62)
235
(147 to 376)
5.93
(1.97 to 18)
7.17
(1.91 to 27)
20
(6.92 to 58)
193
(123 to 301)
101
(36 to 280)
9.56
(2.44 to 37)
21.Secondary Outcome
Title 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
Hide Description The HT-hSBA GMTs against Neisseria meningitidis strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Time Frame Day 1, Day 30 and Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 21 22 16 20 11 20 21 18 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
5/99 (Day 1, N=21,22,14,20,9,19,21,18,17)
18
(9.47 to 34)
18
(9.50 to 34)
31
(12 to 85)
31
(15 to 65)
27
(8.61 to 86)
39
(21 to 74)
2.97
(1.58 to 5.59)
1.8
(1.01 to 3.22)
3.2
(1.44 to 7.09)
5/99 (Day 30, N=21,22,16,20,11,19,21,18,16)
1147
(665 to 1980)
23
(11 to 48)
1598
(864 to 2956)
35
(19 to 65)
2205
(1560 to 3117)
2816
(1856 to 4273)
28
(11 to 67)
29
(10 to 80)
3.98
(1.24 to 13)
5/99 (Day 365, N=21,22,16,20,11,19,21,18,17)
175
(79 to 385)
13
(6.07 to 29)
305
(149 to 625)
23
(11 to 47)
587
(351 to 983)
491
(258 to 936)
6.05
(3.10 to 12)
4.23
(1.48 to 12)
2.45
(1 to 5.99)
H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17)
3.58
(1.66 to 7.71)
2.23
(1.28 to 3.90)
1.49
(0.96 to 2.33)
1.73
(0.97 to 3.10)
3.45
(1.81 to 6.57)
3.43
(1.83 to 6.43)
1.34
(0.85 to 2.13)
1.51
(0.91 to 2.48)
1.19
(0.97 to 1.47)
H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16)
104
(59 to 184)
2.65
(1.48 to 4.78)
57
(32 to 102)
2.03
(1.11 to 3.73)
132
(64 to 271)
79
(40 to 153)
5.27
(2.54 to 11)
3.89
(1.79 to 8.47)
1.6
(0.67 to 3.83)
H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17)
12
(5.18 to 26)
1.93
(1.20 to 3.10)
4.19
(1.93 to 9.11)
1.83
(1.07 to 3.15)
21
(6 to 71)
11
(4.68 to 25)
1.96
(1.21 to 3.19)
1.92
(1.17 to 3.17)
1.49
(0.90 to 2.48)
M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17)
2.33
(1.25 to 4.36)
3.39
(1.43 to 8.05)
2.87
(0.86 to 9.59)
1.26
(0.89 to 1.80)
2.46
(0.72 to 8.40)
6.29
(2.22 to 18)
1.24
(0.79 to 1.94)
1.24
(0.88 to 1.77)
1.68
(0.85 to 3.33)
M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16)
679
(352 to 1310)
3.57
(1.39 to 9.14)
903
(463 to 1761)
1.23
(0.89 to 1.70)
1336
(810 to 2202)
1261
(746 to 2131)
2.68
(1.15 to 6.25)
3.66
(1.21 to 11)
1.89
(0.72 to 4.91)
M01-0240364 (Day 365,N=21,22,16,18,11,19,20,18,17)
30
(9.54 to 93)
3.55
(1.56 to 8.07)
74
(18 to 300)
1.23
(0.91 to 1.68)
303
(174 to 527)
155
(69 to 350)
1.61
(0.99 to 2.63)
1.71
(0.86 to 3.42)
2.03
(0.90 to 4.58)
M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17)
3.68
(2.07 to 6.54)
4.2
(2.25 to 7.85)
2.28
(1.16 to 4.48)
2.36
(1.51 to 3.70)
4.1
(1.89 to 8.90)
7.35
(3.82 to 14)
2.08
(1.26 to 3.42)
2.15
(1.14 to 4.05)
3.5
(1.57 to 7.80)
M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16)
59
(36 to 98)
4.37
(2.29 to 8.31)
36
(20 to 64)
2.2
(1.38 to 3.49)
68
(33 to 142)
66
(35 to 124)
3.26
(1.75 to 6.06)
2.24
(1.14 to 4.38)
4.57
(1.48 to 14)
M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17)
7.96
(4.60 to 14)
3.28
(2.16 to 4.97)
4.09
(2.30 to 7.25)
2.04
(1.43 to 2.92)
10
(4.51 to 24)
11
(6.35 to 18)
2.45
(1.59 to 3.79)
1.91
(1.14 to 3.23)
3.92
(1.90 to 8.07)
M14459 (Day 1, N=21,22,14,20,11,20,21,18,17)
2.69
(1.51 to 4.78)
2.94
(1.77 to 4.89)
1.54
(0.90 to 2.63)
2.01
(1.40 to 2.88)
3.11
(1.74 to 5.56)
3.37
(1.95 to 5.81)
1.85
(1.13 to 3.04)
1.48
(1.03 to 2.13)
2.55
(1.37 to 4.77)
M14459 (Day 30, N=21,22,16,20,11,20,20,18,16)
39
(21 to 70)
2.31
(1.39 to 3.82)
20
(10 to 39)
2.03
(1.38 to 2.98)
56
(27 to 117)
35
(21 to 60)
3.44
(2.05 to 5.75)
2.71
(1.56 to 4.70)
3.05
(1.05 to 8.83)
M14459 (Day 365, N=21,22,16,20,11,20,21,18,17)
7.19
(3.89 to 13)
1.67
(1.07 to 2.60)
2.94
(1.49 to 5.80)
1.47
(1.07 to 2.03)
11
(4.41 to 28)
7.12
(3.59 to 14)
2.09
(1.33 to 3.29)
1.38
(0.98 to 1.93)
2.17
(1.07 to 4.41)
NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17)
1.73
(1.06 to 2.81)
2.34
(1.33 to 4.10)
1.34
(0.94 to 1.93)
1.48
(1.01 to 2.17)
1.72
(0.99 to 2.98)
2.24
(1.20 to 4.17)
1.18
(0.84 to 1.66)
1.19
(0.90 to 1.58)
1.13
(0.94 to 1.37)
NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16)
32
(19 to 52)
2.23
(1.25 to 3.99)
15
(5.93 to 36)
1.75
(0.98 to 3.14)
17
(6.22 to 45)
28
(17 to 47)
2.48
(1.31 to 4.69)
1.62
(0.96 to 2.74)
1.73
(0.77 to 3.90)
NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17)
3.49
(2.12 to 5.74)
1.71
(1.14 to 2.57)
2.67
(1.27 to 5.61)
1.23
(0.90 to 1.69)
3.28
(1.66 to 6.49)
3.77
(1.98 to 7.18)
1.65
(1.04 to 2.61)
1.19
(0.91 to 1.54)
1.28
(0.85 to 1.92)
22.Secondary Outcome
Title 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Hide Description Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination in this study.
Time Frame Day 1, Day 30 and Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 21 22 16 20 11 20 20 18 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
Men A (Day 1, N= 21,22,15,20,10,20,20,17,17)
38
(18.1 to 61.6)
18
(5.2 to 40.3)
20
(4.3 to 48.1)
30
(11.9 to 54.3)
30
(6.7 to 65.2)
35
(15.4 to 59.2)
45
(23.1 to 68.5)
12
(1.5 to 36.4)
41
(18.4 to 67.1)
Men A (Day 30, N= 21,22,15,19,10,20,18,16,16)
100
(83.9 to 100)
32
(13.9 to 54.9)
100
(78.2 to 100)
26
(9.1 to 51.2)
100
(69.2 to 100)
95
(75.1 to 99.87)
100
(81.5 to 100)
94
(69.8 to 99.84)
44
(19.8 to 70.1)
Men A (Day 365, N= 21,22,16,20,10,20,20,18,17)
67
(43 to 85.4)
23
(7.8 to 45.4)
88
(61.7 to 98.4)
25
(8.7 to 49.1)
90
(55.5 to 99.75)
85
(62.1 to 96.8)
85
(62.1 to 96.8)
50
(26 to 74)
35
(14.2 to 61.7)
Men C (Day 1, N= 20,19,14,20,11,19,19,18,16)
65
(40.8 to 84.6)
68
(43.4 to 87.4)
71
(41.9 to 91.6)
65
(40.8 to 84.6)
36
(10.9 to 69.2)
58
(33.5 to 79.7)
58
(33.5 to 79.7)
50
(26 to 74)
75
(47.6 to 92.7)
Men C (Day 30, N= 17,20,10,20,7,14,19,17,16)
100
(80.5 to 100)
65
(40.8 to 84.6)
100
(69.2 to 100)
55
(31.5 to 76.9)
100
(59 to 100)
100
(76.8 to 100)
100
(82.4 to 100)
88
(63.6 to 98.5)
69
(41.3 to 89)
Men C (Day 365, N= 21,21,16,20,11,19,19,18,17)
100
(83.9 to 100)
62
(38.4 to 81.9)
100
(79.4 to 100)
50
(27.2 to 72.8)
82
(48.2 to 97.7)
95
(74 to 99.87)
100
(82.4 to 100)
89
(65.3 to 98.6)
65
(38.3 to 85.8)
Men W (Day 1, 20,22,12,20,11,20,17,18,16)
95
(75.1 to 99.87)
95
(77.2 to 99.88)
75
(42.8 to 94.5)
70
(45.7 to 88.1)
82
(48.2 to 97.7)
75
(50.9 to 91.3)
82
(56.6 to 96.2)
61
(35.7 to 82.7)
56
(29.9 to 80.2)
Men W (Day 30, N= 18,22,15,19,11,18,17,16,14)
100
(81.5 to 100)
86
(65.1 to 97.1)
100
(78.2 to 100)
74
(48.8 to 90.9)
100
(71.5 to 100)
100
(81.5 to 100)
100
(80.5 to 100)
100
(79.4 to 100)
57
(28.9 to 82.3)
Men W (Day 365, N= 21,22,16,20,11,20,19,18,17)
100
(83.9 to 100)
82
(59.7 to 94.8)
100
(79.4 to 100)
65
(40.8 to 84.6)
91
(58.7 to 99.77)
100
(83.2 to 100)
100
(82.4 to 100)
100
(81.5 to 100)
65
(38.3 to 85.8)
Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17)
62
(38.4 to 81.9)
62
(38.4 to 81.9)
71
(41.9 to 91.6)
40
(19.1 to 63.9)
36
(10.9 to 69.2)
11
(1.4 to 34.7)
55
(31.5 to 76.9)
44
(21.5 to 69.2)
41
(18.4 to 67.1)
Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16)
100
(83.9 to 100)
57
(34 to 78.2)
100
(78.2 to 100)
40
(19.1 to 63.9)
82
(48.2 to 97.7)
83
(58.6 to 96.4)
100
(83.2 to 100)
100
(80.5 to 100)
38
(15.2 to 64.6)
Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17)
95
(76.2 to 99.88)
52
(29.8 to 74.3)
100
(79.4 to 100)
40
(19.1 to 63.9)
45
(16.7 to 76.6)
72
(46.5 to 90.3)
100
(83.2 to 100)
89
(65.3 to 98.6)
47
(23 to 72.2)
23.Secondary Outcome
Title 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Hide Description Number of subjects reporting solicited local and systemic adverse events after receiving a booster dose of MenABCWY vaccine or placebo. the below reported events are Erythema- Injection site erythema, Induration- Injection site induration, Pain-injection site pain, Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea, Rash, Fever, Prevention- Prevention of Pain and/or Fever, Treatment- Treatment of Pain and/or Fever and Analgesic/Antipyr.: use of Analgesic/Antipyretics in pain and fever.
Time Frame From day 1 (6 hours) through day 7 after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Solicited Safety Set, i.e. all exposed subjects who provide post vaccination solicited adverse event data.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 2B_Pbo 1M_OMV 1M_qOMV 1M_Pbo Total
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Total of all reporting groups
Overall Number of Participants Analyzed 26 24 17 23 11 21 6 21 19 19 187
Measure Type: Number
Unit of Measure: Participants
Any AEs (N=26,24,17,23,11,21,6,21,19,19,187) 23 10 15 13 11 18 2 20 17 8 137
Any Local (N=26,24,17,23,11,21,6,21,19,19,187) 23 7 15 8 11 18 1 19 17 5 124
Erythema (N=26,23,17,23,11,21,6,21,19,19,186) 11 2 7 3 6 7 0 6 9 2 53
Induration (N=26,23,17,23,11,21,6,21,19,18,185) 7 2 5 2 9 6 0 11 9 1 52
Pain (N=26,24,17,23,11,21,6,21,19,19,187) 20 6 14 7 11 17 1 19 17 4 116
Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187) 12 9 12 6 6 10 1 15 10 5 86
Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184) 3 2 3 1 0 2 0 4 2 3 20
Chills(N=26,23,17,23,11,21,6,21,19,19,186) 3 1 0 0 1 2 0 5 1 1 14
Fatigue(N=26,23,17,23,11,21,6,21,19,19,186) 9 6 8 2 5 8 0 11 6 5 60
Headache(N=26,23,17,23,11,21,6,21,19,19,186) 7 6 8 3 5 4 1 12 5 2 53
Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186 2 1 4 2 1 3 0 8 3 2 26
Myalgia(N=26,23,17,23,10,21,6,21,19,19,185) 6 2 5 0 1 4 0 8 4 1 31
Nausea(N=26,23,17,23,11,21,6,21,19,19,186) 0 2 3 1 3 5 0 4 5 1 24
Rash (N=26,23,17,23,11,21,6,21,18,19,185) 0 0 1 0 0 1 0 1 2 0 5
Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185) 2 0 0 1 0 0 0 0 0 0 3
Prevention (N=25,23,17,23,11,21,6,21,19,19,185) 2 0 1 0 0 0 0 0 0 0 3
Treatment (N=25,23,17,23,11,21,6,21,19,19,185) 2 1 3 2 1 5 0 6 2 0 22
Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1) 0 0 1 0 0 0 0 0 0 0 1
Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1) 0 0 1 0 0 0 0 0 0 0 1
24.Secondary Outcome
Title 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.
Hide Description

Number of subjects reporting unsolicited AEs (any AEs and at least possibly related AEs) after receiving a booster dose of MenABCWY vaccine or placebo from Day 1 to Day 30.

Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.

Time Frame Day 1 through Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 2B_Pbo 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 26 24 17 23 11 21 6 21 19 19
Measure Type: Number
Unit of Measure: Participants
Any AEs 6 4 5 2 3 7 1 6 5 4
At least possibly related 3 1 3 0 2 3 0 2 3 0
25.Secondary Outcome
Title 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
Hide Description Number of subjects reporting any serious unsolicited AEs (SAEs), possibly related SAEs, medically attended AEs, unsolicited AEs leading to withdrawal and deaths after receiving a booster dose of MenABCWY vaccine or placebo, are reported for the entire study period.
Time Frame Day 1 to Day 365
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Hide Analysis Population Description
Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 2B_Pbo 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 26 24 17 23 11 21 6 21 19 19
Measure Type: Number
Unit of Measure: Participants
Any SAEs 0 0 1 1 0 1 0 0 1 1
At Least Possibly related SAEs 0 0 0 0 0 0 0 0 0 0
NOCD 0 3 2 0 0 1 0 1 1 1
Medically attended AEs 12 10 12 9 6 9 1 13 11 11
AEs leading to withdrawal 0 0 0 0 0 0 0 0 0 0
Deaths 0 0 0 0 0 0 0 0 0 0
26.Secondary Outcome
Title 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.
Hide Description Number of subjects reporting New Onset Chronic Disease (NOCD),from the end of the primary parental study V102_03 (NCT01272180) up to Day 1 visit in V102_03E1 study, is reported. (Any NOCD AEs: NOCD V102_03 (NCT01272180) vs. NOCD- Day 1, V102_03E1)
Time Frame From primary parent study completion up to Day 1 in this study.
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Hide Analysis Population Description
Analysis was done on the all enrolled set population. All screened subjects who have been enrolled (ie, attended the first clinic visit and received a subject ID).
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 2B_Pbo 1M_OMV 1M_qOMV 1M_Pbo
Hide Arm/Group Description:
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Overall Number of Participants Analyzed 26 25 17 24 11 21 7 21 19 19
Measure Type: Number
Unit of Measure: Participants
2 4 0 1 0 2 1 2 2 1
Time Frame Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.
Adverse Event Reporting Description Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
 
Arm/Group Title 2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 2B_Pbo 1M_OMV 1M_qOMV 1M_Pbo Total
Hide Arm/Group Description Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study. Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study. Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study. Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study. Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study. Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study. Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study. Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study. Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study. Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study. Total
All-Cause Mortality
2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 2B_Pbo 1M_OMV 1M_qOMV 1M_Pbo Total
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   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 2B_Pbo 1M_OMV 1M_qOMV 1M_Pbo Total
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   0/26 (0.00%)   0/24 (0.00%)   1/17 (5.88%)   1/23 (4.35%)   0/11 (0.00%)   1/21 (4.76%)   0/6 (0.00%)   0/21 (0.00%)   1/19 (5.26%)   1/19 (5.26%)   5/188 (2.66%) 
Infections and infestations                       
Appendicitis * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  1/21 (4.76%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Injury, poisoning and procedural complications                       
Facial bones fracture * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  1/23 (4.35%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Limb injury * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  1/188 (0.53%) 
Nervous system disorders                       
Syncope * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Respiratory, thoracic and mediastinal disorders                       
Asthma * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  1/188 (0.53%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2OMV_OMV 2OMV_Pbo 2qOMV_qOMV 2qOMV_Pbo 2B_OMV 2B_qOMV 2B_Pbo 1M_OMV 1M_qOMV 1M_Pbo Total
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   25/26 (96.15%)   16/24 (66.67%)   16/17 (94.12%)   15/23 (65.22%)   11/11 (100.00%)   19/21 (90.48%)   4/6 (66.67%)   20/21 (95.24%)   17/19 (89.47%)   15/19 (78.95%)   158/188 (84.04%) 
Ear and labyrinth disorders                       
Ear pain * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  1/188 (0.53%) 
Eye disorders                       
Myopia * 1  1/26 (3.85%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  2/188 (1.06%) 
Photophobia * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Gastrointestinal disorders                       
Abdominal pain * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  1/188 (0.53%) 
Diarrhoea * 1  0/26 (0.00%)  2/24 (8.33%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/188 (1.06%) 
Nausea  1  1/26 (3.85%)  2/24 (8.33%)  3/17 (17.65%)  1/23 (4.35%)  3/11 (27.27%)  5/21 (23.81%)  0/6 (0.00%)  4/21 (19.05%)  5/19 (26.32%)  1/19 (5.26%)  25/188 (13.30%) 
Tooth impacted * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
General disorders                       
Chills  1  3/26 (11.54%)  1/24 (4.17%)  0/17 (0.00%)  0/23 (0.00%)  1/11 (9.09%)  2/21 (9.52%)  0/6 (0.00%)  6/21 (28.57%)  1/19 (5.26%)  1/19 (5.26%)  15/188 (7.98%) 
Fatigue  1  9/26 (34.62%)  8/24 (33.33%)  8/17 (47.06%)  2/23 (8.70%)  5/11 (45.45%)  8/21 (38.10%)  0/6 (0.00%)  11/21 (52.38%)  6/19 (31.58%)  5/19 (26.32%)  62/188 (32.98%) 
Induration  1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/188 (1.06%) 
Injection site erythema  1  11/26 (42.31%)  2/24 (8.33%)  7/17 (41.18%)  3/23 (13.04%)  7/11 (63.64%)  7/21 (33.33%)  0/6 (0.00%)  7/21 (33.33%)  9/19 (47.37%)  2/19 (10.53%)  55/188 (29.26%) 
Injection site induration  1  7/26 (26.92%)  2/24 (8.33%)  6/17 (35.29%)  3/23 (13.04%)  10/11 (90.91%)  7/21 (33.33%)  0/6 (0.00%)  11/21 (52.38%)  9/19 (47.37%)  1/19 (5.26%)  56/188 (29.79%) 
Injection site pain  1  21/26 (80.77%)  7/24 (29.17%)  14/17 (82.35%)  7/23 (30.43%)  11/11 (100.00%)  18/21 (85.71%)  1/6 (16.67%)  19/21 (90.48%)  17/19 (89.47%)  6/19 (31.58%)  121/188 (64.36%) 
Injection site pruritus * 1  1/26 (3.85%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  2/188 (1.06%) 
Pyrexia * 1  2/26 (7.69%)  1/24 (4.17%)  0/17 (0.00%)  1/23 (4.35%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  4/188 (2.13%) 
Vaccination site erythema * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Vaccination site pain * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Immune system disorders                       
Hypersensitivity * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  1/188 (0.53%) 
Infections and infestations                       
Acute sinusitis * 1  1/26 (3.85%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  2/188 (1.06%) 
Bronchitis * 1  0/26 (0.00%)  2/24 (8.33%)  2/17 (11.76%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  5/188 (2.66%) 
Conjunctivitis * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  2/21 (9.52%)  0/19 (0.00%)  1/19 (5.26%)  3/188 (1.60%) 
Croup infectious * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  1/188 (0.53%) 
Herpes virus infection * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  1/23 (4.35%)  1/11 (9.09%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/188 (1.06%) 
Influenza * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  2/21 (9.52%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  3/188 (1.60%) 
Laryngitis * 1  1/26 (3.85%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/188 (1.06%) 
Lice infestation * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  2/188 (1.06%) 
Nasopharyngitis * 1  0/26 (0.00%)  2/24 (8.33%)  0/17 (0.00%)  1/23 (4.35%)  1/11 (9.09%)  2/21 (9.52%)  0/6 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  1/19 (5.26%)  8/188 (4.26%) 
Onychomycosis * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  1/188 (0.53%) 
Otitis media * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  1/188 (0.53%) 
Pharyngitis * 1  1/26 (3.85%)  2/24 (8.33%)  2/17 (11.76%)  0/23 (0.00%)  1/11 (9.09%)  1/21 (4.76%)  0/6 (0.00%)  2/21 (9.52%)  0/19 (0.00%)  1/19 (5.26%)  10/188 (5.32%) 
Pharyngitis streptococcal * 1  1/26 (3.85%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  2/21 (9.52%)  0/19 (0.00%)  1/19 (5.26%)  4/188 (2.13%) 
Pneumonia * 1  2/26 (7.69%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  0/19 (0.00%)  3/188 (1.60%) 
Pneumonia mycoplasmal * 1  1/26 (3.85%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/188 (1.06%) 
Respiratory tract infection * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Sinusitis * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  1/23 (4.35%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  0/19 (0.00%)  3/188 (1.60%) 
Tonsillitis * 1  2/26 (7.69%)  0/24 (0.00%)  1/17 (5.88%)  1/23 (4.35%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  4/188 (2.13%) 
Tooth abscess * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  1/19 (5.26%)  2/188 (1.06%) 
Upper respiratory tract infection * 1  0/26 (0.00%)  0/24 (0.00%)  2/17 (11.76%)  1/23 (4.35%)  1/11 (9.09%)  1/21 (4.76%)  0/6 (0.00%)  2/21 (9.52%)  2/19 (10.53%)  1/19 (5.26%)  10/188 (5.32%) 
Viral infection * 1  2/26 (7.69%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/188 (1.06%) 
Viral pharyngitis * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  1/21 (4.76%)  1/19 (5.26%)  1/19 (5.26%)  3/188 (1.60%) 
Injury, poisoning and procedural complications                       
Concussion * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  1/21 (4.76%)  1/19 (5.26%)  0/19 (0.00%)  2/188 (1.06%) 
Head injury * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  1/188 (0.53%) 
Joint dislocation * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  1/188 (0.53%) 
Limb injury * 1  2/26 (7.69%)  1/24 (4.17%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  1/21 (4.76%)  0/6 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  1/19 (5.26%)  6/188 (3.19%) 
Post vaccination syndrome * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Investigations                       
Blood iron decreased * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  1/188 (0.53%) 
Body temperature increased * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  1/6 (16.67%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Metabolism and nutrition disorders                       
Abnormal weight gain * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Decreased appetite * 1  2/26 (7.69%)  1/24 (4.17%)  4/17 (23.53%)  2/23 (8.70%)  1/11 (9.09%)  3/21 (14.29%)  1/6 (16.67%)  8/21 (38.10%)  4/19 (21.05%)  2/19 (10.53%)  28/188 (14.89%) 
Obesity * 1  0/26 (0.00%)  2/24 (8.33%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/188 (1.06%) 
Vitamin D deficiency * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Musculoskeletal and connective tissue disorders                       
Arthralgia * 1  4/26 (15.38%)  2/24 (8.33%)  3/17 (17.65%)  1/23 (4.35%)  0/11 (0.00%)  2/21 (9.52%)  0/6 (0.00%)  4/21 (19.05%)  2/19 (10.53%)  3/19 (15.79%)  21/188 (11.17%) 
Back pain * 1  1/26 (3.85%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  2/188 (1.06%) 
Costochondritis * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  2/19 (10.53%)  2/188 (1.06%) 
Joint effusion * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  1/188 (0.53%) 
Myalgia * 1  6/26 (23.08%)  2/24 (8.33%)  5/17 (29.41%)  0/23 (0.00%)  1/11 (9.09%)  4/21 (19.05%)  0/6 (0.00%)  8/21 (38.10%)  4/19 (21.05%)  1/19 (5.26%)  31/188 (16.49%) 
Myositis * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Scoliosis * 1  0/26 (0.00%)  0/24 (0.00%)  2/17 (11.76%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/188 (1.06%) 
Temporomandibular joint syndrome * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  1/188 (0.53%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
Skin papilloma * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  1/188 (0.53%) 
Nervous system disorders                       
Dizziness postural * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Headache  1  8/26 (30.77%)  6/24 (25.00%)  8/17 (47.06%)  3/23 (13.04%)  5/11 (45.45%)  4/21 (19.05%)  1/6 (16.67%)  14/21 (66.67%)  5/19 (26.32%)  2/19 (10.53%)  56/188 (29.79%) 
Syncope * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Renal and urinary disorders                       
Proteinuria * 1  1/26 (3.85%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  2/188 (1.06%) 
Reproductive system and breast disorders                       
Breast mass * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  1/188 (0.53%) 
Dysmenorrhoea * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  1/21 (4.76%)  1/6 (16.67%)  1/21 (4.76%)  0/19 (0.00%)  0/19 (0.00%)  3/188 (1.60%) 
Respiratory, thoracic and mediastinal disorders                       
Asthma * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  1/6 (16.67%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/188 (1.06%) 
Cough * 1  2/26 (7.69%)  0/24 (0.00%)  1/17 (5.88%)  1/23 (4.35%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  0/19 (0.00%)  5/188 (2.66%) 
Rhinitis allergic * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  1/21 (4.76%)  1/6 (16.67%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/188 (1.06%) 
Skin and subcutaneous tissue disorders                       
Acne * 1  2/26 (7.69%)  1/24 (4.17%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  1/21 (4.76%)  0/19 (0.00%)  1/19 (5.26%)  5/188 (2.66%) 
Dermatitis * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/188 (0.53%) 
Dermatitis contact * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  2/188 (1.06%) 
Erythema * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  1/11 (9.09%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  2/188 (1.06%) 
Rash * 1  0/26 (0.00%)  0/24 (0.00%)  1/17 (5.88%)  0/23 (0.00%)  0/11 (0.00%)  1/21 (4.76%)  0/6 (0.00%)  3/21 (14.29%)  2/19 (10.53%)  0/19 (0.00%)  7/188 (3.72%) 
Urticaria * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  2/11 (18.18%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  2/188 (1.06%) 
Vascular disorders                       
Essential hypertension * 1  0/26 (0.00%)  0/24 (0.00%)  0/17 (0.00%)  0/23 (0.00%)  0/11 (0.00%)  0/21 (0.00%)  0/6 (0.00%)  0/21 (0.00%)  0/19 (0.00%)  1/19 (5.26%)  1/188 (0.53%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
EMail: RegistryContactVaccinesUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01992536    
Other Study ID Numbers: V102_03E1
2012-003937-41 ( EudraCT Number )
First Submitted: November 15, 2013
First Posted: November 25, 2013
Results First Submitted: April 14, 2016
Results First Posted: October 25, 2016
Last Update Posted: October 25, 2016