Trial Outcomes & Findings for Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents (NCT NCT02946385)
NCT ID: NCT02946385
Last Updated: 2019-08-20
Results Overview
The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the percentage of subjects with High-Throughput Human Serum Bactericidal Assay (HT-hSBA) titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
604 participants
Primary outcome timeframe
At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjects
Results posted on
2019-08-20
Participant Flow
All subjects enrolled in the study started the study.
Participant flow,baseline characteristics \& immunogenicity analyses were performed on "randomized" population \& Safety analysis on "treated" population.2 subjects from Naïve\_ABCWY group received rMenB+OMV vaccine \& not MenABCWY.Hence,number of subjects analyzed in Naïve\_B \& Naive\_ABCWY groups in treated population differ from randomized population
Participant milestones
| Measure |
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
|
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
126
|
127
|
99
|
74
|
101
|
77
|
|
Overall Study
COMPLETED
|
126
|
127
|
96
|
74
|
99
|
76
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
ABCWY_0_2
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
Naive_ABCWY
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
|
ABCWY_0_2_6
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
0
|
2
|
1
|
Baseline Characteristics
Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents
Baseline characteristics by cohort
| Measure |
B_0_2
n=126 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
Naive_B
n=99 Participants
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
ABCWY_0_6
n=74 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
Naive_ABCWY
n=101 Participants
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
|
ABCWY_0_2_6
n=77 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
TOTAL
n=604 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
16.8 Years
STANDARD_DEVIATION 3.06 • n=5 Participants
|
16.6 Years
STANDARD_DEVIATION 3.15 • n=7 Participants
|
16.2 Years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
17.3 Years
STANDARD_DEVIATION 2.96 • n=4 Participants
|
16.5 Years
STANDARD_DEVIATION 2.78 • n=21 Participants
|
17.1 Years
STANDARD_DEVIATION 2.98 • n=10 Participants
|
16.7 Years
STANDARD_DEVIATION 2.98 • n=115 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
50 Participants
n=10 Participants
|
363 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
241 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
126 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
75 Participants
n=10 Participants
|
598 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjectsPopulation: Subjects in full analysis set(FAS) persistence(24 months after last vaccination in V102\_15/Day 1)who were randomized(if naive) \& provided evaluable serum sample with hSBA results for atleast 1 serogroup B test strain/serogroups A,C,W/Y at Day 1 in extension study.Subjects in group B\_0\_2 did not receive MenACWY vaccination in the parent study
The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the percentage of subjects with High-Throughput Human Serum Bactericidal Assay (HT-hSBA) titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Outcome measures
| Measure |
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=75 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
n=74 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
n=125 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
n=198 Participants
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis B M14459 Ab
|
18 Percentage of subjects
Interval 11.8 to 26.2
|
16 Percentage of subjects
Interval 8.7 to 26.6
|
25 Percentage of subjects
Interval 15.5 to 36.6
|
17 Percentage of subjects
Interval 10.9 to 24.9
|
5 Percentage of subjects
Interval 2.1 to 8.5
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis B 96217 Ab
|
71 Percentage of subjects
Interval 62.1 to 78.6
|
81 Percentage of subjects
Interval 70.3 to 89.3
|
73 Percentage of subjects
Interval 61.4 to 82.6
|
81 Percentage of subjects
Interval 73.5 to 87.9
|
34 Percentage of subjects
Interval 27.3 to 40.9
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis B NZ98/254 Ab
|
16 Percentage of subjects
Interval 9.9 to 23.3
|
15 Percentage of subjects
Interval 7.6 to 24.7
|
18 Percentage of subjects
Interval 9.7 to 28.2
|
15 Percentage of subjects
Interval 9.5 to 22.9
|
3 Percentage of subjects
Interval 0.8 to 5.8
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis B M07-0241084 Ab
|
29 Percentage of subjects
Interval 21.6 to 38.1
|
31 Percentage of subjects
Interval 20.5 to 42.4
|
36 Percentage of subjects
Interval 24.7 to 47.7
|
28 Percentage of subjects
Interval 20.3 to 36.7
|
17 Percentage of subjects
Interval 12.3 to 23.4
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis A human Ab
|
15 Percentage of subjects
Interval 9.4 to 22.7
|
25 Percentage of subjects
Interval 15.5 to 36.6
|
27 Percentage of subjects
Interval 17.4 to 38.6
|
—
|
3 Percentage of subjects
Interval 0.6 to 8.6
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis C human Ab
|
83 Percentage of subjects
Interval 75.8 to 89.5
|
86 Percentage of subjects
Interval 76.5 to 93.3
|
85 Percentage of subjects
Interval 75.0 to 92.3
|
—
|
32 Percentage of subjects
Interval 23.0 to 42.1
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis W human Ab
|
52 Percentage of subjects
Interval 42.9 to 60.9
|
73 Percentage of subjects
Interval 61.9 to 82.9
|
64 Percentage of subjects
Interval 51.7 to 74.9
|
—
|
27 Percentage of subjects
Interval 18.1 to 36.4
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis Y human Ab
|
52 Percentage of subjects
Interval 43.3 to 61.3
|
75 Percentage of subjects
Interval 63.9 to 84.7
|
62 Percentage of subjects
Interval 49.5 to 72.8
|
—
|
7 Percentage of subjects
Interval 2.9 to 14.0
|
—
|
PRIMARY outcome
Timeframe: At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjectsPopulation: Subjects in full analysis set(FAS) persistence(24 months after last vaccination in V102\_15/Day 1)who were randomized(if naive) \& provided evaluable serum sample with hSBA results for atleast 1 serogroup B test strain/serogroups A,C,W/Y at Day 1 in extension study.Subjects in group B\_0\_2 did not receive MenACWY vaccination in the parent study.
The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Outcome measures
| Measure |
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=75 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
n=74 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
n=125 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
n=198 Participants
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis B M14459 Ab
|
2.05 Titers
Interval 1.68 to 2.5
|
2 Titers
Interval 1.55 to 2.57
|
2.55 Titers
Interval 1.98 to 3.3
|
2.02 Titers
Interval 1.66 to 2.45
|
1.21 Titers
Interval 1.04 to 1.42
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis B 96217 Ab
|
13 Titers
Interval 10.0 to 17.0
|
19 Titers
Interval 14.0 to 27.0
|
15 Titers
Interval 11.0 to 22.0
|
20 Titers
Interval 15.0 to 26.0
|
3.63 Titers
Interval 2.94 to 4.48
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis B NZ98/254 Ab
|
1.78 Titers
Interval 1.48 to 2.16
|
1.72 Titers
Interval 1.34 to 2.19
|
2.1 Titers
Interval 1.64 to 2.69
|
1.72 Titers
Interval 1.42 to 2.08
|
1.1 Titers
Interval 0.95 to 1.28
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis B M07-0241084 Ab
|
3.95 Titers
Interval 3.09 to 5.05
|
4.22 Titers
Interval 3.07 to 5.8
|
5.2 Titers
Interval 3.77 to 7.18
|
4.21 Titers
Interval 3.29 to 5.38
|
2.27 Titers
Interval 1.87 to 2.77
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis A human Ab
|
2.25 Titers
Interval 1.72 to 2.95
|
4.52 Titers
Interval 3.18 to 6.44
|
4.89 Titers
Interval 3.45 to 6.94
|
—
|
1.21 Titers
Interval 0.89 to 1.63
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis C human Ab
|
18 Titers
Interval 14.0 to 23.0
|
29 Titers
Interval 21.0 to 41.0
|
20 Titers
Interval 14.0 to 28.0
|
—
|
2.92 Titers
Interval 2.19 to 3.89
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis W human Ab
|
39 Titers
Interval 29.0 to 51.0
|
53 Titers
Interval 36.0 to 76.0
|
44 Titers
Interval 30.0 to 64.0
|
—
|
6.32 Titers
Interval 4.59 to 8.7
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects
Meningitis Y human Ab
|
9.19 Titers
Interval 6.85 to 12.0
|
29 Titers
Interval 20.0 to 43.0
|
16 Titers
Interval 11.0 to 24.0
|
—
|
1.52 Titers
Interval 1.09 to 2.12
|
—
|
SECONDARY outcome
Timeframe: Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY GroupPopulation: All subjects in the FAS immunogenicity (Day 31, after booster dose\[follow-on\]/first dose\[naive\]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.
The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with HT-hSBA titers greater than or equal to (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Outcome measures
| Measure |
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=77 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
n=73 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
n=100 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis W human Ab
|
100 Percentage of subjects
Interval 97.1 to 100.0
|
100 Percentage of subjects
Interval 95.1 to 100.0
|
100 Percentage of subjects
Interval 95.1 to 100.0
|
78 Percentage of subjects
Interval 68.6 to 85.7
|
—
|
—
|
|
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis B M14459 Ab
|
87 Percentage of subjects
Interval 79.3 to 91.9
|
85 Percentage of subjects
Interval 75.3 to 92.4
|
95 Percentage of subjects
Interval 86.6 to 98.5
|
29 Percentage of subjects
Interval 20.4 to 38.9
|
—
|
—
|
|
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis B 96217 Ab
|
100 Percentage of subjects
Interval 97.1 to 100.0
|
100 Percentage of subjects
Interval 95.3 to 100.0
|
100 Percentage of subjects
Interval 95.1 to 100.0
|
62 Percentage of subjects
Interval 51.7 to 71.5
|
—
|
—
|
|
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis B NZ98/254 Ab
|
69 Percentage of subjects
Interval 60.5 to 77.2
|
68 Percentage of subjects
Interval 56.7 to 78.6
|
81 Percentage of subjects
Interval 69.5 to 88.9
|
27 Percentage of subjects
Interval 18.6 to 36.8
|
—
|
—
|
|
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis B M07-0241084 Ab
|
87 Percentage of subjects
Interval 79.3 to 91.9
|
84 Percentage of subjects
Interval 74.4 to 91.7
|
81 Percentage of subjects
Interval 69.9 to 89.1
|
30 Percentage of subjects
Interval 21.2 to 40.0
|
—
|
—
|
|
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis A human Ab
|
98 Percentage of subjects
Interval 94.3 to 99.81
|
100 Percentage of subjects
Interval 95.3 to 100.0
|
99 Percentage of subjects
Interval 92.6 to 99.97
|
55 Percentage of subjects
Interval 44.7 to 65.2
|
—
|
—
|
|
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis C human Ab
|
100 Percentage of subjects
Interval 97.1 to 100.0
|
100 Percentage of subjects
Interval 95.2 to 100.0
|
100 Percentage of subjects
Interval 95.1 to 100.0
|
91 Percentage of subjects
Interval 83.6 to 95.8
|
—
|
—
|
|
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis Y human Ab
|
100 Percentage of subjects
Interval 97.1 to 100.0
|
100 Percentage of subjects
Interval 95.3 to 100.0
|
99 Percentage of subjects
Interval 92.6 to 99.97
|
71 Percentage of subjects
Interval 61.4 to 80.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY GroupPopulation: All subjects in the FAS immunogenicity (Day 31, after booster dose\[follow-on\]/first dose\[naive\]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.
The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.
Outcome measures
| Measure |
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=75 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
n=73 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
n=99 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis B M14459 Ab
|
54 Percentage of subjects
Interval 44.8 to 63.3
|
49 Percentage of subjects
Interval 37.4 to 61.3
|
65 Percentage of subjects
Interval 53.1 to 76.1
|
8 Percentage of subjects
Interval 3.6 to 15.3
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis B 96217 Ab
|
91 Percentage of subjects
Interval 84.1 to 95.0
|
95 Percentage of subjects
Interval 86.7 to 98.5
|
97 Percentage of subjects
Interval 90.5 to 99.67
|
17 Percentage of subjects
Interval 10.3 to 26.1
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis B NZ98/254 Ab
|
22 Percentage of subjects
Interval 15.2 to 30.3
|
17 Percentage of subjects
Interval 9.6 to 27.8
|
14 Percentage of subjects
Interval 6.9 to 24.1
|
16 Percentage of subjects
Interval 9.5 to 24.9
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis B M07-0241084 Ab
|
38 Percentage of subjects
Interval 29.1 to 46.7
|
19 Percentage of subjects
Interval 10.6 to 29.3
|
17 Percentage of subjects
Interval 8.9 to 27.3
|
11 Percentage of subjects
Interval 5.7 to 19.0
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis A human Ab
|
82 Percentage of subjects
Interval 74.2 to 88.4
|
83 Percentage of subjects
Interval 72.7 to 91.1
|
88 Percentage of subjects
Interval 77.9 to 94.2
|
23 Percentage of subjects
Interval 14.8 to 32.3
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis C human Ab
|
94 Percentage of subjects
Interval 88.0 to 97.2
|
86 Percentage of subjects
Interval 76.5 to 93.3
|
93 Percentage of subjects
Interval 84.7 to 97.7
|
54 Percentage of subjects
Interval 43.2 to 63.6
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis W human Ab
|
93 Percentage of subjects
Interval 86.7 to 96.6
|
92 Percentage of subjects
Interval 82.7 to 96.9
|
85 Percentage of subjects
Interval 74.0 to 92.0
|
36 Percentage of subjects
Interval 26.6 to 46.5
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis Y human Ab
|
94 Percentage of subjects
Interval 87.9 to 97.2
|
89 Percentage of subjects
Interval 79.5 to 95.1
|
90 Percentage of subjects
Interval 81.0 to 96.0
|
46 Percentage of subjects
Interval 35.6 to 56.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY GroupPopulation: All subjects in the FAS immunogenicity (Day 31, after booster dose\[follow-on\]/first dose\[naive\]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.
The immunogenicity of MenABCWY vaccine, was measured as the HT-hSBA Geometric Mean Titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y . The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Outcome measures
| Measure |
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=77 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
n=73 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
n=100 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis B M14459 Ab
|
32 Titers
Interval 25.0 to 41.0
|
30 Titers
Interval 22.0 to 42.0
|
61 Titers
Interval 44.0 to 85.0
|
3.12 Titers
Interval 2.34 to 4.14
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis B 96217 Ab
|
580 Titers
Interval 467.0 to 722.0
|
529 Titers
Interval 400.0 to 700.0
|
544 Titers
Interval 408.0 to 725.0
|
11 Titers
Interval 8.25 to 13.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis B NZ98/254 Ab
|
16 Titers
Interval 12.0 to 21.0
|
13 Titers
Interval 9.04 to 18.0
|
16 Titers
Interval 12.0 to 23.0
|
3.14 Titers
Interval 2.32 to 4.24
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis B M07-0241084 Ab
|
32 Titers
Interval 26.0 to 41.0
|
25 Titers
Interval 18.0 to 33.0
|
21 Titers
Interval 16.0 to 29.0
|
4.48 Titers
Interval 3.47 to 5.78
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis A human Ab
|
271 Titers
Interval 211.0 to 348.0
|
267 Titers
Interval 194.0 to 367.0
|
340 Titers
Interval 245.0 to 472.0
|
17 Titers
Interval 13.0 to 22.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis C human Ab
|
628 Titers
Interval 498.0 to 791.0
|
602 Titers
Interval 446.0 to 812.0
|
529 Titers
Interval 391.0 to 718.0
|
48 Titers
Interval 37.0 to 62.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis W human Ab
|
1309 Titers
Interval 1062.0 to 1614.0
|
1078 Titers
Interval 823.0 to 1413.0
|
979 Titers
Interval 746.0 to 1286.0
|
129 Titers
Interval 102.0 to 162.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1
Meningitis Y human Ab
|
616 Titers
Interval 479.0 to 791.0
|
606 Titers
Interval 439.0 to 836.0
|
578 Titers
Interval 415.0 to 803.0
|
33 Titers
Interval 25.0 to 44.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1, Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 1, Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY GroupPopulation: All subjects in FAS immunogenicity(Days 6 and 31, after booster \[follow-on\]/D66 and 91 after dose 2\[naive\]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.
The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Outcome measures
| Measure |
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=75 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
n=72 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
n=96 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis Y human Ab, Day 1
|
52 Percentage of subjects
Interval 42.9 to 61.0
|
76 Percentage of subjects
Interval 64.9 to 85.6
|
62 Percentage of subjects
Interval 49.7 to 73.2
|
7 Percentage of subjects
Interval 3.0 to 14.7
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis Y human Ab, Day 6 Post
|
97 Percentage of subjects
Interval 92.0 to 99.1
|
100 Percentage of subjects
Interval 95.0 to 100.0
|
97 Percentage of subjects
Interval 90.2 to 99.66
|
95 Percentage of subjects
Interval 88.0 to 98.3
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis Y human Ab, One month Post
|
100 Percentage of subjects
Interval 97.1 to 100.0
|
100 Percentage of subjects
Interval 95.0 to 100.0
|
99 Percentage of subjects
Interval 92.4 to 99.96
|
95 Percentage of subjects
Interval 88.0 to 98.3
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M14459 Ab, Day 1
|
18 Percentage of subjects
Interval 12.0 to 26.6
|
17 Percentage of subjects
Interval 8.9 to 27.3
|
26 Percentage of subjects
Interval 16.0 to 37.6
|
6 Percentage of subjects
Interval 2.4 to 13.4
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M14459 Ab, Day 6 Post
|
64 Percentage of subjects
Interval 54.6 to 72.5
|
82 Percentage of subjects
Interval 71.1 to 90.0
|
89 Percentage of subjects
Interval 78.7 to 94.9
|
64 Percentage of subjects
Interval 53.3 to 73.5
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M14459 Ab, One month Post
|
86 Percentage of subjects
Interval 78.1 to 91.5
|
85 Percentage of subjects
Interval 74.3 to 92.1
|
94 Percentage of subjects
Interval 86.0 to 98.4
|
72 Percentage of subjects
Interval 62.2 to 81.1
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B 96217 Ab, Day 1
|
71 Percentage of subjects
Interval 62.4 to 78.9
|
81 Percentage of subjects
Interval 70.3 to 89.3
|
74 Percentage of subjects
Interval 61.9 to 83.3
|
32 Percentage of subjects
Interval 23.1 to 42.6
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B 96217 Ab, Day 6 Post
|
98 Percentage of subjects
Interval 94.3 to 99.81
|
100 Percentage of subjects
Interval 95.1 to 100.0
|
97 Percentage of subjects
Interval 90.3 to 99.66
|
91 Percentage of subjects
Interval 82.9 to 95.6
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B 96217 Ab, One month Post
|
100 Percentage of subjects
Interval 97.1 to 100.0
|
100 Percentage of subjects
Interval 95.1 to 100.0
|
100 Percentage of subjects
Interval 95.0 to 100.0
|
98 Percentage of subjects
Interval 92.7 to 99.75
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B NZ98/254 Ab, Day 1
|
16 Percentage of subjects
Interval 9.9 to 23.3
|
14 Percentage of subjects
Interval 6.7 to 23.5
|
18 Percentage of subjects
Interval 10.1 to 29.3
|
2 Percentage of subjects
Interval 0.26 to 7.5
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B NZ98/254 Ab, Day 6 Post
|
44 Percentage of subjects
Interval 35.3 to 53.2
|
53 Percentage of subjects
Interval 40.7 to 64.4
|
66 Percentage of subjects
Interval 54.0 to 77.0
|
56 Percentage of subjects
Interval 45.8 to 66.6
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B NZ98/254 Ab, One month Post
|
69 Percentage of subjects
Interval 60.5 to 77.2
|
70 Percentage of subjects
Interval 58.5 to 80.3
|
80 Percentage of subjects
Interval 69.1 to 88.8
|
73 Percentage of subjects
Interval 63.3 to 82.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M07-0241084 Ab, Day 1
|
30 Percentage of subjects
Interval 22.0 to 38.7
|
31 Percentage of subjects
Interval 20.5 to 42.4
|
37 Percentage of subjects
Interval 25.5 to 48.9
|
18 Percentage of subjects
Interval 10.8 to 27.1
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M07-0241084 Ab, Day 6 Post
|
65 Percentage of subjects
Interval 55.4 to 72.9
|
72 Percentage of subjects
Interval 60.4 to 81.8
|
76 Percentage of subjects
Interval 64.5 to 85.4
|
55 Percentage of subjects
Interval 44.2 to 65.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M07-0241084, One month Post
|
86 Percentage of subjects
Interval 79.0 to 91.8
|
85 Percentage of subjects
Interval 75.3 to 92.4
|
80 Percentage of subjects
Interval 69.1 to 88.8
|
62 Percentage of subjects
Interval 51.6 to 71.9
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis A human Ab, Day 1
|
16 Percentage of subjects
Interval 9.6 to 23.2
|
25 Percentage of subjects
Interval 15.8 to 37.1
|
28 Percentage of subjects
Interval 17.9 to 39.6
|
3 Percentage of subjects
Interval 0.7 to 9.1
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis A human Ab, Day 6 Post
|
88 Percentage of subjects
Interval 80.5 to 93.0
|
96 Percentage of subjects
Interval 88.1 to 99.1
|
89 Percentage of subjects
Interval 79.3 to 95.1
|
82 Percentage of subjects
Interval 72.4 to 89.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis A human Ab, One month Post
|
98 Percentage of subjects
Interval 94.2 to 99.8
|
100 Percentage of subjects
Interval 94.9 to 100.0
|
99 Percentage of subjects
Interval 92.5 to 99.96
|
94 Percentage of subjects
Interval 86.5 to 97.6
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis C human Ab, Day 1
|
83 Percentage of subjects
Interval 75.8 to 89.5
|
86 Percentage of subjects
Interval 76.5 to 93.3
|
86 Percentage of subjects
Interval 75.9 to 93.1
|
32 Percentage of subjects
Interval 22.4 to 41.9
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis C human Ab, Day 6 Post
|
99 Percentage of subjects
Interval 95.7 to 99.98
|
100 Percentage of subjects
Interval 95.1 to 100.0
|
99 Percentage of subjects
Interval 92.5 to 99.96
|
99 Percentage of subjects
Interval 94.3 to 99.97
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis C human Ab, One month Post
|
100 Percentage of subjects
Interval 97.1 to 100.0
|
100 Percentage of subjects
Interval 95.1 to 100.0
|
100 Percentage of subjects
Interval 95.0 to 100.0
|
100 Percentage of subjects
Interval 96.2 to 100.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis W human Ab, Day 1
|
52 Percentage of subjects
Interval 42.8 to 61.2
|
73 Percentage of subjects
Interval 61.4 to 83.1
|
64 Percentage of subjects
Interval 51.3 to 75.0
|
27 Percentage of subjects
Interval 18.2 to 37.1
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis W human Ab, Day 6 Post
|
99 Percentage of subjects
Interval 95.5 to 99.98
|
99 Percentage of subjects
Interval 92.4 to 99.96
|
97 Percentage of subjects
Interval 89.9 to 99.65
|
98 Percentage of subjects
Interval 92.4 to 99.74
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis W human Ab, One month Post
|
100 Percentage of subjects
Interval 97.0 to 100.0
|
100 Percentage of subjects
Interval 94.9 to 100.0
|
100 Percentage of subjects
Interval 94.8 to 100.0
|
98 Percentage of subjects
Interval 92.4 to 99.74
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY GroupPopulation: All subjects in FAS immunogenicity(Days 6 and 31, after booster\[follow-on\]/D66 and 91 after dose 2\[naive\]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.
The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.
Outcome measures
| Measure |
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=75 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
n=72 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
n=96 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M14459 Ab, Day 6 Post vacc
|
26 Percentage of subjects
Interval 18.4 to 34.9
|
36 Percentage of subjects
Interval 25.1 to 48.3
|
50 Percentage of subjects
Interval 37.8 to 62.2
|
30 Percentage of subjects
Interval 20.8 to 40.1
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M14459 Ab, One month Post vacc
|
55 Percentage of subjects
Interval 45.2 to 63.8
|
49 Percentage of subjects
Interval 36.7 to 60.7
|
64 Percentage of subjects
Interval 51.9 to 75.4
|
24 Percentage of subjects
Interval 16.2 to 34.4
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B 96217 Ab, Day 6 Post
|
86 Percentage of subjects
Interval 79.1 to 91.9
|
92 Percentage of subjects
Interval 83.2 to 97.0
|
85 Percentage of subjects
Interval 74.3 to 92.1
|
65 Percentage of subjects
Interval 54.2 to 74.1
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B 96217 Ab, One month Post
|
90 Percentage of subjects
Interval 83.8 to 94.9
|
95 Percentage of subjects
Interval 86.7 to 98.5
|
97 Percentage of subjects
Interval 90.3 to 99.66
|
73 Percentage of subjects
Interval 62.9 to 81.5
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B NZ98/254 Ab, Day 6 Post
|
4 Percentage of subjects
Interval 1.3 to 8.9
|
8 Percentage of subjects
Interval 3.0 to 16.8
|
14 Percentage of subjects
Interval 7.0 to 24.4
|
24 Percentage of subjects
Interval 16.2 to 34.4
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B NZ98/254 Ab, One month Post
|
22 Percentage of subjects
Interval 15.2 to 30.3
|
18 Percentage of subjects
Interval 9.7 to 28.2
|
14 Percentage of subjects
Interval 7.0 to 24.4
|
21 Percentage of subjects
Interval 13.5 to 30.9
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M07-0241084 Ab, Day 6 Post
|
14 Percentage of subjects
Interval 8.2 to 21.0
|
11 Percentage of subjects
Interval 4.7 to 19.9
|
8 Percentage of subjects
Interval 3.2 to 17.5
|
8 Percentage of subjects
Interval 3.7 to 15.9
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M07-0241084, One month Post
|
37 Percentage of subjects
Interval 28.6 to 46.2
|
19 Percentage of subjects
Interval 10.6 to 29.3
|
15 Percentage of subjects
Interval 8.0 to 26.0
|
16 Percentage of subjects
Interval 9.1 to 24.7
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis A human Ab, Day 6 Post
|
66 Percentage of subjects
Interval 56.4 to 73.9
|
76 Percentage of subjects
Interval 64.5 to 85.4
|
75 Percentage of subjects
Interval 63.4 to 84.5
|
53 Percentage of subjects
Interval 42.1 to 63.1
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis A human Ab, One month Post
|
82 Percentage of subjects
Interval 74.0 to 88.3
|
85 Percentage of subjects
Interval 74.0 to 92.0
|
88 Percentage of subjects
Interval 77.6 to 94.1
|
46 Percentage of subjects
Interval 35.8 to 56.9
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis C human Ab, Day 6 Post
|
88 Percentage of subjects
Interval 81.3 to 93.2
|
86 Percentage of subjects
Interval 76.5 to 93.3
|
78 Percentage of subjects
Interval 66.4 to 86.7
|
83 Percentage of subjects
Interval 74.1 to 90.1
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis C human Ab, One month Post
|
94 Percentage of subjects
Interval 88.0 to 97.2
|
86 Percentage of subjects
Interval 76.5 to 93.3
|
93 Percentage of subjects
Interval 84.5 to 97.7
|
91 Percentage of subjects
Interval 82.8 to 95.6
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis W human Ab, Day 6 Post
|
80 Percentage of subjects
Interval 71.9 to 86.9
|
85 Percentage of subjects
Interval 74.0 to 92.0
|
75 Percentage of subjects
Interval 63.5 to 84.9
|
62 Percentage of subjects
Interval 51.7 to 72.2
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis W human Ab, One month Post
|
93 Percentage of subjects
Interval 86.3 to 96.5
|
92 Percentage of subjects
Interval 82.5 to 96.8
|
84 Percentage of subjects
Interval 73.3 to 91.8
|
71 Percentage of subjects
Interval 60.6 to 79.9
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis Y human Ab, Day 6 Post
|
81 Percentage of subjects
Interval 72.8 to 87.3
|
85 Percentage of subjects
Interval 74.3 to 92.1
|
79 Percentage of subjects
Interval 67.6 to 87.7
|
78 Percentage of subjects
Interval 67.9 to 85.6
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis Y human Ab, One month Post
|
94 Percentage of subjects
Interval 87.8 to 97.2
|
89 Percentage of subjects
Interval 79.3 to 95.1
|
90 Percentage of subjects
Interval 80.7 to 95.9
|
83 Percentage of subjects
Interval 73.8 to 89.9
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1, Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 1, Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY GroupPopulation: All subjects in FAS immunogenicity(Days 6 and 31, after booster\[follow-on\]/D66 and 91 after dose 2\[naive\]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.
The immunogenicity of MenABCWY vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y . The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Outcome measures
| Measure |
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=75 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
n=72 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
n=96 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M14459 Ab, Day 1
|
2.08 Titers
Interval 1.7 to 2.54
|
2.04 Titers
Interval 1.58 to 2.64
|
2.62 Titers
Interval 2.02 to 3.41
|
1.28 Titers
Interval 1.02 to 1.61
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M14459 Ab, Day 6 post
|
13 Titers
Interval 9.77 to 18.0
|
21 Titers
Interval 14.0 to 31.0
|
40 Titers
Interval 27.0 to 58.0
|
10 Titers
Interval 7.48 to 14.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M14459 Ab, One month post
|
30 Titers
Interval 24.0 to 39.0
|
30 Titers
Interval 22.0 to 42.0
|
61 Titers
Interval 44.0 to 84.0
|
14 Titers
Interval 10.0 to 18.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B 96217 Ab, Day 1
|
13 Titers
Interval 10.0 to 17.0
|
19 Titers
Interval 14.0 to 27.0
|
16 Titers
Interval 11.0 to 23.0
|
3.12 Titers
Interval 2.31 to 4.22
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B 96217 Ab, Day 6 post
|
376 Titers
Interval 287.0 to 493.0
|
486 Titers
Interval 343.0 to 690.0
|
401 Titers
Interval 281.0 to 571.0
|
70 Titers
Interval 51.0 to 95.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B 96217 Ab, One month post
|
587 Titers
Interval 496.0 to 695.0
|
524 Titers
Interval 421.0 to 652.0
|
550 Titers
Interval 440.0 to 687.0
|
94 Titers
Interval 77.0 to 114.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B NZ98/254 Ab, Day 1
|
1.78 Titers
Interval 1.47 to 2.16
|
1.66 Titers
Interval 1.3 to 2.14
|
2.17 Titers
Interval 1.68 to 2.8
|
1.07 Titers
Interval 0.85 to 1.33
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B NZ98/254 Ab, Day 6 post
|
6.02 Titers
Interval 4.58 to 7.92
|
7.63 Titers
Interval 5.33 to 11.0
|
12 Titers
Interval 8.56 to 18.0
|
8.95 Titers
Interval 6.52 to 12.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B NZ98/254 Ab, One month post
|
17 Titers
Interval 13.0 to 21.0
|
14 Titers
Interval 10.0 to 19.0
|
17 Titers
Interval 12.0 to 23.0
|
14 Titers
Interval 10.0 to 18.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M07-0241084 Ab, Day 1
|
3.97 Titers
Interval 3.1 to 5.09
|
4.22 Titers
Interval 3.07 to 5.8
|
5.3 Titers
Interval 3.81 to 7.35
|
2.18 Titers
Interval 1.64 to 2.89
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M07-0241084 Ab, Day 6 post
|
14 Titers
Interval 11.0 to 18.0
|
17 Titers
Interval 12.0 to 24.0
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16 Titers
Interval 12.0 to 23.0
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8.68 Titers
Interval 6.52 to 12.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis B M07-0241084 Ab, One month
|
32 Titers
Interval 26.0 to 40.0
|
26 Titers
Interval 20.0 to 34.0
|
22 Titers
Interval 16.0 to 28.0
|
11 Titers
Interval 8.6 to 14.0
|
—
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—
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|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis A human Ab, Day 1
|
2.31 Titers
Interval 1.75 to 3.04
|
4.53 Titers
Interval 3.16 to 6.48
|
5.13 Titers
Interval 3.59 to 7.34
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1.22 Titers
Interval 0.89 to 1.68
|
—
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—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis A human Ab, Day 6 post
|
137 Titers
Interval 98.0 to 191.0
|
221 Titers
Interval 143.0 to 341.0
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229 Titers
Interval 149.0 to 352.0
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59 Titers
Interval 41.0 to 87.0
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—
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—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis A human Ab, One month post
|
270 Titers
Interval 222.0 to 327.0
|
275 Titers
Interval 213.0 to 354.0
|
340 Titers
Interval 264.0 to 437.0
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85 Titers
Interval 68.0 to 106.0
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—
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—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis C human Ab, Day 1
|
18 Titers
Interval 14.0 to 23.0
|
29 Titers
Interval 21.0 to 41.0
|
21 Titers
Interval 15.0 to 29.0
|
2.91 Titers
Interval 2.17 to 3.92
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis C human Ab, Day 6 post
|
524 Titers
Interval 414.0 to 662.0
|
694 Titers
Interval 511.0 to 942.0
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520 Titers
Interval 381.0 to 710.0
|
153 Titers
Interval 117.0 to 200.0
|
—
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—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis C human Ab, One month post
|
628 Titers
Interval 523.0 to 753.0
|
612 Titers
Interval 482.0 to 776.0
|
539 Titers
Interval 423.0 to 686.0
|
177 Titers
Interval 143.0 to 218.0
|
—
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—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis W human Ab, Day 1
|
38 Titers
Interval 28.0 to 51.0
|
51 Titers
Interval 35.0 to 75.0
|
44 Titers
Interval 30.0 to 65.0
|
6.25 Titers
Interval 4.48 to 8.72
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis W human Ab, Day 6 post
|
820 Titers
Interval 665.0 to 1011.0
|
993 Titers
Interval 756.0 to 1304.0
|
916 Titers
Interval 694.0 to 1208.0
|
279 Titers
Interval 220.0 to 353.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis W human Ab, One month post
|
1345 Titers
Interval 1142.0 to 1584.0
|
1050 Titers
Interval 849.0 to 1299.0
|
999 Titers
Interval 805.0 to 1240.0
|
298 Titers
Interval 247.0 to 359.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis Y human Ab, Day 1
|
9.11 Titers
Interval 6.77 to 12.0
|
31 Titers
Interval 21.0 to 45.0
|
17 Titers
Interval 12.0 to 25.0
|
1.54 Titers
Interval 1.1 to 2.16
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis Y human Ab, Day 6 post
|
351 Titers
Interval 274.0 to 449.0
|
606 Titers
Interval 439.0 to 837.0
|
425 Titers
Interval 307.0 to 589.0
|
145 Titers
Interval 109.0 to 192.0
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups
Meningitis Y human Ab, One month post
|
623 Titers
Interval 517.0 to 750.0
|
646 Titers
Interval 506.0 to 824.0
|
586 Titers
Interval 458.0 to 750.0
|
129 Titers
Interval 104.0 to 159.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMVl vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B GroupPopulation: All subjects in the FAS immunogenicity (Day 31, after booster dose\[follow-on\]/first dose\[naive\]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain at Day 31 in the extension study.
The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Outcome measures
| Measure |
ABCWY_0_2
n=124 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=98 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1
Meningitis B M14459 Ab
|
94 Percentage of subjects
Interval 88.6 to 97.7
|
28 Percentage of subjects
Interval 19.4 to 38.2
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1
Meningitis B 96217 Ab
|
100 Percentage of subjects
Interval 97.1 to 100.0
|
74 Percentage of subjects
Interval 64.7 to 82.8
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1
Meningitis B NZ98/254 Ab
|
87 Percentage of subjects
Interval 79.9 to 92.4
|
27 Percentage of subjects
Interval 18.1 to 36.4
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1
Meningitis B M07-0241084 Ab
|
95 Percentage of subjects
Interval 89.8 to 98.2
|
33 Percentage of subjects
Interval 23.5 to 42.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B GroupPopulation: All subjects in the FAS immunogenicity (Day 31, after booster dose\[follow-on\]/first dose\[naive\]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain at Day 31 in the extension study.
The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.
Outcome measures
| Measure |
ABCWY_0_2
n=123 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=97 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1
Meningitis B M14459 Ab
|
67 Percentage of subjects
Interval 57.5 to 75.0
|
15 Percentage of subjects
Interval 8.3 to 23.5
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1
Meningitis B 96217 Ab
|
97 Percentage of subjects
Interval 91.8 to 99.1
|
19 Percentage of subjects
Interval 11.4 to 27.7
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1
Meningitis B NZ98/254 Ab
|
40 Percentage of subjects
Interval 31.4 to 49.4
|
16 Percentage of subjects
Interval 9.7 to 25.4
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1
Meningitis B M07-0241084 Ab
|
53 Percentage of subjects
Interval 43.6 to 61.9
|
8 Percentage of subjects
Interval 3.7 to 15.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B GroupPopulation: All subjects in the FAS immunogenicity (Day 31, after booster dose\[follow-on\]/first dose\[naive\]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.
The immunogenicity of rMenB+OMV vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Outcome measures
| Measure |
ABCWY_0_2
n=124 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=98 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, at Day 31 After rMenB+OMV Vaccination in V102_15E1
Meningitis B M14459 Ab
|
50 Titers
Interval 39.0 to 65.0
|
3.48 Titers
Interval 2.6 to 4.65
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, at Day 31 After rMenB+OMV Vaccination in V102_15E1
Meningitis B 96217 Ab
|
820 Titers
Interval 658.0 to 1023.0
|
18 Titers
Interval 14.0 to 23.0
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, at Day 31 After rMenB+OMV Vaccination in V102_15E1
Meningitis B NZ98/254 Ab
|
27 Titers
Interval 21.0 to 35.0
|
3.14 Titers
Interval 2.32 to 4.26
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains, at Day 31 After rMenB+OMV Vaccination in V102_15E1
Meningitis B M07-0241084 Ab
|
59 Titers
Interval 47.0 to 74.0
|
4.82 Titers
Interval 3.72 to 6.24
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1, at Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 1, at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B GroupPopulation: All subjects in FAS immunogenicity(Days 6 and 31, after booster\[follow-on\]/D66 and 91 after dose 2\[naive\]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.
The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Outcome measures
| Measure |
ABCWY_0_2
n=122 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=94 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B 96217 Ab, Day 1
|
82 Percentage of subjects
Interval 73.8 to 88.2
|
36 Percentage of subjects
Interval 26.5 to 46.7
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B 96217 Ab, Day 6 Post
|
98 Percentage of subjects
Interval 92.9 to 99.5
|
88 Percentage of subjects
Interval 80.0 to 94.0
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B 96217 Ab, One month Post
|
100 Percentage of subjects
Interval 97.0 to 100.0
|
98 Percentage of subjects
Interval 92.5 to 99.74
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M07-0241084 Ab, Day 1
|
28 Percentage of subjects
Interval 20.1 to 36.7
|
16 Percentage of subjects
Interval 9.4 to 25.5
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M07-0241084 Ab, Day 6 Post
|
70 Percentage of subjects
Interval 60.7 to 77.7
|
57 Percentage of subjects
Interval 45.8 to 66.8
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M07-0241084, One month Post
|
95 Percentage of subjects
Interval 89.6 to 98.2
|
72 Percentage of subjects
Interval 61.4 to 80.6
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M14459 Ab, Day 1
|
18 Percentage of subjects
Interval 11.3 to 25.7
|
3 Percentage of subjects
Interval 0.7 to 9.0
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M14459 Ab, Day 6 Post
|
70 Percentage of subjects
Interval 60.7 to 77.8
|
68 Percentage of subjects
Interval 57.7 to 77.3
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M14459 Ab, One month Post
|
94 Percentage of subjects
Interval 88.3 to 97.6
|
78 Percentage of subjects
Interval 67.9 to 85.6
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B NZ98/254 Ab, Day 1
|
16 Percentage of subjects
Interval 9.7 to 23.4
|
3 Percentage of subjects
Interval 0.7 to 9.0
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B NZ98/254 Ab, Day 6 Post
|
49 Percentage of subjects
Interval 39.6 to 58.0
|
62 Percentage of subjects
Interval 51.1 to 71.5
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B NZ98/254 Ab, One month Post
|
87 Percentage of subjects
Interval 79.4 to 92.2
|
82 Percentage of subjects
Interval 72.6 to 89.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B GroupPopulation: All subjects in FAS immunogenicity(Days 6 and 31, after booster\[follow-on\]/D66 and 91 after dose 2\[naive\]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.
The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.
Outcome measures
| Measure |
ABCWY_0_2
n=116 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=78 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M14459 Ab, Day 6 Post
|
34 Percentage of subjects
Interval 25.0 to 43.1
|
22 Percentage of subjects
Interval 13.4 to 33.0
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M14459 Ab, One month Post
|
66 Percentage of subjects
Interval 56.9 to 75.0
|
31 Percentage of subjects
Interval 21.1 to 42.7
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B 96217 Ab, Day 6 Post
|
78 Percentage of subjects
Interval 69.9 to 85.5
|
69 Percentage of subjects
Interval 57.3 to 78.9
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B 96217 Ab, One month Post
|
97 Percentage of subjects
Interval 92.6 to 99.5
|
81 Percentage of subjects
Interval 69.9 to 88.7
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B NZ98/254 Ab, Day 6 Post
|
13 Percentage of subjects
Interval 7.5 to 20.6
|
21 Percentage of subjects
Interval 12.2 to 31.2
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B NZ98/254 Ab, One month Post
|
41 Percentage of subjects
Interval 31.8 to 50.4
|
41 Percentage of subjects
Interval 30.0 to 52.7
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M07-0241084 Ab, Day 6 Post
|
21 Percentage of subjects
Interval 13.7 to 29.2
|
14 Percentage of subjects
Interval 7.5 to 24.4
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M07-0241084, One month Post
|
53 Percentage of subjects
Interval 43.1 to 61.9
|
24 Percentage of subjects
Interval 14.7 to 34.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1, at Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 1, at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B GroupPopulation: All subjects in FAS immunogenicity(Days 6 and 31, after booster\[follow-on\]/D66 and 91 after dose 2\[naive\]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.
The immunogenicity of rMenB+OMV vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
Outcome measures
| Measure |
ABCWY_0_2
n=122 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=94 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M14459 Ab, Day 1
|
2.04 Titers
Interval 1.67 to 2.49
|
1.18 Titers
Interval 0.94 to 1.47
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M14459 Ab, Day 6 post
|
14 Titers
Interval 11.0 to 19.0
|
12 Titers
Interval 8.41 to 16.0
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M14459 Ab, One month post
|
49 Titers
Interval 38.0 to 63.0
|
16 Titers
Interval 12.0 to 21.0
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B 96217 Ab, Day 1
|
20 Titers
Interval 15.0 to 26.0
|
4.38 Titers
Interval 3.23 to 5.93
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B 96217 Ab, Day 6 post
|
341 Titers
Interval 259.0 to 448.0
|
85 Titers
Interval 63.0 to 116.0
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B 96217 Ab, One month post
|
822 Titers
Interval 692.0 to 975.0
|
122 Titers
Interval 100.0 to 148.0
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B NZ98/254 Ab, Day 1
|
1.72 Titers
Interval 1.41 to 2.09
|
1.15 Titers
Interval 0.92 to 1.44
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B NZ98/254 Ab, Day 6 post
|
6.39 Titers
Interval 4.83 to 8.45
|
9.38 Titers
Interval 6.83 to 13.0
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B NZ98/254 Ab, One month post
|
27 Titers
Interval 21.0 to 34.0
|
22 Titers
Interval 17.0 to 29.0
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M07-0241084 Ab, Day 1
|
4.24 Titers
Interval 3.3 to 5.45
|
2.36 Titers
Interval 1.77 to 3.15
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M07-0241084 Ab, Day 6 post
|
17 Titers
Interval 13.0 to 21.0
|
11 Titers
Interval 8.54 to 15.0
|
—
|
—
|
—
|
—
|
|
hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups
Meningitis B M07-0241084 Ab, One month post
|
59 Titers
Interval 47.0 to 72.0
|
17 Titers
Interval 13.0 to 22.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: within 30 minutes after vaccination at Day 1 (for all subjects) and also Day 61 (for naive subjects only)Population: Analysis was done on subjects in Solicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of the subject's randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination solicited adverse events data
Assessed solicited symptoms were Pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C).
Outcome measures
| Measure |
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=77 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
n=74 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
n=126 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
n=99 Participants
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
n=101 Participants
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Local: Erythema
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Local: Induration
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Local: Pain
|
6 Participants
|
4 Participants
|
3 Participants
|
11 Participants
|
10 Participants
|
13 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Systemic: Arthralgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Systemic: Chills
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Systemic: Fatigue
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Systemic: Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Systemic: Headache
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Systemic: Loss Of Appetite
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Systemic: Myalgia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Systemic: Nausea
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Indicator: Prevention Of Pain / Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination
Indicator: Treatment Of Pain / Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30 minutes after vaccination at Day 1 (for all subjects) and also Day 61 (for naive subjects only)Population: Analysis was to be done on subjects in Unsolicited Safety Set but was not performed as AEs within 30 minutes after vaccination were not collected.
An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a subject and/or parent/legal guardian who has signed the informed consent. Number of subjects reporting any unsolicited AE within 30 minutes after each vaccination. Note: unsolicited AEs within 30 minutes were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Day 1 (6 hours) to Day 7 after vaccination at Day 1 (for all subjects) and Day 61 to Day 67 (for naive subjects only)Population: Analysis was done on subjects in Solicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of the subject's randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination solicited adverse events data
Assessed solicited symptoms were pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C).
Outcome measures
| Measure |
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=77 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
n=74 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
n=126 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
n=99 Participants
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
n=101 Participants
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Local: Erythema
|
22 Participants
|
10 Participants
|
14 Participants
|
22 Participants
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Local: Induration
|
18 Participants
|
14 Participants
|
6 Participants
|
20 Participants
|
22 Participants
|
15 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Local: Pain
|
108 Participants
|
67 Participants
|
64 Participants
|
115 Participants
|
95 Participants
|
93 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Systemic: Arthralgia
|
12 Participants
|
5 Participants
|
9 Participants
|
15 Participants
|
19 Participants
|
17 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Systemic: Chills
|
23 Participants
|
8 Participants
|
12 Participants
|
27 Participants
|
25 Participants
|
26 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Systemic: Fatigue
|
58 Participants
|
33 Participants
|
31 Participants
|
64 Participants
|
59 Participants
|
55 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Systemic: Fever
|
8 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Systemic: Headache
|
55 Participants
|
19 Participants
|
28 Participants
|
61 Participants
|
61 Participants
|
45 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Systemic: Loss Of Appetite
|
15 Participants
|
9 Participants
|
7 Participants
|
20 Participants
|
20 Participants
|
16 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Systemic: Myalgia
|
26 Participants
|
13 Participants
|
14 Participants
|
22 Participants
|
26 Participants
|
21 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Systemic: Nausea
|
13 Participants
|
8 Participants
|
8 Participants
|
24 Participants
|
20 Participants
|
19 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Indicator: Prevention Of Pain / Fever
|
21 Participants
|
8 Participants
|
8 Participants
|
29 Participants
|
24 Participants
|
26 Participants
|
|
Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.
Indicator: Treatment Of Pain / Fever
|
37 Participants
|
18 Participants
|
19 Participants
|
56 Participants
|
47 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 31 for all subjects and Day 61 to Day 91 for naive subjectsPopulation: Analysis was done on subjects in Unsolicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of subject's randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination unsolicited adverse events data
An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a subject and/or parent/legal guardian who has signed the informed consent. Number of subjects reporting any unsolicited AE within 30 minutes after each vaccination.
Outcome measures
| Measure |
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=77 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
n=74 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
n=126 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
n=99 Participants
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
n=101 Participants
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited AEs, 30 Days After Any Vaccination
|
27 Participants
|
12 Participants
|
10 Participants
|
26 Participants
|
40 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects)Population: Analysis was done on subjects in Unsolicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of subject's randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination unsolicited adverse events data
Serious adverse events (SAEs), medically attended adverse events and AEs leading to withdrawal are reported. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: -Death, -Is life-threatening,-Required or prolonged hospitalization, -Persistent or significant disability/incapacity, -Congenital anomaly/or birth defect, -An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Outcome measures
| Measure |
ABCWY_0_2
n=127 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_2_6
n=77 Participants
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
ABCWY_0_6
n=74 Participants
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
B_0_2
n=126 Participants
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
Naive_ALL
n=99 Participants
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY or rMenB+OMV in this extension study
|
Naive_B
n=101 Participants
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal
Any medically attended AE
|
18 Participants
|
7 Participants
|
8 Participants
|
20 Participants
|
24 Participants
|
21 Participants
|
|
Number of Subjects With Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal
Any serious AE
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal
AEs leading to premature withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
B_0_2
Serious events: 2 serious events
Other events: 120 other events
Deaths: 0 deaths
ABCWY_0_2
Serious events: 0 serious events
Other events: 116 other events
Deaths: 0 deaths
Naive_B
Serious events: 1 serious events
Other events: 99 other events
Deaths: 0 deaths
ABCWY_0_6
Serious events: 0 serious events
Other events: 67 other events
Deaths: 0 deaths
Naive_ABCWY
Serious events: 0 serious events
Other events: 96 other events
Deaths: 0 deaths
ABCWY_0_2_6
Serious events: 0 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
B_0_2
n=126 participants at risk
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
ABCWY_0_2
n=127 participants at risk
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
Naive_B
n=101 participants at risk
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
ABCWY_0_6
n=74 participants at risk
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
Naive_ABCWY
n=99 participants at risk
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
|
ABCWY_0_2_6
n=77 participants at risk
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Gastroenteritis
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Nervous system disorders
Headache
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
Other adverse events
| Measure |
B_0_2
n=126 participants at risk
Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study
|
ABCWY_0_2
n=127 participants at risk
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
Naive_B
n=101 participants at risk
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study
|
ABCWY_0_6
n=74 participants at risk
Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
Naive_ABCWY
n=99 participants at risk
Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study
|
ABCWY_0_2_6
n=77 participants at risk
Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.6%
2/127 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/101 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.7%
2/74 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Immune system disorders
Allergy to animal
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Psychiatric disorders
Anxiety
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
15/126 • Number of events 33 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
10.2%
13/127 • Number of events 21 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
16.8%
17/101 • Number of events 33 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
12.2%
9/74 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
20.2%
20/99 • Number of events 38 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
7.8%
6/77 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Investigations
Body temperature increased
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Bronchitis
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/101 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.4%
1/74 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Chest pain
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Chills
|
21.4%
27/126 • Number of events 50 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
18.1%
23/127 • Number of events 39 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
25.7%
26/101 • Number of events 62 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
16.2%
12/74 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
25.3%
25/99 • Number of events 51 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
10.4%
8/77 • Number of events 12 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Conjunctivitis
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Cystitis
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.4%
1/74 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.9%
20/126 • Number of events 39 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
11.8%
15/127 • Number of events 15 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
15.8%
16/101 • Number of events 38 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
9.5%
7/74 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
20.2%
20/99 • Number of events 49 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
11.7%
9/77 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/99 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
3.0%
3/101 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
4.1%
3/74 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.79%
1/126 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Psychiatric disorders
Dyssomnia
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Ear infection
|
1.6%
2/126 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Fatigue
|
50.8%
64/126 • Number of events 164 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
45.7%
58/127 • Number of events 114 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
54.5%
55/101 • Number of events 206 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
41.9%
31/74 • Number of events 77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
59.6%
59/99 • Number of events 201 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
42.9%
33/77 • Number of events 67 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.6%
2/127 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Hangover
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Nervous system disorders
Headache
|
49.2%
62/126 • Number of events 132 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
43.3%
55/127 • Number of events 96 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
45.5%
46/101 • Number of events 160 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
37.8%
28/74 • Number of events 64 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
62.6%
62/99 • Number of events 183 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
26.0%
20/77 • Number of events 41 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Immune system disorders
Hypersensitivity
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Influenza
|
3.2%
4/126 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Influenza like illness
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Injection site erythema
|
46.8%
59/126 • Number of events 129 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
39.4%
50/127 • Number of events 100 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
48.5%
49/101 • Number of events 137 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
36.5%
27/74 • Number of events 67 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
45.5%
45/99 • Number of events 148 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
29.9%
23/77 • Number of events 53 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/101 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Injection site induration
|
31.7%
40/126 • Number of events 117 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
33.9%
43/127 • Number of events 107 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
42.6%
43/101 • Number of events 172 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
24.3%
18/74 • Number of events 51 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
46.5%
46/99 • Number of events 200 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
29.9%
23/77 • Number of events 58 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Injection site pain
|
92.1%
116/126 • Number of events 421 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
85.0%
108/127 • Number of events 321 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
92.1%
93/101 • Number of events 683 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
86.5%
64/74 • Number of events 226 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
96.0%
95/99 • Number of events 593 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
87.0%
67/77 • Number of events 227 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Injection site pruritus
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Injection site rash
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Injection site reaction
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Injection site swelling
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.4%
1/74 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Injection site warmth
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.4%
1/74 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.4%
1/74 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Malaise
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Nervous system disorders
Migraine
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Nervous system disorders
Migraine-triggered seizure
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.5%
22/126 • Number of events 42 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
20.5%
26/127 • Number of events 36 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
20.8%
21/101 • Number of events 40 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
18.9%
14/74 • Number of events 34 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
26.3%
26/99 • Number of events 57 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
16.9%
13/77 • Number of events 17 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
4/126 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
3.0%
3/101 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.4%
1/74 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
6.1%
6/99 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Gastrointestinal disorders
Nausea
|
20.6%
26/126 • Number of events 39 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
10.2%
13/127 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
20.8%
21/101 • Number of events 39 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
10.8%
8/74 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
20.2%
20/99 • Number of events 39 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
10.4%
8/77 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/101 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Otitis media
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Pain
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.4%
1/74 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.4%
1/74 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Pharyngitis
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
6.3%
8/127 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/101 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
4.0%
4/99 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/101 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Pneumonia
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.4%
1/74 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Pyrexia
|
5.6%
7/126 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
7.9%
10/127 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
5.9%
6/101 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.4%
1/74 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
5.1%
5/99 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
5.2%
4/77 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Respiratory tract infection
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.4%
1/74 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.6%
2/77 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Gastrointestinal disorders
Retching
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Rhinitis
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.4%
1/74 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Reproductive system and breast disorders
Scrotal varicose veins
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Sinusitis
|
0.79%
1/126 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/101 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Musculoskeletal and connective tissue disorders
Spinal flattening
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Tonsillitis
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.4%
3/127 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.7%
2/74 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Tooth infection
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/101 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Gastrointestinal disorders
Toothache
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
5/126 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
6.3%
8/127 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
10.9%
11/101 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
5.4%
4/74 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
6.1%
6/99 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract irritation
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Urinary tract infection
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.79%
1/127 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
General disorders
Vaccination site pain
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
2.0%
2/99 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Eye disorders
Vision blurred
|
0.79%
1/126 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Infections and infestations
Wound infection
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.99%
1/101 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/77 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/126 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/127 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/101 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/74 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
0.00%
0/99 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
1.3%
1/77 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7, and Unsolicited AEs from Day 1 to Day 30, after any vaccination. SAEs were collected throughout the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects).
Safety analysis was performed on the treated population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER