Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules (NCT NCT00661713)
NCT ID: NCT00661713
Last Updated: 2019-03-20
Results Overview
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1631 participants
Primary outcome timeframe
Month-1, 2, 3
Results posted on
2019-03-20
Participant Flow
Subjects were enrolled at 10 study centers in Chile.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
128
|
247
|
128
|
247
|
127
|
253
|
373
|
128
|
|
Overall Study
COMPLETED
|
112
|
208
|
111
|
219
|
107
|
216
|
309
|
117
|
|
Overall Study
NOT COMPLETED
|
16
|
39
|
17
|
28
|
20
|
37
|
64
|
11
|
Reasons for withdrawal
| Measure |
rMenB06
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Unable to Classify
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
6
|
3
|
3
|
0
|
2
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
11
|
25
|
12
|
21
|
12
|
26
|
45
|
9
|
|
Overall Study
Lost to Follow-up
|
2
|
7
|
2
|
2
|
5
|
7
|
14
|
1
|
|
Overall Study
Administrative Reason
|
0
|
1
|
0
|
2
|
2
|
2
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Inappropriate Enrollment
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules
Baseline characteristics by cohort
| Measure |
rMenB06
n=128 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=247 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=128 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=247 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=127 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=253 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=373 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=128 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
Total
n=1631 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
13.8 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
13.8 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
13.9 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
13.9 years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
13.7 years
STANDARD_DEVIATION 1.9 • n=21 Participants
|
13.7 years
STANDARD_DEVIATION 1.8 • n=8 Participants
|
13.8 years
STANDARD_DEVIATION 1.9 • n=8 Participants
|
13.8 years
STANDARD_DEVIATION 2 • n=24 Participants
|
13.8 years
STANDARD_DEVIATION 1.9 • n=42 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
138 Participants
n=8 Participants
|
199 Participants
n=8 Participants
|
66 Participants
n=24 Participants
|
913 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
115 Participants
n=8 Participants
|
174 Participants
n=8 Participants
|
62 Participants
n=24 Participants
|
718 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Month-1, 2, 3Population: Analysis was performed as per the protocol dataset
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.
Outcome measures
| Measure |
rMenB06
n=112 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=223 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=113 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=231 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=110 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=232 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=334 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=116 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
44/76-SL- Mo 0
|
42 percentage of Subjects
Interval 33.0 to 52.0
|
47 percentage of Subjects
Interval 40.0 to 54.0
|
41 percentage of Subjects
Interval 32.0 to 50.0
|
38 percentage of Subjects
Interval 32.0 to 45.0
|
37 percentage of Subjects
Interval 28.0 to 47.0
|
47 percentage of Subjects
Interval 40.0 to 53.0
|
46 percentage of Subjects
Interval 41.0 to 52.0
|
46 percentage of Subjects
Interval 36.0 to 55.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
44/76-SL- Mo 1
|
92 percentage of Subjects
Interval 85.0 to 96.0
|
92 percentage of Subjects
Interval 88.0 to 95.0
|
95 percentage of Subjects
Interval 89.0 to 98.0
|
93 percentage of Subjects
Interval 88.0 to 96.0
|
90 percentage of Subjects
Interval 83.0 to 95.0
|
92 percentage of Subjects
Interval 88.0 to 95.0
|
95 percentage of Subjects
Interval 92.0 to 97.0
|
43 percentage of Subjects
Interval 34.0 to 53.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
44/76-SL- Mo 2
|
88 percentage of Subjects
Interval 80.0 to 93.0
|
92 percentage of Subjects
Interval 88.0 to 95.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
88 percentage of Subjects
Interval 80.0 to 93.0
|
89 percentage of Subjects
Interval 85.0 to 93.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
50 percentage of Subjects
Interval 40.0 to 59.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
44/76-SL- Mo 3
|
84 percentage of Subjects
Interval 76.0 to 90.0
|
88 percentage of Subjects
Interval 82.0 to 92.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
48 percentage of Subjects
Interval 38.0 to 58.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
5/99- Mo 0
|
29 percentage of Subjects
Interval 20.0 to 38.0
|
41 percentage of Subjects
Interval 35.0 to 48.0
|
28 percentage of Subjects
Interval 20.0 to 38.0
|
31 percentage of Subjects
Interval 25.0 to 38.0
|
30 percentage of Subjects
Interval 22.0 to 39.0
|
37 percentage of Subjects
Interval 31.0 to 44.0
|
36 percentage of Subjects
Interval 30.0 to 41.0
|
29 percentage of Subjects
Interval 21.0 to 38.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
5/99- Mo 1
|
97 percentage of Subjects
Interval 92.0 to 99.0
|
96 percentage of Subjects
Interval 93.0 to 98.0
|
96 percentage of Subjects
Interval 90.0 to 99.0
|
97 percentage of Subjects
Interval 94.0 to 99.0
|
97 percentage of Subjects
Interval 92.0 to 99.0
|
95 percentage of Subjects
Interval 92.0 to 98.0
|
97 percentage of Subjects
Interval 94.0 to 98.0
|
35 percentage of Subjects
Interval 26.0 to 44.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
5/99- Mo 2
|
95 percentage of Subjects
Interval 90.0 to 98.0
|
94 percentage of Subjects
Interval 90.0 to 97.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
97 percentage of Subjects
Interval 92.0 to 99.0
|
96 percentage of Subjects
Interval 93.0 to 98.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
31 percentage of Subjects
Interval 23.0 to 41.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
5/99- Mo 3
|
92 percentage of Subjects
Interval 85.0 to 96.0
|
89 percentage of Subjects
Interval 84.0 to 93.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
98 percentage of Subjects
Interval 93.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
100 percentage of Subjects
Interval 99.0 to 100.0
|
32 percentage of Subjects
Interval 24.0 to 42.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
NZ98/254-mo 0
|
32 percentage of Subjects
Interval 24.0 to 42.0
|
39 percentage of Subjects
Interval 33.0 to 46.0
|
33 percentage of Subjects
Interval 24.0 to 42.0
|
35 percentage of Subjects
Interval 29.0 to 41.0
|
34 percentage of Subjects
Interval 25.0 to 43.0
|
37 percentage of Subjects
Interval 31.0 to 44.0
|
33 percentage of Subjects
Interval 28.0 to 38.0
|
38 percentage of Subjects
Interval 29.0 to 47.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
NZ98/254-mo 1
|
90 percentage of Subjects
Interval 83.0 to 95.0
|
94 percentage of Subjects
Interval 90.0 to 97.0
|
95 percentage of Subjects
Interval 89.0 to 98.0
|
94 percentage of Subjects
Interval 90.0 to 96.0
|
90 percentage of Subjects
Interval 83.0 to 95.0
|
93 percentage of Subjects
Interval 89.0 to 96.0
|
95 percentage of Subjects
Interval 92.0 to 97.0
|
38 percentage of Subjects
Interval 29.0 to 48.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
NZ98/254-mo 2
|
81 percentage of Subjects
Interval 73.0 to 88.0
|
84 percentage of Subjects
Interval 74.0 to 88.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
78 percentage of Subjects
Interval 69.0 to 86.0
|
85 percentage of Subjects
Interval 79.0 to 89.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
39 percentage of Subjects
Interval 29.0 to 48.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.
NZ98/254-mo 3
|
80 percentage of Subjects
Interval 72.0 to 87.0
|
76 percentage of Subjects
Interval 70.0 to 82.0
|
97 percentage of Subjects
Interval 92.0 to 99.0
|
97 percentage of Subjects
Interval 94.0 to 99.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
99 percentage of Subjects
Interval 97.0 to 100.0
|
43 percentage of Subjects
Interval 33.0 to 52.0
|
PRIMARY outcome
Timeframe: 1 to 7 days after each vaccinationPopulation: Analysis was performed as per the safety dataset.
Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV
Outcome measures
| Measure |
rMenB06
n=128 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=247 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=128 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=247 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=127 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=253 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=373 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=128 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
erythema (local)
|
93 participants
|
162 participants
|
95 participants
|
188 participants
|
94 participants
|
172 participants
|
282 participants
|
85 participants
|
|
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Induration (Local)
|
71 participants
|
130 participants
|
75 participants
|
151 participants
|
82 participants
|
121 participants
|
228 participants
|
57 participants
|
|
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Swelling (Local)
|
72 participants
|
132 participants
|
81 participants
|
144 participants
|
76 participants
|
115 participants
|
226 participants
|
54 participants
|
|
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Pain (Local)
|
122 participants
|
236 participants
|
124 participants
|
237 participants
|
113 participants
|
236 participants
|
345 participants
|
123 participants
|
|
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Med.Att Fever (Systemic)
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Malaise (Systemic)
|
92 participants
|
181 participants
|
96 participants
|
172 participants
|
87 participants
|
185 participants
|
272 participants
|
89 participants
|
|
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Myalgia(Systemic)
|
85 participants
|
141 participants
|
91 participants
|
156 participants
|
81 participants
|
160 participants
|
238 participants
|
91 participants
|
|
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Arthralgia(Systemic)
|
55 participants
|
76 participants
|
55 participants
|
80 participants
|
39 participants
|
105 participants
|
146 participants
|
43 participants
|
|
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Headache(Systemic)
|
79 participants
|
139 participants
|
88 participants
|
160 participants
|
73 participants
|
165 participants
|
244 participants
|
74 participants
|
|
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Nausea(Systemic)
|
41 participants
|
80 participants
|
51 participants
|
72 participants
|
42 participants
|
88 participants
|
143 participants
|
49 participants
|
|
Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination
Fever(Systemic)
|
12 participants
|
8 participants
|
11 participants
|
21 participants
|
18 participants
|
26 participants
|
38 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Month-6 & 7Population: Analysis was performed as per the protocol dataset.
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 \& 7.
Outcome measures
| Measure |
rMenB06
n=100 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=188 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=100 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=198 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=99 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=201 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=278 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=100 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.
44/76-SL- Mo 6
|
76 percentage of Subjects
Interval 66.0 to 84.0
|
72 percentage of Subjects
Interval 65.0 to 79.0
|
93 percentage of Subjects
Interval 86.0 to 97.0
|
92 percentage of Subjects
Interval 88.0 to 96.0
|
97 percentage of Subjects
Interval 91.0 to 99.0
|
98 percentage of Subjects
Interval 94.0 to 99.0
|
97 percentage of Subjects
Interval 94.0 to 99.0
|
46 percentage of Subjects
Interval 36.0 to 56.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.
44/76-SL- Mo 7
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
71 percentage of Subjects
Interval 64.0 to 78.0
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
90 percentage of Subjects
Interval 85.0 to 94.0
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
95 percentage of Subjects
Interval 91.0 to 98.0
|
95 percentage of Subjects
Interval 92.0 to 98.0
|
93 percentage of Subjects
Interval 85.0 to 97.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.
5/99- Mo 6
|
79 percentage of Subjects
Interval 70.0 to 87.0
|
74 percentage of Subjects
Interval 67.0 to 80.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
98 percentage of Subjects
Interval 96.0 to 100.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
28 percentage of Subjects
Interval 19.0 to 38.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.
5/99- Mo 7
|
99 percentage of Subjects
Interval 94.0 to 100.0
|
67 percentage of Subjects
Interval 60.0 to 74.0
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
98 percentage of Subjects
Interval 95.0 to 99.0
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
99 percentage of Subjects
Interval 96.0 to 100.0
|
99 percentage of Subjects
Interval 97.0 to 100.0
|
93 percentage of Subjects
Interval 85.0 to 97.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.
NZ98/254-mo 6
|
81 percentage of Subjects
Interval 72.0 to 88.0
|
69 percentage of Subjects
Interval 62.0 to 76.0
|
93 percentage of Subjects
Interval 86.0 to 97.0
|
89 percentage of Subjects
Interval 84.0 to 93.0
|
97 percentage of Subjects
Interval 91.0 to 99.0
|
96 percentage of Subjects
Interval 92.0 to 98.0
|
97 percentage of Subjects
Interval 94.0 to 99.0
|
45 percentage of Subjects
Interval 35.0 to 55.0
|
|
Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.
NZ98/254-mo 7
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
67 percentage of Subjects
Interval 60.0 to 74.0
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
85 percentage of Subjects
Interval 79.0 to 90.0
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
94 percentage of Subjects
Interval 89.0 to 97.0
|
95 percentage of Subjects
Interval 92.0 to 98.0
|
93 percentage of Subjects
Interval 85.0 to 97.0
|
SECONDARY outcome
Timeframe: at baseline, month-1, month-2, month-3, month-6 and month-7.Population: Analysis was performed as per the protocol dataset.
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.
Outcome measures
| Measure |
rMenB06
n=112 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=223 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=113 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=231 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=110 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=232 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=334 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=116 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
44/76-SL- Mo 0
|
29 percentage of Subjects
Interval 21.0 to 39.0
|
37 percentage of Subjects
Interval 31.0 to 44.0
|
31 percentage of Subjects
Interval 23.0 to 40.0
|
32 percentage of Subjects
Interval 26.0 to 38.0
|
30 percentage of Subjects
Interval 22.0 to 39.0
|
35 percentage of Subjects
Interval 29.0 to 42.0
|
33 percentage of Subjects
Interval 28.0 to 38.0
|
33 percentage of Subjects
Interval 24.0 to 42.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
44/76-SL- Mo 1
|
87 percentage of Subjects
Interval 79.0 to 92.0
|
87 percentage of Subjects
Interval 82.0 to 91.0
|
85 percentage of Subjects
Interval 77.0 to 91.0
|
85 percentage of Subjects
Interval 80.0 to 89.0
|
81 percentage of Subjects
Interval 72.0 to 88.0
|
87 percentage of Subjects
Interval 82.0 to 91.0
|
86 percentage of Subjects
Interval 82.0 to 90.0
|
30 percentage of Subjects
Interval 22.0 to 40.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
44/76-SL- Mo 2
|
79 percentage of Subjects
Interval 70.0 to 86.0
|
84 percentage of Subjects
Interval 78.0 to 89.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
99 percentage of Subjects
Interval 97.0 to 100.0
|
80 percentage of Subjects
Interval 71.0 to 87.0
|
80 percentage of Subjects
Interval 74.0 to 85.0
|
99 percentage of Subjects
Interval 98.0 to 100.0
|
33 percentage of Subjects
Interval 24.0 to 43.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
44/76-SL- Mo 3
|
74 percentage of Subjects
Interval 64.0 to 82.0
|
77 percentage of Subjects
Interval 71.0 to 83.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
98 percentage of Subjects
Interval 95.0 to 99.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
99 percentage of Subjects
Interval 97.0 to 100.0
|
36 percentage of Subjects
Interval 27.0 to 46.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
44/76-SL- Mo 6
|
62 percentage of Subjects
Interval 52.0 to 72.0
|
62 percentage of Subjects
Interval 54.0 to 69.0
|
90 percentage of Subjects
Interval 82.0 to 95.0
|
83 percentage of Subjects
Interval 77.0 to 88.0
|
90 percentage of Subjects
Interval 82.0 to 95.0
|
91 percentage of Subjects
Interval 86.0 to 95.0
|
93 percentage of Subjects
Interval 90.0 to 96.0
|
34 percentage of Subjects
Interval 25.0 to 44.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
44/76-SL- Mo 7
|
99 percentage of Subjects
Interval 94.0 to 100.0
|
57 percentage of Subjects
Interval 49.0 to 64.0
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
82 percentage of Subjects
Interval 75.0 to 87.0
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
88 percentage of Subjects
Interval 82.0 to 92.0
|
91 percentage of Subjects
Interval 86.0 to 94.0
|
89 percentage of Subjects
Interval 81.0 to 95.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
5/99- Mo 0
|
18 percentage of Subjects
Interval 11.0 to 26.0
|
24 percentage of Subjects
Interval 19.0 to 30.0
|
20 percentage of Subjects
Interval 13.0 to 29.0
|
22 percentage of Subjects
Interval 17.0 to 28.0
|
23 percentage of Subjects
Interval 15.0 to 32.0
|
22 percentage of Subjects
Interval 17.0 to 28.0
|
22 percentage of Subjects
Interval 17.0 to 26.0
|
14 percentage of Subjects
Interval 8.0 to 21.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
5/99- Mo 1
|
96 percentage of Subjects
Interval 91.0 to 99.0
|
91 percentage of Subjects
Interval 87.0 to 95.0
|
89 percentage of Subjects
Interval 82.0 to 94.0
|
94 percentage of Subjects
Interval 90.0 to 96.0
|
91 percentage of Subjects
Interval 84.0 to 96.0
|
93 percentage of Subjects
Interval 89.0 to 96.0
|
94 percentage of Subjects
Interval 91.0 to 96.0
|
19 percentage of Subjects
Interval 12.0 to 28.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
5/99- Mo 2
|
89 percentage of Subjects
Interval 81.0 to 94.0
|
85 percentage of Subjects
Interval 80.0 to 90.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
78 percentage of Subjects
Interval 69.0 to 86.0
|
88 percentage of Subjects
Interval 83.0 to 92.0
|
99 percentage of Subjects
Interval 98.0 to 100.0
|
17 percentage of Subjects
Interval 11.0 to 26.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
5/99- Mo 3
|
81 percentage of Subjects
Interval 73.0 to 88.0
|
77 percentage of Subjects
Interval 71.0 to 83.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
98 percentage of Subjects
Interval 93.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
100 percentage of Subjects
Interval 99.0 to 100.0
|
19 percentage of Subjects
Interval 12.0 to 27.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
5/99- Mo 6
|
60 percentage of Subjects
Interval 50.0 to 70.0
|
57 percentage of Subjects
Interval 50.0 to 64.0
|
97 percentage of Subjects
Interval 91.0 to 99.0
|
98 percentage of Subjects
Interval 95.0 to 99.0
|
98 percentage of Subjects
Interval 93.0 to 100.0
|
99 percentage of Subjects
Interval 96.0 to 100.0
|
99 percentage of Subjects
Interval 97.0 to 100.0
|
16 percentage of Subjects
Interval 9.0 to 25.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
5/99- Mo 7
|
99 percentage of Subjects
Interval 94.0 to 100.0
|
48 percentage of Subjects
Interval 40.0 to 56.0
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
97 percentage of Subjects
Interval 93.0 to 99.0
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
97 percentage of Subjects
Interval 94.0 to 99.0
|
98 percentage of Subjects
Interval 95.0 to 99.0
|
86 percentage of Subjects
Interval 78.0 to 93.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
NZ98/254 Mo 0
|
22 percentage of Subjects
Interval 15.0 to 31.0
|
30 percentage of Subjects
Interval 24.0 to 36.0
|
27 percentage of Subjects
Interval 19.0 to 36.0
|
25 percentage of Subjects
Interval 20.0 to 31.0
|
24 percentage of Subjects
Interval 16.0 to 33.0
|
26 percentage of Subjects
Interval 21.0 to 32.0
|
25 percentage of Subjects
Interval 20.0 to 30.0
|
29 percentage of Subjects
Interval 21.0 to 38.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
NZ98/254 Mo 1
|
84 percentage of Subjects
Interval 76.0 to 90.0
|
83 percentage of Subjects
Interval 77.0 to 87.0
|
82 percentage of Subjects
Interval 74.0 to 89.0
|
84 percentage of Subjects
Interval 79.0 to 88.0
|
75 percentage of Subjects
Interval 65.0 to 82.0
|
80 percentage of Subjects
Interval 74.0 to 85.0
|
86 percentage of Subjects
Interval 81.0 to 89.0
|
26 percentage of Subjects
Interval 18.0 to 35.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
NZ98/254 Mo 2
|
72 percentage of Subjects
Interval 62.0 to 80.0
|
70 percentage of Subjects
Interval 64.0 to 76.0
|
98 percentage of Subjects
Interval 93.0 to 100.0
|
99 percentage of Subjects
Interval 97.0 to 100.0
|
65 percentage of Subjects
Interval 55.0 to 74.0
|
75 percentage of Subjects
Interval 68.0 to 80.0
|
99 percentage of Subjects
Interval 97.0 to 100.0
|
31 percentage of Subjects
Interval 23.0 to 41.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
NZ98/254 Mo 3
|
70 percentage of Subjects
Interval 60.0 to 79.0
|
65 percentage of Subjects
Interval 58.0 to 71.0
|
90 percentage of Subjects
Interval 82.0 to 95.0
|
91 percentage of Subjects
Interval 86.0 to 94.0
|
98 percentage of Subjects
Interval 93.0 to 100.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
98 percentage of Subjects
Interval 96.0 to 99.0
|
30 percentage of Subjects
Interval 21.0 to 39.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
NZ98/254 Mo 6
|
60 percentage of Subjects
Interval 49.0 to 69.0
|
54 percentage of Subjects
Interval 47.0 to 62.0
|
80 percentage of Subjects
Interval 71.0 to 87.0
|
77 percentage of Subjects
Interval 70.0 to 82.0
|
86 percentage of Subjects
Interval 77.0 to 92.0
|
86 percentage of Subjects
Interval 80.0 to 90.0
|
91 percentage of Subjects
Interval 87.0 to 94.0
|
38 percentage of Subjects
Interval 28.0 to 48.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.
NZ98/254 Mo 7
|
99 percentage of Subjects
Interval 94.0 to 100.0
|
49 percentage of Subjects
Interval 42.0 to 57.0
|
99 percentage of Subjects
Interval 94.0 to 100.0
|
71 percentage of Subjects
Interval 64.0 to 78.0
|
100 percentage of Subjects
Interval 96.0 to 100.0
|
81 percentage of Subjects
Interval 74.0 to 86.0
|
84 percentage of Subjects
Interval 79.0 to 88.0
|
86 percentage of Subjects
Interval 78.0 to 93.0
|
SECONDARY outcome
Timeframe: Month-1, month-2, month-3 and month-7Population: Analysis was performed as per the protocol dataset.
Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.
Outcome measures
| Measure |
rMenB06
n=112 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=223 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=113 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=231 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=110 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=232 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=333 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=115 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
44/76-SL Mo 1
|
73 percentage of Subjects
Interval 64.0 to 81.0
|
75 percentage of Subjects
Interval 69.0 to 80.0
|
71 percentage of Subjects
Interval 61.0 to 79.0
|
77 percentage of Subjects
Interval 71.0 to 82.0
|
67 percentage of Subjects
Interval 58.0 to 76.0
|
73 percentage of Subjects
Interval 67.0 to 79.0
|
72 percentage of Subjects
Interval 67.0 to 77.0
|
3 percentage of Subjects
Interval 1.0 to 7.0
|
|
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
44/76-SL Mo 2
|
62 percentage of Subjects
Interval 52.0 to 71.0
|
67 percentage of Subjects
Interval 60.0 to 73.0
|
94 percentage of Subjects
Interval 88.0 to 98.0
|
96 percentage of Subjects
Interval 92.0 to 98.0
|
65 percentage of Subjects
Interval 55.0 to 74.0
|
61 percentage of Subjects
Interval 54.0 to 67.0
|
94 percentage of Subjects
Interval 91.0 to 97.0
|
6 percentage of Subjects
Interval 2.0 to 12.0
|
|
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
44/76-SL Mo 3
|
53 percentage of Subjects
Interval 43.0 to 63.0
|
59 percentage of Subjects
Interval 52.0 to 66.0
|
88 percentage of Subjects
Interval 81.0 to 94.0
|
91 percentage of Subjects
Interval 87.0 to 95.0
|
91 percentage of Subjects
Interval 84.0 to 96.0
|
95 percentage of Subjects
Interval 92.0 to 98.0
|
95 percentage of Subjects
Interval 92.0 to 97.0
|
3 percentage of Subjects
Interval 1.0 to 8.0
|
|
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
44/76-SL Mo 7
|
95 percentage of Subjects
Interval 89.0 to 99.0
|
33 percentage of Subjects
Interval 26.0 to 40.0
|
98 percentage of Subjects
Interval 93.0 to 100.0
|
73 percentage of Subjects
Interval 66.0 to 79.0
|
93 percentage of Subjects
Interval 86.0 to 98.0
|
76 percentage of Subjects
Interval 69.0 to 82.0
|
80 percentage of Subjects
Interval 75.0 to 85.0
|
76 percentage of Subjects
Interval 66.0 to 84.0
|
|
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
5/99 Mo 1
|
87 percentage of Subjects
Interval 80.0 to 93.0
|
79 percentage of Subjects
Interval 73.0 to 84.0
|
81 percentage of Subjects
Interval 72.0 to 87.0
|
85 percentage of Subjects
Interval 80.0 to 89.0
|
79 percentage of Subjects
Interval 70.0 to 86.0
|
85 percentage of Subjects
Interval 80.0 to 89.0
|
85 percentage of Subjects
Interval 80.0 to 88.0
|
3 percentage of Subjects
Interval 1.0 to 7.0
|
|
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
5/99 Mo 2
|
78 percentage of Subjects
Interval 69.0 to 85.0
|
65 percentage of Subjects
Interval 58.0 to 72.0
|
98 percentage of Subjects
Interval 93.0 to 100.0
|
98 percentage of Subjects
Interval 95.0 to 100.0
|
63 percentage of Subjects
Interval 53.0 to 72.0
|
74 percentage of Subjects
Interval 68.0 to 80.0
|
98 percentage of Subjects
Interval 96.0 to 99.0
|
5 percentage of Subjects
Interval 2.0 to 10.0
|
|
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
5/99 Mo 3
|
65 percentage of Subjects
Interval 56.0 to 74.0
|
53 percentage of Subjects
Interval 46.0 to 60.0
|
95 percentage of Subjects
Interval 89.0 to 98.0
|
99 percentage of Subjects
Interval 96.0 to 100.0
|
96 percentage of Subjects
Interval 91.0 to 99.0
|
99 percentage of Subjects
Interval 96.0 to 100.0
|
99 percentage of Subjects
Interval 98.0 to 100.0
|
6 percentage of Subjects
Interval 3.0 to 13.0
|
|
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
5/99- Mo 7
|
98 percentage of Subjects
Interval 92.0 to 100.0
|
27 percentage of Subjects
Interval 21.0 to 34.0
|
99 percentage of Subjects
Interval 94.0 to 100.0
|
88 percentage of Subjects
Interval 82.0 to 92.0
|
99 percentage of Subjects
Interval 94.0 to 100.0
|
90 percentage of Subjects
Interval 85.0 to 94.0
|
94 percentage of Subjects
Interval 90.0 to 97.0
|
82 percentage of Subjects
Interval 73.0 to 89.0
|
|
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
NZ98/254 Mo 1
|
72 percentage of Subjects
Interval 63.0 to 80.0
|
70 percentage of Subjects
Interval 63.0 to 76.0
|
65 percentage of Subjects
Interval 56.0 to 74.0
|
74 percentage of Subjects
Interval 67.0 to 79.0
|
59 percentage of Subjects
Interval 49.0 to 68.0
|
64 percentage of Subjects
Interval 58.0 to 70.0
|
73 percentage of Subjects
Interval 68.0 to 78.0
|
3 percentage of Subjects
Interval 1.0 to 7.0
|
|
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
NZ98/254 Mo 2
|
57 percentage of Subjects
Interval 47.0 to 67.0
|
52 percentage of Subjects
Interval 45.0 to 59.0
|
89 percentage of Subjects
Interval 81.0 to 94.0
|
93 percentage of Subjects
Interval 89.0 to 96.0
|
51 percentage of Subjects
Interval 41.0 to 61.0
|
57 percentage of Subjects
Interval 50.0 to 64.0
|
93 percentage of Subjects
Interval 89.0 to 95.0
|
7 percentage of Subjects
Interval 3.0 to 14.0
|
|
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
NZ98/254 Mo 3
|
50 percentage of Subjects
Interval 40.0 to 59.0
|
43 percentage of Subjects
Interval 36.0 to 50.0
|
78 percentage of Subjects
Interval 69.0 to 85.0
|
81 percentage of Subjects
Interval 76.0 to 86.0
|
91 percentage of Subjects
Interval 84.0 to 96.0
|
91 percentage of Subjects
Interval 86.0 to 94.0
|
93 percentage of Subjects
Interval 90.0 to 96.0
|
6 percentage of Subjects
Interval 3.0 to 13.0
|
|
Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.
NZ98/254 Mo 7
|
94 percentage of Subjects
Interval 87.0 to 98.0
|
27 percentage of Subjects
Interval 21.0 to 35.0
|
95 percentage of Subjects
Interval 88.0 to 98.0
|
62 percentage of Subjects
Interval 55.0 to 69.0
|
92 percentage of Subjects
Interval 85.0 to 97.0
|
69 percentage of Subjects
Interval 62.0 to 76.0
|
75 percentage of Subjects
Interval 69.0 to 80.0
|
77 percentage of Subjects
Interval 67.0 to 85.0
|
SECONDARY outcome
Timeframe: month-1, month-2, month-3, month-6 and month-7Population: Analysis was performed as per the protocol dataset.
Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
Outcome measures
| Measure |
rMenB06
n=112 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=223 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=113 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=231 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=110 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=232 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=334 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=116 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
5/99 GMT Mo 2
|
40 Titers
Interval 31.0 to 51.0
|
34 Titers
Interval 28.0 to 40.0
|
505 Titers
Interval 396.0 to 644.0
|
451 Titers
Interval 381.0 to 535.0
|
26 Titers
Interval 20.0 to 33.0
|
40 Titers
Interval 34.0 to 48.0
|
481 Titers
Interval 415.0 to 556.0
|
2.48 Titers
Interval 1.95 to 3.16
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
NZ98/254 GMT Mo1
|
42 Titers
Interval 31.0 to 56.0
|
44 Titers
Interval 36.0 to 55.0
|
47 Titers
Interval 35.0 to 63.0
|
45 Titers
Interval 36.0 to 55.0
|
37 Titers
Interval 27.0 to 50.0
|
42 Titers
Interval 34.0 to 52.0
|
49 Titers
Interval 41.0 to 58.0
|
2.85 Titers
Interval 2.11 to 3.84
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
NZ98/254 GMT Mo 2
|
23 Titers
Interval 17.0 to 30.0
|
25 Titers
Interval 20.0 to 31.0
|
98 Titers
Interval 72.0 to 132.0
|
89 Titers
Interval 72.0 to 110.0
|
19 Titers
Interval 14.0 to 26.0
|
26 Titers
Interval 21.0 to 32.0
|
92 Titers
Interval 77.0 to 110.0
|
3.28 Titers
Interval 2.43 to 4.41
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
NZ98/254 GMT Mo 3
|
17 Titers
Interval 13.0 to 22.0
|
19 Titers
Interval 16.0 to 24.0
|
61 Titers
Interval 46.0 to 82.0
|
52 Titers
Interval 42.0 to 64.0
|
117 Titers
Interval 87.0 to 157.0
|
125 Titers
Interval 102.0 to 154.0
|
122 Titers
Interval 102.0 to 145.0
|
3.57 Titers
Interval 2.68 to 4.75
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
NZ98/254 GMT Mo 6
|
12 Titers
Interval 8.94 to 17.0
|
11 Titers
Interval 8.63 to 14.0
|
31 Titers
Interval 22.0 to 42.0
|
29 Titers
Interval 23.0 to 36.0
|
44 Titers
Interval 32.0 to 61.0
|
49 Titers
Interval 39.0 to 61.0
|
52 Titers
Interval 43.0 to 63.0
|
4.17 Titers
Interval 3.04 to 5.72
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
NZ98/254 GMT Mo 7
|
140 Titers
Interval 101.0 to 195.0
|
10 Titers
Interval 8.01 to 13.0
|
181 Titers
Interval 132.0 to 248.0
|
24 Titers
Interval 19.0 to 30.0
|
168 Titers
Interval 122.0 to 232.0
|
39 Titers
Interval 31.0 to 49.0
|
41 Titers
Interval 34.0 to 50.0
|
47 Titers
Interval 34.0 to 64.0
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
5/99 GMT Mo 3
|
25 Titers
Interval 20.0 to 31.0
|
23 Titers
Interval 20.0 to 27.0
|
303 Titers
Interval 242.0 to 380.0
|
273 Titers
Interval 233.0 to 320.0
|
540 Titers
Interval 431.0 to 677.0
|
822 Titers
Interval 702.0 to 964.0
|
584 Titers
Interval 510.0 to 668.0
|
2.58 Titers
Interval 2.07 to 3.22
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
5/99 GMT Mo 6
|
12 Titers
Interval 9.56 to 16.0
|
11 Titers
Interval 9.26 to 13.0
|
125 Titers
Interval 98.0 to 160.0
|
113 Titers
Interval 95.0 to 135.0
|
124 Titers
Interval 97.0 to 158.0
|
147 Titers
Interval 123.0 to 175.0
|
186 Titers
Interval 160.0 to 216.0
|
2.03 Titers
Interval 1.59 to 2.59
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
5/99 GMT Mo 7
|
880 Titers
Interval 675.0 to 1147.0
|
8.61 Titers
Interval 7.13 to 10.0
|
1094 Titers
Interval 849.0 to 1410.0
|
99 Titers
Interval 82.0 to 119.0
|
994 Titers
Interval 767.0 to 1289.0
|
121 Titers
Interval 101.0 to 146.0
|
164 Titers
Interval 141.0 to 192.0
|
53 Titers
Interval 41.0 to 68.0
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
NZ98/254 GMT Mo 0
|
2.87 Titers
Interval 2.14 to 3.84
|
3.35 Titers
Interval 2.72 to 4.13
|
3.43 Titers
Interval 2.56 to 4.59
|
2.98 Titers
Interval 2.43 to 3.66
|
3.07 Titers
Interval 2.28 to 4.12
|
3.39 Titers
Interval 2.76 to 4.16
|
2.83 Titers
Interval 2.38 to 3.36
|
3.12 Titers
Interval 2.34 to 4.15
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
44/76 GMT Mo 0
|
3.41 Titers
Interval 2.54 to 4.58
|
4.24 Titers
Interval 3.44 to 5.22
|
3.34 Titers
Interval 2.49 to 4.48
|
3.35 Titers
Interval 2.72 to 4.11
|
3.39 Titers
Interval 2.52 to 4.56
|
3.99 Titers
Interval 3.25 to 4.9
|
3.87 Titers
Interval 3.26 to 4.6
|
3.89 Titers
Interval 2.91 to 5.19
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
44/76 GMT Mo 1
|
46 Titers
Interval 33.0 to 63.0
|
58 Titers
Interval 46.0 to 72.0
|
56 Titers
Interval 40.0 to 77.0
|
52 Titers
Interval 41.0 to 65.0
|
44 Titers
Interval 32.0 to 61.0
|
57 Titers
Interval 45.0 to 71.0
|
60 Titers
Interval 49.0 to 72.0
|
3.39 Titers
Interval 2.46 to 4.65
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
44/76 GMT Mo 2
|
31 Titers
Interval 23.0 to 41.0
|
41 Titers
Interval 34.0 to 50.0
|
182 Titers
Interval 138.0 to 240.0
|
187 Titers
Interval 154.0 to 228.0
|
28 Titers
Interval 21.0 to 37.0
|
38 Titers
Interval 31.0 to 46.0
|
193 Titers
Interval 164.0 to 228.0
|
4.09 Titers
Interval 3.11 to 5.38
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
44/76 GMT Mo 3
|
20 Titers
Interval 16.0 to 26.0
|
31 Titers
Interval 26.0 to 38.0
|
132 Titers
Interval 101.0 to 172.0
|
114 Titers
Interval 95.0 to 137.0
|
182 Titers
Interval 139.0 to 236.0
|
230 Titers
Interval 191.0 to 277.0
|
240 Titers
Interval 205.0 to 280.0
|
4.04 Titers
Interval 3.12 to 5.22
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
44/76 GMT Mo 6
|
13 Titers
Interval 9.24 to 18.0
|
15 Titers
Interval 12.0 to 19.0
|
59 Titers
Interval 43.0 to 82.0
|
50 Titers
Interval 39.0 to 63.0
|
54 Titers
Interval 39.0 to 75.0
|
75 Titers
Interval 60.0 to 95.0
|
86 Titers
Interval 70.0 to 104.0
|
3.9 Titers
Interval 2.82 to 5.4
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
44/76 GMT Mo 7
|
218 Titers
Interval 157.0 to 302.0
|
12 Titers
Interval 9.69 to 15.0
|
324 Titers
Interval 236.0 to 443.0
|
36 Titers
Interval 29.0 to 45.0
|
259 Titers
Interval 188.0 to 357.0
|
48 Titers
Interval 38.0 to 60.0
|
59 Titers
Interval 49.0 to 72.0
|
56 Titers
Interval 41.0 to 77.0
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
5/99 GMT Mo 0
|
2.61 Titers
Interval 2.03 to 3.34
|
3.15 Titers
Interval 2.64 to 3.75
|
2.59 Titers
Interval 2.02 to 3.32
|
2.52 Titers
Interval 2.11 to 2.99
|
2.43 Titers
Interval 1.89 to 3.12
|
2.72 Titers
Interval 2.29 to 3.24
|
2.58 Titers
Interval 2.23 to 2.98
|
2.27 Titers
Interval 1.78 to 2.89
|
|
Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.
5/99 GMT Mo 1
|
81 Titers
Interval 61.0 to 109.0
|
64 Titers
Interval 52.0 to 79.0
|
66 Titers
Interval 49.0 to 88.0
|
72 Titers
Interval 59.0 to 88.0
|
57 Titers
Interval 42.0 to 76.0
|
76 Titers
Interval 62.0 to 93.0
|
71 Titers
Interval 60.0 to 84.0
|
2.56 Titers
Interval 1.93 to 3.4
|
SECONDARY outcome
Timeframe: month-1, month-2, month-3, month-6 and month-7Population: Analysis was performed as per the protocol dataset.
Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
Outcome measures
| Measure |
rMenB06
n=112 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=223 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=113 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=231 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=110 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=232 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=333 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=115 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
5/99 GMR Mo 7 to 0
|
355 Ratio
Interval 254.0 to 497.0
|
3.07 Ratio
Interval 2.42 to 3.89
|
430 Ratio
Interval 312.0 to 594.0
|
40 Ratio
Interval 32.0 to 50.0
|
427 Ratio
Interval 307.0 to 593.0
|
46 Ratio
Interval 36.0 to 58.0
|
65 Ratio
Interval 53.0 to 79.0
|
21 Ratio
Interval 16.0 to 29.0
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
5/99 GMR Mo 7 to 6
|
71 Ratio
Interval 55.0 to 90.0
|
0.83 Ratio
Interval 0.7 to 0.99
|
8.98 Ratio
Interval 7.13 to 11.0
|
0.87 Ratio
Interval 0.74 to 1.03
|
7.92 Ratio
Interval 6.26 to 10.0
|
0.83 Ratio
Interval 0.71 to 0.99
|
0.86 Ratio
Interval 0.74 to 0.99
|
26 Ratio
Interval 20.0 to 32.0
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
44/76 GMR Mo 1 to 0
|
13 Ratio
Interval 10.0 to 18.0
|
14 Ratio
Interval 11.0 to 17.0
|
17 Ratio
Interval 12.0 to 22.0
|
16 Ratio
Interval 13.0 to 19.0
|
13 Ratio
Interval 9.71 to 18.0
|
14 Ratio
Interval 12.0 to 17.0
|
15 Ratio
Interval 13.0 to 18.0
|
0.89 Ratio
Interval 0.66 to 1.18
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
44/76 GMR Mo 2 to 0
|
8.92 Ratio
Interval 6.73 to 12.0
|
9.65 Ratio
Interval 7.88 to 12.0
|
53 Ratio
Interval 40.0 to 71.0
|
56 Ratio
Interval 46.0 to 69.0
|
8.43 Ratio
Interval 6.33 to 11.0
|
9.51 Ratio
Interval 7.79 to 12.0
|
50 Ratio
Interval 42.0 to 59.0
|
1.04 Ratio
Interval 0.79 to 1.38
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
44/76 GMR Mo 3 to 0
|
5.98 Ratio
Interval 4.51 to 7.92
|
7.31 Ratio
Interval 5.97 to 8.96
|
37 Ratio
Interval 28.0 to 50.0
|
34 Ratio
Interval 28.0 to 42.0
|
55 Ratio
Interval 41.0 to 73.0
|
58 Ratio
Interval 48.0 to 71.0
|
62 Ratio
Interval 52.0 to 73.0
|
0.98 Ratio
Interval 0.74 to 1.3
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
44/76 GMR Mo 6 to 0
|
3.98 Ratio
Interval 2.96 to 5.35
|
3.64 Ratio
Interval 2.93 to 4.52
|
17 Ratio
Interval 13.0 to 23.0
|
16 Ratio
Interval 13.0 to 19.0
|
16 Ratio
Interval 12.0 to 21.0
|
20 Ratio
Interval 16.0 to 25.0
|
23 Ratio
Interval 19.0 to 27.0
|
0.92 Ratio
Interval 0.69 to 1.24
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
44/76 GMR Mo 7 to 0
|
74 Ratio
Interval 54.0 to 103.0
|
3.09 Ratio
Interval 2.46 to 3.88
|
92 Ratio
Interval 67.0 to 125.0
|
12 Ratio
Interval 9.24 to 14.0
|
79 Ratio
Interval 58.0 to 109.0
|
13 Ratio
Interval 11.0 to 17.0
|
16 Ratio
Interval 13.0 to 19.0
|
13 Ratio
Interval 9.76 to 18.0
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
44/76 GMR Mo 7 to 6
|
18 Ratio
Interval 14.0 to 23.0
|
0.89 Ratio
Interval 0.76 to 1.05
|
5.36 Ratio
Interval 4.3 to 6.68
|
0.72 Ratio
Interval 0.61 to 0.84
|
5.08 Ratio
Interval 4.05 to 6.37
|
0.67 Ratio
Interval 0.57 to 0.79
|
0.67 Ratio
Interval 0.59 to 0.77
|
14 Ratio
Interval 11.0 to 17.0
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
5/99 GMR Mo 6 to 0
|
4.65 Ratio
Interval 3.47 to 6.23
|
3.83 Ratio
Interval 3.09 to 4.75
|
49 Ratio
Interval 37.0 to 66.0
|
45 Ratio
Interval 36.0 to 55.0
|
52 Ratio
Interval 39.0 to 70.0
|
56 Ratio
Interval 45.0 to 69.0
|
74 Ratio
Interval 62.0 to 88.0
|
0.82 Ratio
Interval 0.61 to 1.1
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
5/99 GMR Mo 1 to 0
|
31 Ratio
Interval 23.0 to 42.0
|
20 Ratio
Interval 16.0 to 25.0
|
25 Ratio
Interval 19.0 to 34.0
|
29 Ratio
Interval 23.0 to 35.0
|
23 Ratio
Interval 17.0 to 32.0
|
28 Ratio
Interval 23.0 to 34.0
|
28 Ratio
Interval 23.0 to 33.0
|
1.13 Ratio
Interval 0.84 to 1.52
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
5/99 GMR Mo 2 to 0
|
15 Ratio
Interval 11.0 to 20.0
|
11 Ratio
Interval 8.65 to 13.0
|
198 Ratio
Interval 149.0 to 262.0
|
181 Ratio
Interval 149.0 to 220.0
|
11 Ratio
Interval 8.13 to 14.0
|
15 Ratio
Interval 12.0 to 18.0
|
186 Ratio
Interval 158.0 to 220.0
|
1.06 Ratio
Interval 0.8 to 1.4
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
5/99 GMR Mo 3 to 0
|
9.22 Ratio
Interval 6.94 to 12.0
|
7.37 Ratio
Interval 6.01 to 9.04
|
115 Ratio
Interval 86.0 to 153.0
|
109 Ratio
Interval 89.0 to 133.0
|
233 Ratio
Interval 175.0 to 311.0
|
306 Ratio
Interval 250.0 to 374.0
|
225 Ratio
Interval 190.0 to 267.0
|
1.09 Ratio
Interval 0.82 to 1.44
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
NZ98/254 GMR Mo 1 to 0
|
14 Ratio
Interval 11.0 to 19.0
|
13 Ratio
Interval 11.0 to 16.0
|
14 Ratio
Interval 10.0 to 18.0
|
15 Ratio
Interval 12.0 to 18.0
|
12 Ratio
Interval 9.0 to 16.0
|
12 Ratio
Interval 10.0 to 15.0
|
17 Ratio
Interval 15.0 to 21.0
|
0.91 Ratio
Interval 0.68 to 1.2
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
NZ98/254 GMR Mo 2 to 0
|
7.69 Ratio
Interval 5.86 to 10.0
|
7.24 Ratio
Interval 5.97 to 8.79
|
29 Ratio
Interval 22.0 to 38.0
|
30 Ratio
Interval 24.0 to 36.0
|
6.46 Ratio
Interval 4.91 to 8.5
|
7.96 Ratio
Interval 6.57 to 9.63
|
33 Ratio
Interval 28.0 to 39.0
|
1.06 Ratio
Interval 0.81 to 1.38
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
NZ98/254 GMR Mo 3 to 0
|
6.01 Ratio
Interval 4.54 to 7.96
|
5.5 Ratio
Interval 4.49 to 6.74
|
18 Ratio
Interval 14.0 to 24.0
|
18 Ratio
Interval 14.0 to 21.0
|
40 Ratio
Interval 30.0 to 54.0
|
38 Ratio
Interval 32.0 to 47.0
|
44 Ratio
Interval 37.0 to 52.0
|
1.13 Ratio
Interval 0.86 to 1.5
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
NZ98/254 GMR Mo 6 to 0
|
4.75 Ratio
Interval 3.62 to 6.24
|
3.49 Ratio
Interval 2.86 to 4.26
|
9.26 Ratio
Interval 7.05 to 12.0
|
10 Ratio
Interval 8.29 to 12.0
|
14 Ratio
Interval 11.0 to 19.0
|
15 Ratio
Interval 13.0 to 19.0
|
19 Ratio
Interval 16.0 to 22.0
|
1.28 Ratio
Interval 0.98 to 1.68
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
NZ98/254 GMR Mo 7 to 0
|
59 Ratio
Interval 44.0 to 80.0
|
3.32 Ratio
Interval 2.67 to 4.12
|
53 Ratio
Interval 40.0 to 71.0
|
8.94 Ratio
Interval 7.26 to 11.0
|
57 Ratio
Interval 42.0 to 77.0
|
13 Ratio
Interval 10.0 to 16.0
|
15 Ratio
Interval 12.0 to 18.0
|
15 Ratio
Interval 11.0 to 19.0
|
|
Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.
NZ98/254 GMR Mo 7 to 6
|
11 Ratio
Interval 8.73 to 14.0
|
0.99 Ratio
Interval 0.84 to 1.17
|
5.86 Ratio
Interval 4.7 to 7.3
|
0.85 Ratio
Interval 0.73 to 1.0
|
3.95 Ratio
Interval 3.15 to 4.95
|
0.84 Ratio
Interval 0.72 to 0.99
|
0.81 Ratio
Interval 0.7 to 0.92
|
11 Ratio
Interval 8.98 to 14.0
|
SECONDARY outcome
Timeframe: month-1, month-2, month-3, month-6 and month-7Population: Analysis was performed as per the protocol dataset.
Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.
Outcome measures
| Measure |
rMenB06
n=34 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=35 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=35 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=35 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=35 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=35 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=35 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=35 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.
GMC Mo 0
|
35 IU/ml
Interval 25.0 to 51.0
|
35 IU/ml
Interval 25.0 to 50.0
|
43 IU/ml
Interval 30.0 to 61.0
|
37 IU/ml
Interval 26.0 to 54.0
|
44 IU/ml
Interval 31.0 to 63.0
|
32 IU/ml
Interval 23.0 to 46.0
|
32 IU/ml
Interval 22.0 to 45.0
|
48 IU/ml
Interval 34.0 to 68.0
|
|
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.
GMC Mo 1
|
190 IU/ml
Interval 113.0 to 318.0
|
204 IU/ml
Interval 123.0 to 340.0
|
334 IU/ml
Interval 200.0 to 555.0
|
217 IU/ml
Interval 130.0 to 361.0
|
234 IU/ml
Interval 140.0 to 389.0
|
220 IU/ml
Interval 132.0 to 367.0
|
521 IU/ml
Interval 313.0 to 868.0
|
50 IU/ml
Interval 30.0 to 82.0
|
|
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.
GMC Mo 2
|
173 IU/ml
Interval 115.0 to 261.0
|
154 IU/ml
Interval 102.0 to 231.0
|
3025 IU/ml
Interval 2015.0 to 4543.0
|
3875 IU/ml
Interval 2566.0 to 5854.0
|
175 IU/ml
Interval 117.0 to 263.0
|
144 IU/ml
Interval 96.0 to 216.0
|
3693 IU/ml
Interval 2459.0 to 5545.0
|
42 IU/ml
Interval 28.0 to 62.0
|
|
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.
GMC Mo 3
|
102 IU/ml
Interval 69.0 to 152.0
|
124 IU/ml
Interval 84.0 to 183.0
|
1612 IU/ml
Interval 1093.0 to 2378.0
|
1831 IU/ml
Interval 1234.0 to 2716.0
|
3332 IU/ml
Interval 2259.0 to 4916.0
|
2936 IU/ml
Interval 1990.0 to 4332.0
|
5314 IU/ml
Interval 3602.0 to 7839.0
|
42 IU/ml
Interval 29.0 to 62.0
|
|
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.
GMC Mo 6
|
91 IU/ml
Interval 59.0 to 138.0
|
72 IU/ml
Interval 48.0 to 110.0
|
565 IU/ml
Interval 372.0 to 857.0
|
488 IU/ml
Interval 322.0 to 741.0
|
807 IU/ml
Interval 531.0 to 1224.0
|
628 IU/ml
Interval 414.0 to 953.0
|
1602 IU/ml
Interval 1055.0 to 2431.0
|
37 IU/ml
Interval 24.0 to 56.0
|
|
GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.
GMC Mo 7
|
2240 IU/ml
Interval 1385.0 to 3623.0
|
69 IU/ml
Interval 43.0 to 112.0
|
3840 IU/ml
Interval 2391.0 to 6168.0
|
383 IU/ml
Interval 237.0 to 620.0
|
5492 IU/ml
Interval 3419.0 to 8821.0
|
532 IU/ml
Interval 331.0 to 855.0
|
1111 IU/ml
Interval 692.0 to 1785.0
|
283 IU/ml
Interval 176.0 to 454.0
|
SECONDARY outcome
Timeframe: month-1, month-2, month-3, month-6 and month-7Population: Analysis was performed as per the protocol dataset.
Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen
Outcome measures
| Measure |
rMenB06
n=34 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=35 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=35 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=35 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=35 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=35 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=35 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=35 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination
GMR Mo 1 to 0
|
5.73 Ratio
Interval 3.19 to 9.05
|
5.82 Ratio
Interval 3.48 to 9.73
|
7.75 Ratio
Interval 4.64 to 13.0
|
5.34 Ratio
Interval 3.12 to 9.14
|
5.26 Ratio
Interval 3.14 to 8.79
|
6.85 Ratio
Interval 4.09 to 11.0
|
16 Ratio
Interval 9.77 to 27.0
|
1.03 Ratio
Interval 0.62 to 1.73
|
|
GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination
GMR Mo 2 to 0
|
4.9 Ratio
Interval 3.2 to 7.5
|
4.38 Ratio
Interval 2.88 to 6.66
|
70 Ratio
Interval 46.0 to 107.0
|
112 Ratio
Interval 72.0 to 175.0
|
3.94 Ratio
Interval 2.59 to 5.99
|
4.46 Ratio
Interval 2.93 to 6.79
|
116 Ratio
Interval 76.0 to 176.0
|
0.87 Ratio
Interval 0.57 to 1.32
|
|
GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination
GMR Mo 3 to 0
|
2.9 Ratio
Interval 1.82 to 4.61
|
3.54 Ratio
Interval 2.24 to 5.59
|
37 Ratio
Interval 24.0 to 59.0
|
55 Ratio
Interval 34.0 to 89.0
|
75 Ratio
Interval 47.0 to 118.0
|
91 Ratio
Interval 58.0 to 144.0
|
167 Ratio
Interval 105.0 to 263.0
|
0.88 Ratio
Interval 0.56 to 1.4
|
|
GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination
GMR Mo 6 to 0
|
2.56 Ratio
Interval 1.59 to 4.13
|
2.06 Ratio
Interval 1.29 to 3.3
|
13 Ratio
Interval 8.2 to 21.0
|
13 Ratio
Interval 7.86 to 21.0
|
18 Ratio
Interval 11.0 to 29.0
|
20 Ratio
Interval 12.0 to 31.0
|
50 Ratio
Interval 31.0 to 80.0
|
0.77 Ratio
Interval 0.48 to 1.23
|
|
GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination
GMR Mo 7 to 0
|
63 Ratio
Interval 34.0 to 119.0
|
1.94 Ratio
Interval 1.03 to 3.64
|
89 Ratio
Interval 48.0 to 166.0
|
11 Ratio
Interval 5.67 to 21.0
|
123 Ratio
Interval 66.0 to 229.0
|
17 Ratio
Interval 8.9 to 31.0
|
35 Ratio
Interval 19.0 to 65.0
|
5.9 Ratio
Interval 3.17 to 11.0
|
SECONDARY outcome
Timeframe: Throughout the studyPopulation: Analysis was performed as per the safety dataset.
Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.
Outcome measures
| Measure |
rMenB06
n=128 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=247 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=128 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=247 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=127 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=253 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=373 Participants
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=128 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited AEs Throughout the Study.
Any AE's
|
65 participants
|
137 participants
|
73 participants
|
143 participants
|
72 participants
|
148 participants
|
210 participants
|
80 participants
|
|
Number of Subjects Reporting Unsolicited AEs Throughout the Study.
At least possibly related AEs
|
22 participants
|
36 participants
|
30 participants
|
36 participants
|
24 participants
|
43 participants
|
76 participants
|
26 participants
|
|
Number of Subjects Reporting Unsolicited AEs Throughout the Study.
Serious AEs
|
5 participants
|
4 participants
|
2 participants
|
4 participants
|
2 participants
|
4 participants
|
11 participants
|
3 participants
|
|
Number of Subjects Reporting Unsolicited AEs Throughout the Study.
At least possibly related SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Subjects Reporting Unsolicited AEs Throughout the Study.
AEs leading to discontinuation
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
POST_HOC outcome
Timeframe: At one month after second dose (Month 3)Population: Analysis was performed as per the protocol dataset. Only groups rMenB01 and rMenB02 are applicable to this endpoint as the post-hoc outcome was assessed at an interval of 1 month (rMenB01) or 2 months (rMenB02 ) to kill M10713 strain.
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 against M10713 strain at 1 month after second dose of vaccination (Month 3)
Outcome measures
| Measure |
rMenB06
n=46 Participants
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=46 Participants
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With hSBA Titers≥4 After Receiving Second Dose of Vaccination
Baseline
|
96 Percentage of subjects
Interval 85.0 to 99.0
|
80 Percentage of subjects
Interval 66.0 to 91.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With hSBA Titers≥4 After Receiving Second Dose of Vaccination
1 month after second dose
|
100 Percentage of subjects
Interval 92.0 to 100.0
|
100 Percentage of subjects
Interval 92.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
rMenB06
Serious events: 5 serious events
Other events: 123 other events
Deaths: 0 deaths
rMenB0
Serious events: 4 serious events
Other events: 238 other events
Deaths: 0 deaths
rMenB016
Serious events: 2 serious events
Other events: 126 other events
Deaths: 0 deaths
rMenB01
Serious events: 4 serious events
Other events: 242 other events
Deaths: 0 deaths
rMenB026
Serious events: 2 serious events
Other events: 118 other events
Deaths: 0 deaths
rMenB02
Serious events: 4 serious events
Other events: 240 other events
Deaths: 0 deaths
rMenB012
Serious events: 11 serious events
Other events: 354 other events
Deaths: 0 deaths
rMenB6
Serious events: 3 serious events
Other events: 125 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rMenB06
n=128 participants at risk
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=247 participants at risk
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=128 participants at risk
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=247 participants at risk
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=127 participants at risk
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=253 participants at risk
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=373 participants at risk
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=128 participants at risk
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
APPENDICITIS
|
0.78%
1/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.40%
1/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.78%
1/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.40%
1/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.79%
1/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.40%
1/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.54%
2/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.78%
1/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Infections and infestations
DYSENTERY
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.40%
1/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Infections and infestations
MENINGITIS BACTERlAL
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.27%
1/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.78%
1/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Infections and infestations
SHIGELLAIN FECTION
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.40%
1/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.27%
1/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.27%
1/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.78%
1/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARlOUS AGENTS
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.79%
2/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Musculoskeletal and connective tissue disorders
JUVENILE IDIOPATHIC ARTHRITIS
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.54%
2/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOMA BENIGN
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.78%
1/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENGIN OVARIAN TUMOUR
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.27%
1/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Nervous system disorders
CONVULSION
|
0.78%
1/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.40%
1/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.40%
1/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.27%
1/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE LABOUR
|
0.78%
1/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.78%
1/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.79%
1/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.79%
1/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.40%
1/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.79%
1/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.78%
1/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Renal and urinary disorders
GLOMERULONEPHRITIS MINIMAL LESION
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.40%
1/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Reproductive system and breast disorders
TESTICULAR TORSION
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.40%
1/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMATIC CRISIS
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.27%
1/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.27%
1/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Surgical and medical procedures
ADENOIDECTOMY
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.40%
1/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Surgical and medical procedures
TONSILLECTOMY
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.40%
1/247 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/127 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/253 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/373 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
0.00%
0/128 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
Other adverse events
| Measure |
rMenB06
n=128 participants at risk
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
|
rMenB0
n=247 participants at risk
Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
|
rMenB016
n=128 participants at risk
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
|
rMenB01
n=247 participants at risk
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
|
rMenB026
n=127 participants at risk
Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
|
rMenB02
n=253 participants at risk
Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
|
rMenB012
n=373 participants at risk
Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
|
rMenB6
n=128 participants at risk
Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
32.0%
41/128 • Number of events 80 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
32.4%
80/247 • Number of events 120 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
39.8%
51/128 • Number of events 109 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
29.1%
72/247 • Number of events 126 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
33.1%
42/127 • Number of events 72 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
35.2%
89/253 • Number of events 156 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
38.3%
143/373 • Number of events 276 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
38.3%
49/128 • Number of events 90 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
72.7%
93/128 • Number of events 211 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
65.6%
162/247 • Number of events 338 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
75.8%
97/128 • Number of events 225 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
76.1%
188/247 • Number of events 428 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
74.0%
94/127 • Number of events 251 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
68.0%
172/253 • Number of events 389 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
75.6%
282/373 • Number of events 680 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
67.2%
86/128 • Number of events 169 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
General disorders
INJECTION SITE INDURATION
|
56.2%
72/128 • Number of events 149 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
52.6%
130/247 • Number of events 240 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
59.4%
76/128 • Number of events 167 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
61.1%
151/247 • Number of events 328 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
64.6%
82/127 • Number of events 191 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
48.2%
122/253 • Number of events 234 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
61.1%
228/373 • Number of events 564 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
45.3%
58/128 • Number of events 116 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
General disorders
INJECTION SITE PAIN
|
95.3%
122/128 • Number of events 378 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
95.5%
236/247 • Number of events 667 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
96.9%
124/128 • Number of events 396 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
96.0%
237/247 • Number of events 729 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
89.0%
113/127 • Number of events 398 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
93.3%
236/253 • Number of events 749 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
92.5%
345/373 • Number of events 1160 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
96.1%
123/128 • Number of events 398 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
General disorders
INJECTION SITE SWELLING
|
57.0%
73/128 • Number of events 129 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
53.4%
132/247 • Number of events 244 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
63.3%
81/128 • Number of events 172 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
58.3%
144/247 • Number of events 310 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
59.8%
76/127 • Number of events 171 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
45.5%
115/253 • Number of events 242 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
60.6%
226/373 • Number of events 523 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
43.0%
55/128 • Number of events 92 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
General disorders
MALAISE
|
71.9%
92/128 • Number of events 222 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
73.3%
181/247 • Number of events 371 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
75.0%
96/128 • Number of events 238 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
69.6%
172/247 • Number of events 405 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
68.5%
87/127 • Number of events 235 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
73.1%
185/253 • Number of events 444 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
72.9%
272/373 • Number of events 690 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
69.5%
89/128 • Number of events 205 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
General disorders
PYREXIA
|
9.4%
12/128 • Number of events 17 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
3.2%
8/247 • Number of events 11 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
10.2%
13/128 • Number of events 18 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
8.5%
21/247 • Number of events 22 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
14.2%
18/127 • Number of events 20 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
10.3%
26/253 • Number of events 30 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
10.2%
38/373 • Number of events 50 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
15.6%
20/128 • Number of events 27 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Infections and infestations
BRONCHITIS
|
4.7%
6/128 • Number of events 6 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.8%
7/247 • Number of events 7 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
3.9%
5/128 • Number of events 5 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
4.0%
10/247 • Number of events 10 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
7.1%
9/127 • Number of events 9 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.4%
6/253 • Number of events 6 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
3.8%
14/373 • Number of events 14 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
8.6%
11/128 • Number of events 14 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Infections and infestations
GASTROENTERITIS
|
3.1%
4/128 • Number of events 4 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.8%
7/247 • Number of events 8 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
1.6%
2/128 • Number of events 2 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
6.1%
15/247 • Number of events 15 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
1.6%
2/127 • Number of events 2 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
5.5%
14/253 • Number of events 15 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
6.2%
23/373 • Number of events 27 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.3%
3/128 • Number of events 3 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.0%
9/128 • Number of events 9 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
9.7%
24/247 • Number of events 26 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
14.1%
18/128 • Number of events 18 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
8.1%
20/247 • Number of events 21 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
7.1%
9/127 • Number of events 11 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
11.1%
28/253 • Number of events 30 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
11.5%
43/373 • Number of events 46 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
10.2%
13/128 • Number of events 15 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Infections and infestations
PHARYNGITIS
|
5.5%
7/128 • Number of events 7 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
4.5%
11/247 • Number of events 11 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
3.9%
5/128 • Number of events 6 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
3.6%
9/247 • Number of events 10 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
3.1%
4/127 • Number of events 4 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.8%
7/253 • Number of events 7 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
5.6%
21/373 • Number of events 24 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
6.2%
8/128 • Number of events 9 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Infections and infestations
TONSILLITIS
|
2.3%
3/128 • Number of events 4 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.0%
5/247 • Number of events 5 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
3.1%
4/128 • Number of events 5 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.8%
7/247 • Number of events 9 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.4%
3/127 • Number of events 3 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.4%
6/253 • Number of events 7 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
4.3%
16/373 • Number of events 18 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
5.5%
7/128 • Number of events 8 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
3.1%
4/128 • Number of events 4 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.4%
6/247 • Number of events 6 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.3%
3/128 • Number of events 3 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.8%
7/247 • Number of events 8 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
5.5%
7/127 • Number of events 7 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
2.8%
7/253 • Number of events 7 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
4.0%
15/373 • Number of events 15 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
3.1%
4/128 • Number of events 4 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
43.8%
56/128 • Number of events 101 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
30.8%
76/247 • Number of events 131 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
43.0%
55/128 • Number of events 106 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
32.8%
81/247 • Number of events 175 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
30.7%
39/127 • Number of events 81 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
41.5%
105/253 • Number of events 215 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
39.1%
146/373 • Number of events 320 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
34.4%
44/128 • Number of events 77 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
66.4%
85/128 • Number of events 170 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
57.1%
141/247 • Number of events 266 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
71.1%
91/128 • Number of events 187 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
64.0%
158/247 • Number of events 335 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
64.6%
82/127 • Number of events 193 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
63.2%
160/253 • Number of events 357 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
63.8%
238/373 • Number of events 568 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
71.1%
91/128 • Number of events 198 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
|
Nervous system disorders
HEADACHE
|
61.7%
79/128 • Number of events 185 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
56.7%
140/247 • Number of events 346 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
68.8%
88/128 • Number of events 256 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
64.8%
160/247 • Number of events 444 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
58.3%
74/127 • Number of events 208 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
65.2%
165/253 • Number of events 452 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
65.4%
244/373 • Number of events 704 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
59.4%
76/128 • Number of events 209 • Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER