Trial Outcomes & Findings for Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single Dose of a Meningococcal Reference Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age (NCT NCT04368429)
NCT ID: NCT04368429
Last Updated: 2025-09-15
Results Overview
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
360 participants
Primary outcome timeframe
Day 30 (post-vaccination)
Results posted on
2025-09-15
Participant Flow
Study participants were enrolled at 4 active centers in Japan from 22 May 2020 to 05 October 2020.
A total of 360 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Group 1: MenACYW Conjugate Vaccine
Participants received a single intramuscular (IM) dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) on Day 0.
|
Group 2: Menactra® Vaccine
Participants received a single IM dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine) on Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
180
|
|
Overall Study
Safety Analysis Set
|
179
|
180
|
|
Overall Study
COMPLETED
|
179
|
180
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: MenACYW Conjugate Vaccine
Participants received a single intramuscular (IM) dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) on Day 0.
|
Group 2: Menactra® Vaccine
Participants received a single IM dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine) on Day 0.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single Dose of a Meningococcal Reference Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age
Baseline characteristics by cohort
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=180 Participants
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menactra® Vaccine
n=180 Participants
Participants received a single IM dose of Menactra® vaccine on Day 0.
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.1 years
STANDARD_DEVIATION 11.09 • n=5 Participants
|
24.1 years
STANDARD_DEVIATION 10.27 • n=7 Participants
|
24.6 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
180 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on Per-Protocol Analysis Set (PPAS) population that included participants who received 1 dose of the study vaccine and had a valid post-vaccination blood sample result with no relevant protocol deviations. Here, 'number analyzed'=participants with available data for each specified category.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=174 Participants
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menactra® Vaccine
n=179 Participants
Participants received a single IM dose of Menactra® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis
Serogroup A
|
85.6 percentage of participants
Interval 79.5 to 90.5
|
65.4 percentage of participants
Interval 57.9 to 72.3
|
|
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis
Serogroup C
|
96.6 percentage of participants
Interval 92.6 to 98.7
|
62.6 percentage of participants
Interval 55.0 to 69.7
|
|
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis
Serogroup Y
|
97.7 percentage of participants
Interval 94.2 to 99.4
|
63.5 percentage of participants
Interval 56.0 to 70.6
|
|
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis
Serogroup W
|
87.4 percentage of participants
Interval 81.5 to 91.9
|
49.2 percentage of participants
Interval 41.6 to 56.7
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS population. Here, 'number analyzed'=participants with available data for each specified category.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=174 Participants
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menactra® Vaccine
n=179 Participants
Participants received a single IM dose of Menactra® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A
|
85.6 percentage of participants
Interval 79.5 to 90.5
|
65.4 percentage of participants
Interval 57.9 to 72.3
|
|
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y
|
97.7 percentage of participants
Interval 94.2 to 99.4
|
63.5 percentage of participants
Interval 56.0 to 70.6
|
|
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C
|
96.6 percentage of participants
Interval 92.6 to 98.7
|
62.6 percentage of participants
Interval 55.0 to 69.7
|
|
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W
|
87.4 percentage of participants
Interval 81.5 to 91.9
|
49.2 percentage of participants
Interval 41.6 to 56.7
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination); Day 30 (post-vaccination)Population: Analysis was performed on PPAS population. Here, 'number analyzed'=participants with available data for each specified category.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Percentage of participants With hSBA antibody titers \>=1:4 and \>=1:8 for serogroups A, C, Y, and W were reported in the outcome measure.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=174 Participants
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menactra® Vaccine
n=179 Participants
Participants received a single IM dose of Menactra® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: >= 1:4: Day 0
|
55.2 percentage of participants
Interval 47.5 to 62.7
|
65.9 percentage of participants
Interval 58.5 to 72.8
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: >= 1:8: Day 0
|
31.6 percentage of participants
Interval 24.8 to 39.1
|
38.5 percentage of participants
Interval 31.4 to 46.1
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: >= 1:4: Day 0
|
82.8 percentage of participants
Interval 76.3 to 88.1
|
82.1 percentage of participants
Interval 75.7 to 87.4
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: >= 1:8: Day 0
|
42.5 percentage of participants
Interval 35.1 to 50.2
|
46.9 percentage of participants
Interval 39.4 to 54.5
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: >= 1:4: Day 30
|
98.3 percentage of participants
Interval 95.0 to 99.6
|
98.9 percentage of participants
Interval 96.0 to 99.9
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: >= 1:8: Day 30
|
96.6 percentage of participants
Interval 92.6 to 98.7
|
92.7 percentage of participants
Interval 87.9 to 96.1
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: >= 1:4: Day 30
|
100 percentage of participants
Interval 97.9 to 100.0
|
90.5 percentage of participants
Interval 85.2 to 94.4
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: >= 1:8: Day 30
|
98.9 percentage of participants
Interval 95.9 to 99.9
|
81.0 percentage of participants
Interval 74.5 to 86.5
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: >= 1:4: Day 0
|
39.7 percentage of participants
Interval 32.3 to 47.3
|
44.9 percentage of participants
Interval 37.5 to 52.6
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: >= 1:8: Day 0
|
27.0 percentage of participants
Interval 20.6 to 34.3
|
29.2 percentage of participants
Interval 22.7 to 36.5
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: >= 1:4: Day 30
|
100 percentage of participants
Interval 97.9 to 100.0
|
97.2 percentage of participants
Interval 93.6 to 99.1
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: >= 1:8: Day 30
|
100 percentage of participants
Interval 97.9 to 100.0
|
89.4 percentage of participants
Interval 83.9 to 93.5
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W: >= 1:4: Day 0
|
73.0 percentage of participants
Interval 65.7 to 79.4
|
76.0 percentage of participants
Interval 69.0 to 82.0
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W: >= 1:8: Day 0
|
51.1 percentage of participants
Interval 43.5 to 58.8
|
58.7 percentage of participants
Interval 51.1 to 66.0
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W: >= 1:4: Day 30
|
100 percentage of participants
Interval 97.9 to 100.0
|
96.6 percentage of participants
Interval 92.8 to 98.8
|
|
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W: >= 1:8: Day 30
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
91.1 percentage of participants
Interval 85.9 to 94.8
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination); Day 30 (post-vaccination)Population: Analysis was performed on PPAS population. Here, 'number analyzed'=participants with available data for each specified category.
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=174 Participants
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menactra® Vaccine
n=179 Participants
Participants received a single IM dose of Menactra® vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: Day 0
|
5.79 titers
Interval 5.06 to 6.63
|
5.96 titers
Interval 5.28 to 6.73
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: Day 30
|
123 titers
Interval 99.4 to 152.0
|
41.3 titers
Interval 33.3 to 51.3
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: Day 0
|
4.47 titers
Interval 3.86 to 5.18
|
5.27 titers
Interval 4.53 to 6.12
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: Day 30
|
544 titers
Interval 431.0 to 685.0
|
36.6 titers
Interval 28.3 to 47.5
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: Day 0
|
3.95 titers
Interval 3.36 to 4.65
|
4.29 titers
Interval 3.62 to 5.08
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: Day 30
|
221 titers
Interval 183.0 to 267.0
|
41.5 titers
Interval 32.7 to 52.6
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W: Day 0
|
7.39 titers
Interval 6.21 to 8.79
|
8.41 titers
Interval 7.09 to 9.98
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W: Day 30
|
125 titers
Interval 104.0 to 151.0
|
36.5 titers
Interval 29.3 to 45.5
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS population.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Percentage of participants with hSBA titers \<1:4, 1:4, 1:8, 1:16,1:32, 1:64, 1:128, 1:256, 1:512, 1:1024, 1:2048 and 1:4096 for serogroups A, C, Y, and W; with hSBA titers of 1:8192 for serogroup Y; and with hSBA titers of 1:8192, 1:16384, 1:32768 for serogroup C were reported.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=174 Participants
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menactra® Vaccine
n=179 Participants
Participants received a single IM dose of Menactra® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: 1:2048
|
0.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: 1:4096
|
0.6 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C:<1:4
|
0 percentage of participants
|
9.5 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:8
|
0.6 percentage of participants
|
8.9 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:128
|
7.5 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:256
|
12.6 percentage of participants
|
8.4 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:4096
|
7.5 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y:<1:4
|
0 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y:1:4
|
0 percentage of participants
|
7.8 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A:<1:4
|
1.7 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: 1:4
|
1.7 percentage of participants
|
6.1 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: 1:8
|
2.9 percentage of participants
|
12.3 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: 1:16
|
4.6 percentage of participants
|
18.4 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: 1:32
|
11.5 percentage of participants
|
17.9 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: 1:64
|
13.2 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: 1:128
|
24.1 percentage of participants
|
13.4 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: 1:256
|
16.1 percentage of participants
|
8.9 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: 1:512
|
15.5 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A: 1:1024
|
7.5 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:4
|
1.1 percentage of participants
|
9.5 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:16
|
2.3 percentage of participants
|
10.1 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:32
|
3.4 percentage of participants
|
15.1 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:64
|
4.0 percentage of participants
|
14.0 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:512
|
22.4 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:1024
|
25.9 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:2048
|
8.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:8192
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:16384
|
1.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C: 1:32768
|
1.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y:1:8
|
0.6 percentage of participants
|
11.7 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: 1:16
|
1.7 percentage of participants
|
15.1 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: 1:32
|
6.9 percentage of participants
|
16.8 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: 1:64
|
16.1 percentage of participants
|
19.0 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: 1:128
|
20.7 percentage of participants
|
7.8 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: 1:256
|
20.7 percentage of participants
|
6.1 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: 1:512
|
14.4 percentage of participants
|
8.4 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: 1:1024
|
12.6 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: 1:2048
|
4.0 percentage of participants
|
1.7 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: 1:4096
|
1.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y: 1:8192
|
1.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W:<1:4
|
0 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W:1:4
|
0.6 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W:1:8
|
1.7 percentage of participants
|
10.1 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W:1:16
|
5.2 percentage of participants
|
19.6 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W:1:32
|
13.8 percentage of participants
|
24.6 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W:1:64
|
16.1 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W:1:128
|
25.3 percentage of participants
|
9.5 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W:1:256
|
19.0 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W:1:512
|
10.3 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W:1:1024
|
6.3 percentage of participants
|
7.3 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W:1:2048
|
1.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W:1:4096
|
0.6 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 0) to Day 30 (post-vaccination)Population: Analysis was performed on PPAS population. Here, 'number analyzed'=participants with available data for each specified category.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=174 Participants
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menactra® Vaccine
n=179 Participants
Participants received a single IM dose of Menactra® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup W
|
87.4 percentage of participants
Interval 81.5 to 91.9
|
49.2 percentage of participants
Interval 41.6 to 56.7
|
|
Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup A
|
85.6 percentage of participants
Interval 79.5 to 90.5
|
65.4 percentage of participants
Interval 57.9 to 72.3
|
|
Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup C
|
96.6 percentage of participants
Interval 92.6 to 98.7
|
62.6 percentage of participants
Interval 55.0 to 69.7
|
|
Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Serogroup Y
|
97.7 percentage of participants
Interval 94.2 to 99.4
|
63.5 percentage of participants
Interval 56.0 to 70.6
|
SECONDARY outcome
Timeframe: Within 30 minutes post-vaccinationPopulation: Analysis was performed on Safety Analysis Set which included participants who received at least one dose of the study vaccine and had any safety data available; analyzed according to the vaccine they actually received.
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=179 Participants
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menactra® Vaccine
n=180 Participants
Participants received a single IM dose of Menactra® vaccine on Day 0.
|
|---|---|---|
|
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post-vaccinationPopulation: Analysis was performed on Safety Analysis Set.
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions included pain, erythema, swelling, and induration. Solicited systemic reactions included fever, headache, malaise and myalgia.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=179 Participants
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menactra® Vaccine
n=180 Participants
Participants received a single IM dose of Menactra® vaccine on Day 0.
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Injection site induration
|
6 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Fever
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Headache
|
34 Participants
|
17 Participants
|
|
Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Injection site pain
|
72 Participants
|
66 Participants
|
|
Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Injection site erythema
|
16 Participants
|
8 Participants
|
|
Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Injection site swelling
|
14 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Malaise
|
22 Participants
|
9 Participants
|
|
Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Myalgia
|
38 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days post-vaccinationPopulation: Analysis was performed on Safety Analysis Set.
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=179 Participants
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menactra® Vaccine
n=180 Participants
Participants received a single IM dose of Menactra® vaccine on Day 0.
|
|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
|
15 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to 30 days post-vaccinationPopulation: Analysis was performed on Safety Analysis Set.
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=179 Participants
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menactra® Vaccine
n=180 Participants
Participants received a single IM dose of Menactra® vaccine on Day 0.
|
|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: MenACYW Conjugate Vaccine
Serious events: 0 serious events
Other events: 98 other events
Deaths: 0 deaths
Group 2: Menactra® Vaccine
Serious events: 0 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=179 participants at risk
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menactra® Vaccine
n=180 participants at risk
Participants received a single IM dose of Menactra® vaccine on Day 0.
|
|---|---|---|
|
General disorders
Injection Site Erythema
|
8.9%
16/179 • Number of events 16 • Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Analysis was performed on Safety Analysis Set.
|
4.4%
8/180 • Number of events 8 • Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Injection Site Pain
|
40.2%
72/179 • Number of events 72 • Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Analysis was performed on Safety Analysis Set.
|
36.7%
66/180 • Number of events 66 • Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Injection Site Swelling
|
7.8%
14/179 • Number of events 14 • Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Analysis was performed on Safety Analysis Set.
|
3.3%
6/180 • Number of events 6 • Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Malaise
|
12.3%
22/179 • Number of events 22 • Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Analysis was performed on Safety Analysis Set.
|
5.0%
9/180 • Number of events 9 • Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Analysis was performed on Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.2%
38/179 • Number of events 38 • Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Analysis was performed on Safety Analysis Set.
|
16.7%
30/180 • Number of events 30 • Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Analysis was performed on Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
20.1%
36/179 • Number of events 36 • Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Analysis was performed on Safety Analysis Set.
|
9.4%
17/180 • Number of events 17 • Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Analysis was performed on Safety Analysis Set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER