Trial Outcomes & Findings for Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents (NCT NCT02140762)
NCT ID: NCT02140762
Last Updated: 2018-09-12
Results Overview
The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
305 participants
Primary outcome timeframe
One month after the second vaccination (month 3)
Results posted on
2018-09-12
Participant Flow
Subjects were recruited from 8 study sites in USA.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
MenABCWY
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
151
|
|
Overall Study
COMPLETED
|
137
|
139
|
|
Overall Study
NOT COMPLETED
|
17
|
12
|
Reasons for withdrawal
| Measure |
MenABCWY
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
5
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
Baseline characteristics by cohort
| Measure |
MenABCWY
n=154 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=151 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.9 Years
STANDARD_DEVIATION 2.18 • n=39 Participants
|
12.2 Years
STANDARD_DEVIATION 2.42 • n=41 Participants
|
12 Years
STANDARD_DEVIATION 2.3 • n=35 Participants
|
|
Sex/Gender, Customized
FEMALE
|
67 participants
n=39 Participants
|
61 participants
n=41 Participants
|
128 participants
n=35 Participants
|
|
Sex/Gender, Customized
MALE
|
87 participants
n=39 Participants
|
90 participants
n=41 Participants
|
177 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: One month after the second vaccination (month 3)Population: Analysis was done on Full Analysis Set (FAS) effectiveness (month 3): all subjects in the All Enrolled Set who received a study vaccination and provided evaluable serum sample with enc-hSBA for at least one N. meningitidis serogroup B invasive disease strain at one month after the 2-dose series (Visit Month 3).
The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.
Outcome measures
| Measure |
MenABCWY
n=139 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=135 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.
|
25.17 Percentages of subjects
Standard Deviation 30.77
|
76.19 Percentages of subjects
Standard Deviation 27.32
|
SECONDARY outcome
Timeframe: Four months after the second vaccination (month 6)Population: Analysis was done on FAS effectiveness (month 6): All subjects in the All Enrolled Set who received a study vaccination and provided evaluable serum sample with enc-hSBA for at least one N. meningitidis serogroup B invasive disease strain at four months after the 2-dose series (Visit Month 6).
The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.
Outcome measures
| Measure |
MenABCWY
n=136 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=135 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.
|
42.91 Percentage of subjects
Standard Deviation 33.429
|
76.67 Percentage of subjects
Standard Deviation 27.706
|
SECONDARY outcome
Timeframe: One month after the second vaccination (month 3)Population: Analysis was done on FAS effectiveness ( month 3)
The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.
Outcome measures
| Measure |
MenABCWY
n=139 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=135 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination
|
47.7 Percentage of subjects
Standard Deviation 37.04
|
88.28 Percentage of subjects
Standard Deviation 22.05
|
SECONDARY outcome
Timeframe: Four months after the second vaccination (month 6)Population: Analysis was done on FAS effectiveness (month 6).
The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.
Outcome measures
| Measure |
MenABCWY
n=136 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=135 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.
|
70.89 Percentage of subjects
Standard Deviation 29.625
|
88.53 Percentage of subjects
Standard Deviation 21.442
|
SECONDARY outcome
Timeframe: Baseline, one month after second vaccination (month 3)Population: Analysis was done on FAS effectiveness (month 3)
The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at one month after the 2-dose vaccination series is reported.
Outcome measures
| Measure |
MenABCWY
n=139 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=135 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
Baseline (1:4) (N=136, 132)
|
20.08 Mean percentages of strains
Standard Deviation 16.25
|
19.76 Mean percentages of strains
Standard Deviation 15.48
|
|
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
1 month after 2nd vaccination (1:4)
|
74.47 Mean percentages of strains
Standard Deviation 14.55
|
22.93 Mean percentages of strains
Standard Deviation 16.11
|
|
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
Baseline (1:8) (N=136, 132)
|
9.25 Mean percentages of strains
Standard Deviation 8.35
|
9.54 Mean percentages of strains
Standard Deviation 9.49
|
|
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
1 month after 2nd vaccination (1:8)
|
52.16 Mean percentages of strains
Standard Deviation 17.11
|
11.39 Mean percentages of strains
Standard Deviation 10.35
|
SECONDARY outcome
Timeframe: Baseline, four months after second vaccination (month 6)Population: Analysis was done on FAS effectiveness (month 6).
The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at four months after the 2-dose vaccination series is reported.
Outcome measures
| Measure |
MenABCWY
n=136 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=135 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
Baseline (1:4) (N=133, 132)
|
19.82 Mean percentage of strains
Standard Deviation 16.227
|
19.73 Mean percentage of strains
Standard Deviation 15.079
|
|
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
4 months after 2nd vaccination (1:4)
|
56.38 Mean percentage of strains
Standard Deviation 18.703
|
22.66 Mean percentage of strains
Standard Deviation 16.593
|
|
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
Baseline (1:8) (N=133, 132)
|
9.19 Mean percentage of strains
Standard Deviation 8.336
|
9.52 Mean percentage of strains
Standard Deviation 9.346
|
|
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
4 months after 2nd vaccination (1:8)
|
28.52 Mean percentage of strains
Standard Deviation 18.484
|
11.19 Mean percentage of strains
Standard Deviation 11.078
|
SECONDARY outcome
Timeframe: One month after the second vaccination (month 3)Population: Analysis was done on FAS Immunogenicity (Month 3): all subjects in the All Enrolled Set who received a study vaccination, provided evaluable serum samples respectively at 1 month post-second vaccination (Visit Month 3) whose immunogenicity assay result is available for at least one N. meningitidis serogroup B test strain or serogroups A, C, W or Y.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA \>= 1:4 and enc-hSBA titer \>= 1:8 against four N. meningitidis serogroup B test strains at one month after the 2-dose vaccination series is reported.
Outcome measures
| Measure |
MenABCWY
n=134 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=130 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series
96217 (1:8, 1 month after 2nd vacc) (N=93,82)
|
99 Percentage of Subjects
Interval 94.2 to 99.97
|
15 Percentage of Subjects
Interval 7.8 to 24.2
|
|
Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series
NZ98/254 (1:4, 1 month after 2nd vacc) (N=132,130)
|
67 Percentage of Subjects
Interval 57.9 to 74.6
|
1 Percentage of Subjects
Interval 0.02 to 4.2
|
|
Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series
NZ98/254 (1:8, 1 month after 2nd vacc) (N=132,130)
|
24 Percentage of Subjects
Interval 17.2 to 32.5
|
0 Percentage of Subjects
Interval 0.0 to 2.8
|
|
Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series
M14459 (1:4, 1 month after 2nd vacc) (N=134,129)
|
96 Percentage of Subjects
Interval 90.5 to 98.3
|
12 Percentage of Subjects
Interval 7.3 to 19.4
|
|
Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series
M14459 (1:8, 1 month after 2nd vacc) (N=134,129)
|
64 Percentage of Subjects
Interval 55.4 to 72.3
|
3 Percentage of Subjects
Interval 0.9 to 7.7
|
|
Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series
M07-0241084(1:4,1 month after 2nd vacc)(N=131,120)
|
59 Percentage of Subjects
Interval 49.8 to 67.3
|
20 Percentage of Subjects
Interval 13.3 to 28.3
|
|
Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series
M07-0241084(1:8,1 month after 2nd vacc)(N=131,120)
|
21 Percentage of Subjects
Interval 14.7 to 29.4
|
7 Percentage of Subjects
Interval 2.9 to 12.7
|
|
Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series
96217 (1:4, 1 month after 2nd vacc) (N=93,82)
|
100 Percentage of Subjects
Interval 96.1 to 100.0
|
49 Percentage of Subjects
Interval 37.6 to 60.1
|
SECONDARY outcome
Timeframe: Four months after the second vaccination (month 6)Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA titer ≥ 1:8 against four N. meningitidis serogroup B test strains at four months after the 2-dose vaccination series is reported.
Outcome measures
| Measure |
MenABCWY
n=132 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=131 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series
NZ98/254(1:4) (N=132,131)
|
14 Percentage of subjects
Interval 8.9 to 21.6
|
5 Percentage of subjects
Interval 1.7 to 9.7
|
|
Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series
NZ98/254(1:8) (N=132,131)
|
3 Percentage of subjects
Interval 0.8 to 7.6
|
2 Percentage of subjects
Interval 0.19 to 5.4
|
|
Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series
M14459 (1:4) (N=103,119)
|
83 Percentage of subjects
Interval 73.8 to 89.3
|
20 Percentage of subjects
Interval 13.4 to 28.5
|
|
Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series
M14459(1:8) (N=103,119)
|
26 Percentage of subjects
Interval 18.0 to 35.8
|
3 Percentage of subjects
Interval 0.5 to 7.2
|
|
Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series
M07-0241084 (1:4) (N=121,120)
|
33 Percentage of subjects
Interval 24.8 to 42.2
|
19 Percentage of subjects
Interval 12.6 to 27.4
|
|
Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series
M07-0241084(1:8) (N=121,120)
|
7 Percentage of subjects
Interval 3.5 to 13.7
|
7 Percentage of subjects
Interval 2.9 to 12.7
|
|
Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series
96217 (1:4) (N=87,76)
|
100 Percentage of subjects
Interval 95.8 to 100.0
|
64 Percentage of subjects
Interval 52.7 to 75.1
|
|
Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series
96217 (1:8) (N=87,76)
|
94 Percentage of subjects
Interval 87.1 to 98.1
|
14 Percentage of subjects
Interval 7.5 to 24.4
|
SECONDARY outcome
Timeframe: One month after the second vaccination (month 3)Population: Analysis was done on FAS Immunogenicity (Month 3). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs against serogroup B test strains, at one month after the 2-dose vaccination series.
Outcome measures
| Measure |
MenABCWY
n=138 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=133 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
NZ98/254 (1 month after 2nd vacc)
|
6.03 Titers
Interval 5.16 to 7.03
|
1.04 Titers
Interval 0.89 to 1.22
|
|
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
M14459 (1 month after 2nd vacc) (N=138,132)
|
13.4 Titers
Interval 11.0 to 16.0
|
1.08 Titers
Interval 0.92 to 1.28
|
|
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
M07-0241084 (1 month after 2nd vacc) (N=124,122)
|
5.05 Titers
Interval 4.08 to 6.26
|
1.65 Titers
Interval 1.33 to 2.05
|
|
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
96217 (1 month after 2nd vacc) (N=124,118)
|
169.22 Titers
Interval 133.0 to 215.0
|
3.16 Titers
Interval 2.48 to 4.04
|
SECONDARY outcome
Timeframe: Four months after the second vaccination (month 6)Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against serogroup B test strains, at four months after the 2-dose vaccination series.
Outcome measures
| Measure |
MenABCWY
n=133 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=134 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
NZ98/254 (N=133,134)
|
1.75 Titers
Interval 1.53 to 2.0
|
1.06 Titers
Interval 0.93 to 1.21
|
|
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
M14459 (N=133,134)
|
3.04 Titers
Interval 2.6 to 3.56
|
1.12 Titers
Interval 0.96 to 1.31
|
|
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
M07-0241084 (N=126,127)
|
1.77 Titers
Interval 1.47 to 2.12
|
1.56 Titers
Interval 1.3 to 1.87
|
|
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
96217 (N=131,133)
|
57.85 Titers
Interval 45.0 to 74.0
|
3 Titers
Interval 2.35 to 3.82
|
SECONDARY outcome
Timeframe: One month after the second vaccination (month 3)Population: Analysis was done on FAS Immunogenicity (Month 3)
The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs to serogroups A, C, W, and Y, at one month after the 2-dose vaccination series.
Outcome measures
| Measure |
MenABCWY
n=137 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=125 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y
Men A (1 month after 2nd vacc) (N=137,115)
|
77.02 Titers
Interval 59.0 to 101.0
|
22.08 Titers
Interval 17.0 to 30.0
|
|
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y
Men C (1 month after 2nd vacc) (N=134,125)
|
235.88 Titers
Interval 171.0 to 325.0
|
38.61 Titers
Interval 28.0 to 54.0
|
|
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y
Men W (1 month after 2nd vacc) (N=119,115)
|
157.72 Titers
Interval 120.0 to 207.0
|
37.51 Titers
Interval 28.0 to 49.0
|
|
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y
Men Y (1 month after 2nd vacc) (N=107,94)
|
155.43 Titers
Interval 110.0 to 220.0
|
27.76 Titers
Interval 19.0 to 40.0
|
SECONDARY outcome
Timeframe: Four months after the second vaccination (month 6)Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at four months after the 2-dose vaccination series.
Outcome measures
| Measure |
MenABCWY
n=133 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=133 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y
Men A (N=124,130)
|
12.91 Titers
Interval 9.19 to 18.0
|
5.56 Titers
Interval 3.99 to 7.73
|
|
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y
Men C (N=133,133)
|
117.18 Titers
Interval 84.0 to 163.0
|
25.64 Titers
Interval 19.0 to 36.0
|
|
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y
Men W (N=131,130)
|
91.22 Titers
Interval 70.0 to 119.0
|
42.97 Titers
Interval 33.0 to 56.0
|
|
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y
Men Y (N=132,132)
|
59.51 Titers
Interval 42.0 to 85.0
|
19.53 Titers
Interval 14.0 to 28.0
|
SECONDARY outcome
Timeframe: At baseline(day 1) and One month after the second vaccination (month 3)Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ LLQ, at baseline(day 1) and one month after the 2-dose vaccination series, is reported. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively.
Outcome measures
| Measure |
MenABCWY
n=132 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=131 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.
96217 -Baseline (N=108,112)
|
30 percentage of subjects
Interval 21.2 to 39.2
|
32 percentage of subjects
Interval 23.6 to 41.6
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.
96217- Month 3 (N=119,114)
|
99 percentage of subjects
Interval 95.4 to 99.98
|
30 percentage of subjects
Interval 21.6 to 39.1
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.
M07-0241084-Baseline (N=123,128)
|
3 percentage of subjects
Interval 0.9 to 8.1
|
7 percentage of subjects
Interval 3.3 to 12.9
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.
M07-0241084-Month 3 (N=117,118)
|
34 percentage of subjects
Interval 25.7 to 43.5
|
10 percentage of subjects
Interval 5.4 to 17.1
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.
M14459-baseline(N=132,131)
|
1 percentage of subjects
Interval 0.02 to 4.2
|
1 percentage of subjects
Interval 0.02 to 4.2
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.
M14459-month 3 (N=131,128)
|
73 percentage of subjects
Interval 64.9 to 80.6
|
2 percentage of subjects
Interval 0.49 to 6.7
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.
NZ98/254-Baseline(N=131,131)
|
1 percentage of subjects
Interval 0.02 to 4.2
|
0 percentage of subjects
Interval 0.0 to 2.8
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.
NZ98/254-Month 3(N=131,129)
|
44 percentage of subjects
Interval 34.9 to 52.5
|
2 percentage of subjects
Interval 0.19 to 5.5
|
SECONDARY outcome
Timeframe: At Baseline and One month after the second vaccination (month 3)Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ against serogroups A, C, W, Y, at baseline(day 1) and one month after the 2-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively.
Outcome measures
| Measure |
MenABCWY
n=130 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=131 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series
Men C-Month 3(N=127,121)
|
100 percentage of subjects
Interval 97.1 to 100.0
|
82 percentage of subjects
Interval 73.8 to 88.2
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series
Men A -baseline(N=128,129)
|
2 percentage of subjects
Interval 0.19 to 5.5
|
1 percentage of subjects
Interval 0.02 to 4.2
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series
Men A- Month 3(N=130,112)
|
93 percentage of subjects
Interval 87.3 to 96.8
|
63 percentage of subjects
Interval 52.9 to 71.5
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series
Men C-baseline(N=130,131)
|
32 percentage of subjects
Interval 23.7 to 40.3
|
43 percentage of subjects
Interval 34.2 to 51.7
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series
Men W-baseline(N=116,119)
|
12 percentage of subjects
Interval 6.8 to 19.4
|
16 percentage of subjects
Interval 9.9 to 23.8
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series
Men W-Month 3 (N=112,111)
|
90 percentage of subjects
Interval 83.1 to 95.0
|
52 percentage of subjects
Interval 42.6 to 61.8
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series
Men Y-baseline(N=122,123)
|
10 percentage of subjects
Interval 5.2 to 16.6
|
11 percentage of subjects
Interval 5.8 to 17.4
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series
Men Y-Month 3(N=102,91)
|
96 percentage of subjects
Interval 90.3 to 98.9
|
70 percentage of subjects
Interval 59.8 to 79.5
|
SECONDARY outcome
Timeframe: Four months after the second vaccination (month 6)Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ LLQ, at four months after the 2-dose vaccination series, is reported. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively
Outcome measures
| Measure |
MenABCWY
n=133 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=134 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
96217 (N=131,133)
|
95 percentage of subjects
Interval 90.3 to 98.3
|
30 percentage of subjects
Interval 22.4 to 38.6
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
M14459(N=133,134)
|
26 percentage of subjects
Interval 19.1 to 34.7
|
1 percentage of subjects
Interval 0.18 to 5.3
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
M07-0231084 (N=126,127)
|
10 percentage of subjects
Interval 5.6 to 17.0
|
10 percentage of subjects
Interval 5.6 to 16.9
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
NZ98/254(N=133,134)
|
9 percentage of subjects
Interval 4.8 to 15.2
|
1 percentage of subjects
Interval 0.02 to 4.1
|
SECONDARY outcome
Timeframe: Four months after the second vaccination (month 6)Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y at four months after the 2-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively.
Outcome measures
| Measure |
MenABCWY
n=133 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=133 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
Men A (N=124, 130)
|
48 Percentages of subjects
Interval 39.3 to 57.5
|
32 Percentages of subjects
Interval 24.4 to 41.1
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
Men C (N=133,133)
|
98 Percentages of subjects
Interval 94.7 to 99.82
|
78 Percentages of subjects
Interval 70.2 to 84.9
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
Men W (N=131,130)
|
77 Percentages of subjects
Interval 69.0 to 84.0
|
58 Percentages of subjects
Interval 48.7 to 66.3
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
Men Y (N=132,132)
|
85 Percentages of subjects
Interval 77.6 to 90.5
|
63 Percentages of subjects
Interval 54.0 to 71.1
|
SECONDARY outcome
Timeframe: Four months after the second vaccination (month 6)Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at four months after the 2-dose vaccination series, is reported.
Outcome measures
| Measure |
MenABCWY
n=133 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=134 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
NZ98/254 ≥ 5 (N=133,134)
|
14 Percentage of subjects
Interval 8.8 to 21.4
|
2 Percentage of subjects
Interval 0.46 to 6.4
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
NZ98/254 ≥ 8 (N=133,134)
|
9 Percentage of subjects
Interval 4.7 to 15.2
|
1 Percentage of subjects
Interval 0.18 to 5.3
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
NZ98/254 ≥ 16 (N=133,134)
|
3 Percentage of subjects
Interval 0.8 to 7.5
|
0 Percentage of subjects
Interval 0.0 to 2.7
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
NZ98/254 ≥ 32 (N=133,134)
|
2 Percentage of subjects
Interval 0.18 to 5.3
|
0 Percentage of subjects
Interval 0.0 to 2.7
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
NZ98/254 ≥ 64 (N=133,134)
|
2 Percentage of subjects
Interval 0.18 to 5.3
|
0 Percentage of subjects
Interval 0.0 to 2.7
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
NZ98/254 ≥ 128 (N=133,134)
|
1 Percentage of subjects
Interval 0.02 to 4.1
|
0 Percentage of subjects
Interval 0.0 to 2.7
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
M14459 ≥ 5 (N=133,134)
|
39 Percentage of subjects
Interval 30.8 to 47.9
|
3 Percentage of subjects
Interval 0.8 to 7.5
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
M14459 ≥ 8 (N=133,134)
|
26 Percentage of subjects
Interval 19.1 to 34.7
|
1 Percentage of subjects
Interval 0.18 to 5.3
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
M14459 ≥ 16 (N=133,134)
|
9 Percentage of subjects
Interval 4.7 to 15.2
|
1 Percentage of subjects
Interval 0.02 to 4.1
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
M14459 ≥ 32 (N=133,134)
|
2 Percentage of subjects
Interval 0.47 to 6.5
|
0 Percentage of subjects
Interval 0.0 to 2.7
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
M14459 ≥ 64 (N=133,134)
|
1 Percentage of subjects
Interval 0.02 to 4.1
|
0 Percentage of subjects
Interval 0.0 to 2.7
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
M14459 ≥ 128 (N=133,134)
|
0 Percentage of subjects
Interval 0.0 to 2.7
|
0 Percentage of subjects
Interval 0.0 to 2.7
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
M07-0241084 ≥ 5 (N=126,127)
|
16 Percentage of subjects
Interval 10.0 to 23.4
|
13 Percentage of subjects
Interval 8.0 to 20.6
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
M07-0241084 ≥ 8 (N=126,127)
|
11 Percentage of subjects
Interval 6.2 to 17.9
|
11 Percentage of subjects
Interval 6.2 to 17.8
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
M07-0241084 ≥ 16 (N=126,127)
|
6 Percentage of subjects
Interval 2.3 to 11.1
|
8 Percentage of subjects
Interval 3.8 to 14.0
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
M07-0241084 ≥ 32 (N=126,127)
|
2 Percentage of subjects
Interval 0.49 to 6.8
|
2 Percentage of subjects
Interval 0.19 to 5.6
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
M07-0241084 ≥ 64 (N=126,127)
|
1 Percentage of subjects
Interval 0.02 to 4.3
|
0 Percentage of subjects
Interval 0.0 to 2.9
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
M07-0241084 ≥128 (N=126,127)
|
0 Percentage of subjects
Interval 0.0 to 2.9
|
0 Percentage of subjects
Interval 0.0 to 2.9
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
96217 ≥ 5 (N=131,133)
|
95 Percentage of subjects
Interval 90.3 to 98.3
|
35 Percentage of subjects
Interval 27.3 to 44.1
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
96217 ≥ 8 (N=131,133)
|
95 Percentage of subjects
Interval 90.3 to 98.3
|
32 Percentage of subjects
Interval 23.8 to 40.2
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
96217 ≥ 16 (N=131,133)
|
93 Percentage of subjects
Interval 87.4 to 96.8
|
22 Percentage of subjects
Interval 15.1 to 29.8
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
96217 ≥ 32 (N=131,133)
|
77 Percentage of subjects
Interval 68.9 to 84.0
|
8 Percentage of subjects
Interval 3.7 to 13.4
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
96217 ≥ 64 (N=131,133)
|
48 Percentage of subjects
Interval 39.3 to 57.0
|
5 Percentage of subjects
Interval 1.7 to 9.6
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
96217 ≥ 128 (N=131,133)
|
19 Percentage of subjects
Interval 12.7 to 26.9
|
2 Percentage of subjects
Interval 0.18 to 5.3
|
SECONDARY outcome
Timeframe: Four months after the second vaccination (month 6)Population: Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroups A, C, W, Y at four months after the 2-dose vaccination series.
Outcome measures
| Measure |
MenABCWY
n=133 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=133 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men W ≥ 16 (N=131,130)
|
95 Percentage of subjects
Interval 90.3 to 98.3
|
82 Percentage of subjects
Interval 74.6 to 88.4
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men W ≥ 32 (N=131,130)
|
84 Percentage of subjects
Interval 76.5 to 89.8
|
66 Percentage of subjects
Interval 57.3 to 74.2
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men W ≥ 64 (N=131,130)
|
61 Percentage of subjects
Interval 52.2 to 69.5
|
39 Percentage of subjects
Interval 30.8 to 48.2
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men W ≥ 128 (N=131,130)
|
36 Percentage of subjects
Interval 27.7 to 44.7
|
24 Percentage of subjects
Interval 16.8 to 32.1
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men Y ≥ 8 (N=132,132)
|
89 Percentage of subjects
Interval 82.8 to 94.1
|
67 Percentage of subjects
Interval 58.7 to 75.3
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men Y ≥ 16 (N=132,132)
|
83 Percentage of subjects
Interval 75.9 to 89.3
|
61 Percentage of subjects
Interval 52.5 to 69.7
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men Y ≥ 32 (N=132,132)
|
72 Percentage of subjects
Interval 63.5 to 79.4
|
48 Percentage of subjects
Interval 39.7 to 57.3
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men Y ≥ 64 (N=132,132)
|
50 Percentage of subjects
Interval 41.2 to 58.8
|
37 Percentage of subjects
Interval 28.9 to 46.0
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men Y ≥ 128 (N=132,132)
|
32 Percentage of subjects
Interval 24.0 to 40.5
|
19 Percentage of subjects
Interval 12.6 to 26.7
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men A ≥ 8 (N=124,130)
|
72 Percentage of subjects
Interval 63.0 to 79.5
|
43 Percentage of subjects
Interval 34.4 to 52.0
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men A ≥ 16 (N=124,130)
|
65 Percentage of subjects
Interval 56.3 to 73.6
|
38 Percentage of subjects
Interval 29.3 to 46.6
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men A ≥ 32 (N=124,130)
|
36 Percentage of subjects
Interval 27.8 to 45.4
|
29 Percentage of subjects
Interval 21.6 to 37.8
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men A ≥ 64 (N=124,130)
|
16 Percentage of subjects
Interval 10.1 to 23.8
|
17 Percentage of subjects
Interval 10.9 to 24.5
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men A ≥ 128 (N=124,130)
|
5 Percentage of subjects
Interval 1.8 to 10.2
|
8 Percentage of subjects
Interval 4.3 to 14.6
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men C ≥ 8 (N=133,133)
|
97 Percentage of subjects
Interval 92.5 to 99.2
|
75 Percentage of subjects
Interval 67.0 to 82.3
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men C ≥ 16 (N=133,133)
|
93 Percentage of subjects
Interval 87.5 to 96.9
|
55 Percentage of subjects
Interval 46.0 to 63.5
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men C ≥ 32 (N=133,133)
|
82 Percentage of subjects
Interval 74.4 to 88.1
|
44 Percentage of subjects
Interval 35.0 to 52.5
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men C ≥ 64 (N=133,133)
|
67 Percentage of subjects
Interval 58.2 to 74.8
|
32 Percentage of subjects
Interval 23.8 to 40.2
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men C ≥ 128 (N=133,133)
|
47 Percentage of subjects
Interval 37.9 to 55.5
|
26 Percentage of subjects
Interval 18.4 to 33.8
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Men W ≥ 8 (N=131,130)
|
96 Percentage of subjects
Interval 91.3 to 98.7
|
87 Percentage of subjects
Interval 79.9 to 92.2
|
SECONDARY outcome
Timeframe: One month after the second vaccination (month 3)Population: Analysis was done on the FAS immunogenicity (month 3). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at one month after the 2-dose vaccination series, is reported.
Outcome measures
| Measure |
MenABCWY
n=138 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=133 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
NZ98/254 ≥ 8 (N=138,133)
|
45 Percentage of subjects
Interval 36.5 to 53.6
|
2 Percentage of subjects
Interval 0.18 to 5.3
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
M14459 ≥ 32 (N=138,132)
|
22 Percentage of subjects
Interval 15.8 to 30.3
|
0 Percentage of subjects
Interval 0.0 to 0.28
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
NZ98/254 ≥ 5 (N=138,133)
|
60 Percentage of subjects
Interval 51.5 to 68.4
|
2 Percentage of subjects
Interval 0.18 to 5.3
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
NZ98/254 ≥ 16 (N=138,133)
|
17 Percentage of subjects
Interval 11.5 to 24.8
|
0 Percentage of subjects
Interval 0.0 to 0.27
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
NZ98/254 ≥ 32 (N=138,133)
|
5 Percentage of subjects
Interval 2.1 to 10.2
|
0 Percentage of subjects
Interval 0.0 to 2.7
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
NZ98/254 ≥ 64 (N=138,133)
|
2 Percentage of subjects
Interval 0.45 to 6.2
|
0 Percentage of subjects
Interval 0.0 to 2.7
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
NZ98/254 ≥ 128 (N=138,133)
|
1 Percentage of subjects
Interval 0.18 to 5.1
|
0 Percentage of subjects
Interval 0.0 to 2.7
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
M14459 ≥ 64 (N=138,132)
|
7 Percentage of subjects
Interval 3.5 to 12.9
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
M14459 ≥ 5 (N=138,132)
|
83 Percentage of subjects
Interval 75.2 to 88.5
|
4 Percentage of subjects
Interval 1.2 to 8.6
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
M14459 ≥ 8 (N=138,132)
|
73 Percentage of subjects
Interval 65.0 to 80.4
|
2 Percentage of subjects
Interval 0.47 to 6.5
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
M14459 ≥ 16 (N=138,132)
|
56 Percentage of subjects
Interval 47.1 to 64.2
|
1 Percentage of subjects
Interval 0.02 to 4.1
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
M14459 ≥ 128 (N=138,132)
|
0 Percentage of subjects
Interval 0.0 to 2.6
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
M07-0241084 ≥ 5 (N=124,122)
|
50 Percentage of subjects
Interval 40.9 to 59.1
|
16 Percentage of subjects
Interval 9.6 to 23.2
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
M07-0241084 ≥ 8 (N=124,122)
|
40 Percentage of subjects
Interval 31.6 to 49.5
|
12 Percentage of subjects
Interval 7.0 to 19.5
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
M07-0241084 ≥ 16 (N=124,122)
|
20 Percentage of subjects
Interval 13.5 to 28.3
|
7 Percentage of subjects
Interval 2.9 to 12.5
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
M07-0241084 ≥ 32 (N=124,122)
|
5 Percentage of subjects
Interval 1.8 to 10.2
|
2 Percentage of subjects
Interval 0.5 to 7.0
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
M07-0241084 ≥ 64 (N=124,122)
|
2 Percentage of subjects
Interval 0.5 to 6.9
|
1 Percentage of subjects
Interval 0.02 to 4.5
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
M07-0241084 ≥128 (N=124,122)
|
2 Percentage of subjects
Interval 0.5 to 6.9
|
0 Percentage of subjects
Interval 0.0 to 3.0
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
96217 ≥ 5 (N=124,118)
|
99 Percentage of subjects
Interval 95.6 to 99.98
|
34 Percentage of subjects
Interval 25.4 to 43.2
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
96217 ≥ 8 (N=124,118)
|
99 Percentage of subjects
Interval 95.6 to 99.98
|
31 Percentage of subjects
Interval 23.1 to 40.5
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
96217 ≥ 16 (N=124,118)
|
98 Percentage of subjects
Interval 94.3 to 99.8
|
21 Percentage of subjects
Interval 14.2 to 29.7
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
96217 ≥ 32 (N=124,118)
|
96 Percentage of subjects
Interval 90.8 to 98.7
|
13 Percentage of subjects
Interval 7.3 to 20.1
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
96217 ≥ 64 (N=124,118)
|
88 Percentage of subjects
Interval 80.8 to 93.1
|
4 Percentage of subjects
Interval 1.4 to 9.6
|
|
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
96217 ≥ 128 (N=124,118)
|
66 Percentage of subjects
Interval 57.1 to 74.4
|
2 Percentage of subjects
Interval 0.21 to 6.0
|
SECONDARY outcome
Timeframe: One month after the second vaccination (month 3)Population: Analysis was done on the FAS immunogenicity (month 3). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128, against serogroups A, C, W, Y, at one month after the 2-dose vaccination series.
Outcome measures
| Measure |
MenABCWY
n=137 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=125 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men A ≥ 8 (N=137,115)
|
98 Percentage of subjects
Interval 93.7 to 99.55
|
72 Percentage of subjects
Interval 63.0 to 80.1
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men A ≥ 16 (N=137,115)
|
96 Percentage of subjects
Interval 90.7 to 98.4
|
69 Percentage of subjects
Interval 59.4 to 77.0
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men A ≥ 32 (N=137,115)
|
90 Percentage of subjects
Interval 83.4 to 94.3
|
57 Percentage of subjects
Interval 47.8 to 66.6
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men A ≥ 64 (N=137,115)
|
66 Percentage of subjects
Interval 57.1 to 73.6
|
42 Percentage of subjects
Interval 32.6 to 51.3
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men A ≥ 128 (N=137,115)
|
31 Percentage of subjects
Interval 23.7 to 39.9
|
19 Percentage of subjects
Interval 12.4 to 27.5
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men C ≥ 8 (N=134,125)
|
99 Percentage of subjects
Interval 95.9 to 99.98
|
74 Percentage of subjects
Interval 65.8 to 81.8
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men C ≥ 16 (N=134,125)
|
99 Percentage of subjects
Interval 95.9 to 99.98
|
64 Percentage of subjects
Interval 54.9 to 72.4
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men C ≥ 32 (N=134,125)
|
98 Percentage of subjects
Interval 93.6 to 99.54
|
52 Percentage of subjects
Interval 42.9 to 61.0
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men C ≥ 64 (N=134,125)
|
84 Percentage of subjects
Interval 77.0 to 90.0
|
39 Percentage of subjects
Interval 30.6 to 48.3
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men C ≥ 128 (N=134,125)
|
68 Percentage of subjects
Interval 59.3 to 75.7
|
30 Percentage of subjects
Interval 22.5 to 39.3
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men W ≥ 8 (N=119,115)
|
99 Percentage of subjects
Interval 95.4 to 99.98
|
86 Percentage of subjects
Interval 78.4 to 91.8
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men W ≥ 16 (N=119,115)
|
98 Percentage of subjects
Interval 94.1 to 99.8
|
81 Percentage of subjects
Interval 72.5 to 87.6
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men W ≥ 32 (N=119,115)
|
92 Percentage of subjects
Interval 85.1 to 95.9
|
61 Percentage of subjects
Interval 51.3 to 69.8
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men W ≥ 64 (N=119,115)
|
79 Percentage of subjects
Interval 70.6 to 85.9
|
36 Percentage of subjects
Interval 26.9 to 45.1
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men W ≥ 128 (N=119,115)
|
58 Percentage of subjects
Interval 48.6 to 67.0
|
23 Percentage of subjects
Interval 16.1 to 32.3
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men Y ≥ 8 (N=107,94)
|
96 Percentage of subjects
Interval 90.7 to 99.0
|
71 Percentage of subjects
Interval 61.0 to 80.1
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men Y ≥ 16 (N=107,94)
|
95 Percentage of subjects
Interval 89.4 to 98.5
|
69 Percentage of subjects
Interval 58.8 to 78.3
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men Y ≥ 32 (N=107,94)
|
92 Percentage of subjects
Interval 84.6 to 96.1
|
63 Percentage of subjects
Interval 52.2 to 72.5
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men Y ≥ 64 (N=107,94)
|
79 Percentage of subjects
Interval 70.5 to 86.6
|
48 Percentage of subjects
Interval 37.5 to 58.4
|
|
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Men Y ≥ 128 (N=107,94)
|
60 Percentage of subjects
Interval 49.9 to 69.2
|
30 Percentage of subjects
Interval 20.8 to 40.1
|
SECONDARY outcome
Timeframe: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)Population: Analysis was performed on FAS immunogenicity- month 3 and month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.The 2-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥2 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 2 times of the prevaccination hSBA
Outcome measures
| Measure |
MenABCWY
n=137 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=131 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
M14459-Month 6(N=132,131)
|
9 Percentage of subjects
Interval 4.8 to 15.3
|
1 Percentage of subjects
Interval 0.02 to 4.2
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
NZ98/254-Month 6(N=131,131)
|
2 Percentage of subjects
Interval 0.47 to 6.6
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
96217-Month 3(N=101,99)
|
92 Percentage of subjects
Interval 85.0 to 96.5
|
6 Percentage of subjects
Interval 2.3 to 12.7
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
M07-0241084-Month 3(N=115,119)
|
13 Percentage of subjects
Interval 7.5 to 20.6
|
2 Percentage of subjects
Interval 0.2 to 5.9
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
M14459-Month 3(N=137,130)
|
55 Percentage of subjects
Interval 46.8 to 64.0
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
NZ98/254-Month 3(N=136,131)
|
17 Percentage of subjects
Interval 11.0 to 24.3
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
96217-Month 6(N=106,111)
|
81 Percentage of subjects
Interval 72.4 to 88.1
|
5 Percentage of subjects
Interval 2.0 to 11.4
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
M07-0241084-Month 6(N=117,121)
|
3 Percentage of subjects
Interval 0.5 to 7.3
|
1 Percentage of subjects
Interval 0.02 to 4.5
|
SECONDARY outcome
Timeframe: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)Population: Analysis was performed on FAS immunogenicity-month 3 and month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 3-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.The 3-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥3 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 3 times of the prevaccination hSBA.
Outcome measures
| Measure |
MenABCWY
n=137 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=131 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
96217-month 3(N=101,99)
|
91 Percentage of subjects
Interval 83.8 to 95.8
|
2 Percentage of subjects
Interval 0.25 to 7.1
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
M07-0231084-month 3(N=115,119)
|
8 Percentage of subjects
Interval 3.6 to 14.3
|
0 Percentage of subjects
Interval 0.0 to 3.0
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
M14459-month 3(N=137,130)
|
34 Percentage of subjects
Interval 26.4 to 42.9
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
NZ98/254-month 3(N=136,131)
|
10 Percentage of subjects
Interval 5.2 to 15.8
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
96217-Month 6(N=106,111)
|
70 Percentage of subjects
Interval 60.1 to 78.4
|
2 Percentage of subjects
Interval 0.22 to 6.4
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
M07-0241084-Month 6(N=117,121)
|
2 Percentage of subjects
Interval 0.21 to 6.0
|
1 Percentage of subjects
Interval 0.02 to 4.5
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
M14459-Month 6(N=132,131)
|
4 Percentage of subjects
Interval 1.2 to 8.6
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
NZ98/254-Month 6(N=131,131)
|
2 Percentage of subjects
Interval 0.47 to 6.6
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
SECONDARY outcome
Timeframe: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)Population: Analaysis was performed on FAS immunogenicity-Month 3 and Month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 4-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series. The 4-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥4 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 4 times of the prevaccination hSBA.
Outcome measures
| Measure |
MenABCWY
n=137 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=131 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
96217-month 3(N=101,99)
|
87 Percentage of subjects
Interval 79.0 to 93.0
|
1 Percentage of subjects
Interval 0.03 to 5.5
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
M07-0231084-month 3(N=115,119)
|
2 Percentage of subjects
Interval 0.21 to 6.1
|
0 Percentage of subjects
Interval 0.0 to 3.0
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
M14459-month 3(N=137,130)
|
22 Percentage of subjects
Interval 15.3 to 29.8
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
NZ98/25-month 3(N=136,131)
|
5 Percentage of subjects
Interval 2.1 to 10.3
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
96217-Month 6(N=106,111)
|
63 Percentage of subjects
Interval 53.3 to 72.4
|
1 Percentage of subjects
Interval 0.02 to 4.9
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
M07-0241084-Month 6(N=117,121)
|
2 Percentage of subjects
Interval 0.21 to 6.0
|
0 Percentage of subjects
Interval 0.0 to 3.0
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
M14459-Month 6(N=132,131)
|
2 Percentage of subjects
Interval 0.47 to 6.5
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
NZ98/254-Month 6(N=131,131)
|
2 Percentage of subjects
Interval 0.19 to 5.4
|
0 Percentage of subjects
Interval 0.0 to 2.8
|
SECONDARY outcome
Timeframe: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)Population: Analysis was performed on FAS immunogenicity-Month 3 and Month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y, at 1 and 4 months after the 2-dose vaccination series. The 2-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥2 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 2 times of the prevaccination hSBA.
Outcome measures
| Measure |
MenABCWY
n=132 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=130 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men A-month 3(N=132,110)
|
81 Percentage of subjects
Interval 73.3 to 87.4
|
48 Percentage of subjects
Interval 38.6 to 57.9
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men C-month 3(N=131,123)
|
98 Percentage of subjects
Interval 94.6 to 99.81
|
66 Percentage of subjects
Interval 56.8 to 74.2
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men W-month 3(N=107,103)
|
74 Percentage of subjects
Interval 64.5 to 81.9
|
25 Percentage of subjects
Interval 17.2 to 34.8
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men Y-Month 3(N=99,86)
|
92 Percentage of subjects
Interval 84.7 to 96.5
|
59 Percentage of subjects
Interval 48.2 to 69.8
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men A-Month 6(N=119,126)
|
23 Percentage of subjects
Interval 15.5 to 31.3
|
21 Percentage of subjects
Interval 13.9 to 28.8
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men C-Month 6(N=130,130)
|
94 Percentage of subjects
Interval 88.2 to 97.3
|
55 Percentage of subjects
Interval 45.7 to 63.4
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men W-Month 6(N=114,116)
|
54 Percentage of subjects
Interval 43.9 to 62.9
|
30 Percentage of subjects
Interval 22.0 to 39.4
|
|
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men Y-Month 6(N=122,121)
|
72 Percentage of subjects
Interval 63.3 to 79.9
|
47 Percentage of subjects
Interval 38.0 to 56.4
|
SECONDARY outcome
Timeframe: At Month 3 and Month 6 (one and four months after 2 doses of vaccination)Population: Analysis was performed on FAS immunogenicity-Month 3 and Month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y at 1 and 4 months after the 2-dose vaccination series. The 3-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥3 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 3 times of the prevaccination hSBA.
Outcome measures
| Measure |
MenABCWY
n=132 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=130 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.
Men A-Month 6(N=119,126)
|
13 Percentage of subjects
Interval 7.9 to 20.9
|
14 Percentage of subjects
Interval 8.7 to 21.6
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.
Men C-Month 6(N=130,130)
|
88 Percentage of subjects
Interval 81.7 to 93.4
|
48 Percentage of subjects
Interval 38.9 to 56.6
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.
Men W-Month 6(N=114,116)
|
32 Percentage of subjects
Interval 24.0 to 41.9
|
22 Percentage of subjects
Interval 14.5 to 30.2
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.
Men Y-Month 6(N=122,121)
|
61 Percentage of subjects
Interval 51.4 to 69.4
|
40 Percentage of subjects
Interval 31.7 to 49.8
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.
Men A-Month 3(N=132,110)
|
61 Percentage of subjects
Interval 51.7 to 69.0
|
36 Percentage of subjects
Interval 27.4 to 46.1
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.
Men C-Month 3(N=131,123)
|
98 Percentage of subjects
Interval 94.6 to 99.81
|
58 Percentage of subjects
Interval 48.5 to 66.6
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.
Men W-Month 3(N=107,103)
|
56 Percentage of subjects
Interval 46.2 to 65.7
|
19 Percentage of subjects
Interval 12.3 to 28.4
|
|
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.
Men Y-Month 3(N=99,86)
|
85 Percentage of subjects
Interval 76.2 to 91.3
|
50 Percentage of subjects
Interval 39.0 to 61.0
|
SECONDARY outcome
Timeframe: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)Population: Analysis was performed on FAS immunogenicity- Month 3 and Month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 4-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y, at 1 and 4 months after the 2-dose vaccination series. The 4-fold rise in titer is defined as follows: a)for subjects with prevaccination hSBA titers \<LLQ, a postvaccination hSBA ≥4 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 4 times of the prevaccination hSBA.
Outcome measures
| Measure |
MenABCWY
n=132 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=130 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men A-Month 3(N=132,110)
|
45 Percentage of subjects
Interval 36.0 to 53.6
|
26 Percentage of subjects
Interval 18.4 to 35.6
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men C-month 3(N=131,123)
|
95 Percentage of subjects
Interval 89.3 to 97.8
|
54 Percentage of subjects
Interval 44.4 to 62.7
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men W-Month 3(N=107,103)
|
50 Percentage of subjects
Interval 39.7 to 59.4
|
15 Percentage of subjects
Interval 8.4 to 22.9
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men Y-month 3(N=99,86)
|
81 Percentage of subjects
Interval 71.7 to 88.0
|
47 Percentage of subjects
Interval 35.7 to 57.6
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men A-Month 6(N=119,126)
|
8 Percentage of subjects
Interval 3.5 to 13.9
|
11 Percentage of subjects
Interval 6.2 to 17.9
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men C-Month 6(N=130,130)
|
86 Percentage of subjects
Interval 79.0 to 91.6
|
43 Percentage of subjects
Interval 34.4 to 52.1
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men W-Month 6(N=114,116)
|
27 Percentage of subjects
Interval 19.3 to 36.3
|
17 Percentage of subjects
Interval 10.9 to 25.4
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Men Y-Month 6(N=122,121)
|
49 Percentage of subjects
Interval 40.0 to 58.4
|
35 Percentage of subjects
Interval 26.3 to 43.9
|
SECONDARY outcome
Timeframe: From day 1 (6 hours) until day 7 after any vaccinationPopulation: Analysis was done on Solicited Safety Set: all subjects in the All Exposed Set who have provided any solicited adverse event data and/or other indicators or reactogenicity
Reactogenicity was presented in terms of number of subjects reporting solicited local and systemic AEs and other indicators.
Outcome measures
| Measure |
MenABCWY
n=149 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=146 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Any
|
129 subjects
|
92 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Any Local Reactions
|
128 subjects
|
65 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Any Systemic Reactions
|
70 subjects
|
66 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Induration (mm) (N=149,145)
|
21 subjects
|
8 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Erythema (mm) (N=149,145)
|
23 subjects
|
5 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Pain (N=149,145)
|
127 subjects
|
63 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Nausea
|
9 subjects
|
19 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Fatigue
|
40 subjects
|
35 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Myalgia
|
20 subjects
|
14 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Arthralgia
|
18 subjects
|
5 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Headache
|
40 subjects
|
42 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Fever (N=148,146)
|
9 subjects
|
0 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Chills
|
15 subjects
|
8 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Loss of appetite
|
23 subjects
|
12 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Prevention of pain/fever (N=149,144)
|
4 subjects
|
2 subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Treatment of pain/fever (N=149,144)
|
60 subjects
|
9 subjects
|
SECONDARY outcome
Timeframe: From day 1 to day 30 after any vaccination for any unsolicited AE. From day 1 to study termination (day 181) for all other categories.Population: Analysis was done on the unsolicited safety set, ie, all subjects in the exposed set with any unsolicited adverse event data and/or indicators of unsolicited adverse events. Analysis for AEs leading to withdrawal was done on All Enrolled Set population.
Percentages of subjects reporting unsolicited AEs including serious adverse events (SAEs).
Outcome measures
| Measure |
MenABCWY
n=150 Participants
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=146 Participants
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited AEs.
Any unsolicited AEs
|
28 Subjects
|
28 Subjects
|
|
Number of Subjects Reporting Unsolicited AEs.
Possibly or probably related AEs
|
7 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Unsolicited AEs.
Medically-attended AEs
|
37 Subjects
|
44 Subjects
|
|
Number of Subjects Reporting Unsolicited AEs.
AEs leading to withdrawal
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Unsolicited AEs.
Any SAEs
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Unsolicited AEs.
SAE leading to death
|
0 Subjects
|
0 Subjects
|
Adverse Events
MenABCWY
Serious events: 0 serious events
Other events: 132 other events
Deaths: 0 deaths
Placebo/MenACWY
Serious events: 1 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenABCWY
n=151 participants at risk；n=150 participants at risk
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=147 participants at risk；n=146 participants at risk
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/150 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
0.68%
1/146 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
Other adverse events
| Measure |
MenABCWY
n=151 participants at risk；n=150 participants at risk
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2.
|
Placebo/MenACWY
n=147 participants at risk；n=146 participants at risk
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2.
|
|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
6.6%
10/151 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
13.6%
20/147 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
|
General disorders
CHILLS
|
9.9%
15/151 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
6.1%
9/147 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
|
General disorders
FATIGUE
|
27.8%
42/151 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
27.2%
40/147 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
39.7%
60/151 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
16.3%
24/147 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
|
General disorders
INJECTION SITE INDURATION
|
33.8%
51/151 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
10.9%
16/147 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
|
General disorders
INJECTION SITE PAIN
|
86.1%
130/151 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
48.3%
71/147 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
|
General disorders
PYREXIA
|
7.3%
11/151 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
0.00%
0/147 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
15.9%
24/151 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
8.2%
12/147 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
12.6%
19/151 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
4.8%
7/147 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
15.2%
23/151 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
10.2%
15/147 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
|
Nervous system disorders
HEADACHE
|
27.8%
42/151 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
29.9%
44/147 • Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
Data are presented in terms of number of subjects reporting AEs and in terms of number of subjects reporting AEs with a frequency \>5% in at least one group. For serious AEs, analysis was done on Unsolicited Safety set. For solicited/unsolicited AEs with a frequency \>5%, analysis was done on Overall Safety Set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place