Trial Outcomes & Findings for A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY (NCT NCT01018732)
NCT ID: NCT01018732
Last Updated: 2015-07-15
Results Overview
Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \>= 8 \[i.e. percentage of subjects with hsBA titer \>=8\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Day 1 (5 years after primary vaccination)
Results posted on
2015-07-15
Participant Flow
Participants were enrolled at 3 centers in the USA
All subjects enrolled were included in the trial.
Participant milestones
| Measure |
I: MenACWY-CRM Vaccine
Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
|
II: Licensed Polysaccharide Meningococcal Vaccine
Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
|
III: Meningococcal Naive
Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
54
|
|
Overall Study
COMPLETED
|
49
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
4
|
Reasons for withdrawal
| Measure |
I: MenACWY-CRM Vaccine
Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
|
II: Licensed Polysaccharide Meningococcal Vaccine
Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
|
III: Meningococcal Naive
Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Inappropriate Enrollment
|
0
|
1
|
0
|
|
Overall Study
Unable to Classify
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
Baseline characteristics by cohort
| Measure |
I: MenACWY-CRM Vaccine
n=50 Participants
Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
|
II: Licensed Polysaccharide Meningococcal Vaccine
n=51 Participants
Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
|
III: Meningococcal Naive
n=54 Participants
Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
18.8 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
19.2 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
20.5 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
19.5 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 (5 years after primary vaccination)Population: Full analysis set (all subjects who had no major protocol violation as defined prior to database lock).
Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \>= 8 \[i.e. percentage of subjects with hsBA titer \>=8\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Outcome measures
| Measure |
I:MenACWY
n=50 Participants
Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
II:Licensed Polysacharide Meningococcal Vaccine
n=50 Participants
Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
III: Meningococcal-naive
n=53 Participants
Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
|
|---|---|---|---|
|
Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination
Men A
|
30 Percentage of participants
Interval 18.0 to 45.0
|
44 Percentage of participants
Interval 30.0 to 59.0
|
11 Percentage of participants
Interval 4.0 to 23.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination
Men C
|
76 Percentage of participants
Interval 62.0 to 87.0
|
62 Percentage of participants
Interval 47.0 to 75.0
|
51 Percentage of participants
Interval 37.0 to 65.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination
Men W-135
|
72 Percentage of participants
Interval 58.0 to 84.0
|
56 Percentage of participants
Interval 41.0 to 70.0
|
51 Percentage of participants
Interval 37.0 to 65.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination
Men Y
|
76 Percentage of participants
Interval 62.0 to 87.0
|
50 Percentage of participants
Interval 36.0 to 64.0
|
55 Percentage of participants
Interval 40.0 to 68.0
|
PRIMARY outcome
Timeframe: Day 8, Day 29 (5 years after primary vaccination)Population: Full analysis set
Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Outcome measures
| Measure |
I:MenACWY
n=49 Participants
Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
II:Licensed Polysacharide Meningococcal Vaccine
n=49 Participants
Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
III: Meningococcal-naive
n=50 Participants
Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
|
|---|---|---|---|
|
Geometric Mean Titer After Booster Vaccination
Baseline, Men A
|
5.16 Titer
Interval 3.46 to 7.7
|
7.31 Titer
Interval 4.94 to 11.0
|
3.06 Titer
Interval 2.06 to 4.55
|
|
Geometric Mean Titer After Booster Vaccination
Day 8, Men A,
|
1059 Titer
Interval 585.0 to 1917.0
|
45 Titer
Interval 25.0 to 80.0
|
34 Titer
Interval 19.0 to 61.0
|
|
Geometric Mean Titer After Booster Vaccination
Day 29, Men A, (N=48, G I)
|
819 Titer
Interval 514.0 to 1305.0
|
147 Titer
Interval 94.0 to 232.0
|
113 Titer
Interval 72.0 to 179.0
|
|
Geometric Mean Titer After Booster Vaccination
Baseline, Men C
|
20 Titer
Interval 13.0 to 33.0
|
19 Titer
Interval 12.0 to 31.0
|
7.34 Titer
Interval 4.6 to 12.0
|
|
Geometric Mean Titer After Booster Vaccination
Day 8, Men C
|
1603 Titer
Interval 893.0 to 2877.0
|
36 Titer
Interval 20.0 to 64.0
|
70 Titer
Interval 39.0 to 124.0
|
|
Geometric Mean Titer After Booster Vaccination
Day 29, Men C
|
1217 Titer
Interval 717.0 to 2066.0
|
51 Titer
Interval 30.0 to 86.0
|
127 Titer
Interval 75.0 to 214.0
|
|
Geometric Mean Titer After Booster Vaccination
Baseline, Men W-135
|
29 Titer
Interval 17.0 to 49.0
|
12 Titer
Interval 7.02 to 19.0
|
11 Titer
Interval 6.31 to 18.0
|
|
Geometric Mean Titer After Booster Vaccination
Day 8, Men W-135
|
1685 Titer
Interval 1042.0 to 2725.0
|
34 Titer
Interval 21.0 to 54.0
|
63 Titer
Interval 39.0 to 101.0
|
|
Geometric Mean Titer After Booster Vaccination
Day 29, Men W-135
|
1644 Titer
Interval 1090.0 to 2481.0
|
47 Titer
Interval 32.0 to 71.0
|
79 Titer
Interval 52.0 to 118.0
|
|
Geometric Mean Titer After Booster Vaccination
Baseline, Men Y
|
28 Titer
Interval 18.0 to 45.0
|
7.8 Titer
Interval 4.91 to 12.0
|
8.69 Titer
Interval 5.45 to 14.0
|
|
Geometric Mean Titer After Booster Vaccination
Day 8, Men Y, (N=48, GI)
|
2561 Titer
Interval 1526.0 to 4298.0
|
21 Titer
Interval 13.0 to 35.0
|
64 Titer
Interval 39.0 to 107.0
|
|
Geometric Mean Titer After Booster Vaccination
Day 29, Men Y
|
2092 Titer
Interval 1340.0 to 3268.0
|
63 Titer
Interval 41.0 to 98.0
|
110 Titer
Interval 70.0 to 170.0
|
SECONDARY outcome
Timeframe: Day 1 (5 years after primary vaccination )Population: Full analysis set
Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) \>= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Outcome measures
| Measure |
I:MenACWY
n=50 Participants
Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
II:Licensed Polysacharide Meningococcal Vaccine
n=50 Participants
Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
III: Meningococcal-naive
n=53 Participants
Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
|
|---|---|---|---|
|
Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination
Men A
|
34 Percentage of participants
Interval 21.0 to 49.0
|
50 Percentage of participants
Interval 36.0 to 64.0
|
23 Percentage of participants
Interval 12.0 to 36.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination
Men C
|
84 Percentage of participants
Interval 71.0 to 93.0
|
68 Percentage of participants
Interval 53.0 to 80.0
|
70 Percentage of participants
Interval 56.0 to 82.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination
Men W-135
|
80 Percentage of participants
Interval 66.0 to 90.0
|
58 Percentage of participants
Interval 43.0 to 72.0
|
55 Percentage of participants
Interval 40.0 to 68.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination
Men Y
|
76 Percentage of participants
Interval 62.0 to 87.0
|
60 Percentage of participants
Interval 45.0 to 74.0
|
60 Percentage of participants
Interval 46.0 to 74.0
|
SECONDARY outcome
Timeframe: Day 1 (5 years after primary vaccination )Population: Full analysis set
Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Outcome measures
| Measure |
I:MenACWY
n=50 Participants
Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
II:Licensed Polysacharide Meningococcal Vaccine
n=50 Participants
Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
III: Meningococcal-naive
n=53 Participants
Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
|
|---|---|---|---|
|
Geometric Mean Titer at 5 Years After Primary Vaccination
Men A
|
5.21 Titer
Interval 3.51 to 7.74
|
7.56 Titer
Interval 5.12 to 11.0
|
3 Titer
Interval 2.05 to 4.4
|
|
Geometric Mean Titer at 5 Years After Primary Vaccination
Men C
|
20 Titer
Interval 12.0 to 31.0
|
19 Titer
Interval 12.0 to 30.0
|
7.62 Titer
Interval 4.86 to 12.0
|
|
Geometric Mean Titer at 5 Years After Primary Vaccination
Men W-135
|
28 Titer
Interval 17.0 to 46.0
|
12 Titer
Interval 7.17 to 20.0
|
11 Titer
Interval 6.53 to 17.0
|
|
Geometric Mean Titer at 5 Years After Primary Vaccination
Men Y
|
27 Titer
Interval 17.0 to 43.0
|
7.67 Titer
Interval 4.85 to 12.0
|
9.38 Titer
Interval 5.98 to 15.0
|
SECONDARY outcome
Timeframe: Day 7, Day 28 post booster (5 years after primary vaccination)Population: Full Analysis set
Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) \>= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.
Outcome measures
| Measure |
I:MenACWY
n=49 Participants
Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
II:Licensed Polysacharide Meningococcal Vaccine
n=49 Participants
Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
III: Meningococcal-naive
n=50 Participants
Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
|
|---|---|---|---|
|
Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination
Day 7 post booster, Men A
|
100 Percentage of participants
Interval 93.0 to 100.0
|
76 Percentage of participants
Interval 61.0 to 87.0
|
66 Percentage of participants
Interval 51.0 to 79.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination
Day 28 post booster, Men A
|
98 Percentage of participants
Interval 89.0 to 100.0
|
94 Percentage of participants
Interval 83.0 to 99.0
|
92 Percentage of participants
Interval 81.0 to 98.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination
Day 7 post booster, Men C
|
100 Percentage of participants
Interval 93.0 to 100.0
|
82 Percentage of participants
Interval 68.0 to 91.0
|
94 Percentage of participants
Interval 83.0 to 99.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination
Day 28 post booster, Men C
|
100 Percentage of participants
Interval 93.0 to 100.0
|
90 Percentage of participants
Interval 78.0 to 97.0
|
98 Percentage of participants
Interval 89.0 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination
Day 7 post booster, Men W-135
|
100 Percentage of participants
Interval 93.0 to 100.0
|
86 Percentage of participants
Interval 73.0 to 94.0
|
92 Percentage of participants
Interval 81.0 to 98.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination
Day 28 post booster, Men W-135
|
100 Percentage of participants
Interval 93.0 to 100.0
|
94 Percentage of participants
Interval 83.0 to 99.0
|
94 Percentage of participants
Interval 83.0 to 99.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination
Day 7 post booster, Men Y
|
98 Percentage of participants
Interval 89.0 to 100.0
|
78 Percentage of participants
Interval 63.0 to 88.0
|
92 Percentage of participants
Interval 81.0 to 98.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination
Day 28 post booster, Men Y
|
100 Percentage of participants
Interval 93.0 to 100.0
|
100 Percentage of participants
Interval 93.0 to 100.0
|
100 Percentage of participants
Interval 93.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 7, Day 28 post booster (5 years after primary vaccination)Population: Full Analysis set
Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) \>= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.
Outcome measures
| Measure |
I:MenACWY
n=49 Participants
Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
II:Licensed Polysacharide Meningococcal Vaccine
n=49 Participants
Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
III: Meningococcal-naive
n=50 Participants
Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
|
|---|---|---|---|
|
Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination
Day 7 post booster, Men A
|
100 Percentage of participants
Interval 93.0 to 100.0
|
73 Percentage of participants
Interval 59.0 to 85.0
|
64 Percentage of participants
Interval 49.0 to 77.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination
Day 28 post booster, Men A
|
98 Percentage of participants
Interval 89.0 to 100.0
|
94 Percentage of participants
Interval 83.0 to 99.0
|
92 Percentage of participants
Interval 81.0 to 98.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination
Day 7 post booster, Men C
|
100 Percentage of participants
Interval 93.0 to 100.0
|
78 Percentage of participants
Interval 63.0 to 88.0
|
90 Percentage of participants
Interval 78.0 to 97.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination
Day 28 post booster, Men C
|
100 Percentage of participants
Interval 93.0 to 100.0
|
84 Percentage of participants
Interval 70.0 to 93.0
|
98 Percentage of participants
Interval 89.0 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination
Day 7 post booster, Men W-135
|
100 Percentage of participants
Interval 93.0 to 100.0
|
84 Percentage of participants
Interval 70.0 to 93.0
|
88 Percentage of participants
Interval 76.0 to 95.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination
Day 28 post booster, Men W-135
|
100 Percentage of participants
Interval 93.0 to 100.0
|
92 Percentage of participants
Interval 80.0 to 98.0
|
94 Percentage of participants
Interval 83.0 to 99.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination
Day 7 post booster, Men Y
|
98 Percentage of participants
Interval 89.0 to 100.0
|
76 Percentage of participants
Interval 61.0 to 87.0
|
90 Percentage of participants
Interval 78.0 to 97.0
|
|
Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination
Day 28 post booster, Men Y
|
100 Percentage of participants
Interval 93.0 to 100.0
|
96 Percentage of participants
Interval 86.0 to 100.0
|
98 Percentage of participants
Interval 89.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 8 and Day 29 (at 5 Years After Primary Vaccination)Population: full analysis set
Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1
Outcome measures
| Measure |
I:MenACWY
n=49 Participants
Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
II:Licensed Polysacharide Meningococcal Vaccine
n=49 Participants
Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
III: Meningococcal-naive
n=50 Participants
Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
|
|---|---|---|---|
|
Geometric Mean Ratio After Booster Vaccination
Men C (Day 8:1)
|
78 Geometric mean ratio
Interval 47.0 to 130.0
|
1.85 Geometric mean ratio
Interval 1.13 to 3.03
|
9.48 Geometric mean ratio
Interval 5.76 to 16.0
|
|
Geometric Mean Ratio After Booster Vaccination
Men A (Day 8:1)
|
205 Geometric mean ratio
Interval 113.0 to 373.0
|
6.1 Geometric mean ratio
Interval 3.4 to 11.0
|
11 Geometric mean ratio
Interval 6.17 to 20.0
|
|
Geometric Mean Ratio After Booster Vaccination
Men A (Day 29:1), N=48, N=49, N=50
|
155 Geometric mean ratio
Interval 92.0 to 262.0
|
20 Geometric mean ratio
Interval 12.0 to 33.0
|
37 Geometric mean ratio
Interval 22.0 to 62.0
|
|
Geometric Mean Ratio After Booster Vaccination
Men C (Day 29:1)
|
60 Geometric mean ratio
Interval 37.0 to 97.0
|
2.64 Geometric mean ratio
Interval 1.64 to 4.24
|
17 Geometric mean ratio
Interval 11.0 to 28.0
|
|
Geometric Mean Ratio After Booster Vaccination
Men W-135 (Day 8:1)
|
58 Geometric mean ratio
Interval 34.0 to 97.0
|
2.92 Geometric mean ratio
Interval 1.75 to 4.87
|
5.95 Geometric mean ratio
Interval 3.55 to 9.99
|
|
Geometric Mean Ratio After Booster Vaccination
Men W-135 (Day 29:1)
|
56 Geometric mean ratio
Interval 33.0 to 95.0
|
4.06 Geometric mean ratio
Interval 2.43 to 6.77
|
7.48 Geometric mean ratio
Interval 4.46 to 13.0
|
|
Geometric Mean Ratio After Booster Vaccination
Men Y (Day 8:1), N=48, N=49, N=50
|
96 Geometric mean ratio
Interval 56.0 to 167.0
|
2.69 Geometric mean ratio
Interval 1.58 to 4.58
|
7.29 Geometric mean ratio
Interval 4.26 to 12.0
|
|
Geometric Mean Ratio After Booster Vaccination
Men Y (Day 29:1)
|
74 Geometric mean ratio
Interval 43.0 to 129.0
|
8.12 Geometric mean ratio
Interval 4.73 to 14.0
|
13 Geometric mean ratio
Interval 7.3 to 22.0
|
SECONDARY outcome
Timeframe: Day 8, Day 29 (5 years after primary vaccination)Population: Full analysis set
For a subject with hSBA titer \<4 at baseline, seroresponse is defined as a postvaccination hSBA titer \>=8; and for a subject with hSBA titer \>=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.
Outcome measures
| Measure |
I:MenACWY
n=49 Participants
Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
II:Licensed Polysacharide Meningococcal Vaccine
n=49 Participants
Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
III: Meningococcal-naive
n=50 Participants
Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
|
|---|---|---|---|
|
Percentage of Subjects With hSBA Seroresponse After Booster Vaccination
Men A, Day 8
|
100 Percentage of participants
Interval 93.0 to 100.0
|
51 Percentage of participants
Interval 36.0 to 66.0
|
60 Percentage of participants
Interval 45.0 to 74.0
|
|
Percentage of Subjects With hSBA Seroresponse After Booster Vaccination
Men A, Day 29
|
100 Percentage of participants
Interval 93.0 to 100.0
|
76 Percentage of participants
Interval 61.0 to 87.0
|
90 Percentage of participants
Interval 78.0 to 97.0
|
|
Percentage of Subjects With hSBA Seroresponse After Booster Vaccination
Men C, Day 8
|
96 Percentage of participants
Interval 86.0 to 100.0
|
16 Percentage of participants
Interval 7.0 to 30.0
|
62 Percentage of participants
Interval 47.0 to 75.0
|
|
Percentage of Subjects With hSBA Seroresponse After Booster Vaccination
Men C, Day 29
|
96 Percentage of participants
Interval 86.0 to 100.0
|
31 Percentage of participants
Interval 18.0 to 45.0
|
80 Percentage of participants
Interval 66.0 to 90.0
|
|
Percentage of Subjects With hSBA Seroresponse After Booster Vaccination
Men W-135, Day 8
|
96 Percentage of participants
Interval 86.0 to 100.0
|
37 Percentage of participants
Interval 23.0 to 52.0
|
48 Percentage of participants
Interval 34.0 to 63.0
|
|
Percentage of Subjects With hSBA Seroresponse After Booster Vaccination
Men W-135, Day 29
|
98 Percentage of participants
Interval 89.0 to 100.0
|
47 Percentage of participants
Interval 33.0 to 62.0
|
58 Percentage of participants
Interval 43.0 to 72.0
|
|
Percentage of Subjects With hSBA Seroresponse After Booster Vaccination
Men Y, Day 8, (N=48, G I)
|
94 Percentage of participants
Interval 83.0 to 99.0
|
33 Percentage of participants
Interval 20.0 to 48.0
|
54 Percentage of participants
Interval 39.0 to 68.0
|
|
Percentage of Subjects With hSBA Seroresponse After Booster Vaccination
Men Y, Day 29
|
94 Percentage of participants
Interval 83.0 to 99.0
|
55 Percentage of participants
Interval 40.0 to 69.0
|
76 Percentage of participants
Interval 62.0 to 87.0
|
SECONDARY outcome
Timeframe: Up to Day 7Local and systemic reactions were solicited to assess safety and tolerability of vaccination
Outcome measures
| Measure |
I:MenACWY
n=50 Participants
Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
II:Licensed Polysacharide Meningococcal Vaccine
n=50 Participants
Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
|
III: Meningococcal-naive
n=53 Participants
Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
|
|---|---|---|---|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Local Reactions (any-total)
|
30 participants
|
32 participants
|
40 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Pain (any)
|
29 participants
|
27 participants
|
33 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Erythema (any)
|
8 participants
|
8 participants
|
15 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Induration (any)
|
5 participants
|
8 participants
|
5 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Sytemic Reactions (any-total)
|
31 participants
|
25 participants
|
38 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Chills (any)
|
7 participants
|
5 participants
|
3 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Nausea (any)
|
8 participants
|
9 participants
|
11 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Malaise (any)
|
10 participants
|
11 participants
|
15 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Myalgia (any)
|
16 participants
|
13 participants
|
17 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Arthalgia (any)
|
3 participants
|
5 participants
|
6 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Headache (any)
|
21 participants
|
17 participants
|
31 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Fever >= 38C
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Stayed at home
|
0 participants
|
2 participants
|
2 participants
|
|
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Analgesic antipyretic medication used
|
10 participants
|
8 participants
|
9 participants
|
Adverse Events
I: MenACWY-CRM Vaccine
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
II: Licensed Polysaccharide Meningococcal Vaccine
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
III: Meningococcal Naive
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
I: MenACWY-CRM Vaccine
n=50 participants at risk
Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
|
II: Licensed Polysaccharide Meningococcal Vaccine
n=50 participants at risk
Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
|
III: Meningococcal Naive
n=53 participants at risk
Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
16.0%
8/50 • Number of events 8 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
18.0%
9/50 • Number of events 9 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
20.8%
11/53 • Number of events 11 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
|
General disorders
Chills
|
14.0%
7/50 • Number of events 7 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
10.0%
5/50 • Number of events 5 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
5.7%
3/53 • Number of events 3 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
|
General disorders
Injection site erythema
|
16.0%
8/50 • Number of events 8 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
16.0%
8/50 • Number of events 8 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
28.3%
15/53 • Number of events 15 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
|
General disorders
Injection site induration
|
10.0%
5/50 • Number of events 5 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
16.0%
8/50 • Number of events 8 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
9.4%
5/53 • Number of events 5 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
|
General disorders
Injection site pain
|
58.0%
29/50 • Number of events 29 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
54.0%
27/50 • Number of events 27 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
62.3%
33/53 • Number of events 33 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
|
General disorders
Malaise
|
20.0%
10/50 • Number of events 10 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
22.0%
11/50 • Number of events 11 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
28.3%
15/53 • Number of events 15 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
3/50 • Number of events 3 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
10.0%
5/50 • Number of events 5 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
11.3%
6/53 • Number of events 6 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
36.0%
18/50 • Number of events 18 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
26.0%
13/50 • Number of events 13 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
34.0%
18/53 • Number of events 18 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
|
Nervous system disorders
Headache
|
42.0%
21/50 • Number of events 21 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
34.0%
17/50 • Number of events 17 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
58.5%
31/53 • Number of events 31 • safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60