Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines (NCT NCT01367158)
NCT ID: NCT01367158
Last Updated: 2014-11-19
Results Overview
Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
440 participants
Primary outcome timeframe
At month 6 and month 7
Results posted on
2014-11-19
Participant Flow
Participant milestones
| Measure |
3ABCWY
Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
|
2ABCWY
Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
|
3ABx2CWY
Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
|
2ABx2CWY
Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
|
3ABCWY+OMV
Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
|
2ABCWY+OMV
Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
|
3ABCWYqOMV
Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
|
2ABCWYqOMV
Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
|
3 B
Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
|
2 B
Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
|
1ACWY
One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
49
|
24
|
49
|
25
|
48
|
25
|
49
|
23
|
50
|
73
|
|
Overall Study
COMPLETED
|
25
|
46
|
23
|
48
|
23
|
46
|
25
|
47
|
23
|
50
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
1
|
2
|
2
|
0
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
3ABCWY
Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
|
2ABCWY
Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
|
3ABx2CWY
Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
|
2ABx2CWY
Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
|
3ABCWY+OMV
Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
|
2ABCWY+OMV
Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
|
3ABCWYqOMV
Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
|
2ABCWYqOMV
Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
|
3 B
Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
|
2 B
Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
|
1ACWY
One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrew consent
|
0
|
2
|
1
|
0
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines
Baseline characteristics by cohort
| Measure |
3ABCWY
n=25 Participants
Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
|
2ABCWY
n=49 Participants
Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
|
3ABx2CWY
n=24 Participants
Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
|
2ABx2CWY
n=49 Participants
Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
|
3ABCWY+OMV
n=25 Participants
Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
|
2ABCWY+OMV
n=48 Participants
Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
|
3ABCWYqOMV
n=25 Participants
Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
|
2ABCWYqOMV
n=49 Participants
Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
|
3 B
n=23 Participants
Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
|
2 B
n=50 Participants
Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
|
1ACWY
n=73 Participants
One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
|
Total
n=440 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
14.3 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
14.2 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
14.4 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
14.4 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
14.9 years
STANDARD_DEVIATION 2.6 • n=21 Participants
|
14.2 years
STANDARD_DEVIATION 2.1 • n=8 Participants
|
14.3 years
STANDARD_DEVIATION 2.0 • n=8 Participants
|
14.4 years
STANDARD_DEVIATION 2.1 • n=24 Participants
|
14.8 years
STANDARD_DEVIATION 2.5 • n=42 Participants
|
15.0 years
STANDARD_DEVIATION 2.0 • n=42 Participants
|
14.8 years
STANDARD_DEVIATION 2.1 • n=42 Participants
|
14.5 years
STANDARD_DEVIATION 2.1 • n=42 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
232 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
30 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
208 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: At month 6 and month 7Population: Analysis was done by Modified Intention-To-Treat (MITT) Month 7 Set. MITT is defined as all subjects in the enrolled set who received a study vaccination at Month 6 and provided one evaluable serum sample at Month 7.
Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).
Outcome measures
| Measure |
3ABCWY
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=25 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=25 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=72 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. A - month 6 (n=23,24,24,25,23,69)
|
52 Percentages of subjects
Interval 31.0 to 73.0
|
79 Percentages of subjects
Interval 58.0 to 93.0
|
75 Percentages of subjects
Interval 53.0 to 90.0
|
68 Percentages of subjects
Interval 46.0 to 85.0
|
35 Percentages of subjects
Interval 16.0 to 57.0
|
55 Percentages of subjects
Interval 43.0 to 67.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. A - month 7 (n=24,24,21,25,22,71)
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 84.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
91 Percentages of subjects
Interval 71.0 to 99.0
|
58 Percentages of subjects
Interval 45.0 to 69.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. C - month 6 (n=22,24,24,24,21,70)
|
100 Percentages of subjects
Interval 85.0 to 100.0
|
96 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
33 Percentages of subjects
Interval 15.0 to 57.0
|
76 Percentages of subjects
Interval 64.0 to 85.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. C - month 7 (n=23,24,23,25,22,72)
|
100 Percentages of subjects
Interval 85.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 85.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
73 Percentages of subjects
Interval 50.0 to 89.0
|
68 Percentages of subjects
Interval 56.0 to 79.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. W - month 6 (n=24,24,25,24,22,69)
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
96 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
55 Percentages of subjects
Interval 32.0 to 76.0
|
97 Percentages of subjects
Interval 90.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. W - month 7 (n=23,24,21,25,21,72)
|
100 Percentages of subjects
Interval 85.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 84.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
90 Percentages of subjects
Interval 70.0 to 99.0
|
96 Percentages of subjects
Interval 88.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. Y - month 6 (n=24,24,24,25,23,72)
|
96 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
96 Percentages of subjects
Interval 79.0 to 100.0
|
92 Percentages of subjects
Interval 74.0 to 99.0
|
4 Percentages of subjects
Interval 0.0 to 22.0
|
85 Percentages of subjects
Interval 74.0 to 92.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. Y - month 7 (n=25,24,24,25,22,72)
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
96 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
14 Percentages of subjects
Interval 3.0 to 35.0
|
85 Percentages of subjects
Interval 74.0 to 92.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At month 6 and month 7Population: Analysis was done by MITT Month 7 Set.
Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)
Outcome measures
| Measure |
3ABCWY
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=25 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=25 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M01-0240364(NadA) - month 7 (n=24,23,24,25,23,71)
|
96 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 85.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
96 Percentages of subjects
Interval 78.0 to 100.0
|
4 Percentages of subjects
Interval 1.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
H44/76 (fHbp) - month 6 (n=25,24,25,24,23,72)
|
40 Percentages of subjects
Interval 21.0 to 61.0
|
46 Percentages of subjects
Interval 26.0 to 67.0
|
52 Percentages of subjects
Interval 31.0 to 72.0
|
29 Percentages of subjects
Interval 13.0 to 51.0
|
35 Percentages of subjects
Interval 16.0 to 57.0
|
3 Percentages of subjects
Interval 0.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
H44/76 (fHbp) - month 7 (n=25,24,24,24,25,22,73)
|
92 Percentages of subjects
Interval 74.0 to 99.0
|
96 Percentages of subjects
Interval 79.0 to 100.0
|
96 Percentages of subjects
Interval 79.0 to 100.0
|
92 Percentages of subjects
Interval 74.0 to 99.0
|
91 Percentages of subjects
Interval 71.0 to 99.0
|
4 Percentages of subjects
Interval 1.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
5/99 (NadA) - month 6 (n=25,24,24,25,23,72)
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
96 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 85.0 to 100.0
|
15 Percentages of subjects
Interval 8.0 to 26.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
5/99 (NadA) - month 7 (n=25,24,24,25,23,73)
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 85.0 to 100.0
|
16 Percentages of subjects
Interval 9.0 to 27.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
NZ98/254(PorA) - month 6 (n=25,24,24,25,23,72)
|
12 Percentages of subjects
Interval 3.0 to 31.0
|
8 Percentages of subjects
Interval 1.0 to 27.0
|
29 Percentages of subjects
Interval 13.0 to 51.0
|
12 Percentages of subjects
Interval 3.0 to 31.0
|
9 Percentages of subjects
Interval 1.0 to 28.0
|
0 Percentages of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
NZ98/254(PorA) - month 7 (n=25,24,24,25,23,73)
|
20 Percentages of subjects
Interval 7.0 to 41.0
|
29 Percentages of subjects
Interval 13.0 to 51.0
|
88 Percentages of subjects
Interval 68.0 to 97.0
|
76 Percentages of subjects
Interval 55.0 to 91.0
|
17 Percentages of subjects
Interval 5.0 to 39.0
|
1 Percentages of subjects
Interval 0.035 to 7.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M14459(fHBP) - month 6 (n=25,24,25,25,23,71)
|
24 Percentages of subjects
Interval 9.0 to 45.0
|
25 Percentages of subjects
Interval 10.0 to 47.0
|
32 Percentages of subjects
Interval 15.0 to 54.0
|
16 Percentages of subjects
Interval 5.0 to 36.0
|
17 Percentages of subjects
Interval 5.0 to 39.0
|
6 Percentages of subjects
Interval 2.0 to 14.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M14459(fHBP) - month 7 (n=25,24,23,25,22,73)
|
80 Percentages of subjects
Interval 59.0 to 93.0
|
79 Percentages of subjects
Interval 58.0 to 93.0
|
87 Percentages of subjects
Interval 66.0 to 97.0
|
88 Percentages of subjects
Interval 69.0 to 97.0
|
64 Percentages of subjects
Interval 41.0 to 83.0
|
8 Percentages of subjects
Interval 3.0 to 17.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M07-0241084(NHBA) - month 6 (n=25,23,23,25,23,70)
|
20 Percentages of subjects
Interval 7.0 to 41.0
|
35 Percentages of subjects
Interval 16.0 to 57.0
|
39 Percentages of subjects
Interval 20.0 to 61.0
|
52 Percentages of subjects
Interval 31.0 to 72.0
|
30 Percentages of subjects
Interval 13.0 to 53.0
|
30 Percentages of subjects
Interval 20.0 to 42.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M07-0241084(NHBA) - month 7 (n=25,23,22,25,21,72)
|
68 Percentages of subjects
Interval 46.0 to 85.0
|
61 Percentages of subjects
Interval 39.0 to 80.0
|
95 Percentages of subjects
Interval 77.0 to 100.0
|
92 Percentages of subjects
Interval 74.0 to 99.0
|
62 Percentages of subjects
Interval 38.0 to 82.0
|
29 Percentages of subjects
Interval 19.0 to 41.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M01-0240364(NadA) - month 6 (n=25,21,24,24,21,71)
|
16 Percentages of subjects
Interval 5.0 to 36.0
|
38 Percentages of subjects
Interval 18.0 to 62.0
|
25 Percentages of subjects
Interval 10.0 to 47.0
|
33 Percentages of subjects
Interval 16.0 to 55.0
|
33 Percentages of subjects
Interval 15.0 to 57.0
|
4 Percentages of subjects
Interval 1.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 6 and month 7Population: Analysis was done by MITT Month 7 Set.
Antibody response was measured as Geometric Mean hSBA Titers against N meningitidis Serogroups A, C, W and Y at One of Four MenABCWY Formulations or rMenB at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)
Outcome measures
| Measure |
3ABCWY
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=25 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=25 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=72 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. A - month 6 (n=23,24,24,25,23,69)
|
15 Titers
Interval 6.66 to 33.0
|
44 Titers
Interval 20.0 to 96.0
|
31 Titers
Interval 14.0 to 68.0
|
21 Titers
Interval 9.53 to 44.0
|
4.52 Titers
Interval 2.02 to 10.0
|
21 Titers
Interval 13.0 to 34.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. A - month 7 (n=24,24,21,25,22,71)
|
247 Titers
Interval 120.0 to 509.0
|
322 Titers
Interval 157.0 to 659.0
|
242 Titers
Interval 113.0 to 521.0
|
274 Titers
Interval 136.0 to 553.0
|
135 Titers
Interval 64.0 to 287.0
|
22 Titers
Interval 14.0 to 33.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. C - month 6 (n=22,24,24,24,21,70)
|
211 Titers
Interval 125.0 to 355.0
|
153 Titers
Interval 93.0 to 251.0
|
168 Titers
Interval 102.0 to 278.0
|
137 Titers
Interval 83.0 to 224.0
|
4.54 Titers
Interval 2.66 to 7.75
|
25 Titers
Interval 18.0 to 34.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. C - month 7 (n=23,24,23,25,22,72)
|
796 Titers
Interval 472.0 to 1343.0
|
716 Titers
Interval 430.0 to 1193.0
|
670 Titers
Interval 397.0 to 1130.0
|
634 Titers
Interval 385.0 to 1044.0
|
31 Titers
Interval 18.0 to 53.0
|
19 Titers
Interval 14.0 to 26.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. W - month 6 (n=24,24,25,24,22,69)
|
189 Titers
Interval 116.0 to 305.0
|
184 Titers
Interval 144.0 to 296.0
|
202 Titers
Interval 127.0 to 324.0
|
164 Titers
Interval 102.0 to 263.0
|
11 Titers
Interval 6.67 to 18.0
|
128 Titers
Interval 95.0 to 173.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. W - month 7 (n=23,24,21,25,21,72)
|
710 Titers
Interval 442.0 to 1143.0
|
695 Titers
Interval 441.0 to 1096.0
|
929 Titers
Interval 570.0 to 1512.0
|
684 Titers
Interval 438.0 to 1069.0
|
126 Titers
Interval 77.0 to 207.0
|
130 Titers
Interval 98.0 to 172.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. Y - month 6 (n=24,24,24,25,23,72)
|
203 Titers
Interval 111.0 to 372.0
|
233 Titers
Interval 128.0 to 425.0
|
158 Titers
Interval 86.0 to 289.0
|
129 Titers
Interval 72.0 to 233.0
|
1.72 Titers
Interval 0.93 to 3.18
|
97 Titers
Interval 67.0 to 140.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. Y - month 7 (n=25,24,24,25,22,72)
|
695 Titers
Interval 385.0 to 1255.0
|
629 Titers
Interval 346.0 to 1144.0
|
619 Titers
Interval 339.0 to 1129.0
|
432 Titers
Interval 241.0 to 776.0
|
2.64 Titers
Interval 1.41 to 4.96
|
85 Titers
Interval 59.0 to 122.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 7Population: Analysis was done by MITT Month 7 Set.
Antibody response was measured as Geometric Mean Ratio (95% CI), against N meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination (month 7) With One of Four MenABCWY Formulations or rMenB
Outcome measures
| Measure |
3ABCWY
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=25 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=25 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=72 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. A (n=22,24,21,25,22,68)
|
15 Ratio
Interval 8.88 to 25.0
|
7.53 Ratio
Interval 4.58 to 12.0
|
10 Ratio
Interval 6.1 to 18.0
|
14 Ratio
Interval 8.37 to 22.0
|
34 Ratio
Interval 20.0 to 57.0
|
1.05 Ratio
Interval 0.77 to 1.43
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. C (n=21,24,22,24,20,70)
|
3.43 Ratio
Interval 2.59 to 4.54
|
4.63 Ratio
Interval 3.56 to 6.02
|
3.85 Ratio
Interval 2.92 to 5.06
|
5.01 Ratio
Interval 3.85 to 6.5
|
8.41 Ratio
Interval 6.31 to 11.0
|
0.75 Ratio
Interval 0.64 to 0.89
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. W (n=23,24,21,24,20,69)
|
3.42 Ratio
Interval 2.41 to 4.85
|
3.66 Ratio
Interval 2.62 to 5.12
|
3.98 Ratio
Interval 2.78 to 5.69
|
4.05 Ratio
Interval 2.9 to 5.66
|
11 Ratio
Interval 7.55 to 16.0
|
1.01 Ratio
Interval 0.82 to 1.24
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. Y (n=24,24,23,25,22,71)
|
3.33 Ratio
Interval 2.31 to 4.79
|
2.68 Ratio
Interval 1.87 to 3.85
|
4.45 Ratio
Interval 3.06 to 6.45
|
3.32 Ratio
Interval 2.33 to 4.73
|
1.46 Ratio
Interval 1.0 to 2.14
|
0.81 Ratio
Interval 0.65 to 1.02
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 6 and month 7Population: Analysis was done by MITT Month 7 Set.
Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Outcome measures
| Measure |
3ABCWY
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=25 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=25 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
H44/76 (fHbp) - month 6 (n=25,24,25,24,23,72)
|
5.9 Titers
Interval 3.07 to 11.0
|
6.88 Titers
Interval 3.56 to 13.0
|
12 Titers
Interval 6.14 to 23.0
|
5.25 Titers
Interval 2.71 to 10.0
|
6.42 Titers
Interval 3.27 to 13.0
|
1.18 Titers
Interval 1.01 to 1.37
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
H44/76 (fHbp) - month 7 (n= 25,24,24,25,22,73)
|
109 Titers
Interval 60.0 to 201.0
|
154 Titers
Interval 83.0 to 285.0
|
181 Titers
Interval 97.0 to 336.0
|
114 Titers
Interval 62.0 to 208.0
|
109 Titers
Interval 57.0 to 209.0
|
1.21 Titers
Interval 1.04 to 1.4
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
5/99 (NadA) - month 6 (n=25,24,24,25,23,72)
|
78 Titers
Interval 52.0 to 118.0
|
122 Titers
Interval 80.0 to 186.0
|
46 Titers
Interval 30.0 to 71.0
|
84 Titers
Interval 56.0 to 127.0
|
152 Titers
Interval 99.0 to 234.0
|
1.74 Titers
Interval 1.36 to 2.22
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
5/99 (NadA) - month 7 (n=25,24,24,25,23,73)
|
546 Titers
Interval 365.0 to 817.0
|
740 Titers
Interval 492.0 to 1112.0
|
665 Titers
Interval 441.0 to 1002.0
|
527 Titers
Interval 354.0 to 786.0
|
832 Titers
Interval 548.0 to 1263.0
|
1.93 Titers
Interval 1.5 to 2.48
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
NZ98/254(PorA) - month 6 (n=25,24,24,25,23,72)
|
1.96 Titers
Interval 1.29 to 3.0
|
1.85 Titers
Interval 1.21 to 2.85
|
3.47 Titers
Interval 2.26 to 5.35
|
1.89 Titers
Interval 1.24 to 2.88
|
1.81 Titers
Interval 1.17 to 2.81
|
1.15 Titers
Interval 1.05 to 1.25
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
NZ98/254(PorA) - month 7 (n=25,24,24,25,23,72)
|
2.37 Titers
Interval 1.5 to 3.74
|
3.26 Titers
Interval 2.06 to 5.17
|
24 Titers
Interval 15.0 to 37.0
|
12 Titers
Interval 7.57 to 19.0
|
2.64 Titers
Interval 1.65 to 4.23
|
1.2 Titers
Interval 1.07 to 1.33
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M14459(fHBP) - month 6 (n=25,24,25,25,23,71)
|
2.71 Titers
Interval 1.72 to 4.27
|
3.29 Titers
Interval 2.08 to 5.21
|
4.49 Titers
Interval 2.85 to 7.06
|
2.34 Titers
Interval 1.49 to 3.67
|
2.48 Titers
Interval 1.55 to 3.97
|
1.28 Titers
Interval 1.11 to 1.49
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M14459(fHBP) - month 7 (n=25,24,23,25,22,73)
|
16 Titers
Interval 10.0 to 27.0
|
27 Titers
Interval 17.0 to 44.0
|
45 Titers
Interval 27.0 to 75.0
|
20 Titers
Interval 13.0 to 33.0
|
12 Titers
Interval 7.07 to 20.0
|
1.28 Titers
Interval 1.1 to 1.49
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M07-0241084(NHBA) - month 6 (n=25,23,23,25,23,70)
|
3.37 Titers
Interval 1.98 to 5.73
|
3.66 Titers
Interval 2.12 to 6.34
|
6.92 Titers
Interval 3.99 to 12.0
|
6.45 Titers
Interval 3.81 to 11.0
|
3.32 Titers
Interval 1.91 to 5.75
|
2.99 Titers
Interval 2.16 to 4.14
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M07-0241084(NHBA) - month 7 (n=25,23,22,25,21,72)
|
12 Titers
Interval 7.07 to 21.0
|
9.48 Titers
Interval 5.37 to 17.0
|
38 Titers
Interval 21.0 to 69.0
|
25 Titers
Interval 15.0 to 44.0
|
9.73 Titers
Interval 5.33 to 18.0
|
3.03 Titers
Interval 2.22 to 4.15
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M01-0240364 (NadA) - month 6 (n=25,21,23,24,21,71)
|
4.62 Titers
Interval 2.15 to 9.95
|
9.98 Titers
Interval 4.37 to 23.0
|
6.95 Titers
Interval 3.19 to 15.0
|
7.44 Titers
Interval 3.44 to 16.0
|
7.21 Titers
Interval 3.15 to 17.0
|
1.18 Titers
Interval 1.0 to 1.39
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M01-0240364 (NadA) - month 7 (n=24,23,23,25,23,71)
|
311 Titers
Interval 152.0 to 637.0
|
533 Titers
Interval 259.0 to 1098.0
|
385 Titers
Interval 188.0 to 786.0
|
286 Titers
Interval 143.0 to 573.0
|
474 Titers
Interval 229.0 to 980.0
|
1.18 Titers
Interval 1.0 to 1.39
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 7Population: Analysis was done by MITT Month 7 Set.
Antibody response was measured as Geometric Mean Ratio (95% CI), against Serogroup B Test Strains at One Month After the Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Outcome measures
| Measure |
3ABCWY
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=25 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=25 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
H44/76 (fHbp) (n=25,24,24,24,22,72)
|
18 Ratio
Interval 12.0 to 29.0
|
22 Ratio
Interval 14.0 to 36.0
|
14 Ratio
Interval 8.88 to 23.0
|
22 Ratio
Interval 14.0 to 36.0
|
16 Ratio
Interval 9.83 to 26.0
|
1.03 Ratio
Interval 0.98 to 1.08
|
—
|
—
|
—
|
—
|
—
|
|
GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
5/99 (NadA) (n=25,24,23,25,23,72)
|
6.96 Ratio
Interval 5.15 to 9.42
|
6.04 Ratio
Interval 4.45 to 8.21
|
14 Ratio
Interval 11.0 to 20.0
|
6.25 Ratio
Interval 4.63 to 8.44
|
5.47 Ratio
Interval 4.0 to 7.48
|
1.12 Ratio
Interval 0.93 to 1.36
|
—
|
—
|
—
|
—
|
—
|
|
GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
NZ98/254 (PorA) (n=25,24,23,25,23,72)
|
1.21 Ratio
Interval 0.87 to 1.67
|
1.76 Ratio
Interval 1.26 to 2.45
|
6.56 Ratio
Interval 4.67 to 9.2
|
6.29 Ratio
Interval 4.55 to 8.69
|
1.45 Ratio
Interval 1.04 to 2.04
|
1.05 Ratio
Interval 0.95 to 1.15
|
—
|
—
|
—
|
—
|
—
|
|
GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M14459 (fHBP) (n=25,24,23,25,22,71)
|
5.99 Ratio
Interval 4.11 to 8.73
|
8.1 Ratio
Interval 5.54 to 12.0
|
9.08 Ratio
Interval 6.14 to 13.0
|
8.58 Ratio
Interval 5.91 to 12.0
|
4.37 Ratio
Interval 2.93 to 6.53
|
1.01 Ratio
Interval 0.91 to 1.11
|
—
|
—
|
—
|
—
|
—
|
|
GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M07-0241084 (NHBA) (n=25,22,20,25,21,69)
|
3.61 Ratio
Interval 2.57 to 5.09
|
2.46 Ratio
Interval 1.71 to 3.54
|
5.18 Ratio
Interval 3.53 to 7.58
|
3.92 Ratio
Interval 2.8 to 5.51
|
2.75 Ratio
Interval 1.89 to 4.01
|
1.01 Ratio
Interval 0.91 to 1.12
|
—
|
—
|
—
|
—
|
—
|
|
GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M01-0240364 (NadA) (n=24,20,23,24,21,69)
|
65 Ratio
Interval 37.0 to 114.0
|
50 Ratio
Interval 27.0 to 92.0
|
65 Ratio
Interval 37.0 to 116.0
|
40 Ratio
Interval 23.0 to 71.0
|
66 Ratio
Interval 36.0 to 120.0
|
1 Ratio
Interval 0.97 to 1.04
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 7Population: Analysis was done by MITT month 7 Set.
Antibody response was measured as the percentage of subjects with seroresponse Against N meningitidis Serogroups A, C, W and Y, after pre and post vaccination at month 6 and after the third vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo. Seroresponse to N meningitidis serogroups A, C, W and Y is defined as: For subjects with a prevaccination hSBA \<1:4, a postvaccination hSBA ≥1:8;For subjects with a prevaccination hSBA ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Outcome measures
| Measure |
3ABCWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=23 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=25 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=22 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=71 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. A (n=22,24,21,25,22,68)
|
59 Percentages of subjects
Interval 36.0 to 79.0
|
67 Percentages of subjects
Interval 45.0 to 84.0
|
67 Percentages of subjects
Interval 43.0 to 85.0
|
72 Percentages of subjects
Interval 51.0 to 88.0
|
82 Percentages of subjects
Interval 60.0 to 95.0
|
3 Percentages of subjects
Interval 0.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. C (n=21,24,22,24,20,70)
|
48 Percentages of subjects
Interval 26.0 to 70.0
|
54 Percentages of subjects
Interval 33.0 to 74.0
|
59 Percentages of subjects
Interval 36.0 to 79.0
|
67 Percentages of subjects
Interval 45.0 to 84.0
|
60 Percentages of subjects
Interval 36.0 to 81.0
|
0 Percentages of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. W (n=23,24,21,24,20,69)
|
35 Percentages of subjects
Interval 16.0 to 57.0
|
38 Percentages of subjects
Interval 19.0 to 59.0
|
48 Percentages of subjects
Interval 26.0 to 70.0
|
58 Percentages of subjects
Interval 37.0 to 78.0
|
60 Percentages of subjects
Interval 36.0 to 81.0
|
3 Percentages of subjects
Interval 0.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Ser. Y (n=24,24,23,25,22,71)
|
29 Percentages of subjects
Interval 13.0 to 51.0
|
38 Percentages of subjects
Interval 19.0 to 59.0
|
43 Percentages of subjects
Interval 23.0 to 66.0
|
32 Percentages of subjects
Interval 15.0 to 54.0
|
5 Percentages of subjects
Interval 0.0 to 23.0
|
0 Percentages of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 7Population: Analysis was done by MITT month 7 Set.
Antibody response was measured as the percentage of subjects with 4-fold Increase in human serum bactericidal assay (hSBA) titers and associated 95% CI, Against Serogroup B Test Strains at One Month After Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Outcome measures
| Measure |
3ABCWY
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=24 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=25 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=72 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
H44/76 (fHbp) (n=25,24,24,24,22,72)
|
80 Percentages of subjects
Interval 59.0 to 93.0
|
88 Percentages of subjects
Interval 68.0 to 97.0
|
83 Percentages of subjects
Interval 63.0 to 95.0
|
88 Percentages of subjects
Interval 68.0 to 97.0
|
73 Percentages of subjects
Interval 50.0 to 89.0
|
0 Percentages of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
5/99 (NadA) (n=25,24,23,25,23,72)
|
80 Percentages of subjects
Interval 59.0 to 93.0
|
67 Percentages of subjects
Interval 45.0 to 84.0
|
83 Percentages of subjects
Interval 61.0 to 95.0
|
76 Percentages of subjects
Interval 55.0 to 91.0
|
57 Percentages of subjects
Interval 34.0 to 77.0
|
3 Percentages of subjects
Interval 0.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
NZ98/254 (PorA) (n=25,24,23,25,23,72)
|
4 Percentages of subjects
Interval 0.0 to 20.0
|
17 Percentages of subjects
Interval 5.0 to 37.0
|
61 Percentages of subjects
Interval 39.0 to 80.0
|
44 Percentages of subjects
Interval 24.0 to 65.0
|
17 Percentages of subjects
Interval 5.0 to 39.0
|
1 Percentages of subjects
Interval 0.035 to 7.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M14459 (fHBP) (n=25,24,23,25,22,71)
|
56 Percentages of subjects
Interval 35.0 to 76.0
|
54 Percentages of subjects
Interval 33.0 to 74.0
|
65 Percentages of subjects
Interval 43.0 to 84.0
|
52 Percentages of subjects
Interval 31.0 to 72.0
|
50 Percentages of subjects
Interval 28.0 to 72.0
|
1 Percentages of subjects
Interval 0.036 to 8.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M07-0241084 (NHBA) (n=25,22,20,25,21,69)
|
36 Percentages of subjects
Interval 18.0 to 57.0
|
23 Percentages of subjects
Interval 8.0 to 45.0
|
60 Percentages of subjects
Interval 36.0 to 81.0
|
44 Percentages of subjects
Interval 24.0 to 65.0
|
29 Percentages of subjects
Interval 11.0 to 52.0
|
0 Percentages of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
M01-0240364 (NadA) (n=24,20,23,24,21,69)
|
88 Percentages of subjects
Interval 68.0 to 97.0
|
80 Percentages of subjects
Interval 56.0 to 94.0
|
83 Percentages of subjects
Interval 61.0 to 95.0
|
79 Percentages of subjects
Interval 58.0 to 93.0
|
90 Percentages of subjects
Interval 70.0 to 99.0
|
0 Percentages of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 1, 3, 6, 7 and 12Population: Analysis was done by MITT Set.
Antibody response was measured as Geometric Mean hSBA Titers Against N meningitidis Serogroups A, C, W and Y after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.
Outcome measures
| Measure |
3ABCWY
n=49 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=48 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=48 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=49 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=50 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 12 (n=45,47,45,46,50,70)
|
88 Titers
Interval 55.0 to 141.0
|
112 Titers
Interval 71.0 to 178.0
|
55 Titers
Interval 34.0 to 88.0
|
75 Titers
Interval 47.0 to 121.0
|
1.59 Titers
Interval 1.01 to 2.5
|
47 Titers
Interval 31.0 to 69.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 7 (n=46,47,45,47,45,72)
|
173 Titers
Interval 125.0 to 240.0
|
167 Titers
Interval 121.0 to 230.0
|
118 Titers
Interval 85.0 to 164.0
|
168 Titers
Interval 121.0 to 234.0
|
13 Titers
Interval 9.72 to 19.0
|
121 Titers
Interval 93.0 to 159.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 1 (n=48,48,47,49,50,70)
|
61 Titers
Interval 35.0 to 107.0
|
61 Titers
Interval 35.0 to 107.0
|
49 Titers
Interval 28.0 to 86.0
|
37 Titers
Interval 21.0 to 65.0
|
2.96 Titers
Interval 1.71 to 5.13
|
107 Titers
Interval 66.0 to 172.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 3 (n=49,48,47,48,50,72)
|
162 Titers
Interval 106.0 to 249.0
|
206 Titers
Interval 134.0 to 316.0
|
183 Titers
Interval 118.0 to 282.0
|
169 Titers
Interval 109.0 to 262.0
|
44 Titers
Interval 29.0 to 68.0
|
36 Titers
Interval 25.0 to 52.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 6 (n=46,46,48,44,49,69)
|
28 Titers
Interval 16.0 to 49.0
|
44 Titers
Interval 25.0 to 78.0
|
21 Titers
Interval 12.0 to 36.0
|
24 Titers
Interval 14.0 to 44.0
|
4.22 Titers
Interval 2.43 to 7.33
|
20 Titers
Interval 12.0 to 32.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 7 (n=48,47,46,49,50,71)
|
24 Titers
Interval 14.0 to 39.0
|
28 Titers
Interval 17.0 to 46.0
|
17 Titers
Interval 9.94 to 28.0
|
17 Titers
Interval 10.0 to 29.0
|
3.18 Titers
Interval 1.95 to 5.19
|
21 Titers
Interval 13.0 to 31.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 12 (n=43,44,45,46,50,71)
|
10 Titers
Interval 5.69 to 18.0
|
9.73 Titers
Interval 5.6 to 17.0
|
8.88 Titers
Interval 5.09 to 15.0
|
8.08 Titers
Interval 4.64 to 14.0
|
2.21 Titers
Interval 1.31 to 3.75
|
14 Titers
Interval 9.03 to 22.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 1 (n=48,48,48,48,50,71)
|
51 Titers
Interval 33.0 to 80.0
|
116 Titers
Interval 75.0 to 180.0
|
99 Titers
Interval 64.0 to 155.0
|
101 Titers
Interval 64.0 to 159.0
|
8.76 Titers
Interval 5.63 to 14.0
|
75 Titers
Interval 51.0 to 109.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 3 (n=49,47,46,48,50,71)
|
340 Titers
Interval 252.0 to 460.0
|
501 Titers
Interval 370.0 to 680.0
|
338 Titers
Interval 248.0 to 461.0
|
380 Titers
Interval 278.0 to 520.0
|
17 Titers
Interval 12.0 to 22.0
|
45 Titers
Interval 35.0 to 58.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 6 (n=46,48,47,48,49,70)
|
133 Titers
Interval 94.0 to 189.0
|
186 Titers
Interval 133.0 to 261.0
|
117 Titers
Interval 83.0 to 165.0
|
157 Titers
Interval 111.0 to 223.0
|
6.77 Titers
Interval 4.82 to 9.52
|
23 Titers
Interval 17.0 to 31.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 7 (n=48,47,46,49,50,72)
|
110 Titers
Interval 78.0 to 156.0
|
153 Titers
Interval 108.0 to 217.0
|
88 Titers
Interval 61.0 to 126.0
|
128 Titers
Interval 90.0 to 183.0
|
5.53 Titers
Interval 3.9 to 7.84
|
18 Titers
Interval 13.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 12 (n=44,46,46,46,50,72)
|
55 Titers
Interval 38.0 to 81.0
|
66 Titers
Interval 45.0 to 95.0
|
45 Titers
Interval 31.0 to 65.0
|
72 Titers
Interval 49.0 to 105.0
|
6.03 Titers
Interval 4.19 to 8.69
|
14 Titers
Interval 10.0 to 19.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 1 (n=48,48,47,48,49,72)
|
163 Titers
Interval 113.0 to 237.0
|
243 Titers
Interval 168.0 to 352.0
|
173 Titers
Interval 119.0 to 252.0
|
233 Titers
Interval 160.0 to 341.0
|
29 Titers
Interval 20.0 to 42.0
|
210 Titers
Interval 154.0 to 287.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 3 (n=49,46,47,48,50,72)
|
370 Titers
Interval 290.0 to 472.0
|
514 Titers
Interval 400.0 to 661.0
|
349 Titers
Interval 272.0 to 448.0
|
435 Titers
Interval 338.0 to 559.0
|
140 Titers
Interval 110.0 to 179.0
|
166 Titers
Interval 135.0 to 204.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 6 (n=44,47,45,45,43,69)
|
202 Titers
Interval 144.0 to 284.0
|
196 Titers
Interval 141.0 to 272.0
|
143 Titers
Interval 102.0 to 200.0
|
194 Titers
Interval 138.0 to 274.0
|
15 Titers
Interval 11.0 to 21.0
|
117 Titers
Interval 88.0 to 154.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 12 (n=45,45,45,43,46,69)
|
119 Titers
Interval 82.0 to 174.0
|
113 Titers
Interval 77.0 to 164.0
|
83 Titers
Interval 57.0 to 120.0
|
109 Titers
Interval 73.0 to 161.0
|
11 Titers
Interval 7.81 to 17.0
|
75 Titers
Interval 55.0 to 103.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 3 (n=49,48,47,49,50,73)
|
214 Titers
Interval 162.0 to 281.0
|
283 Titers
Interval 215.0 to 374.0
|
195 Titers
Interval 147.0 to 258.0
|
226 Titers
Interval 172.0 to 298.0
|
4.7 Titers
Interval 3.58 to 6.18
|
72 Titers
Interval 57.0 to 91.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 1 (n=48,48,48,49,49,73)
|
98 Titers
Interval 66.0 to 145.0
|
119 Titers
Interval 80.0 to 177.0
|
76 Titers
Interval 51.0 to 113.0
|
92 Titers
Interval 62.0 to 136.0
|
5.6 Titers
Interval 3.77 to 8.32
|
92 Titers
Interval 66.0 to 128.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 6 (n=48,48,48,48,49,72)
|
206 Titers
Interval 134.0 to 315.0
|
249 Titers
Interval 162.0 to 382.0
|
138 Titers
Interval 90.0 to 212.0
|
154 Titers
Interval 100.0 to 237.0
|
1.93 Titers
Interval 1.26 to 2.95
|
84 Titers
Interval 58.0 to 120.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 7 (n=46,48,46,49,50,72)
|
180 Titers
Interval 116.0 to 278.0
|
213 Titers
Interval 139.0 to 327.0
|
100 Titers
Interval 65.0 to 155.0
|
127 Titers
Interval 83.0 to 194.0
|
2.05 Titers
Interval 1.34 to 3.13
|
75 Titers
Interval 52.0 to 108.0
|
—
|
—
|
—
|
—
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—
|
SECONDARY outcome
Timeframe: At month 1, 3, 6, 7 and 12Population: Analysis was done by Per MITT Set.
Antibody response was measured as Geometric Mean Ratios (95%CI) Against N meningitidis Serogroups A, C, W and Y after after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Outcome measures
| Measure |
3ABCWY
n=49 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=48 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=48 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=49 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=50 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 6 (n=46,48,47,46,49,69)
|
29 Ratio
Interval 19.0 to 45.0
|
41 Ratio
Interval 27.0 to 63.0
|
22 Ratio
Interval 14.0 to 34.0
|
31 Ratio
Interval 20.0 to 47.0
|
1.07 Ratio
Interval 0.7 to 1.63
|
5.14 Ratio
Interval 3.57 to 7.39
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 7 (n=48,47,46,47,50,71)
|
24 Ratio
Interval 16.0 to 37.0
|
33 Ratio
Interval 21.0 to 51.0
|
16 Ratio
Interval 10.0 to 25.0
|
25 Ratio
Interval 16.0 to 38.0
|
0.85 Ratio
Interval 0.55 to 1.3
|
3.9 Ratio
Interval 2.7 to 5.64
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 12 (n=44,46,46,44,50,71)
|
12 Ratio
Interval 7.82 to 19.0
|
16 Ratio
Interval 10.0 to 24.0
|
8.88 Ratio
Interval 5.7 to 14.0
|
15 Ratio
Interval 9.57 to 24.0
|
0.99 Ratio
Interval 0.65 to 1.52
|
3.06 Ratio
Interval 2.12 to 4.4
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 1 (n=48,47,47,46,49,72)
|
9.2 Ratio
Interval 5.41 to 16.0
|
13 Ratio
Interval 7.42 to 21.0
|
7.41 Ratio
Interval 4.34 to 13.0
|
10 Ratio
Interval 6.1 to 18.0
|
1.15 Ratio
Interval 0.68 to 1.95
|
10 Ratio
Interval 6.49 to 16.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 3 (n=49,45,47,46,50,72)
|
20 Ratio
Interval 11.0 to 34.0
|
27 Ratio
Interval 15.0 to 48.0
|
12 Ratio
Interval 6.7 to 21.0
|
19 Ratio
Interval 11.0 to 35.0
|
4.83 Ratio
Interval 2.76 to 8.46
|
7.32 Ratio
Interval 4.53 to 12.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 6 (n=44,46,45,43,43,69)
|
11 Ratio
Interval 6.33 to 20.0
|
9.75 Ratio
Interval 5.64 to 17.0
|
5.44 Ratio
Interval 3.11 to 9.52
|
9.75 Ratio
Interval 5.51 to 17.0
|
0.58 Ratio
Interval 0.33 to 1.02
|
5.17 Ratio
Interval 3.25 to 8.24
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 7 (n=46,46,45,45,45,72)
|
9.21 Ratio
Interval 5.2 to 16.0
|
8.17 Ratio
Interval 4.64 to 14.0
|
4.84 Ratio
Interval 2.72 to 8.62
|
7.94 Ratio
Interval 4.44 to 14.0
|
0.55 Ratio
Interval 0.31 to 0.97
|
5.47 Ratio
Interval 3.4 to 8.8
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 12 (n=45,44,45,42,46,69)
|
7.33 Ratio
Interval 4.08 to 13.0
|
6.54 Ratio
Interval 3.62 to 12.0
|
3.52 Ratio
Interval 1.95 to 6.33
|
4.83 Ratio
Interval 2.62 to 8.92
|
0.49 Ratio
Interval 0.27 to 0.89
|
3.62 Ratio
Interval 2.21 to 5.94
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 1 (n=48,47,48,49,49,73)
|
21 Ratio
Interval 13.0 to 32.0
|
26 Ratio
Interval 17.0 to 40.0
|
15 Ratio
Interval 9.89 to 24.0
|
20 Ratio
Interval 13.0 to 31.0
|
1.02 Ratio
Interval 0.66 to 1.58
|
16 Ratio
Interval 11.0 to 23.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 7 (n=46,47,46,49,50,72)
|
37 Ratio
Interval 22.0 to 61.0
|
45 Ratio
Interval 27.0 to 74.0
|
19 Ratio
Interval 11.0 to 31.0
|
26 Ratio
Interval 16.0 to 43.0
|
0.35 Ratio
Interval 0.21 to 0.56
|
12 Ratio
Interval 7.76 to 18.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 12 (n=45,46,45,46,50,70)
|
18 Ratio
Interval 11.0 to 31.0
|
25 Ratio
Interval 15.0 to 42.0
|
10 Ratio
Interval 6.14 to 18.0
|
16 Ratio
Interval 9.64 to 28.0
|
0.27 Ratio
Interval 0.16 to 0.45
|
7.27 Ratio
Interval 4.68 to 11.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 1 (n=48,48,47,48,50,70)
|
41 Ratio
Interval 23.0 to 73.0
|
45 Ratio
Interval 26.0 to 80.0
|
36 Ratio
Interval 20.0 to 65.0
|
30 Ratio
Interval 17.0 to 53.0
|
2.25 Ratio
Interval 1.28 to 3.93
|
78 Ratio
Interval 48.0 to 127.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 3 (n=49,48,47,47,50,72)
|
107 Ratio
Interval 68.0 to 168.0
|
150 Ratio
Interval 95.0 to 235.0
|
135 Ratio
Interval 85.0 to 214.0
|
137 Ratio
Interval 86.0 to 217.0
|
34 Ratio
Interval 21.0 to 52.0
|
26 Ratio
Interval 18.0 to 38.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 6 (n=46,46,48,44,49,69)
|
19 Ratio
Interval 11.0 to 34.0
|
32 Ratio
Interval 18.0 to 57.0
|
15 Ratio
Interval 8.77 to 27.0
|
20 Ratio
Interval 11.0 to 35.0
|
3.19 Ratio
Interval 1.85 to 5.59
|
15 Ratio
Interval 9.12 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 7 (n=48,47,46,48,50,71)
|
16 Ratio
Interval 9.83 to 27.0
|
21 Ratio
Interval 12.0 to 34.0
|
12 Ratio
Interval 7.36 to 21.0
|
14 Ratio
Interval 8.22 to 23.0
|
2.41 Ratio
Interval 1.47 to 3.97
|
15 Ratio
Interval 9.87 to 23.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 12 (n=43,44,45,45,50,71)
|
6.97 Ratio
Interval 3.93 to 12.0
|
7.18 Ratio
Interval 4.11 to 13.0
|
6.61 Ratio
Interval 3.77 to 12.0
|
6.42 Ratio
Interval 3.67 to 11.0
|
1.68 Ratio
Interval 0.99 to 2.85
|
11 Ratio
Interval 6.65 to 17.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 1 (n=48,48,48,47,50,70)
|
11 Ratio
Interval 6.83 to 19.0
|
26 Ratio
Interval 16.0 to 43.0
|
19 Ratio
Interval 12.0 to 31.0
|
20 Ratio
Interval 12.0 to 33.0
|
1.42 Ratio
Interval 0.87 to 2.32
|
16 Ratio
Interval 11.0 to 25.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 3 (n=49,47,46,46,50,70)
|
72 Ratio
Interval 47.0 to 110.0
|
114 Ratio
Interval 74.0 to 175.0
|
60 Ratio
Interval 39.0 to 93.0
|
71 Ratio
Interval 45.0 to 110.0
|
2.36 Ratio
Interval 1.54 to 3.59
|
9.54 Ratio
Interval 6.61 to 14.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 6 (n=48,47,48,48,49,72)
|
44 Ratio
Interval 27.0 to 71.0
|
56 Ratio
Interval 34.0 to 91.0
|
27 Ratio
Interval 16.0 to 44.0
|
33 Ratio
Interval 20.0 to 54.0
|
0.35 Ratio
Interval 0.21 to 0.56
|
14 Ratio
Interval 9.04 to 21.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 3 (n=49,47,47,49,50,73)
|
44 Ratio
Interval 30.0 to 63.0
|
59 Ratio
Interval 41.0 to 85.0
|
37 Ratio
Interval 25.0 to 54.0
|
47 Ratio
Interval 33.0 to 68.0
|
0.8 Ratio
Interval 0.56 to 1.15
|
12 Ratio
Interval 8.54 to 16.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 1, 3, 6, 7 and 12Population: Analysis was done by MITT Set.
Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, After Third Vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Outcome measures
| Measure |
3ABCWY
n=49 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=49 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=48 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=49 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=50 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 1 (n=48,48,48,49,50,73)
|
5.56 Titers
Interval 3.44 to 8.99
|
10 Titers
Interval 6.38 to 17.0
|
15 Titers
Interval 9.5 to 25.0
|
11 Titers
Interval 6.93 to 18.0
|
4.56 Titers
Interval 2.84 to 7.3
|
1.51 Titers
Interval 1.19 to 1.92
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 3 (n=49,48,46,48,50,72)
|
74 Titers
Interval 53.0 to 102.0
|
114 Titers
Interval 82.0 to 158.0
|
114 Titers
Interval 81.0 to 159.0
|
133 Titers
Interval 96.0 to 186.0
|
44 Titers
Interval 32.0 to 61.0
|
1.27 Titers
Interval 1.07 to 1.5
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 6 (n=47,48,48,48,50,72)
|
7.87 Titers
Interval 5.04 to 12.0
|
7.76 Titers
Interval 4.98 to 12.0
|
9.44 Titers
Interval 6.04 to 15.0
|
14 Titers
Interval 9.2 to 23.0
|
4.34 Titers
Interval 2.81 to 6.71
|
1.18 Titers
Interval 1.01 to 1.37
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 7 (n=48,48,47,49,49,73)
|
4.62 Titers
Interval 3.04 to 7.02
|
5.75 Titers
Interval 3.79 to 8.73
|
6.12 Titers
Interval 4.0 to 9.37
|
11 Titers
Interval 7.15 to 17.0
|
3.55 Titers
Interval 2.35 to 5.37
|
1.21 Titers
Interval 1.04 to 1.4
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 1 (n=48,48,47,49,50,72)
|
44 Titers
Interval 29.0 to 65.0
|
91 Titers
Interval 62.0 to 135.0
|
23 Titers
Interval 15.0 to 34.0
|
34 Titers
Interval 23.0 to 51.0
|
58 Titers
Interval 39.0 to 85.0
|
2.27 Titers
Interval 1.82 to 2.85
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 3 (n=49,48,47,47,50,71)
|
257 Titers
Interval 203.0 to 324.0
|
401 Titers
Interval 318.0 to 507.0
|
337 Titers
Interval 266.0 to 427.0
|
363 Titers
Interval 285.0 to 462.0
|
322 Titers
Interval 255.0 to 406.0
|
2.11 Titers
Interval 1.65 to 2.7
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 6 (n=47,49,48,48,48,72)
|
69 Titers
Interval 51.0 to 93.0
|
122 Titers
Interval 91.0 to 163.0
|
55 Titers
Interval 41.0 to 74.0
|
72 Titers
Interval 53.0 to 97.0
|
73 Titers
Interval 54.0 to 98.0
|
1.74 Titers
Interval 1.36 to 2.22
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 7 (n=47,48,47,49,50,73)
|
55 Titers
Interval 42.0 to 73.0
|
96 Titers
Interval 72.0 to 127.0
|
44 Titers
Interval 33.0 to 58.0
|
59 Titers
Interval 45.0 to 79.0
|
68 Titers
Interval 51.0 to 90.0
|
1.93 Titers
Interval 1.5 to 2.48
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 12 (n=45,47,46,46,50,72)
|
31 Titers
Interval 22.0 to 44.0
|
46 Titers
Interval 33.0 to 64.0
|
30 Titers
Interval 21.0 to 42.0
|
35 Titers
Interval 25.0 to 49.0
|
32 Titers
Interval 23.0 to 44.0
|
1.53 Titers
Interval 1.25 to 1.88
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 1 (n=48,48,48,49,50,72)
|
2.14 Titers
Interval 1.58 to 2.9
|
2.42 Titers
Interval 1.8 to 3.26
|
4.95 Titers
Interval 3.66 to 6.7
|
4.26 Titers
Interval 3.15 to 5.77
|
2.01 Titers
Interval 1.49 to 2.71
|
1.51 Titers
Interval 1.32 to 1.74
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 6 (n=48,49,48,48,49,72)
|
1.7 Titers
Interval 1.28 to 2.26
|
1.88 Titers
Interval 1.42 to 2.48
|
3.19 Titers
Interval 2.4 to 4.25
|
3.09 Titers
Interval 2.31 to 4.13
|
1.47 Titers
Interval 1.1 to 1.95
|
1.15 Titers
Interval 1.05 to 1.25
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 7 (n=47,48,47,49,50,73)
|
1.45 Titers
Interval 1.05 to 2.0
|
1.76 Titers
Interval 1.29 to 2.41
|
2.62 Titers
Interval 1.9 to 3.62
|
2.49 Titers
Interval 1.81 to 3.43
|
1.45 Titers
Interval 1.06 to 2.0
|
1.2 Titers
Interval 1.07 to 1.33
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 12 (n=45,47,46,46,50,72)
|
1.57 Titers
Interval 1.2 to 2.06
|
1.6 Titers
Interval 1.23 to 2.09
|
2.47 Titers
Interval 1.89 to 3.24
|
2.18 Titers
Interval 1.66 to 2.86
|
1.21 Titers
Interval 0.93 to 1.57
|
1.15 Titers
Interval 1.05 to 1.25
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 3 (n=49,48,45,43,50,70)
|
6.31 Titers
Interval 4.28 to 9.32
|
13 Titers
Interval 8.91 to 20.0
|
17 Titers
Interval 11.0 to 26.0
|
20 Titers
Interval 13.0 to 30.0
|
5.04 Titers
Interval 3.39 to 7.47
|
1.29 Titers
Interval 1.1 to 1.51
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 6 (n=47,47,48,48,50,71)
|
2.1 Titers
Interval 1.59 to 2.79
|
2.63 Titers
Interval 1.99 to 3.49
|
3.33 Titers
Interval 2.49 to 4.44
|
3.15 Titers
Interval 2.35 to 4.24
|
2.05 Titers
Interval 1.55 to 2.71
|
1.28 Titers
Interval 1.11 to 1.49
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 7 (n=47,48,47,49,50,73)
|
1.79 Titers
Interval 1.29 to 2.49
|
2.4 Titers
Interval 1.74 to 3.33
|
2.75 Titers
Interval 1.96 to 3.86
|
3.59 Titers
Interval 2.55 to 5.06
|
1.87 Titers
Interval 1.35 to 2.59
|
1.28 Titers
Interval 1.1 to 1.49
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 12 ( n=45,47,45,47,50,72)
|
1.73 Titers
Interval 1.31 to 2.27
|
1.64 Titers
Interval 1.25 to 2.14
|
2.43 Titers
Interval 1.83 to 3.23
|
2.53 Titers
Interval 1.91 to 3.36
|
1.44 Titers
Interval 1.1 to 1.87
|
1.37 Titers
Interval 1.15 to 1.64
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084 (NHBA) - month 3 (n=48,48,42,45,49,68)
|
4.34 Titers
Interval 3.27 to 5.75
|
6.27 Titers
Interval 4.71 to 8.33
|
12 Titers
Interval 8.71 to 17.0
|
14 Titers
Interval 10.0 to 19.0
|
6.25 Titers
Interval 4.71 to 8.28
|
2.85 Titers
Interval 2.08 to 3.91
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084 (NHBA) - month 6 (n=47,48,48,48,49,70)
|
3.78 Titers
Interval 2.88 to 4.95
|
3.3 Titers
Interval 2.51 to 4.34
|
5.43 Titers
Interval 4.0 to 7.37
|
6.93 Titers
Interval 5.23 to 9.19
|
3.36 Titers
Interval 2.56 to 4.4
|
2.99 Titers
Interval 2.16 to 4.14
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084 (NHBA) - month 7 (n=47,48,47,48,50,72)
|
3.51 Titers
Interval 2.54 to 4.85
|
3.19 Titers
Interval 2.3 to 4.41
|
5.18 Titers
Interval 3.58 to 7.48
|
6.58 Titers
Interval 4.7 to 9.22
|
3.78 Titers
Interval 2.74 to 5.2
|
3.03 Titers
Interval 2.22 to 4.15
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 1 (n=48,44,46,48,50,72)
|
5.46 Titers
Interval 3.1 to 9.61
|
6.42 Titers
Interval 3.54 to 12.0
|
4.7 Titers
Interval 2.58 to 8.58
|
4.24 Titers
Interval 2.33 to 7.71
|
4.25 Titers
Interval 2.44 to 7.41
|
1.12 Titers
Interval 0.98 to 1.29
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 6 (n=46,48,48,48,48,71)
|
8.59 Titers
Interval 4.95 to 15.0
|
17 Titers
Interval 9.65 to 29.0
|
11 Titers
Interval 6.48 to 20.0
|
6.27 Titers
Interval 3.52 to 11.0
|
7.02 Titers
Interval 4.07 to 12.0
|
1.18 Titers
Interval 1.0 to 1.39
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 7 (n=44,48,48,48,50,71)
|
5.38 Titers
Interval 3.2 to 9.03
|
9.65 Titers
Interval 5.83 to 16.0
|
7.51 Titers
Interval 4.45 to 13.0
|
4.13 Titers
Interval 2.43 to 7.01
|
5.72 Titers
Interval 3.49 to 9.35
|
1.18 Titers
Interval 1.0 to 1.39
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 12 (n=45,47,45,46,50,71)
|
3.24 Titers
Interval 2.18 to 4.8
|
2.31 Titers
Interval 1.57 to 3.39
|
4 Titers
Interval 2.69 to 5.97
|
4.31 Titers
Interval 2.91 to 6.4
|
2.42 Titers
Interval 1.66 to 3.52
|
1.13 Titers
Interval 1.0 to 1.29
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 3 (n=49,48,47,48,50,72)
|
2.98 Titers
Interval 2.18 to 4.06
|
3.86 Titers
Interval 2.83 to 5.26
|
14 Titers
Interval 10.0 to 19.0
|
12 Titers
Interval 8.96 to 17.0
|
2.81 Titers
Interval 2.06 to 3.84
|
1.49 Titers
Interval 1.29 to 1.72
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 1 (n=48,48,47,49,50,72)
|
1.99 Titers
Interval 1.44 to 2.75
|
2.66 Titers
Interval 1.92 to 3.68
|
4.59 Titers
Interval 3.28 to 6.44
|
3.47 Titers
Interval 2.47 to 4.89
|
2.02 Titers
Interval 1.46 to 2.8
|
1.26 Titers
Interval 1.08 to 1.47
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084 (NHBA) - month 1 (n=48,48,48,48,50,72)
|
2.88 Titers
Interval 2.17 to 3.81
|
3.17 Titers
Interval 2.39 to 4.21
|
7.11 Titers
Interval 5.18 to 9.76
|
5.51 Titers
Interval 4.12 to 7.36
|
3.76 Titers
Interval 2.85 to 4.97
|
2.68 Titers
Interval 1.93 to 3.7
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 3 (n=48,48,44,42,49,70)
|
67 Titers
Interval 38.0 to 118.0
|
192 Titers
Interval 109.0 to 339.0
|
133 Titers
Interval 72.0 to 245.0
|
125 Titers
Interval 67.0 to 233.0
|
88 Titers
Interval 50.0 to 154.0
|
1.41 Titers
Interval 1.07 to 1.85
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month12 (n=43,45,44,44,50,72)
|
3.85 Titers
Interval 2.16 to 6.84
|
4.79 Titers
Interval 2.72 to 8.44
|
5.76 Titers
Interval 3.19 to 10.0
|
3.23 Titers
Interval 1.78 to 5.87
|
2.88 Titers
Interval 1.68 to 4.92
|
1.15 Titers
Interval 0.97 to 1.37
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084(NHBA) - month 12 (n=45,46,45,47,50,70)
|
3.71 Titers
Interval 2.74 to 5.03
|
2.82 Titers
Interval 2.08 to 3.83
|
4.92 Titers
Interval 3.51 to 6.89
|
6.16 Titers
Interval 4.53 to 8.38
|
3.09 Titers
Interval 2.31 to 4.14
|
2.91 Titers
Interval 2.06 to 4.12
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 1, 3, 6, 7 and 12Population: Analysis was done by MITT Set.
Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (month 6) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Outcome measures
| Measure |
3ABCWY
n=49 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=49 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=48 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=49 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=50 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459(fHBP) - month 6 (n=47,46,45,44,50,70)
|
1.65 Ratio
Interval 1.25 to 2.19
|
2.04 Ratio
Interval 1.54 to 2.71
|
2.58 Ratio
Interval 1.94 to 3.45
|
2.46 Ratio
Interval 1.83 to 3.31
|
1.53 Ratio
Interval 1.16 to 2.02
|
0.99 Ratio
Interval 0.87 to 1.12
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459(fHBP) - month 7 (n=47,47,44,45,50,72)
|
1.4 Ratio
Interval 1.0 to 1.96
|
1.82 Ratio
Interval 1.31 to 2.54
|
2.08 Ratio
Interval 1.48 to 2.94
|
2.75 Ratio
Interval 1.95 to 3.9
|
1.3 Ratio
Interval 0.94 to 1.8
|
0.97 Ratio
Interval 0.83 to 1.13
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 1 (n=48,47,47,48,50,73)
|
4.42 Ratio
Interval 2.73 to 7.16
|
7.99 Ratio
Interval 4.95 to 13.0
|
12 Ratio
Interval 7.44 to 20.0
|
8.82 Ratio
Interval 5.43 to 14.0
|
3.53 Ratio
Interval 2.2 to 5.65
|
1.15 Ratio
Interval 0.98 to 1.35
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 3 (n=49,47,45,47,50,72)
|
61 Ratio
Interval 42.0 to 87.0
|
84 Ratio
Interval 58.0 to 121.0
|
87 Ratio
Interval 60.0 to 127.0
|
103 Ratio
Interval 71.0 to 150.0
|
32 Ratio
Interval 22.0 to 46.0
|
1.05 Ratio
Interval 0.89 to 1.24
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 6 (n=47,47,47,47,50,72)
|
6.3 Ratio
Interval 4.01 to 9.9
|
5.94 Ratio
Interval 3.79 to 9.3
|
7.37 Ratio
Interval 4.69 to 12.0
|
11 Ratio
Interval 7.14 to 18.0
|
3.31 Ratio
Interval 2.13 to 5.14
|
0.89 Ratio
Interval 0.78 to 1.02
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 1 (n=48,48,47,48,50,72)
|
18 Ratio
Interval 12.0 to 29.0
|
42 Ratio
Interval 27.0 to 65.0
|
12 Ratio
Interval 7.41 to 18.0
|
16 Ratio
Interval 10.0 to 26.0
|
21 Ratio
Interval 13.0 to 33.0
|
1 Ratio
Interval 0.85 to 1.18
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 3 (n=49,48,47,46,50,71)
|
106 Ratio
Interval 74.0 to 151.0
|
184 Ratio
Interval 129.0 to 263.0
|
176 Ratio
Interval 122.0 to 253.0
|
174 Ratio
Interval 120.0 to 252.0
|
107 Ratio
Interval 75.0 to 153.0
|
1 Ratio
Interval 0.8 to 1.26
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 6 (n=47,49,48,47,48,72)
|
28 Ratio
Interval 19.0 to 41.0
|
56 Ratio
Interval 39.0 to 82.0
|
29 Ratio
Interval 20.0 to 42.0
|
35 Ratio
Interval 24.0 to 51.0
|
25 Ratio
Interval 17.0 to 37.0
|
0.78 Ratio
Interval 0.61 to 0.99
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 7 (n=47,48,47,48,50,73)
|
23 Ratio
Interval 16.0 to 34.0
|
44 Ratio
Interval 30.0 to 63.0
|
23 Ratio
Interval 16.0 to 33.0
|
29 Ratio
Interval 20.0 to 42.0
|
23 Ratio
Interval 16.0 to 34.0
|
0.86 Ratio
Interval 0.68 to 1.08
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 12 (n=45,47,46,45,50,72)
|
13 Ratio
Interval 8.78 to 20.0
|
21 Ratio
Interval 14.0 to 31.0
|
15 Ratio
Interval 10.0 to 23.0
|
18 Ratio
Interval 12.0 to 28.0
|
11 Ratio
Interval 7.48 to 16.0
|
0.7 Ratio
Interval 0.59 to 0.83
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254(PorA) - month 1 (n=48,48,48,48,50,72)
|
1.27 Ratio
Interval 0.93 to 1.73
|
1.46 Ratio
Interval 1.07 to 1.98
|
2.91 Ratio
Interval 2.14 to 3.96
|
2.51 Ratio
Interval 1.84 to 3.42
|
1.08 Ratio
Interval 0.8 to 1.46
|
1 Ratio
Interval 0.87 to 1.16
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364(NadA) - month 6 (n=46,46,44,44,48,70)
|
7.07 Ratio
Interval 4.05 to 12.0
|
13 Ratio
Interval 7.46 to 22.0
|
9.18 Ratio
Interval 5.17 to 16.0
|
4.78 Ratio
Interval 2.68 to 8.54
|
5.32 Ratio
Interval 3.08 to 9.19
|
1.05 Ratio
Interval 0.9 to 1.23
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364(NadA) - month 12 (n=43,43,41,40,50,71)
|
3.17 Ratio
Interval 1.77 to 5.69
|
3.77 Ratio
Interval 2.12 to 6.69
|
4.65 Ratio
Interval 2.55 to 8.47
|
2.52 Ratio
Interval 1.38 to 4.62
|
2.17 Ratio
Interval 1.26 to 3.72
|
1.03 Ratio
Interval 0.87 to 1.22
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254(PorA) - month 12 (n=45,47,46,45,50,72)
|
0.91 Ratio
Interval 0.68 to 1.22
|
0.97 Ratio
Interval 0.73 to 1.29
|
1.41 Ratio
Interval 1.05 to 1.88
|
1.25 Ratio
Interval 0.93 to 1.68
|
0.6 Ratio
Interval 0.46 to 0.8
|
0.77 Ratio
Interval 0.66 to 0.9
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459(fHBP) - month 3 (n=49,47,42,41,50,69)
|
4.96 Ratio
Interval 3.35 to 7.36
|
10 Ratio
Interval 6.77 to 15.0
|
13 Ratio
Interval 8.66 to 20.0
|
15 Ratio
Interval 9.83 to 23.0
|
3.54 Ratio
Interval 2.4 to 5.23
|
1.04 Ratio
Interval 0.9 to 1.2
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 7 (n=48,47,46,48,49,73)
|
3.73 Ratio
Interval 2.43 to 5.75
|
4.34 Ratio
Interval 2.82 to 6.68
|
4.75 Ratio
Interval 3.06 to 7.37
|
8.48 Ratio
Interval 5.49 to 13.0
|
2.66 Ratio
Interval 1.73 to 4.08
|
0.92 Ratio
Interval 0.79 to 1.06
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 12 (n=45,46,44,45,50,71)
|
2.58 Ratio
Interval 1.73 to 3.84
|
1.77 Ratio
Interval 1.2 to 2.61
|
3.11 Ratio
Interval 2.08 to 4.66
|
3.41 Ratio
Interval 2.29 to 5.09
|
1.85 Ratio
Interval 1.27 to 2.71
|
0.86 Ratio
Interval 0.73 to 1.01
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254(PorA) - month 3 (n=49,48,47,47,50,72)
|
1.74 Ratio
Interval 1.26 to 2.4
|
2.33 Ratio
Interval 1.69 to 3.21
|
8.25 Ratio
Interval 5.95 to 11.0
|
7.17 Ratio
Interval 5.16 to 9.96
|
1.46 Ratio
Interval 1.06 to 2.01
|
0.99 Ratio
Interval 0.83 to 1.17
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254(PorA) - month 6 (n=48,49,48,47,49,72)
|
0.99 Ratio
Interval 0.73 to 1.33
|
1.14 Ratio
Interval 0.85 to 1.53
|
1.86 Ratio
Interval 1.38 to 2.52
|
1.79 Ratio
Interval 1.32 to 2.44
|
0.75 Ratio
Interval 0.56 to 1.02
|
0.76 Ratio
Interval 0.65 to 0.89
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254(PorA) - month 7 (n=47,48,47,48,50,73)
|
0.85 Ratio
Interval 0.61 to 1.19
|
1.07 Ratio
Interval 0.76 to 1.49
|
1.53 Ratio
Interval 1.09 to 2.15
|
1.45 Ratio
Interval 1.03 to 2.03
|
0.73 Ratio
Interval 0.52 to 1.01
|
0.8 Ratio
Interval 0.67 to 0.94
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459(fHBP) - month 1 (n=48,47,44,45,50,71)
|
1.57 Ratio
Interval 1.13 to 2.17
|
2.09 Ratio
Interval 1.51 to 2.89
|
3.61 Ratio
Interval 2.58 to 5.06
|
2.73 Ratio
Interval 1.95 to 3.84
|
1.57 Ratio
Interval 1.14 to 2.16
|
0.95 Ratio
Interval 0.87 to 1.03
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364(NadA) - month 3 (n=48,46,40,40,49,69)
|
57 Ratio
Interval 32.0 to 102.0
|
145 Ratio
Interval 80.0 to 261.0
|
105 Ratio
Interval 56.0 to 199.0
|
89 Ratio
Interval 47.0 to 170.0
|
64 Ratio
Interval 36.0 to 113.0
|
1.28 Ratio
Interval 1.01 to 1.63
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364(NadA) - month 7 (n=44,46,44,44,50,70)
|
4.46 Ratio
Interval 2.63 to 7.56
|
7.43 Ratio
Interval 4.45 to 12.0
|
6.03 Ratio
Interval 3.54 to 10.0
|
3.11 Ratio
Interval 1.81 to 5.33
|
4.29 Ratio
Interval 2.6 to 7.08
|
1.07 Ratio
Interval 0.92 to 1.25
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084(NHBA) - month 7(n=46,45,36,43,50,66)
|
1.29 Ratio
Interval 0.91 to 1.82
|
1.05 Ratio
Interval 0.74 to 1.48
|
1.81 Ratio
Interval 1.22 to 2.68
|
2.41 Ratio
Interval 1.68 to 3.46
|
1.12 Ratio
Interval 0.8 to 1.57
|
1.21 Ratio
Interval 0.96 to 1.51
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459(fHBP) - month 12 (n=45,46,42,43,50,71)
|
1.35 Ratio
Interval 1.02 to 1.77
|
1.26 Ratio
Interval 0.96 to 1.65
|
1.86 Ratio
Interval 1.4 to 2.47
|
1.96 Ratio
Interval 1.48 to 2.61
|
1.05 Ratio
Interval 0.81 to 1.37
|
1.03 Ratio
Interval 0.87 to 1.24
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084(NHBA) - month 12 (n=44,43,36,43,50,64)
|
1.38 Ratio
Interval 0.99 to 1.9
|
0.94 Ratio
Interval 0.68 to 1.3
|
1.7 Ratio
Interval 1.18 to 2.43
|
2.24 Ratio
Interval 1.61 to 3.12
|
0.94 Ratio
Interval 0.69 to 1.28
|
1.19 Ratio
Interval 0.9 to 1.58
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364(NadA) - month 1 (n=48,42,42,44,50,71)
|
4.42 Ratio
Interval 2.51 to 7.77
|
5.08 Ratio
Interval 2.8 to 9.2
|
3.77 Ratio
Interval 2.07 to 6.88
|
3.35 Ratio
Interval 1.84 to 6.08
|
3.35 Ratio
Interval 1.93 to 5.83
|
1 Ratio
Interval 0.86 to 1.16
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084(NHBA) - month 1 (n=47,45,37,44,50,66)
|
1.07 Ratio
Interval 0.81 to 1.42
|
1.14 Ratio
Interval 0.86 to 1.52
|
2.6 Ratio
Interval 1.89 to 3.57
|
2.03 Ratio
Interval 1.52 to 2.73
|
1.31 Ratio
Interval 1.0 to 1.72
|
1.02 Ratio
Interval 0.87 to 1.19
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084(NHBA) - month 3 (n=47,45,33,40,49,65)
|
1.62 Ratio
Interval 1.19 to 2.19
|
2.1 Ratio
Interval 1.55 to 2.85
|
4.46 Ratio
Interval 3.11 to 6.39
|
4.94 Ratio
Interval 3.56 to 6.84
|
1.91 Ratio
Interval 1.42 to 2.56
|
1.13 Ratio
Interval 0.89 to 1.44
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084(NHBA) - month 6 (n=46,45,37,43,49,65)
|
1.39 Ratio
Interval 1.04 to 1.85
|
1.13 Ratio
Interval 0.85 to 1.5
|
1.91 Ratio
Interval 1.39 to 2.64
|
2.53 Ratio
Interval 1.88 to 3.4
|
1.07 Ratio
Interval 0.81 to 1.42
|
1.2 Ratio
Interval 0.97 to 1.49
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 1, 3, 6, 7 and 12Population: Analysis was done by MITT Set.
Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Outcome measures
| Measure |
3ABCWY
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=25 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=25 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 12 (n=25,23,21,25,23,70)
|
295 Titers
Interval 158.0 to 550.0
|
351 Titers
Interval 184.0 to 670.0
|
210 Titers
Interval 107.0 to 413.0
|
205 Titers
Interval 110.0 to 381.0
|
1.46 Titers
Interval 0.76 to 2.78
|
47 Titers
Interval 31.0 to 69.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 1 (n=24,24,24,25,23,70)
|
42 Titers
Interval 19.0 to 92.0
|
98 Titers
Interval 45.0 to 213.0
|
44 Titers
Interval 20.0 to 95.0
|
46 Titers
Interval 21.0 to 98.0
|
4.35 Titers
Interval 1.97 to 9.6
|
107 Titers
Interval 66.0 to 172.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 3 (n=25,24,25,25,23,72)
|
132 Titers
Interval 73.0 to 237.0
|
252 Titers
Interval 139.0 to 456.0
|
185 Titers
Interval 103.0 to 333.0
|
153 Titers
Interval 86.0 to 275.0
|
98 Titers
Interval 53.0 to 181.0
|
36 Titers
Interval 25.0 to 52.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 7 (n=24,24,21,25,22,71)
|
247 Titers
Interval 124.0 to 495.0
|
296 Titers
Interval 149.0 to 591.0
|
253 Titers
Interval 121.0 to 530.0
|
256 Titers
Interval 130.0 to 503.0
|
140 Titers
Interval 68.0 to 289.0
|
21 Titers
Interval 13.0 to 31.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 3 (n=25,24,25,24,23,72)
|
398 Titers
Interval 285.0 to 557.0
|
455 Titers
Interval 324.0 to 639.0
|
499 Titers
Interval 357.0 to 697.0
|
406 Titers
Interval 289.0 to 570.0
|
139 Titers
Interval 98.0 to 197.0
|
166 Titers
Interval 135.0 to 204.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 3 (n=25,24,25,24,23,71)
|
482 Titers
Interval 318.0 to 731.0
|
384 Titers
Interval 252.0 to 585.0
|
346 Titers
Interval 228.0 to 523.0
|
381 Titers
Interval 250.0 to 580.0
|
20 Titers
Interval 13.0 to 31.0
|
45 Titers
Interval 35.0 to 58.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 6 (n=22,24,24,24,21,70)
|
182 Titers
Interval 111.0 to 297.0
|
143 Titers
Interval 90.0 to 229.0
|
157 Titers
Interval 98.0 to 251.0
|
118 Titers
Interval 74.0 to 189.0
|
4.58 Titers
Interval 2.77 to 7.57
|
23 Titers
Interval 17.0 to 31.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 6 (n=24,24,25,24,22,69)
|
166 Titers
Interval 105.0 to 261.0
|
176 Titers
Interval 112.0 to 275.0
|
191 Titers
Interval 123.0 to 297.0
|
148 Titers
Interval 94.0 to 231.0
|
10 Titers
Interval 6.28 to 16.0
|
117 Titers
Interval 88.0 to 154.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 7 (n=23,24,23,25,22,72)
|
676 Titers
Interval 410.0 to 1114.0
|
676 Titers
Interval 416.0 to 1097.0
|
636 Titers
Interval 387.0 to 1046.0
|
553 Titers
Interval 344.0 to 891.0
|
33 Titers
Interval 20.0 to 55.0
|
18 Titers
Interval 13.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 12 (n=25,23,21,25,23,72)
|
202 Titers
Interval 123.0 to 334.0
|
185 Titers
Interval 110.0 to 309.0
|
153 Titers
Interval 89.0 to 263.0
|
157 Titers
Interval 96.0 to 258.0
|
7.8 Titers
Interval 4.65 to 13.0
|
14 Titers
Interval 10.0 to 19.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 1 (n=25,24,24,25,23,72)
|
152 Titers
Interval 92.0 to 253.0
|
180 Titers
Interval 108.0 to 300.0
|
237 Titers
Interval 141.0 to 396.0
|
144 Titers
Interval 87.0 to 238.0
|
19 Titers
Interval 11.0 to 32.0
|
210 Titers
Interval 154.0 to 287.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 7 (n=23,24,21,25,21,72)
|
640 Titers
Interval 405.0 to 1014.0
|
670 Titers
Interval 432.0 to 1039.0
|
876 Titers
Interval 548.0 to 1402.0
|
627 Titers
Interval 407.0 to 965.0
|
116 Titers
Interval 72.0 to 187.0
|
121 Titers
Interval 93.0 to 159.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 12(n=24,22,19,24,23,69)
|
264 Titers
Interval 159.0 to 438.0
|
258 Titers
Interval 153.0 to 433.0
|
257 Titers
Interval 147.0 to 449.0
|
212 Titers
Interval 128.0 to 349.0
|
17 Titers
Interval 10.0 to 29.0
|
75 Titers
Interval 55.0 to 103.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 1 (n=25,24,23,25,23,73)
|
75 Titers
Interval 44.0 to 129.0
|
48 Titers
Interval 28.0 to 82.0
|
62 Titers
Interval 36.0 to 109.0
|
71 Titers
Interval 42.0 to 121.0
|
4.38 Titers
Interval 2.51 to 7.67
|
92 Titers
Interval 66.0 to 128.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 3 (n=25,24,25,25,23,73)
|
225 Titers
Interval 154.0 to 328.0
|
179 Titers
Interval 122.0 to 262.0
|
214 Titers
Interval 147.0 to 312.0
|
170 Titers
Interval 117.0 to 247.0
|
4.91 Titers
Interval 3.32 to 7.26
|
72 Titers
Interval 57.0 to 91.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 6 (n=24,24,24,25,23,72)
|
185 Titers
Interval 102.0 to 336.0
|
216 Titers
Interval 119.0 to 390.0
|
147 Titers
Interval 81.0 to 267.0
|
121 Titers
Interval 68.0 to 216.0
|
1.69 Titers
Interval 0.92 to 3.09
|
84 Titers
Interval 58.0 to 120.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 7 (n=25,24,24,25,22,72)
|
648 Titers
Interval 362.0 to 1162.0
|
590 Titers
Interval 327.0 to 1066.0
|
599 Titers
Interval 331.0 to 1085.0
|
408 Titers
Interval 229.0 to 728.0
|
2.56 Titers
Interval 1.38 to 4.77
|
75 Titers
Interval 52.0 to 108.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 6 (n=23,24,24,25,23,69)
|
14 Titers
Interval 6.54 to 32.0
|
40 Titers
Interval 19.0 to 86.0
|
32 Titers
Interval 15.0 to 69.0
|
19 Titers
Interval 8.99 to 41.0
|
4.65 Titers
Interval 2.12 to 10.0
|
20 Titers
Interval 12.0 to 32.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 12 (n=25,23,21,25,22,71)
|
33 Titers
Interval 16.0 to 68.0
|
58 Titers
Interval 27.0 to 123.0
|
47 Titers
Interval 21.0 to 103.0
|
38 Titers
Interval 18.0 to 78.0
|
11 Titers
Interval 5.1 to 24.0
|
14 Titers
Interval 9.03 to 22.0
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 1 (n=25,24,24,25,23,71)
|
125 Titers
Interval 68.0 to 230.0
|
87 Titers
Interval 47.0 to 161.0
|
112 Titers
Interval 61.0 to 208.0
|
74 Titers
Interval 41.0 to 136.0
|
5.93 Titers
Interval 3.16 to 11.0
|
75 Titers
Interval 51.0 to 109.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 1, 3, 6, 7 and 12Population: Analysis was done by MITT Set.
Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Outcome measures
| Measure |
3ABCWY
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=25 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=25 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 1 (n=24,24,24,25,23,70)
|
32 Ratio
Interval 15.0 to 71.0
|
71 Ratio
Interval 32.0 to 155.0
|
35 Ratio
Interval 16.0 to 77.0
|
33 Ratio
Interval 15.0 to 72.0
|
3.45 Ratio
Interval 1.54 to 7.73
|
78 Ratio
Interval 48.0 to 127.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 3 (n=25,24,25,25,23,72)
|
99 Ratio
Interval 53.0 to 185.0
|
176 Ratio
Interval 94.0 to 330.0
|
150 Ratio
Interval 81.0 to 280.0
|
109 Ratio
Interval 59.0 to 202.0
|
79 Ratio
Interval 42.0 to 150.0
|
26 Ratio
Interval 18.0 to 38.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 6 (n=23,24,24,25,23,69)
|
11 Ratio
Interval 4.86 to 24.0
|
29 Ratio
Interval 13.0 to 63.0
|
25 Ratio
Interval 12.0 to 56.0
|
14 Ratio
Interval 6.47 to 30.0
|
3.69 Ratio
Interval 1.66 to 8.2
|
15 Ratio
Interval 9.12 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 1 (n=25,24,24,25,23,70)
|
23 Ratio
Interval 11.0 to 45.0
|
19 Ratio
Interval 9.55 to 38.0
|
26 Ratio
Interval 13.0 to 52.0
|
14 Ratio
Interval 7.09 to 28.0
|
1.51 Ratio
Interval 0.74 to 3.07
|
16 Ratio
Interval 11.0 to 25.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 3 (n=25,24,25,24,23,70)
|
80 Ratio
Interval 44.0 to 143.0
|
81 Ratio
Interval 45.0 to 148.0
|
75 Ratio
Interval 42.0 to 135.0
|
63 Ratio
Interval 35.0 to 114.0
|
5.17 Ratio
Interval 2.81 to 9.52
|
9.54 Ratio
Interval 6.61 to 14.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 6 (n=22,24,24,24,21,69)
|
33 Ratio
Interval 18.0 to 61.0
|
31 Ratio
Interval 17.0 to 56.0
|
33 Ratio
Interval 19.0 to 60.0
|
22 Ratio
Interval 12.0 to 39.0
|
1.16 Ratio
Interval 0.62 to 2.18
|
5.14 Ratio
Interval 3.57 to 7.39
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 7 (n=23,24,23,25,22,71)
|
115 Ratio
Interval 62.0 to 214.0
|
146 Ratio
Interval 80.0 to 266.0
|
139 Ratio
Interval 75.0 to 258.0
|
100 Ratio
Interval 56.0 to 181.0
|
9.09 Ratio
Interval 4.84 to 17.0
|
3.9 Ratio
Interval 2.7 to 5.64
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. C - month 12 (n=25,23,21,25,23,71)
|
37 Ratio
Interval 21.0 to 67.0
|
41 Ratio
Interval 22.0 to 75.0
|
33 Ratio
Interval 18.0 to 63.0
|
30 Ratio
Interval 17.0 to 53.0
|
2.01 Ratio
Interval 1.09 to 3.69
|
3.06 Ratio
Interval 2.12 to 4.4
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 1 (n=25,24,24,25,23,72)
|
6.44 Ratio
Interval 3.12 to 13.0
|
9.65 Ratio
Interval 4.64 to 20.0
|
13 Ratio
Interval 6.09 to 27.0
|
6.3 Ratio
Interval 3.07 to 13.0
|
0.81 Ratio
Interval 0.38 to 1.72
|
10 Ratio
Interval 6.49 to 16.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 3 (n=25,24,25,24,23,72)
|
15 Ratio
Interval 6.85 to 33.0
|
24 Ratio
Interval 11.0 to 52.0
|
24 Ratio
Interval 11.0 to 53.0
|
14 Ratio
Interval 6.51 to 31.0
|
5.42 Ratio
Interval 2.42 to 12.0
|
7.32 Ratio
Interval 4.53 to 12.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 6 (n=24,24,25,24,22,69)
|
6.45 Ratio
Interval 3.03 to 14.0
|
9.27 Ratio
Interval 4.4 to 20.0
|
9.6 Ratio
Interval 4.6 to 20.0
|
6.36 Ratio
Interval 3.02 to 13.0
|
0.45 Ratio
Interval 0.21 to 0.98
|
5.17 Ratio
Interval 3.25 to 8.24
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 7 (n=23,24,21,25,21,72)
|
24 Ratio
Interval 11.0 to 54.0
|
35 Ratio
Interval 16.0 to 76.0
|
41 Ratio
Interval 18.0 to 94.0
|
26 Ratio
Interval 12.0 to 55.0
|
4.78 Ratio
Interval 2.08 to 11.0
|
5.47 Ratio
Interval 3.4 to 8.8
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. W - month 12 (n=24,22,19,24,23,69)
|
11 Ratio
Interval 4.99 to 24.0
|
15 Ratio
Interval 6.76 to 34.0
|
15 Ratio
Interval 6.38 to 37.0
|
9.44 Ratio
Interval 4.32 to 21.0
|
0.75 Ratio
Interval 0.34 to 1.67
|
3.62 Ratio
Interval 2.21 to 5.94
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 1 (n=25,24,23,25,23,73)
|
15 Ratio
Interval 8.32 to 28.0
|
9.78 Ratio
Interval 5.33 to 18.0
|
13 Ratio
Interval 6.88 to 24.0
|
15 Ratio
Interval 8.2 to 27.0
|
1.02 Ratio
Interval 0.55 to 1.9
|
16 Ratio
Interval 11.0 to 23.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 3 (n=25,24,25,25,23,73)
|
43 Ratio
Interval 26.0 to 71.0
|
35 Ratio
Interval 21.0 to 58.0
|
43 Ratio
Interval 26.0 to 72.0
|
34 Ratio
Interval 21.0 to 56.0
|
1.13 Ratio
Interval 0.67 to 1.9
|
12 Ratio
Interval 8.54 to 16.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 6 (n=24,24,24,25,23,72)
|
36 Ratio
Interval 18.0 to 70.0
|
43 Ratio
Interval 22.0 to 84.0
|
30 Ratio
Interval 15.0 to 59.0
|
25 Ratio
Interval 13.0 to 48.0
|
0.39 Ratio
Interval 0.2 to 0.78
|
14 Ratio
Interval 9.04 to 21.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 7 (n=24,24,21,25,22,71)
|
190 Ratio
Interval 94.0 to 385.0
|
214 Ratio
Interval 106.0 to 432.0
|
201 Ratio
Interval 95.0 to 425.0
|
187 Ratio
Interval 94.0 to 372.0
|
110 Ratio
Interval 53.0 to 230.0
|
15 Ratio
Interval 9.87 to 23.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 7 (n=25,24,24,25,22,72)
|
123 Ratio
Interval 63.0 to 242.0
|
115 Ratio
Interval 58.0 to 227.0
|
129 Ratio
Interval 65.0 to 257.0
|
81 Ratio
Interval 42.0 to 159.0
|
0.55 Ratio
Interval 0.27 to 1.14
|
12 Ratio
Interval 7.76 to 18.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. Y - month 12 (n=25,23,21,25,23,70)
|
56 Ratio
Interval 28.0 to 114.0
|
67 Ratio
Interval 32.0 to 139.0
|
43 Ratio
Interval 20.0 to 93.0
|
41 Ratio
Interval 20.0 to 83.0
|
0.33 Ratio
Interval 0.16 to 0.69
|
7.27 Ratio
Interval 4.68 to 11.0
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Ser. A - month 12 (n=25,23,21,25,22,71)
|
25 Ratio
Interval 12.0 to 52.0
|
42 Ratio
Interval 20.0 to 90.0
|
36 Ratio
Interval 16.0 to 81.0
|
28 Ratio
Interval 13.0 to 57.0
|
8.75 Ratio
Interval 4.01 to 19.0
|
11 Ratio
Interval 6.65 to 17.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 1, 3, 6, 7 and 12Population: Analysis was done by MITT Set.
Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Outcome measures
| Measure |
3ABCWY
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=25 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=25 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 3 (n=25,24,24,25,23,72)
|
62 Titers
Interval 40.0 to 97.0
|
115 Titers
Interval 73.0 to 180.0
|
153 Titers
Interval 97.0 to 241.0
|
110 Titers
Interval 71.0 to 171.0
|
71 Titers
Interval 45.0 to 112.0
|
1.27 Titers
Interval 1.07 to 1.5
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 7 (n=25,24,24,25,22,73)
|
108 Titers
Interval 61.0 to 190.0
|
149 Titers
Interval 84.0 to 264.0
|
169 Titers
Interval 95.0 to 302.0
|
118 Titers
Interval 67.0 to 208.0
|
104 Titers
Interval 57.0 to 191.0
|
1.21 Titers
Interval 1.04 to 1.4
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 1 (n=25,24,24,25,23,72)
|
54 Titers
Interval 31.0 to 93.0
|
128 Titers
Interval 74.0 to 222.0
|
29 Titers
Interval 17.0 to 51.0
|
42 Titers
Interval 24.0 to 71.0
|
157 Titers
Interval 90.0 to 276.0
|
2.27 Titers
Interval 1.82 to 2.85
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 3 (n=24,24,25,24,23,71)
|
328 Titers
Interval 237.0 to 455.0
|
426 Titers
Interval 308.0 to 589.0
|
367 Titers
Interval 267.0 to 506.0
|
382 Titers
Interval 277.0 to 528.0
|
454 Titers
Interval 326.0 to 632.0
|
2.11 Titers
Interval 1.65 to 2.7
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 7 (n=25,24,24,25,23,73)
|
530 Titers
Interval 361.0 to 779.0
|
741 Titers
Interval 502.0 to 1092.0
|
674 Titers
Interval 456.0 to 996.0
|
527 Titers
Interval 360.0 to 771.0
|
856 Titers
Interval 575.0 to 1274.0
|
1.93 Titers
Interval 1.5 to 2.48
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 6 (n=25,24,24,25,23,72)
|
1.9 Titers
Interval 1.29 to 2.81
|
1.85 Titers
Interval 1.25 to 2.74
|
3.33 Titers
Interval 2.24 to 4.96
|
1.83 Titers
Interval 1.24 to 2.69
|
1.83 Titers
Interval 1.22 to 2.73
|
1.15 Titers
Interval 1.05 to 1.25
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 7 (n=25,24,24,25,23,73)
|
2.3 Titers
Interval 1.49 to 3.54
|
3.24 Titers
Interval 2.09 to 5.02
|
23 Titers
Interval 15.0 to 35.0
|
12 Titers
Interval 7.5 to 18.0
|
2.65 Titers
Interval 1.69 to 4.14
|
1.2 Titers
Interval 1.07 to 1.33
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 12 (n=25,23,21,25,23,72)
|
1.41 Titers
Interval 0.98 to 2.02
|
1.94 Titers
Interval 1.34 to 2.81
|
5.01 Titers
Interval 3.4 to 7.39
|
2.39 Titers
Interval 1.68 to 3.42
|
1.79 Titers
Interval 1.23 to 2.59
|
1.15 Titers
Interval 1.05 to 1.25
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 1 (n=25,24,24,25,23,72)
|
1.87 Titers
Interval 1.2 to 2.91
|
2.78 Titers
Interval 1.78 to 4.36
|
4.4 Titers
Interval 2.8 to 6.91
|
2.69 Titers
Interval 1.69 to 4.29
|
2.08 Titers
Interval 1.32 to 3.3
|
1.26 Titers
Interval 1.08 to 1.47
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 3 (n=25,24,25,24,23,70)
|
5.94 Titers
Interval 3.47 to 10.0
|
15 Titers
Interval 8.59 to 25.0
|
22 Titers
Interval 13.0 to 38.0
|
11 Titers
Interval 6.03 to 19.0
|
9.66 Titers
Interval 5.55 to 17.0
|
1.29 Titers
Interval 1.1 to 1.51
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 6 (n=25,24,25,25,23,71)
|
2.25 Titers
Interval 1.54 to 3.3
|
2.64 Titers
Interval 1.8 to 3.89
|
4 Titers
Interval 2.73 to 5.86
|
2.11 Titers
Interval 1.42 to 3.15
|
2.27 Titers
Interval 1.53 to 3.37
|
1.28 Titers
Interval 1.11 to 1.49
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 7 (n=25,24,23,25,22,73)
|
14 Titers
Interval 9.12 to 22.0
|
23 Titers
Interval 14.0 to 36.0
|
41 Titers
Interval 26.0 to 65.0
|
17 Titers
Interval 11.0 to 27.0
|
11 Titers
Interval 6.77 to 17.0
|
1.28 Titers
Interval 1.1 to 1.49
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 12 (n=25,23,21,25,23,72)
|
1.79 Titers
Interval 1.25 to 2.57
|
2.63 Titers
Interval 1.81 to 3.81
|
5.99 Titers
Interval 4.06 to 8.85
|
2.35 Titers
Interval 1.61 to 3.43
|
2.8 Titers
Interval 1.93 to 4.07
|
1.37 Titers
Interval 1.15 to 1.64
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084(NHBA) - month 1 (n=25,24,23,23,23,72)
|
3.42 Titers
Interval 2.33 to 5.02
|
3.23 Titers
Interval 2.19 to 4.75
|
6.8 Titers
Interval 4.57 to 10.0
|
5.73 Titers
Interval 3.76 to 8.71
|
4.07 Titers
Interval 2.76 to 6.01
|
2.68 Titers
Interval 1.93 to 3.7
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084 (NHBA) - month 3 (n=25,24,22,21,22,68)
|
4.04 Titers
Interval 2.75 to 5.93
|
5.1 Titers
Interval 3.46 to 7.53
|
12 Titers
Interval 8.04 to 19.0
|
8.09 Titers
Interval 5.18 to 13.0
|
6.48 Titers
Interval 4.35 to 9.66
|
2.85 Titers
Interval 2.08 to 3.91
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084 (NHBA) - month 6 (n=25,23,23,25,23,70)
|
3.27 Titers
Interval 2.26 to 4.73
|
3.21 Titers
Interval 2.19 to 4.69
|
5.91 Titers
Interval 3.99 to 8.74
|
4.57 Titers
Interval 3.08 to 6.78
|
3.67 Titers
Interval 2.52 to 5.34
|
2.99 Titers
Interval 2.16 to 4.14
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084 (NHBA) - month 7 (n=25,23,22,25,21,72)
|
12 Titers
Interval 7.85 to 19.0
|
8.91 Titers
Interval 5.64 to 14.0
|
33 Titers
Interval 20.0 to 53.0
|
22 Titers
Interval 14.0 to 35.0
|
11 Titers
Interval 6.65 to 17.0
|
3.03 Titers
Interval 2.22 to 4.15
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084(NHBA) - month 12 (n=25,23,21,25,23,70)
|
2.77 Titers
Interval 1.85 to 4.13
|
3.05 Titers
Interval 2.01 to 4.61
|
9.99 Titers
Interval 6.39 to 16.0
|
4.92 Titers
Interval 3.2 to 7.56
|
5.74 Titers
Interval 3.82 to 8.64
|
2.91 Titers
Interval 2.06 to 4.12
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 1 (n=23,24,24,25,23,72)
|
2.94 Titers
Interval 1.32 to 6.58
|
10 Titers
Interval 4.75 to 22.0
|
6 Titers
Interval 2.71 to 13.0
|
5.52 Titers
Interval 2.46 to 12.0
|
3.84 Titers
Interval 1.74 to 8.52
|
1.12 Titers
Interval 0.98 to 1.29
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 3 (n=25,24,24,24,23,70)
|
41 Titers
Interval 19.0 to 88.0
|
245 Titers
Interval 113.0 to 532.0
|
126 Titers
Interval 57.0 to 280.0
|
205 Titers
Interval 91.0 to 459.0
|
226 Titers
Interval 102.0 to 501.0
|
1.41 Titers
Interval 1.07 to 1.85
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 6 (n=25,21,24,24,21,71)
|
4.39 Titers
Interval 2.09 to 9.19
|
9.54 Titers
Interval 4.3 to 21.0
|
7.3 Titers
Interval 3.44 to 15.0
|
9.08 Titers
Interval 4.1 to 20.0
|
7.87 Titers
Interval 3.54 to 18.0
|
1.18 Titers
Interval 1.0 to 1.39
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 7 (n=24,23,24,25,23,71)
|
294 Titers
Interval 147.0 to 589.0
|
513 Titers
Interval 255.0 to 1035.0
|
409 Titers
Interval 202.0 to 829.0
|
280 Titers
Interval 137.0 to 572.0
|
507 Titers
Interval 251.0 to 1027.0
|
1.18 Titers
Interval 1.0 to 1.39
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364(NadA) - month 12 (n=23,21,20,25,22,72)
|
7.32 Titers
Interval 3.4 to 16.0
|
24 Titers
Interval 11.0 to 54.0
|
17 Titers
Interval 7.37 to 38.0
|
19 Titers
Interval 8.71 to 41.0
|
41 Titers
Interval 19.0 to 88.0
|
1.15 Titers
Interval 0.97 to 1.37
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 1 (n=25,24,24,24,23,73)
|
4.84 Titers
Interval 2.52 to 9.3
|
14 Titers
Interval 7.0 to 26.0
|
22 Titers
Interval 11.0 to 42.0
|
11 Titers
Interval 5.83 to 22.0
|
5.03 Titers
Interval 2.55 to 9.9
|
1.51 Titers
Interval 1.19 to 1.92
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 6 (n=25,24,25,24,23,72)
|
5.75 Titers
Interval 3.15 to 11.0
|
6.56 Titers
Interval 3.56 to 12.0
|
11 Titers
Interval 5.95 to 20.0
|
5.41 Titers
Interval 2.93 to 9.98
|
6.1 Titers
Interval 3.27 to 11.0
|
1.18 Titers
Interval 1.01 to 1.37
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 12 (n=25,23,21,25,23,71)
|
5.42 Titers
Interval 3.22 to 9.11
|
9.63 Titers
Interval 5.64 to 16.0
|
22 Titers
Interval 12.0 to 38.0
|
8.09 Titers
Interval 4.84 to 14.0
|
9.02 Titers
Interval 5.26 to 15.0
|
1.13 Titers
Interval 1.0 to 1.29
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 6 (n=25,24,24,25,23,72)
|
75 Titers
Interval 50.0 to 112.0
|
122 Titers
Interval 81.0 to 183.0
|
48 Titers
Interval 32.0 to 72.0
|
84 Titers
Interval 56.0 to 125.0
|
156 Titers
Interval 103.0 to 237.0
|
1.74 Titers
Interval 1.36 to 2.22
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 12 (n=25,23,21,25,23,72)
|
140 Titers
Interval 89.0 to 220.0
|
202 Titers
Interval 127.0 to 322.0
|
126 Titers
Interval 77.0 to 206.0
|
127 Titers
Interval 81.0 to 199.0
|
274 Titers
Interval 172.0 to 439.0
|
1.53 Titers
Interval 1.25 to 1.88
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 1 (n=25,24,24,25,23,72)
|
2.13 Titers
Interval 1.41 to 3.21
|
2.22 Titers
Interval 1.46 to 3.36
|
6.22 Titers
Interval 4.09 to 9.45
|
2.92 Titers
Interval 1.95 to 4.39
|
1.76 Titers
Interval 1.15 to 2.7
|
1.51 Titers
Interval 1.32 to 1.74
|
—
|
—
|
—
|
—
|
—
|
|
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 3 (n=25,24,25,24,23,72)
|
2.87 Titers
Interval 1.87 to 4.4
|
3.14 Titers
Interval 2.04 to 4.83
|
18 Titers
Interval 12.0 to 27.0
|
8.95 Titers
Interval 5.85 to 14.0
|
2.75 Titers
Interval 1.77 to 4.28
|
1.49 Titers
Interval 1.29 to 1.72
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 1, 3, 6, 7 and 12Population: Analysis was done by MITT Set.
Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Outcome measures
| Measure |
3ABCWY
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=25 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=25 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 1 (n=25,24,24,24,23,73)
|
3.79 Ratio
Interval 1.97 to 7.29
|
11 Ratio
Interval 5.45 to 20.0
|
17 Ratio
Interval 8.59 to 33.0
|
8.95 Ratio
Interval 4.62 to 17.0
|
3.92 Ratio
Interval 1.99 to 7.72
|
1.15 Ratio
Interval 0.98 to 1.35
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 7 (n=25,24,24,25,22,73)
|
83 Ratio
Interval 46.0 to 150.0
|
113 Ratio
Interval 63.0 to 206.0
|
126 Ratio
Interval 69.0 to 229.0
|
95 Ratio
Interval 53.0 to 170.0
|
79 Ratio
Interval 42.0 to 147.0
|
0.92 Ratio
Interval 0.79 to 1.06
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 1 (n=25,24,24,25,23,72)
|
23 Ratio
Interval 12.0 to 42.0
|
60 Ratio
Interval 32.0 to 110.0
|
14 Ratio
Interval 7.59 to 26.0
|
19 Ratio
Interval 11.0 to 35.0
|
79 Ratio
Interval 42.0 to 148.0
|
1 Ratio
Interval 0.85 to 1.18
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 3 (n=24,24,25,24,23,71)
|
131 Ratio
Interval 79.0 to 216.0
|
197 Ratio
Interval 120.0 to 324.0
|
182 Ratio
Interval 112.0 to 298.0
|
182 Ratio
Interval 111.0 to 299.0
|
233 Ratio
Interval 140.0 to 387.0
|
1 Ratio
Interval 0.8 to 1.26
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 6 (n=25,24,25,24,23,72)
|
4.47 Ratio
Interval 2.43 to 8.23
|
5.06 Ratio
Interval 2.73 to 9.37
|
8.28 Ratio
Interval 4.5 to 15.0
|
4.31 Ratio
Interval 2.32 to 8.01
|
4.7 Ratio
Interval 2.5 to 8.85
|
0.89 Ratio
Interval 0.78 to 1.02
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 12 (n=25,23,21,25,23,71)
|
4.22 Ratio
Interval 2.49 to 7.14
|
7.44 Ratio
Interval 4.33 to 13.0
|
16 Ratio
Interval 9.28 to 29.0
|
6.45 Ratio
Interval 3.83 to 11.0
|
6.97 Ratio
Interval 4.04 to 12.0
|
0.86 Ratio
Interval 0.73 to 1.01
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 6 (n=25,24,24,25,23,72)
|
31 Ratio
Interval 19.0 to 53.0
|
56 Ratio
Interval 34.0 to 95.0
|
24 Ratio
Interval 14.0 to 41.0
|
39 Ratio
Interval 23.0 to 64.0
|
79 Ratio
Interval 46.0 to 134.0
|
0.78 Ratio
Interval 0.61 to 0.99
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 7 (n=25,24,24,25,23,73)
|
221 Ratio
Interval 133.0 to 368.0
|
344 Ratio
Interval 206.0 to 574.0
|
325 Ratio
Interval 194.0 to 545.0
|
244 Ratio
Interval 147.0 to 403.0
|
435 Ratio
Interval 257.0 to 736.0
|
0.86 Ratio
Interval 0.68 to 1.08
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
5/99 (NadA) - month 12 (n=25,23,21,25,23,72)
|
58 Ratio
Interval 34.0 to 101.0
|
95 Ratio
Interval 54.0 to 167.0
|
62 Ratio
Interval 34.0 to 111.0
|
58 Ratio
Interval 34.0 to 100.0
|
138 Ratio
Interval 78.0 to 243.0
|
0.7 Ratio
Interval 0.59 to 0.83
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 1 (n=25,24,24,25,23,72)
|
1.25 Ratio
Interval 0.82 to 1.9
|
1.32 Ratio
Interval 0.86 to 2.02
|
3.63 Ratio
Interval 2.37 to 5.57
|
1.71 Ratio
Interval 1.13 to 2.6
|
1.06 Ratio
Interval 0.68 to 1.63
|
1 Ratio
Interval 0.87 to 1.16
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 3 (n=25,24,25,24,23,72)
|
1.67 Ratio
Interval 1.07 to 2.6
|
1.86 Ratio
Interval 1.19 to 2.91
|
10 Ratio
Interval 6.67 to 16.0
|
5.16 Ratio
Interval 3.31 to 8.06
|
1.64 Ratio
Interval 1.04 to 2.6
|
0.99 Ratio
Interval 0.83 to 1.17
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 6 (n=25,24,24,25,23,72)
|
1.11 Ratio
Interval 0.73 to 1.67
|
1.1 Ratio
Interval 0.73 to 1.67
|
1.93 Ratio
Interval 1.27 to 2.92
|
1.06 Ratio
Interval 0.71 to 1.59
|
1.09 Ratio
Interval 0.71 to 1.67
|
0.76 Ratio
Interval 0.65 to 0.89
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 7 (n=25,24,24,25,23,73)
|
1.33 Ratio
Interval 0.84 to 2.1
|
1.93 Ratio
Interval 1.21 to 3.07
|
13 Ratio
Interval 8.14 to 21.0
|
6.66 Ratio
Interval 4.23 to 10.0
|
1.59 Ratio
Interval 0.99 to 2.55
|
0.8 Ratio
Interval 0.67 to 0.94
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
NZ98/254 (PorA) - month 12 (n=25,23,21,25,23,72)
|
0.81 Ratio
Interval 0.55 to 1.19
|
1.13 Ratio
Interval 0.76 to 1.69
|
2.81 Ratio
Interval 1.85 to 4.27
|
1.37 Ratio
Interval 0.94 to 2.02
|
1.06 Ratio
Interval 0.71 to 1.58
|
0.77 Ratio
Interval 0.66 to 0.9
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 1 (n=25,24,24,22,23,71)
|
1.46 Ratio
Interval 0.94 to 2.27
|
2.18 Ratio
Interval 1.39 to 3.4
|
3.46 Ratio
Interval 2.2 to 5.42
|
2.12 Ratio
Interval 1.33 to 3.38
|
1.64 Ratio
Interval 1.04 to 2.59
|
0.95 Ratio
Interval 0.87 to 1.03
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 3 (n=25,24,25,22,23,69)
|
4.41 Ratio
Interval 2.57 to 7.57
|
11 Ratio
Interval 6.28 to 19.0
|
17 Ratio
Interval 9.77 to 29.0
|
8.26 Ratio
Interval 4.68 to 15.0
|
7.4 Ratio
Interval 4.22 to 13.0
|
1.04 Ratio
Interval 0.9 to 1.2
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 6 (n=25,24,25,22,23,70)
|
1.73 Ratio
Interval 1.18 to 2.53
|
2.02 Ratio
Interval 1.37 to 2.96
|
3.1 Ratio
Interval 2.12 to 4.54
|
1.66 Ratio
Interval 1.11 to 2.48
|
1.77 Ratio
Interval 1.19 to 2.63
|
0.99 Ratio
Interval 0.87 to 1.12
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 7 (n=25,24,23,22,22,72)
|
10 Ratio
Interval 6.66 to 16.0
|
16 Ratio
Interval 10.0 to 26.0
|
31 Ratio
Interval 19.0 to 49.0
|
13 Ratio
Interval 8.26 to 21.0
|
8.18 Ratio
Interval 5.06 to 13.0
|
0.97 Ratio
Interval 0.83 to 1.13
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M14459 (fHBP) - month 12 (n=25,23,21,22,23,71)
|
1.35 Ratio
Interval 0.94 to 1.94
|
1.97 Ratio
Interval 1.35 to 2.86
|
4.57 Ratio
Interval 3.09 to 6.77
|
1.83 Ratio
Interval 1.25 to 2.68
|
2.16 Ratio
Interval 1.48 to 3.14
|
1.03 Ratio
Interval 0.87 to 1.24
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084 (NHBA) - month 1 (n=24,23,22,20,23,66)
|
1.28 Ratio
Interval 0.87 to 1.89
|
1.19 Ratio
Interval 0.8 to 1.75
|
2.5 Ratio
Interval 1.67 to 3.74
|
2.1 Ratio
Interval 1.38 to 3.21
|
1.55 Ratio
Interval 1.05 to 2.29
|
1.02 Ratio
Interval 0.87 to 1.19
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084 (NHBA) - month 3 (n=24,23,20,18,22,65)
|
1.52 Ratio
Interval 1.0 to 2.3
|
1.82 Ratio
Interval 1.2 to 2.77
|
4.54 Ratio
Interval 2.89 to 7.11
|
2.81 Ratio
Interval 1.74 to 4.54
|
2.56 Ratio
Interval 1.67 to 3.93
|
1.13 Ratio
Interval 0.89 to 1.44
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084 (NHBA) - month 6 (n=24,22,21,21,23,65)
|
1.22 Ratio
Interval 0.83 to 1.8
|
1.14 Ratio
Interval 0.76 to 1.7
|
2.14 Ratio
Interval 1.42 to 3.23
|
1.62 Ratio
Interval 1.07 to 2.46
|
1.42 Ratio
Interval 0.95 to 2.1
|
1.2 Ratio
Interval 0.97 to 1.49
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084 (NHBA) - month 7 (n=24,22,20,21,21,66)
|
4.55 Ratio
Interval 2.84 to 7.29
|
3.1 Ratio
Interval 1.9 to 5.05
|
12 Ratio
Interval 6.98 to 20.0
|
7.7 Ratio
Interval 4.65 to 13.0
|
4.15 Ratio
Interval 2.49 to 6.9
|
1.21 Ratio
Interval 0.96 to 1.51
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M07-0241084 (NHBA) - month 12(n=24,22,19,21,23,64)
|
1.03 Ratio
Interval 0.67 to 1.59
|
1.07 Ratio
Interval 0.68 to 1.66
|
3.56 Ratio
Interval 2.21 to 5.75
|
1.73 Ratio
Interval 1.09 to 2.74
|
2.24 Ratio
Interval 1.44 to 3.46
|
1.19 Ratio
Interval 0.9 to 1.58
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 1 (n=23,24,23,22,23,71)
|
2.33 Ratio
Interval 1.04 to 5.2
|
8.23 Ratio
Interval 3.79 to 18.0
|
4.84 Ratio
Interval 2.19 to 11.0
|
4.48 Ratio
Interval 2.0 to 10.0
|
3.12 Ratio
Interval 1.41 to 6.91
|
1 Ratio
Interval 0.86 to 1.16
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 3 (n=25,24,23,22,23,69)
|
31 Ratio
Interval 14.0 to 68.0
|
190 Ratio
Interval 85.0 to 424.0
|
105 Ratio
Interval 46.0 to 239.0
|
177 Ratio
Interval 77.0 to 408.0
|
196 Ratio
Interval 86.0 to 446.0
|
1.28 Ratio
Interval 1.01 to 1.63
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 6 (n=25,21,24,21,21,70)
|
3.41 Ratio
Interval 1.62 to 7.2
|
7.46 Ratio
Interval 3.33 to 17.0
|
5.97 Ratio
Interval 2.79 to 13.0
|
7.56 Ratio
Interval 3.39 to 17.0
|
6.57 Ratio
Interval 2.93 to 15.0
|
1.05 Ratio
Interval 0.9 to 1.23
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 7 (n=24,23,23,22,23,70)
|
226 Ratio
Interval 111.0 to 459.0
|
401 Ratio
Interval 196.0 to 820.0
|
336 Ratio
Interval 164.0 to 690.0
|
236 Ratio
Interval 114.0 to 488.0
|
428 Ratio
Interval 209.0 to 879.0
|
1.07 Ratio
Interval 0.92 to 1.25
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
M01-0240364 (NadA) - month 12(n=23,21,20,22,22,71)
|
5.61 Ratio
Interval 2.58 to 12.0
|
19 Ratio
Interval 8.45 to 42.0
|
14 Ratio
Interval 6.13 to 32.0
|
16 Ratio
Interval 7.28 to 35.0
|
34 Ratio
Interval 16.0 to 76.0
|
1.03 Ratio
Interval 0.87 to 1.22
|
—
|
—
|
—
|
—
|
—
|
|
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
H44/76 (fHbp) - month 3 (n=25,24,24,25,23,72)
|
48 Ratio
Interval 29.0 to 78.0
|
86 Ratio
Interval 52.0 to 143.0
|
111 Ratio
Interval 67.0 to 185.0
|
90 Ratio
Interval 55.0 to 147.0
|
53 Ratio
Interval 32.0 to 89.0
|
1.05 Ratio
Interval 0.89 to 1.24
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to Day 7 after vaccinationPopulation: Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).
Unsolicited AEs were collected with onset from Day 1 through Day 7 After Vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
Outcome measures
| Measure |
3ABCWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=49 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=24 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=49 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=48 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
n=24 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
n=50 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
n=50 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
At least possibly related SAEs
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
1 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
Any AEs
|
3 Number of Subjects
|
6 Number of Subjects
|
1 Number of Subjects
|
4 Number of Subjects
|
2 Number of Subjects
|
3 Number of Subjects
|
3 Number of Subjects
|
2 Number of Subjects
|
2 Number of Subjects
|
6 Number of Subjects
|
6 Number of Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
At least possibly related AEs
|
1 Number of Subjects
|
4 Number of Subjects
|
0 Number of Subjects
|
2 Number of Subjects
|
1 Number of Subjects
|
1 Number of Subjects
|
3 Number of Subjects
|
0 Number of Subjects
|
1 Number of Subjects
|
3 Number of Subjects
|
3 Number of Subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
Serious AEs
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
1 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
SECONDARY outcome
Timeframe: Day 8 After vaccination Through Study Termination, up to 6 monthsPopulation: Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).
Unsolicited AEs were collected from Day 8 After vaccination Through Study Termination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
Outcome measures
| Measure |
3ABCWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=48 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=24 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=49 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=48 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
n=24 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
n=50 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
n=50 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Numbers of Subjects With Other Unsolicited AEs
Medically attended AEs
|
5 Number of Subjects
|
7 Number of Subjects
|
4 Number of Subjects
|
10 Number of Subjects
|
6 Number of Subjects
|
7 Number of Subjects
|
2 Number of Subjects
|
5 Number of Subjects
|
4 Number of Subjects
|
14 Number of Subjects
|
15 Number of Subjects
|
|
Numbers of Subjects With Other Unsolicited AEs
AEs leading to Withdrawal
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
|
Numbers of Subjects With Other Unsolicited AEs
At least possibly related AEs
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
1 Number of Subjects
|
|
Numbers of Subjects With Other Unsolicited AEs
SAEs
|
0 Number of Subjects
|
0 Number of Subjects
|
1 Number of Subjects
|
1 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
1 Number of Subjects
|
0 Number of Subjects
|
1 Number of Subjects
|
0 Number of Subjects
|
|
Numbers of Subjects With Other Unsolicited AEs
At least possibly related SAEs
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
SECONDARY outcome
Timeframe: From Day 1 to Day 7 after vaccinationPopulation: Analysis was done on Safety Set (all subjects in the exposed set who provided post-vaccination solicited AE data).
Solicited local and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
Outcome measures
| Measure |
3ABCWY
n=24 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABx2CWY
n=48 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
3ABCWY+OMV
n=24 Participants
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
3ABCWYqOMV
n=49 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
3 B
n=25 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
1ACWY
n=48 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
3ABCWYqOMV
n=24 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
n=50 Participants
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
n=23 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
n=50 Participants
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
n=73 Participants
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Fatigue
|
3 Number of Subjects
|
9 Number of Subjects
|
3 Number of Subjects
|
9 Number of Subjects
|
5 Number of Subjects
|
11 Number of Subjects
|
4 Number of Subjects
|
7 Number of Subjects
|
3 Number of Subjects
|
10 Number of Subjects
|
9 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Any Solicited Systemic AEs
|
10 Number of Subjects
|
33 Number of Subjects
|
14 Number of Subjects
|
25 Number of Subjects
|
20 Number of Subjects
|
23 Number of Subjects
|
18 Number of Subjects
|
24 Number of Subjects
|
14 Number of Subjects
|
34 Number of Subjects
|
43 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Headache
|
5 Number of Subjects
|
20 Number of Subjects
|
6 Number of Subjects
|
17 Number of Subjects
|
9 Number of Subjects
|
11 Number of Subjects
|
10 Number of Subjects
|
15 Number of Subjects
|
6 Number of Subjects
|
18 Number of Subjects
|
27 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Rash
|
1 Number of Subjects
|
2 Number of Subjects
|
2 Number of Subjects
|
1 Number of Subjects
|
0 Number of Subjects
|
1 Number of Subjects
|
1 Number of Subjects
|
0 Number of Subjects
|
1 Number of Subjects
|
1 Number of Subjects
|
2 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Fever (≥38°C)
|
3 Number of Subjects
|
5 Number of Subjects
|
0 Number of Subjects
|
3 Number of Subjects
|
3 Number of Subjects
|
0 Number of Subjects
|
3 Number of Subjects
|
1 Number of Subjects
|
2 Number of Subjects
|
2 Number of Subjects
|
4 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Any other indicators of reactogenicity
|
4 Number of Subjects
|
8 Number of Subjects
|
3 Number of Subjects
|
5 Number of Subjects
|
6 Number of Subjects
|
3 Number of Subjects
|
7 Number of Subjects
|
4 Number of Subjects
|
3 Number of Subjects
|
5 Number of Subjects
|
11 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Stay home
|
0 Number of Subjects
|
5 Number of Subjects
|
0 Number of Subjects
|
2 Number of Subjects
|
1 Number of Subjects
|
0 Number of Subjects
|
3 Number of Subjects
|
1 Number of Subjects
|
0 Number of Subjects
|
0 Number of Subjects
|
3 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Any Solicited Local AEs
|
18 Number of Subjects
|
33 Number of Subjects
|
18 Number of Subjects
|
35 Number of Subjects
|
23 Number of Subjects
|
36 Number of Subjects
|
20 Number of Subjects
|
30 Number of Subjects
|
17 Number of Subjects
|
38 Number of Subjects
|
53 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Injection site erythema
|
5 Number of Subjects
|
13 Number of Subjects
|
7 Number of Subjects
|
12 Number of Subjects
|
12 Number of Subjects
|
11 Number of Subjects
|
13 Number of Subjects
|
3 Number of Subjects
|
9 Number of Subjects
|
13 Number of Subjects
|
19 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Injection site induration
|
7 Number of Subjects
|
14 Number of Subjects
|
11 Number of Subjects
|
12 Number of Subjects
|
10 Number of Subjects
|
17 Number of Subjects
|
11 Number of Subjects
|
6 Number of Subjects
|
7 Number of Subjects
|
14 Number of Subjects
|
18 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Injection site pain
|
18 Number of Subjects
|
33 Number of Subjects
|
15 Number of Subjects
|
35 Number of Subjects
|
23 Number of Subjects
|
35 Number of Subjects
|
19 Number of Subjects
|
30 Number of Subjects
|
17 Number of Subjects
|
36 Number of Subjects
|
52 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Swelling
|
5 Number of Subjects
|
11 Number of Subjects
|
9 Number of Subjects
|
10 Number of Subjects
|
10 Number of Subjects
|
14 Number of Subjects
|
13 Number of Subjects
|
5 Number of Subjects
|
7 Number of Subjects
|
14 Number of Subjects
|
14 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Chills
|
3 Number of Subjects
|
10 Number of Subjects
|
4 Number of Subjects
|
2 Number of Subjects
|
7 Number of Subjects
|
7 Number of Subjects
|
4 Number of Subjects
|
5 Number of Subjects
|
5 Number of Subjects
|
5 Number of Subjects
|
8 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Malaise
|
6 Number of Subjects
|
12 Number of Subjects
|
7 Number of Subjects
|
14 Number of Subjects
|
8 Number of Subjects
|
9 Number of Subjects
|
7 Number of Subjects
|
8 Number of Subjects
|
5 Number of Subjects
|
13 Number of Subjects
|
13 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Myalgia
|
6 Number of Subjects
|
23 Number of Subjects
|
9 Number of Subjects
|
20 Number of Subjects
|
15 Number of Subjects
|
18 Number of Subjects
|
14 Number of Subjects
|
19 Number of Subjects
|
9 Number of Subjects
|
21 Number of Subjects
|
32 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Arthralgia
|
2 Number of Subjects
|
6 Number of Subjects
|
5 Number of Subjects
|
7 Number of Subjects
|
6 Number of Subjects
|
5 Number of Subjects
|
8 Number of Subjects
|
3 Number of Subjects
|
2 Number of Subjects
|
8 Number of Subjects
|
9 Number of Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Nausea
|
4 Number of Subjects
|
6 Number of Subjects
|
2 Number of Subjects
|
3 Number of Subjects
|
4 Number of Subjects
|
6 Number of Subjects
|
6 Number of Subjects
|
3 Number of Subjects
|
2 Number of Subjects
|
4 Number of Subjects
|
6 Number of Subjects
|
Adverse Events
3ABCWY
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
2ABCWY
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
3ABx2CWY
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
2ABx2CWY
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
3ABCWY+OMV
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
2ABCWY+OMV
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
3ABCWYqOMV
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
2ABCWYqOMV
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
3 B
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
2 B
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
1ACWY
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3ABCWY
n=24 participants at risk
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
2ABCWY
n=49 participants at risk
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
|
3ABx2CWY
n=24 participants at risk
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
2ABx2CWY
n=49 participants at risk
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
|
3ABCWY+OMV
n=25 participants at risk
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
2ABCWY+OMV
n=48 participants at risk
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
|
3ABCWYqOMV
n=24 participants at risk
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
n=50 participants at risk
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
n=23 participants at risk
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
n=50 participants at risk
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
n=73 participants at risk
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendiceal Abscess
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
4.2%
1/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
2.0%
1/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
Infections and infestations
Peritonsillar Abscess
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
2.0%
1/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
Injury, poisoning and procedural complications
Burns Second Degree
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
2.0%
1/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
Injury, poisoning and procedural complications
Vaccination Complication
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
4.2%
1/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
Other adverse events
| Measure |
3ABCWY
n=24 participants at risk
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
2ABCWY
n=49 participants at risk
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
|
3ABx2CWY
n=24 participants at risk
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
|
2ABx2CWY
n=49 participants at risk
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
|
3ABCWY+OMV
n=25 participants at risk
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
|
2ABCWY+OMV
n=48 participants at risk
Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
|
3ABCWYqOMV
n=24 participants at risk
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
|
2ABCWYqOMV
n=50 participants at risk
Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
|
3 B
n=23 participants at risk
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
|
2 B
n=50 participants at risk
Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
|
1ACWY
n=73 participants at risk
One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
4/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
12.2%
6/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
8.3%
2/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
6.1%
3/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
16.0%
4/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
14.6%
7/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
25.0%
6/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
6.0%
3/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
8.7%
2/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
8.0%
4/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
8.2%
6/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
General disorders
Chills
|
12.5%
3/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
20.4%
10/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
16.7%
4/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
4.1%
2/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
28.0%
7/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
16.7%
8/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
16.7%
4/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
10.0%
5/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
21.7%
5/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
10.0%
5/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
11.0%
8/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
General disorders
Fatigue
|
12.5%
3/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
18.4%
9/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
12.5%
3/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
18.4%
9/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
20.0%
5/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
22.9%
11/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
16.7%
4/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
14.0%
7/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
13.0%
3/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
20.0%
10/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
12.3%
9/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
General disorders
Injection Site Erythema
|
20.8%
5/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
32.7%
16/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
29.2%
7/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
28.6%
14/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
52.0%
13/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
25.0%
12/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
66.7%
16/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
10.0%
5/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
43.5%
10/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
28.0%
14/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
27.4%
20/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
General disorders
Injection Site Induration
|
29.2%
7/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
32.7%
16/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
45.8%
11/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
26.5%
13/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
48.0%
12/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
35.4%
17/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
54.2%
13/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
16.0%
8/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
34.8%
8/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
30.0%
15/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
26.0%
19/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
General disorders
Injection Site Pain
|
75.0%
18/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
67.3%
33/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
62.5%
15/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
71.4%
35/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
92.0%
23/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
72.9%
35/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
79.2%
19/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
62.0%
31/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
73.9%
17/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
72.0%
36/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
71.2%
52/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
General disorders
Injection Site Swelling
|
20.8%
5/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
22.4%
11/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
37.5%
9/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
22.4%
11/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
44.0%
11/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
29.2%
14/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
58.3%
14/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
12.0%
6/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
34.8%
8/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
28.0%
14/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
21.9%
16/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
General disorders
Malaise
|
25.0%
6/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
24.5%
12/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
29.2%
7/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
28.6%
14/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
32.0%
8/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
18.8%
9/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
33.3%
8/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
16.0%
8/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
21.7%
5/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
26.0%
13/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
17.8%
13/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
General disorders
Pyrexia
|
12.5%
3/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
12.2%
6/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
6.1%
3/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
12.0%
3/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
20.8%
5/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
2.0%
1/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
8.7%
2/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
6.0%
3/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
5.5%
4/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
2/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
4.1%
2/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
8.2%
4/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
4.0%
1/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
2.1%
1/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
4.2%
1/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
4.0%
2/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
4.3%
1/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
6.0%
3/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
5.5%
4/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
8.3%
2/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
12.2%
6/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
20.8%
5/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
14.3%
7/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
24.0%
6/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
10.4%
5/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
33.3%
8/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
6.0%
3/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
8.7%
2/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
16.0%
8/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
12.3%
9/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
6/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
46.9%
23/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
37.5%
9/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
40.8%
20/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
60.0%
15/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
37.5%
18/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
58.3%
14/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
38.0%
19/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
39.1%
9/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
42.0%
21/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
43.8%
32/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
Nervous system disorders
Headache
|
20.8%
5/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
40.8%
20/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
25.0%
6/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
34.7%
17/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
36.0%
9/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
22.9%
11/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
41.7%
10/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
30.0%
15/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
30.4%
7/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
36.0%
18/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
37.0%
27/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
1/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
4.1%
2/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
8.3%
2/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
2.0%
1/49 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/25 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
2.1%
1/48 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/24 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/23 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/50 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
0.00%
0/73 • Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER