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Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28

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ClinicalTrials.gov Identifier: NCT01894919
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningoccocal Disease
Meningococcal Meningitis
Interventions Biological: Bexsero® vaccine (1 dose at study month zero)
Biological: Bexsero® vaccine (2 doses 1 month apart)
Enrollment 851
Recruitment Details Subjects were recruited from 9 study sites in Hungary and 8 study sites in Spain.
Pre-assignment Details All enrolled subjects were included in the study.
Arm/Group Title 2H3H511_V 2H3H511_NV 3H5_11_V 3H5_11_NV 68_11_V 68_11_NV 02_2_5_V 02_2_5_NV 02_6_10_V 02_6_10_NV NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence. In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence. In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence. In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence. In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), these subjects received two catchup doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence. Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Period Title: Overall Study
Started 98 47 89 43 81 39 32 36 91 90 100 55 50
Completed 96 47 89 43 78 39 32 36 91 89 98 55 50
Not Completed 2 0 0 0 3 0 0 0 0 1 2 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0             1             0             0             0             0             1             1             0             0
Adverse Event             0             0             0             0             0             0             0             0             0             0             1             0             0
Other-Unspecified             1             0             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             0             0             2             0             0             0             0             0             0             0             0
Arm/Group Title 2H3H511_V 2H3H511_NV 3H5_11_V 3H5_11_NV 68_11_V 68_11_NV 02_2_5_V 02_2_5_NV 02_6_10_V 02_6_10_NV NAIVE 123 NAIVE_4A NAIVE_4B Total
Hide Arm/Group Description In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence. In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence. In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence. In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence. In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), these subjects received two catchup doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence. Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. Total of all reporting groups
Overall Number of Baseline Participants 98 47 89 43 81 39 32 36 91 90 100 55 50 851
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 47 participants 89 participants 43 participants 81 participants 39 participants 32 participants 36 participants 91 participants 90 participants 100 participants 55 participants 50 participants 851 participants
3.1  (0.2) 3  (0.18) 3.1  (0.23) 3.1  (0.22) 3.2  (0.29) 3.2  (0.26) 6.5  (1.15) 6.7  (1.16) 10.4  (1.43) 10.4  (1.44) 3.4  (0.29) 5.8  (1.12) 9.7  (1.38) 5.6  (3.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 47 participants 89 participants 43 participants 81 participants 39 participants 32 participants 36 participants 91 participants 90 participants 100 participants 55 participants 50 participants 851 participants
Female
44
  44.9%
27
  57.4%
48
  53.9%
22
  51.2%
35
  43.2%
23
  59.0%
19
  59.4%
15
  41.7%
44
  48.4%
46
  51.1%
46
  46.0%
26
  47.3%
27
  54.0%
422
  49.6%
Male
54
  55.1%
20
  42.6%
41
  46.1%
21
  48.8%
46
  56.8%
16
  41.0%
13
  40.6%
21
  58.3%
47
  51.6%
44
  48.9%
54
  54.0%
29
  52.7%
23
  46.0%
429
  50.4%
1.Primary Outcome
Title Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains
Hide Description

The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules, is presented in terms of the percentage of subjects in each vaccine group, with hSBA titers ≥ 4 for what concerns the H44/76, 5/99 and NZ98/254 strains, and hSBA titers ≥ 5 for M10713 strain, alongside with the corresponding antibody responses in age-matched vaccine naïve subjects at baseline.

The functional bactericidal antibodies directed against serogroup B meningococcal were assessed by the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).

Time Frame 24 or 36 months after booster dose in the parent study; baseline for vaccine-naïve subjects
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Full Analysis Set (FAS)-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.
Arm/Group Title 2H3H511 3H5_11 68_11 NAIVE 123 02_2_5 NAIVE_4A 02_6_10 NAIVE_4B
Hide Arm/Group Description:
Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01894919).
Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01894919).
Combined group 3D_6-11Y/B + group 3D_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01894919).
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study V72_28 (NCT01894919).
Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01894919).
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study V72_28 (NCT01894919).
Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01894919).
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study V72_28 (NCT01894919).
Overall Number of Participants Analyzed 140 131 119 100 68 55 179 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H44/76 (N=140;131;119;100;67;55;178;50)
51
(42.8 to 60)
53
(43.8 to 61.5)
61
(52 to 70.1)
38
(28.5 to 48.3)
52
(39.7 to 64.6)
27
(16.1 to 41)
58
(50.3 to 65.2)
20
(10 to 33.7)
5/99 (N=140;131;119;100;67;55;179;50)
84
(77.2 to 89.9)
88
(80.9 to 92.9)
93
(87.2 to 97.1)
3
(0.6 to 8.5)
79
(67.4 to 88.1)
4
(0.44 to 12.5)
85
(79.4 to 90.3)
8
(2.2 to 19.2)
NZ98/254 (N=140;131;119;100;67;55;179;50)
45
(36.6 to 53.6)
38
(29.8 to 47.1)
56
(46.9 to 65.4)
2
(0.24 to 7)
29
(19 to 41.7)
7
(2 to 17.6)
50
(42.2 to 57.3)
6
(1.3 to 16.5)
M10713 (N=127;111;109;93;65;53;173;49)
31
(22.8 to 39.5)
36
(27.1 to 45.7)
39
(29.4 to 48.3)
37
(26.8 to 47.2)
34
(22.6 to 46.6)
38
(24.8 to 52.1)
61
(53.0 to 68.0)
55
(40.2 to 69.3)
2.Primary Outcome
Title Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains
Hide Description The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules is presented in terms of the percentage of subjects in each vaccine group with hSBA titers ≥ 8, alongside with the corresponding antibody responses in age matched vaccine naïve subjects at baseline.
Time Frame At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.
Arm/Group Title 2H3H511 3H5_11 68_11 NAIVE 123 02_2_5 NAIVE_4A 02_6_10 NAIVE_4B
Hide Arm/Group Description:
Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01894919).
Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01894919).
Combined group 3D_6-11Y/B + group 3D_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01894919).
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study V72_28 (NCT01894919).
Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01894919).
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study V72_28 (NCT01894919).
Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01894919).
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study V72_28 (NCT01894919).
Overall Number of Participants Analyzed 140 131 119 100 68 55 179 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H44/76 (N=140;131;119;100;67;55;178;50)
28
(20.6 to 36.1)
26
(18.7 to 34.3)
32
(23.7 to 41.1)
18
(11 to 26.9)
24
(14.3 to 35.9)
16
(7.8 to 28.8)
34
(26.8 to 41.2)
10
(3.3 to 21.8)
5/99 (N=140;131;119;100;67;55;179;50)
80
(72.4 to 86.3)
82
(74.8 to 88.5)
89
(82 to 94.1)
2
(0.24 to 7)
73
(60.9 to 83.2)
4
(0.44 to 12.5)
66
(59.1 to 73.3)
6
(1.3 to 16.5)
NZ98/254 (N=140;131;119;100;67;55;179;50)
21
(14.9 to 29.2)
18
(12.1 to 26)
29
(20.7 to 37.6)
0
(0 to 3.6)
15
(7.3 to 25.4)
2
(0.05 to 9.7)
28
(21.5 to 35.1)
0
(0 to 7.1)
M10713 (N=127;111;109;93;65;53;173;49)
24
(16.5 to 32)
22
(14.4 to 30.4)
28
(20.2 to 37.9)
26
(17.3 to 35.9)
31
(19.9 to 43.4)
36
(23.1 to 50.2)
54
(46 to 61.4)
49
(34.4 to 63.7)
3.Primary Outcome
Title The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains
Hide Description The hSBA antibody titers in subjects, 24 to 36 months after completion of Bexsero® vaccination course according to different schedules in the parent study, are presented in terms of vaccine-group-specific GMTs, alongside with the corresponding antibody responses in age-matched vaccine-naïve subjects at baseline.
Time Frame 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1. The number of participants analyzed is the number of subjects assessed for this particular endpoint.
Arm/Group Title 2H3H511 3H5_11 68_11 NAIVE 123 02_2_5 NAIVE_4A 02_6_10 NAIVE_4B
Hide Arm/Group Description:
Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01894919).
Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01894919).
Combined group 3D_6-11Y/B + group 3D_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01894919).
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study V72_28 (NCT01894919).
Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01894919).
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study V72_28 (NCT01894919).
Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01894919).
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study V72_28 (NCT01894919).
Overall Number of Participants Analyzed 140 131 119 100 68 55 179 50
Geometric Mean (97.5% Confidence Interval)
Unit of Measure: Titers
H44/76 (N=140;131;119;100;67;55;178;50)
4.17
(3.4 to 5.13)
4.48
(3.6 to 5.57)
5.62
(4.48 to 7.04)
2.79
(2.25 to 3.45)
3.97
(2.99 to 5.28)
2.33
(1.77 to 3.07)
5.75
(4.78 to 6.91)
1.93
(1.39 to 2.68)
5/99 (N=140;131;119;100;67;55;179;50)
44
(32 to 60)
52
(37 to 72)
83
(58 to 117)
1.15
(1.03 to 1.29)
21
(14 to 33)
1.2
(0.96 to 1.51)
21
(16 to 28)
1.38
(1.1 to 1.73)
NZ98/254 (N=140;131;119;100;67;55;179;50)
3.48
(2.78 to 4.36)
2.98
(2.35 to 3.78)
4.86
(3.8 to 6.22)
1.14
(1.06 to 1.22)
2.81
(2.07 to 3.82)
1.37
(1.17 to 1.61)
4.57
(3.74 to 5.59)
1.22
(1.06 to 1.41)
M10713 (N=127;111;109;93;65;53;173;49)
2.77
(2.06 to 3.71)
3.03
(2.2 to 4.16)
3.17
(2.3 to 4.38)
3.3
(2.52 to 4.32)
3.53
(2.38 to 5.25)
4.26
(2.61 to 6.97)
7.82
(6.04 to 10)
6.95
(4.18 to 12)
4.Primary Outcome
Title The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study.
Hide Description The within-subjects GMR of GMTs at 24 to 36 months versus 1 month after completion of Bexsero® vaccination course according to different schedules vaccination in parent study are reported.
Time Frame At Day 1 in this study over one month after the completion of the vaccination course in the parent study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1. The number of participants analyzed is the number of subjects assessed for this particular endpoint.
Arm/Group Title 2H3H511 3H5_11 68_11 02_2_5 02_6_10
Hide Arm/Group Description:
Combined group 4D_2-11M/B + group 4D_2-11M - Subjects who received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01894919).
Combined group 3D_3-11M/B + group 3D_3-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01894919).
Combined group 3D_6-11Y/B + group 3D_6-11M - Subjects who received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively, in the parent study V72_28 (NCT01894919).
Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01894919).
Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01894919).
Overall Number of Participants Analyzed 137 130 118 68 176
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
H44/76 (N=137;129;118;67;173)
0.029
(0.023 to 0.036)
0.022
(0.017 to 0.028)
0.03
(0.023 to 0.038)
0.028
(0.021 to 0.038)
0.042
(0.035 to 0.052)
5/99 (N=136;130;118;66;176)
0.023
(0.017 to 0.03)
0.031
(0.023 to 0.041)
0.054
(0.04 to 0.073)
0.045
(0.031 to 0.066)
0.049
(0.038 to 0.063)
NZ98/254 (N=136;129;116;68;174)
0.059
(0.047 to 0.074)
0.038
(0.03 to 0.048)
0.07
(0.055 to 0.09)
0.061
(0.044 to 0.083)
0.095
(0.077 to 0.12)
M10713 (N=105;84;78;61;160)
0.19
(0.13 to 0.28)
0.16
(0.11 to 0.25)
0.19
(0.12 to 0.29)
0.17
(0.11 to 0.28)
0.24
(0.17 to 0.32)
5.Primary Outcome
Title The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study.
Hide Description The within-subjects GMR of GMTs at 24 to 36 months versus visit 1 in the vaccination course according to different schedules vaccination in the parent study are reported.
Time Frame At Day 1 in this study over visit 1 in the vaccination course in the parent study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.This outcome measure applies to only groups 02_2_5 & 02_6_10 as the GMRs were calculated at 24-36 months after completion of vaccination course in the parent study over subjects belonging to groups 02_2_5 & 02_6_10.
Arm/Group Title 02_2_5 02_6_10
Hide Arm/Group Description:
Combined group 2D_2-5Y/B + group 2D_2-5Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 2 and 5 years of age, respectively, in the parent study V72_28 (NCT01894919).
Combined group 2D_6-10Y/B + group 2D_6-10Y- Subjects who received two catch-up doses of Bexsero® vaccine two months apart, at 6 and 10 years of age, respectively, in the parent study V72_28 (NCT01894919).
Overall Number of Participants Analyzed 67 177
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
H44/76 (N=67;177)
1.88
(1.32 to 2.69)
2.94
(2.33 to 3.71)
5/99 (N=67;177)
20
(12 to 32)
14
(10 to 20)
NZ98/254 (N=67;177)
2.48
(1.76 to 3.49)
3.06
(2.44 to 3.83)
M10713 (N=56;163)
0.89
(0.49 to 1.61)
0.94
(0.64 to 1.37)
6.Secondary Outcome
Title Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study.
Hide Description The percentage of subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and with hSBA titers ≥ 5 against M10713 strain, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study), alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Time Frame At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS - booster: All subjects in the Enrolled Set who receive a study vaccination and provide an evaluable serum sample at visit 2 (one month after the booster dose administration) and received all scheduled vaccinations in the parent study V72_28 (excluding naïve groups).
Arm/Group Title 2H3H511_V 3H5_11_V 68_11_V 02_2_5_V 02_6_10_V NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description:
In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 96 86 76 32 91 96 55 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H44/76 (pre-vacc.) (N=92;86;75;31;91;96;55;50)
48
(37.3 to 58.5)
51
(40.1 to 62.1)
64
(52.1 to 74.8)
39
(21.8 to 57.8)
59
(48.5 to 69.5)
39
(28.8 to 49)
27
(16.1 to 41)
20
(10 to 33.7)
H44/76 (post-vacc.) (N=96;86;75;32;91;96;55;50)
99
(94.3 to 99.97)
100
(95.8 to 100)
100
(95.2 to 100)
97
(83.8 to 99.92)
99
(94 to 99.97)
95
(88.3 to 98.3)
91
(80 to 97)
80
(66.3 to 90)
5/99 (pre-vacc.) (N=92;87;76;31;91;96;55;50)
84
(74.5 to 90.6)
91
(82.7 to 95.9)
95
(87.1 to 98.5)
74
(55.4 to 88.1)
86
(76.8 to 92.2)
3
(0.6 to 8.9)
4
(0.44 to 12.5)
8
(2.2 to 19.2)
5/99 (post-vacc.) (N=96;87;76;32;91;96;55;50)
99
(94.3 to 99.97)
99
(93.8 to 99.97)
97
(90.8 to 99.68)
100
(89.1 to 100)
100
(96 to 100)
88
(79.2 to 93.4)
93
(82.4 to 98)
80
(66.3 to 90)
NZ98/254 (pre-vacc.) (N=92;86;75;32;91;96;54;50)
45
(34.2 to 55.3)
42
(31.3 to 53)
52
(40.2 to 63.7)
25
(11.5 to 43.4)
47
(36.7 to 58)
2
(0.25 to 7.3)
7
(2.1 to 17.9)
6
(1.3 to 16.5)
NZ98/254 (post-vacc.) (N=96;86;75;32;91;96;54;50)
99
(94.3 to 99.97)
100
(95.8 to 100)
100
(95.2 to 100)
100
(89.1 to 100)
100
(96 to 100)
78
(68.5 to 85.9)
85
(72.9 to 93.4)
70
(55.4 to 82.1)
M10713 (pre-vacc.) (N=78;68;65;29;87;84;49;46)
36
(25.3 to 47.6)
35
(24.1 to 47.8)
45
(32.3 to 57.5)
21
(8 to 39.7)
63
(52.2 to 73.3)
39
(28.8 to 50.5)
41
(27 to 55.8)
59
(43.2 to 73)
M10713 (post-vacc.) (N=88;79;67;30;89;88;51;47)
70
(59.8 to 79.7)
81
(70.6 to 89)
97
(89.6 to 99.64)
97
(77.9 to 99.2)
96
(88.9 to 98.8)
47
(35.9 to 57.5)
59
(44.2 to 72.4)
60
(44.3 to 73.6)
7.Secondary Outcome
Title Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study.
Hide Description The percentage of subjects with hSBA titers ≥ 8, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Time Frame At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.
Arm/Group Title 2H3H511_V 3H5_11_V 68_11_V 02_2_5_V 02_6_10_V NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description:
In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 96 87 76 32 91 96 55 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H44/76 (pre-vacc.) (N=92;86;75;31;91;96;55;50)
26
(17.5 to 36.3)
31
(21.8 to 42.3)
33
(22.9 to 45.2)
19
(7.5 to 37.5)
30
(20.5 to 40.2)
18
(10.7 to 26.8)
16
(7.8 to 28.8)
10
(3.3 to 21.8)
H44/76 (post-vacc.) (N=96;86;75;32;91;96;55;50)
97
(91.1 to 99.4)
98
(91.9 to 99.72)
99
(92.8 to 99.97)
97
(83.8 to 99.92)
97
(90.7 to 99.3)
68
(57.4 to 76.9)
71
(57.1 to 82.4)
60
(45.2 to 73.6)
5/99 (pre-vacc.) (N=92;87;76;31;91;96;55;50)
79
(69.6 to 87.1)
85
(75.8 to 91.8)
91
(81.9 to 96.2)
71
(52 to 85.8)
68
(57.5 to 77.5)
2
(0.25 to 7.3)
4
(0.44 to 12.5)
6
(1.3 to 16.5)
5/99 (post-vacc.) (N=96;87;76;32;91;96;55;50)
99
(94.3 to 99.97)
99
(93.8 to 99.97)
97
(90.8 to 99.68)
100
(89.1 to 100)
100
(96 to 100)
77
(67.4 to 85)
78
(65 to 88.2)
60
(45.2 to 73.6)
NZ98/254 (pre-vacc.) (N=92;86;75;32;91;96;54;50)
22
(13.8 to 31.6)
19
(11 to 28.4)
28
(18.2 to 39.6)
13
(3.5 to 29)
26
(17.7 to 36.7)
0
(0 to 3.8)
2
(0.05 to 9.9)
0
(0 to 7.1)
NZ98/54 (post-vacc.) (N=96;86;75;32;91;96;54;50)
97
(91.1 to 99.4)
98
(91.9 to 99.72)
100
(95.2 to 100)
97
(83.8 to 99.92)
97
(90.7 to 99.3)
34
(25 to 44.8)
54
(39.6 to 67.4)
40
(26.4 to 54.8)
M10713 (pre-vacc.) (N=78;68;65;29;87;84;49;46)
28
(18.6 to 39.5)
22
(12.9 to 33.8)
34
(22.6 to 46.6)
17
(5.8 to 35.8)
55
(44.1 to 65.9)
27
(18.2 to 38.2)
39
(25.2 to 53.8)
52
(36.9 to 67.1)
M10713 (post-vacc.) (N=88;79;67;30;89;88;51;47)
64
(52.7 to 73.6)
71
(59.6 to 80.6)
94
(85.4 to 98.3)
90
(73.5 to 97.9)
92
(84.5 to 96.8)
34
(24.3 to 45)
51
(36.6 to 65.2)
57
(42.2 to 71.7)
8.Secondary Outcome
Title Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study.
Hide Description The percentage of subjects with a four-fold rise in hSBA titers after receiving Bexsero® booster vaccination in this study to pre vaccination (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Time Frame One month after booster vaccination (day 31)/24-36 months (Visit 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.
Arm/Group Title 2H3H511_V 3H5_11_V 68_11_V 02_2_5_V 02_6_10_V NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description:
In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 92 87 76 32 91 96 55 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H44/76 (Day 31/PRE) (N=92;86;75;31;91;96;55;50)
95
(87.8 to 98.2)
95
(88.5 to 98.7)
97
(90.7 to 99.68)
94
(78.6 to 99.2)
97
(90.7 to 99.3)
43
(32.7 to 53.2)
53
(38.8 to 66.3)
46
(31.8 to 60.7)
5/99 (Day 31/PRE) (N=92;87;76;31;91;96;55;50)
98
(92.4 to 99.74)
98
(91.9 to 99.72)
95
(87.1 to 98.5)
100
(88.8 to 100)
98
(92.3 to 99.73)
77
(67.4 to 85)
76
(63 to 86.8)
60
(45.2 to 73.6)
NZ98/254 (Day 31/PRE) (N=92;86;75;32;91;96;54;50)
92
(84.9 to 96.9)
95
(88.5 to 98.7)
93
(85.1 to 97.8)
94
(79.2 to 99.2)
86
(76.8 to 92.2)
34
(25 to 44.8)
54
(39.6 to 67.4)
40
(26.4 to 54.8)
M10713 (Day 31/PRE) (N=78;68;65;29;87;84;49;46)
41
(30 to 52.7)
50
(37.6 to 62.4)
68
(54.9 to 78.8)
72
(52.8 to 87.3)
53
(41.9 to 63.7)
11
(5 to 19.4)
20
(10.2 to 34.3)
13
(4.9 to 26.3)
9.Secondary Outcome
Title The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
Hide Description The hSBA antibody titers in subjects after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the 1st dose of Bexsero® vaccine in age matched vaccine-naïve subjects in terms of GMTs.
Time Frame At Visit 1 and one month post booster vaccination (Day 31)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28(excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.
Arm/Group Title 2H3H511_V 3H5_11_V 68_11_V 02_2_5_V 02_6_10_V NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description:
In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 96 87 76 32 91 96 55 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H44/76 (pre-vacc.) (N=92;86;75;31;91;96;55;50)
3.91
(3.01 to 5.08)
4.84
(3.66 to 6.41)
6.21
(4.65 to 8.31)
3.14
(2.08 to 4.75)
6.15
(4.77 to 7.93)
2.82
(2.26 to 3.5)
2.33
(1.77 to 3.07)
1.93
(1.39 to 2.68)
H44/76 (post-vacc.) (N=96;86;75;32;91;96;55;50)
158
(116 to 215)
205
(147 to 287)
288
(204 to 408)
155
(95 to 252)
258
(190 to 349)
14
(11 to 17)
16
(12 to 23)
13
(8.67 to 20)
5/99 (pre-vacc.) (N=92;87;76;31;91;96;55;50)
39
(26 to 58)
53
(35 to 82)
89
(57 to 139)
19
(9.92 to 35)
22
(15 to 32)
1.15
(1.02 to 1.29)
1.2
(0.96 to 1.51)
1.38
(1.1 to 1.73)
5/99 (post-vacc.) (N=96;87;76;32;91;96;55;50)
2908
(2059 to 4107)
3593
(2474 to 5218)
3677
(2495 to 5419)
3205
(1860 to 5526)
2921
(2079 to 4104)
38
(28 to 54)
27
(18 to 40)
20
(12 to 33)
NZ98/254 (pre-vacc.) (N=92;86;75;32;91;96;54;50)
3.41
(2.57 to 4.54)
3.17
(2.34 to 4.31)
4.86
(3.54 to 6.67)
2.99
(1.92 to 4.65)
4.49
(3.4 to 5.92)
1.14
(1.06 to 1.23)
1.35
(1.15 to 1.59)
1.22
(1.06 to 1.41)
NZ98/254 (post-vacc.) (N=96;86;75;32;91;96;54;50)
92
(70 to 122)
91
(68 to 123)
133
(97 to 181)
71
(46 to 110)
82
(63 to 108)
6.94
(5.6 to 8.59)
13
(8.88 to 19)
8.56
(5.51 to 13)
M10713 (pre-vacc.) (N=78;68;65;29;87;84;49;46)
3.05
(2.08 to 4.46)
3.1
(2.05 to 4.68)
3.58
(2.35 to 5.45)
2.31
(1.29 to 4.13)
7.83
(5.52 to 11)
3.53
(2.64 to 4.71)
4.8
(2.86 to 8.06)
7.7
(4.55 to 13)
M10713 (post-vacc.) (N=88;79;67;30;89;88;51;47)
13
(9.15 to 18)
18
(13 to 26)
40
(27 to 59)
32
(19 to 54)
53
(38 to 73)
4.92
(3.39 to 7.13)
9.44
(5.84 to 15)
12
(6.61 to 21)
10.Secondary Outcome
Title The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
Hide Description The within-subjects GMR of hSBA antibody titers (one month post booster vaccination versus pre vaccination) after Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the within-subject GMR for the 1st dose of rMenB+OMV NZ vaccination of age matched naïve subjects.
Time Frame Day 1 and Day 31
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2 (1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
Arm/Group Title 2H3H511_V 3H5_11_V 68_11_V 02_2_5_V 02_6_10_V NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description:
In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 92 87 76 32 91 96 55 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
H44/76 (Day 31/PRE) (N=92;86;75;31;91;96;55;50)
41
(30 to 55)
43
(31 to 59)
46
(33 to 65)
50
(31 to 80)
42
(31 to 56)
4.81
(3.81 to 6.07)
7.08
(5.07 to 9.88)
6.87
(4.62 to 10)
5/99 (Day 31/PRE) (N=92;87;76;31;91;96;55;50)
75
(54 to 104)
67
(47 to 96)
41
(29 to 60)
160
(95 to 270)
135
(98 to 186)
34
(24 to 46)
22
(15 to 34)
14
(9.11 to 23)
NZ98/254 (Day 31/PRE)(N=92;86;75;32;91;96;54;50)
28
(20 to 38)
29
(21 to 41)
27
(19 to 39)
24
(15 to 40)
18
(13 to 25)
6.07
(4.97 to 7.41)
9.58
(6.8 to 13)
7.01
(4.54 to 11)
M10713 (Day 31/PRE) (N=78;68;65;29;87;84;49;46)
4.07
(2.8 to 5.91)
5.65
(3.77 to 8.47)
11
(7.15 to 16)
13
(7.29 to 23)
6.85
(4.86 to 9.66)
1.38
(1.01 to 1.88)
2.06
(1.36 to 3.12)
1.55
(1.1 to 2.18)
11.Secondary Outcome
Title Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination
Hide Description The percentage of vaccine-naïve subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and ≥ 5 against M10713 strain, one month after receiving two catch up doses of Bexsero® booster vaccination in this study.
Time Frame At Baseline and One month post second vaccination (Day 61)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).
Arm/Group Title NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description:
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 98 54 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H44/76 (baseline) (N=98;54;49)
38
(28.2 to 48.1)
26
(15 to 39.7)
20
(10.2 to 34.3)
H44/76 (Day 61) (N=98;54;49)
100
(96.3 to 100)
98
(90.1 to 99.95)
100
(92.7 to 100)
5/99 (baseline) (N=98;54;49)
3
(0.6 to 8.7)
4
(0.45 to 12.7)
6
(1.3 to 16.9)
5/99 (Day 61) (N=98;54;49)
100
(96.3 to 100)
100
(93.4 to 100)
100
(92.7 to 100)
NZ98/254 (baseline) (N=98;54;48)
2
(0.25 to 7.2)
7
(2.1 to 17.9)
6
(1.3 to 17.2)
NZ98/254 (Day 61) (N=98;54;48)
100
(96.3 to 100)
100
(93.4 to 100)
100
(92.6 to 100)
M10713 (baseline) (N=87;50;49)
34
(24.6 to 45.4)
40
(26.4 to 54.8)
55
(40.2 to 69.3)
M10713 (Day 61) (N=91;52;49)
75
(64.5 to 83.3)
69
(54.9 to 81.3)
76
(61.1 to 86.7)
12.Secondary Outcome
Title Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination.
Hide Description The percentage of vaccine-naïve subjects with hSBA titers ≥8, one month after receiving two catch up doses of Bexsero® booster vaccination in this study are reported.
Time Frame At Baseline and One month post second vaccination (Day 61)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).
Arm/Group Title NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description:
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 98 54 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H44/76 (baseline) (N=98;54;49)
17
(10.4 to 26.3)
15
(6.6 to 27.1)
10
(3.4 to 22.2)
H44/76 (Day 61) (N=98;54;49)
99
(94.4 to 99.97)
96
(87.3 to 99.55)
98
(89.1 to 99.95)
5/99 (baseline) (N=98;54;49)
2
(0.25 to 7.2)
4
(0.45 to 12.7)
4
(0.5 to 14)
5/99 (Day 61) (N=98;54;49)
100
(96.3 to 100)
100
(93.4 to 100)
98
(89.1 to 99.95)
NZ98/254 (baseline) (N=98;54;48)
0
(0 to 3.7)
2
(0.05 to 9.9)
0
(0 to 7.4)
NZ98/254 (Day 61) (N=98;54;48)
96
(89.9 to 98.9)
93
(82.1 to 97.9)
94
(82.8 to 98.7)
M10713 (baseline) (N=87;50;49)
25
(16.6 to 35.7)
38
(24.7 to 52.8)
49
(34.4 to 63.7)
M10713 (Day 61) (N=91;52;49)
65
(54.1 to 74.6)
63
(49 to 76.4)
69
(54.6 to 81.7)
13.Secondary Outcome
Title Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination.
Hide Description The percentage of vaccine-naïve subjects with a four-fold rise in hSBA titers from baseline, one month after receiving two catch up doses of Bexsero® booster vaccination in comparison to prevaccination in this study are reported.
Time Frame One month post second vaccination (Day 61)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).
Arm/Group Title NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description:
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 98 54 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H44/76 (N=98;54;49)
94
(87.1 to 97.7)
89
(77.4 to 95.8)
94
(83.1 to 98.7)
5/99 (N=98;54;49)
100
(96.3 to 100)
100
(93.4 to 100)
98
(89.1 to 99.95)
NZ98/254 (N=98;54;48)
94
(87.1 to 97.7)
91
(79.7 to 96.9)
94
(82.8 to 98.7)
M10713 (N=87;50;49)
37
(26.7 to 47.8)
28
(16.2 to 42.5)
22
(11.8 to 36.6)
14.Secondary Outcome
Title The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination.
Hide Description The hSBA antibody titers in vaccine-naïve subjects , after receiving two catch up doses of Bexsero® vaccination in this study, are reported in terms of GMTs.
Time Frame At Baseline and One month post second vaccination (Day 61)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).
Arm/Group Title NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description:
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 98 54 49
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H44/76 (baseline) (N=98;54;49)
2.3
(1.75 to 3.01)
2.15
(1.55 to 3)
1.56
(1.11 to 2.2)
H44/76 (Day 61) (N=98;54;49)
107
(84 to 135)
74
(56 to 99)
63
(47 to 85)
5/99 (baseline) (N=98;54;49)
1.13
(0.94 to 1.36)
1.13
(0.9 to 1.41)
1.31
(1.04 to 1.65)
5/99 (Day 61) (N=98;54;49)
631
(503 to 792)
421
(319 to 555)
317
(238 to 423)
NZ98/254 (baseline) (N=98;54;48)
1.11
(0.98 to 1.26)
1.34
(1.15 to 1.56)
1.2
(1.02 to 1.4)
NZ98/254 (Day 61) (N=98;54;48)
34
(27 to 42)
37
(28 to 49)
34
(26 to 46)
M10713 (baseline) (N=87;50;49)
2.9
(1.94 to 4.34)
4.12
(2.54 to 6.69)
6.4
(3.91 to 10)
M10713 (Day 61) (N=91;52;49)
12
(7.57 to 18)
11
(6.87 to 19)
14
(8.34 to 24)
15.Secondary Outcome
Title The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline.
Hide Description The within-subject GMRs of hSBA titers at one month after receiving the second catch up dose to hSBA titers at baseline, for naïve subjects who received two catch up doses of Bexsero® vaccination in this study are reported.
Time Frame At Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).
Arm/Group Title NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description:
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 98 54 49
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
H44/76 (N=98;54;49)
46
(34 to 63)
34
(24 to 50)
41
(27 to 60)
5/99 (N=98;54;49)
558
(423 to 737)
373
(266 to 524)
242
(171 to 344)
NZ98/254 (N=98;54;48)
30
(24 to 39)
27
(20 to 37)
29
(21 to 39)
M10713 (N=87;50;49)
3.86
(2.62 to 5.69)
2.93
(1.84 to 4.67)
2.2
(1.37 to 3.53)
16.Secondary Outcome
Title Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine.
Hide Description The number of subjects (35 months to 7 years of age) with solicited local and systemic adverse events after receivingBexsero® booster vaccine in the present study.
Time Frame From day 1 (6 hr) through day 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data
Arm/Group Title 2H3H511_V 3H5_11_V 68_11_V 02_2_5_V
Hide Arm/Group Description:
In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Overall Number of Participants Analyzed 97 89 80 32
Measure Type: Number
Unit of Measure: Subjects
Any local AEs 87 81 73 31
Erythema 60 63 42 22
Induration 48 48 33 15
Swelling 49 50 37 20
Tenderness 84 80 71 31
Any systemic AEs 66 63 54 18
Change in eating habits 31 32 30 5
Diarrhea 4 8 5 0
Irritability 54 52 46 9
Persistent Crying 31 24 25 4
Rash 13 1 3 5
Sleepiness 28 23 26 5
Vomiting 5 5 2 1
Fever (>38.0° C) 17 18 11 2
Medically-Attended Fever 1 0 2 0
Prevention of Pain and/or Fever 23 14 15 1
Treatment of Pain and/or Fever 38 39 41 13
17.Secondary Outcome
Title Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine.
Hide Description The number of newly recruited subjects (aged 35 months to 7 years) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.
Time Frame The number of newly recruited subjects (aged 35 months to 7 years) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.
Arm/Group Title NAIVE 123 NAIVE_4A
Hide Arm/Group Description:
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 100 55
Measure Type: Number
Unit of Measure: Subjects
Any local AEs (1st vacc.) (N=100;55) 88 55
Erythema (1st vacc.) (N=100;55) 54 28
Induration (1st vacc.) (N=100;55) 38 17
Swelling (1st vacc.) (N=100;55) 40 24
Tenderness (1st vacc.) (N=100;55) 87 55
Any systemic AEs (1st vacc.) (N=100;55) 64 24
Change in Eating Habits (1st vacc.) (N=100;55) 31 5
Diarrhea (1st vacc.) (N=100;55) 4 3
Irritability (1st vacc.) (N=100;55) 40 16
Persistent Crying (1st vacc.) (N=100;55) 15 4
Rash (1st vacc.) (N=100;55) 5 3
Sleepiness (1st vacc.) (N=100;55) 18 9
Vomiting (1st vacc.) (N=100;55) 7 2
Fever (>38.0° C) (1st vacc.) (N=100;55) 15 2
Medically-Attended Fever (1st vacc.) (N=100;55) 1 0
Prevention of Pain/Fever (1st vacc.) (N=100;55) 18 3
Treatment of Pain/Fever (1st vacc.) (N=99;55) 41 22
Any local AEs (2nd vacc.) (N=99;55) 79 51
Erythema (2nd vacc.) (N=99;55) 44 32
Induration (2nd vacc.) (N=99;55) 29 22
Swelling (2nd vacc.) (N=99;55) 32 25
Tenderness (2nd vacc.) (N=99;55) 77 51
Any systemic AEs (2nd vacc.) (N=99;55) 46 18
Change in Eating Habits (2nd vacc.) (N=99;55) 15 9
Diarrhea (2nd vacc.) (N=99;55) 2 3
Irritability (2nd vacc.) (N=99;55) 25 11
Persistent Crying (2nd vacc.) (N=99;55) 13 6
Rash (2nd vacc.) (N=99;55) 2 1
Sleepiness (2nd vacc.) (N=99;55) 12 5
Vomiting (2nd vacc.) (N=99;55) 4 2
Fever (>38.0° C) (2nd vacc.) (N=99;55) 12 3
Medically-Attended Fever (2nd vacc.) (N=99;55) 0 1
Prevention of Pain/Fever (2nd vacc.) (N=99;55) 21 4
Treatment of Pain/Fever (2nd vacc.) (N=99;55) 30 13
18.Secondary Outcome
Title Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine.
Hide Description Number of subjects (8 to 12 years of age) reporting solicited local and systemic adverse events after receiving Bexsero® booster vaccine.
Time Frame From day 1 (6 hr) through day 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.
Arm/Group Title 02_6_10_V
Hide Arm/Group Description:
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: Subjects
Any local AEs (N=91) 85
Erythema (N=91) 57
Induration (N=91) 44
Swelling (N=91) 52
Pain (N=90) 84
Any systemic AEs (N=91) 57
Arthralgia (N=90) 18
Chills (N=90) 23
Headache (N=90) 27
Malaise (N=90) 35
Myalgia (N=90) 24
Nausea (N=90) 12
Rash (N=90) 10
Fever (>38.0° C) (N=91) 10
Medically-Attended Fever (N=91) 0
Prevention of Pain and/or Fever (N=90) 12
Treatment of Pain and/or Fever (N=91) 47
19.Secondary Outcome
Title Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine.
Hide Description The number newly recruited naïve subjects (aged 8 to12 years of age) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.
Time Frame From day 1(6 hr) through day 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.
Arm/Group Title NAIVE_4B
Hide Arm/Group Description:
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: Subjects
Any local AEs (1st vacc.) (N=50) 49
Erythema (1st vacc.) (N=50) 31
Induration (1st vacc.) (N=50) 19
Swelling (1st vacc.) (N=50) 29
Pain (1st vacc.) (N=49) 47
Any systemic AEs (1st vacc.) (N=50) 24
Arthralgia (1st vacc.) (N=49) 6
Chills (1st vacc.) (N=49) 4
Headache (1st vacc.) (N=49) 15
Malaise (1st vacc.) (N=49) 7
Myalgia (1st vacc.) (N=49) 12
Nausea (1st vacc.) (N=49) 5
Rash (1st vacc.) (N=50) 1
Fever (>38.0° C) (1st vacc.) (N=50) 3
Medically-Attended Fever (1st vacc.) (N=50) 0
Prevention of Pain and/or Fever (1st vacc.) (N=50) 2
Treatment of Pain and/or Fever (1st vacc.) (N=50) 21
Any local AEs (2nd vacc.) (N=50) 43
Erythema (2nd vacc.) (N=50) 21
Induration (2nd vacc.) (N=50) 17
Swelling (2nd vacc.) (N=50) 21
Pain (2nd vacc.) (N=50) 41
Any systemic AEs (2nd vacc.) (N=50) 25
Arthralgia (2nd vacc.) (N=50) 3
Chills (2nd vacc.) (N=50) 5
Headache (2nd vacc.) (N=50) 10
Malaise (2nd vacc.) (N=50) 13
Myalgia (2nd vacc.) (N=50) 8
Nausea (2nd vacc.) (N=50) 4
Rash (2nd vacc.) (N=50) 3
Fever (>38.0° C) (2nd vacc.) (N=50) 1
Medically-Attended Fever (2nd vacc.) (N=50) 0
Prevention of Pain and/or Fever (2nd vacc.) (N=50) 3
Treatment of Pain and/or Fever (2nd vacc.) (N=50) 12
20.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination.
Hide Description The number of subjects reporting unsolicited adverse events after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in parent study) or two cach up schedule of Bexsero® vaccine is reported.
Time Frame From day 1 through day 7 after any vaccination and throughout entire study period for all other AEs.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on unsolicited safety set: All subjects in the Exposed Set with unsolicited adverse event data.
Arm/Group Title 2H3H511_V 3H5_11_V 68_11_V 02_2_5_V 02_6_10_V NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description:
In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 96 89 78 32 91 100 55 50
Measure Type: Number
Unit of Measure: Subjects
Any AEs 26 19 26 9 14 43 25 12
Possibly or Probably Related AEs 9 7 10 6 11 12 10 6
AEs leading to Premature Withdrawal 0 0 0 0 0 1 0 0
21.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period.
Hide Description The number of subjects reporting unsolicited SAEs, medically attended AEs and AEs leading to withdrawal after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in the parent study) or two catch-up schedule of Bexsero® vaccine is reported.
Time Frame Throughout the entire study period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on unsolicited safety set: All subjects in the Exposed Set with unsolicited adverse event data.
Arm/Group Title 2H3H511_V 3H5_11_V 68_11_V 02_2_5_V 02_6_10_V NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description:
In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
Overall Number of Participants Analyzed 96 89 78 32 91 100 55 50
Measure Type: Number
Unit of Measure: Subjects
Any SAEs 0 0 0 0 0 0 0 0
Possibly or probably related SAEs 0 0 0 0 0 0 0 0
Time Frame Solicited and unsolicited AEs were collected from Day 1 (30 minutes ) throughout Day 7; SAEs, medically-attended AEs and AEs leading to premature withdrawal were collected throughout the entire study period.
Adverse Event Reporting Description Subjects in the 2H3H511_NV Group, 3H5_11_NV Group, 68_11_NV Group, 02_2_5_NV Group and 02_6_10_NV Group were only evaluated for antibody persistence and hence not included in the safety analysis.
 
Arm/Group Title 2H3H511_V 3H5_11_V 68_11_V 02_2_5_V 02_6_10_V NAIVE 123 NAIVE_4A NAIVE_4B
Hide Arm/Group Description In the parent study V72_28 (NCT01894919), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study. In the parent study V72_28 (NCT01894919), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study. Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study.
All-Cause Mortality
2H3H511_V 3H5_11_V 68_11_V 02_2_5_V 02_6_10_V NAIVE 123 NAIVE_4A NAIVE_4B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
2H3H511_V 3H5_11_V 68_11_V 02_2_5_V 02_6_10_V NAIVE 123 NAIVE_4A NAIVE_4B
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   0/97 (0.00%)   0/89 (0.00%)   0/80 (0.00%)   0/32 (0.00%)   0/91 (0.00%)   0/100 (0.00%)   0/55 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2H3H511_V 3H5_11_V 68_11_V 02_2_5_V 02_6_10_V NAIVE 123 NAIVE_4A NAIVE_4B
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   91/97 (93.81%)   84/89 (94.38%)   75/80 (93.75%)   31/32 (96.88%)   86/91 (94.51%)   97/100 (97.00%)   55/55 (100.00%)   50/50 (100.00%) 
Gastrointestinal disorders                 
Diarrhoea  1  4/96 (4.17%)  8/89 (8.99%)  5/78 (6.41%)  0/32 (0.00%)  0/91 (0.00%)  7/100 (7.00%)  6/55 (10.91%)  0/50 (0.00%) 
Nausea  1  0/96 (0.00%)  0/89 (0.00%)  0/78 (0.00%)  0/32 (0.00%)  12/91 (13.19%)  0/100 (0.00%)  0/55 (0.00%)  8/50 (16.00%) 
Vomiting  1  5/96 (5.21%)  6/89 (6.74%)  2/78 (2.56%)  1/32 (3.13%)  0/91 (0.00%)  10/100 (10.00%)  5/55 (9.09%)  0/50 (0.00%) 
General disorders                 
Chills  1  0/96 (0.00%)  0/89 (0.00%)  0/78 (0.00%)  0/32 (0.00%)  23/91 (25.27%)  0/100 (0.00%)  0/55 (0.00%)  7/50 (14.00%) 
Crying  1  31/96 (32.29%)  24/89 (26.97%)  25/78 (32.05%)  4/32 (12.50%)  0/91 (0.00%)  23/100 (23.00%)  8/55 (14.55%)  0/50 (0.00%) 
Injection site erythema  1  61/96 (63.54%)  63/89 (70.79%)  42/78 (53.85%)  22/32 (68.75%)  57/91 (62.64%)  65/100 (65.00%)  38/55 (69.09%)  37/50 (74.00%) 
Injection site induration  1  48/96 (50.00%)  48/89 (53.93%)  33/78 (42.31%)  15/32 (46.88%)  44/91 (48.35%)  48/100 (48.00%)  28/55 (50.91%)  25/50 (50.00%) 
Injection site pain  1  84/96 (87.50%)  80/89 (89.89%)  71/78 (91.03%)  31/32 (96.88%)  84/91 (92.31%)  94/100 (94.00%)  55/55 (100.00%)  48/50 (96.00%) 
Injection site swelling  1  49/96 (51.04%)  50/89 (56.18%)  37/78 (47.44%)  20/32 (62.50%)  52/91 (57.14%)  51/100 (51.00%)  36/55 (65.45%)  34/50 (68.00%) 
Malaise  1  0/96 (0.00%)  0/89 (0.00%)  0/78 (0.00%)  0/32 (0.00%)  35/91 (38.46%)  0/100 (0.00%)  0/55 (0.00%)  16/50 (32.00%) 
Pyrexia  1  17/96 (17.71%)  18/89 (20.22%)  12/78 (15.38%)  2/32 (6.25%)  10/91 (10.99%)  25/100 (25.00%)  5/55 (9.09%)  4/50 (8.00%) 
Infections and infestations                 
Pharyngitis  1  3/96 (3.13%)  2/89 (2.25%)  1/78 (1.28%)  0/32 (0.00%)  0/91 (0.00%)  2/100 (2.00%)  0/55 (0.00%)  15/50 (30.00%) 
Tonsillitis  1  1/96 (1.04%)  1/89 (1.12%)  2/78 (2.56%)  0/32 (0.00%)  0/91 (0.00%)  6/100 (6.00%)  4/55 (7.27%)  1/50 (2.00%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia  1  0/96 (0.00%)  0/89 (0.00%)  0/78 (0.00%)  0/32 (0.00%)  18/91 (19.78%)  0/100 (0.00%)  0/55 (0.00%)  8/50 (16.00%) 
Myalgia  1  0/96 (0.00%)  0/89 (0.00%)  0/78 (0.00%)  0/32 (0.00%)  24/91 (26.37%)  0/100 (0.00%)  0/55 (0.00%)  15/50 (30.00%) 
Nervous system disorders                 
Headache  1  0/96 (0.00%)  0/89 (0.00%)  0/78 (0.00%)  0/32 (0.00%)  27/91 (29.67%)  0/100 (0.00%)  1/55 (1.82%)  20/50 (40.00%) 
Somnolence  1  28/96 (29.17%)  23/89 (25.84%)  26/78 (33.33%)  5/32 (15.63%)  0/91 (0.00%)  23/100 (23.00%)  10/55 (18.18%)  0/50 (0.00%) 
Psychiatric disorders                 
Eating disorder  1  31/96 (32.29%)  32/89 (35.96%)  30/78 (38.46%)  5/32 (15.63%)  0/91 (0.00%)  36/100 (36.00%)  13/55 (23.64%)  0/50 (0.00%) 
Irritability  1  54/96 (56.25%)  52/89 (58.43%)  46/78 (58.97%)  9/32 (28.13%)  0/91 (0.00%)  48/100 (48.00%)  19/55 (34.55%)  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders                 
Cough  1  1/96 (1.04%)  0/89 (0.00%)  1/78 (1.28%)  2/32 (6.25%)  0/91 (0.00%)  2/100 (2.00%)  0/55 (0.00%)  0/50 (0.00%) 
Skin and subcutaneous tissue disorders                 
Rash  1  13/96 (13.54%)  1/89 (1.12%)  3/78 (3.85%)  5/32 (15.63%)  10/91 (10.99%)  8/100 (8.00%)  4/55 (7.27%)  4/50 (8.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines
EMail: RegistryContactVaccinesUS@novartis.com
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Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01894919     History of Changes
Other Study ID Numbers: V72_28E1
2012-000657-30 ( EudraCT Number )
First Submitted: June 26, 2013
First Posted: July 10, 2013
Results First Submitted: November 15, 2016
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018