Trial Outcomes & Findings for Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older (NCT NCT01732627)
NCT ID: NCT01732627
Last Updated: 2022-04-04
Results Overview
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
301 participants
Primary outcome timeframe
Day 0 (pre-vaccination)
Results posted on
2022-04-04
Participant Flow
Study was conducted from 12-November-2012 to 17-January-2013 at 12 sites in the United States.
A total of 301 participants were enrolled and vaccinated in the study.
Participant milestones
| Measure |
Group 1: MenACYW Conjugate Vaccine
Adult participants aged greater than or equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
|
Group 2: Menomune® A/C/Y/W 135 Vaccine
Adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined (Menomune®) vaccine on Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
201
|
100
|
|
Overall Study
Safety Analysis Set (SafAS)
|
199
|
100
|
|
Overall Study
COMPLETED
|
200
|
100
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: MenACYW Conjugate Vaccine
Adult participants aged greater than or equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
|
Group 2: Menomune® A/C/Y/W 135 Vaccine
Adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined (Menomune®) vaccine on Day 0.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older
Baseline characteristics by cohort
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=201 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=100 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 7.15 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 6.58 • n=7 Participants
|
65.9 years
STANDARD_DEVIATION 6.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
190 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
287 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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 0 (pre-vaccination)Population: Analysis was performed on Per-Protocol Analysis Set (PPAS) population which included participants who received at least one dose of the study vaccine, had any valid serology result, and no protocol deviations.
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=94 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=195 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup A: ≥1:4
|
96.8 percentage of participants
Interval 91.0 to 99.3
|
95.9 percentage of participants
Interval 92.1 to 98.2
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup A: ≥1:8
|
79.8 percentage of participants
Interval 70.2 to 87.4
|
76.4 percentage of participants
Interval 69.8 to 82.2
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup C: ≥1:4
|
30.9 percentage of participants
Interval 21.7 to 41.2
|
27.7 percentage of participants
Interval 21.5 to 34.5
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup C: ≥1:8
|
10.6 percentage of participants
Interval 5.2 to 18.7
|
17.4 percentage of participants
Interval 12.4 to 23.5
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup Y: ≥1:4
|
26.6 percentage of participants
Interval 18.0 to 36.7
|
22.1 percentage of participants
Interval 16.4 to 28.5
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup Y: ≥1:8
|
24.5 percentage of participants
Interval 16.2 to 34.4
|
13.3 percentage of participants
Interval 8.9 to 18.9
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup W 135: ≥1:4
|
26.6 percentage of participants
Interval 18.0 to 36.7
|
26.2 percentage of participants
Interval 20.1 to 32.9
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup W 135: ≥1:8
|
8.5 percentage of participants
Interval 3.7 to 16.1
|
13.3 percentage of participants
Interval 8.9 to 18.9
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS population.
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=94 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=195 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup Y: ≥1:8
|
59.6 percentage of participants
Interval 49.0 to 69.6
|
80.5 percentage of participants
Interval 74.2 to 85.8
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup A: ≥1:4
|
93.6 percentage of participants
Interval 86.6 to 97.6
|
97.4 percentage of participants
Interval 94.1 to 99.2
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup A: ≥1:8
|
85.1 percentage of participants
Interval 76.3 to 91.6
|
93.8 percentage of participants
Interval 89.5 to 96.8
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup C: ≥1:4
|
79.8 percentage of participants
Interval 70.2 to 87.4
|
85.6 percentage of participants
Interval 79.9 to 90.2
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup C: ≥1:8
|
62.8 percentage of participants
Interval 52.2 to 72.5
|
74.9 percentage of participants
Interval 68.2 to 80.8
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup Y: ≥1:4
|
73.4 percentage of participants
Interval 63.3 to 82.0
|
87.2 percentage of participants
Interval 81.7 to 91.5
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup W 135: ≥1:4
|
77.7 percentage of participants
Interval 67.9 to 85.6
|
88.7 percentage of participants
Interval 83.4 to 92.8
|
|
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup W 135: ≥1:8
|
60.6 percentage of participants
Interval 50.0 to 70.6
|
79.5 percentage of participants
Interval 73.1 to 84.9
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS population.
Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=94 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=195 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup A
|
46.8 percentage of participants
Interval 36.4 to 57.4
|
65.1 percentage of participants
Interval 58.0 to 71.8
|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup C
|
59.6 percentage of participants
Interval 49.0 to 69.6
|
70.8 percentage of participants
Interval 63.8 to 77.0
|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup Y
|
48.9 percentage of participants
Interval 38.5 to 59.5
|
75.4 percentage of participants
Interval 68.7 to 81.3
|
|
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup W 135
|
55.3 percentage of participants
Interval 44.7 to 65.6
|
74.4 percentage of participants
Interval 67.6 to 80.3
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination)Population: Analysis was performed on PPAS population.
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=94 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=195 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup A
|
10.4 titers (1/dilution)
Interval 8.58 to 12.5
|
9.73 titers (1/dilution)
Interval 8.65 to 10.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup C
|
2.87 titers (1/dilution)
Interval 2.49 to 3.31
|
3.32 titers (1/dilution)
Interval 2.87 to 3.85
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup Y
|
3.53 titers (1/dilution)
Interval 2.84 to 4.38
|
3.02 titers (1/dilution)
Interval 2.63 to 3.47
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup W 135
|
2.83 titers (1/dilution)
Interval 2.4 to 3.33
|
2.83 titers (1/dilution)
Interval 2.56 to 3.14
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS population.
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=94 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=195 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup A
|
31.8 titers (1/dilution)
Interval 22.5 to 44.9
|
51.0 titers (1/dilution)
Interval 40.7 to 63.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup C
|
18.5 titers (1/dilution)
Interval 12.1 to 28.3
|
48.3 titers (1/dilution)
Interval 34.8 to 67.1
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup Y
|
16.6 titers (1/dilution)
Interval 11.3 to 24.5
|
41.9 titers (1/dilution)
Interval 31.8 to 55.3
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup W 135
|
17.1 titers (1/dilution)
Interval 11.6 to 25.2
|
29.0 titers (1/dilution)
Interval 22.5 to 37.3
|
PRIMARY outcome
Timeframe: Day 0 (pre-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 135 were measured by rSBA assay method.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=94 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=195 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup A: ≥1:8
|
26.9 percentage of participants
Interval 18.2 to 37.1
|
28.2 percentage of participants
Interval 22.0 to 35.1
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup A: ≥1:128
|
22.6 percentage of participants
Interval 14.6 to 32.4
|
22.1 percentage of participants
Interval 16.4 to 28.5
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup C: ≥1:8
|
9.6 percentage of participants
Interval 4.5 to 17.4
|
12.3 percentage of participants
Interval 8.0 to 17.8
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup C: ≥1:128
|
4.3 percentage of participants
Interval 1.2 to 10.5
|
8.2 percentage of participants
Interval 4.8 to 13.0
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup Y: ≥1:8
|
50.0 percentage of participants
Interval 39.5 to 60.5
|
50.3 percentage of participants
Interval 43.0 to 57.5
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup Y: ≥1:128
|
20.2 percentage of participants
Interval 12.6 to 29.8
|
27.7 percentage of participants
Interval 21.5 to 34.5
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup W 135: ≥1:8
|
27.7 percentage of participants
Interval 18.9 to 37.8
|
20.0 percentage of participants
Interval 14.6 to 26.3
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup W 135: ≥1:128
|
14.9 percentage of participants
Interval 8.4 to 23.7
|
12.8 percentage of participants
Interval 8.5 to 18.3
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=94 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=193 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup A: ≥1:8
|
94.7 percentage of participants
Interval 88.0 to 98.3
|
95.9 percentage of participants
Interval 92.0 to 98.2
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup A: ≥1:128
|
89.4 percentage of participants
Interval 81.3 to 94.8
|
94.3 percentage of participants
Interval 90.0 to 97.1
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup C: ≥1:8
|
87.2 percentage of participants
Interval 78.8 to 93.2
|
95.9 percentage of participants
Interval 92.0 to 98.2
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup C: ≥1:128
|
77.7 percentage of participants
Interval 67.9 to 85.6
|
93.3 percentage of participants
Interval 88.8 to 96.4
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup Y: ≥1:8
|
94.7 percentage of participants
Interval 88.0 to 98.3
|
97.4 percentage of participants
Interval 94.1 to 99.2
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup Y: ≥1:128
|
73.4 percentage of participants
Interval 63.3 to 82.0
|
88.1 percentage of participants
Interval 82.7 to 92.3
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup W 135: ≥1:8
|
94.7 percentage of participants
Interval 88.0 to 98.3
|
98.4 percentage of participants
Interval 95.5 to 99.7
|
|
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®
Serogroup W 135: ≥1:128
|
79.8 percentage of participants
Interval 70.2 to 87.4
|
94.3 percentage of participants
Interval 90.0 to 97.1
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers \<1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=94 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=195 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup A
|
89.2 percentage of participants
Interval 81.1 to 94.7
|
90.2 percentage of participants
Interval 85.1 to 94.0
|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup C
|
86.2 percentage of participants
Interval 77.5 to 92.4
|
94.8 percentage of participants
Interval 90.7 to 97.5
|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup Y
|
75.5 percentage of participants
Interval 65.6 to 83.8
|
86.5 percentage of participants
Interval 80.9 to 91.0
|
|
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup W 135
|
90.4 percentage of participants
Interval 82.6 to 95.5
|
95.3 percentage of participants
Interval 91.3 to 97.8
|
PRIMARY outcome
Timeframe: Day 0 (pre-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 135 antibody titers were measured by rSBA assay method.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=94 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=195 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup A
|
7.32 titers (1/dilution)
Interval 4.62 to 11.6
|
7.75 titers (1/dilution)
Interval 5.65 to 10.6
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup C
|
2.93 titers (1/dilution)
Interval 2.28 to 3.77
|
3.40 titers (1/dilution)
Interval 2.76 to 4.18
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup Y
|
13.1 titers (1/dilution)
Interval 8.63 to 19.9
|
15.3 titers (1/dilution)
Interval 11.4 to 20.7
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup W 135
|
6.05 titers (1/dilution)
Interval 4.11 to 8.89
|
4.74 titers (1/dilution)
Interval 3.68 to 6.12
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=94 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=193 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup A
|
746 titers (1/dilution)
Interval 501.0 to 1109.0
|
1054 titers (1/dilution)
Interval 825.0 to 1346.0
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup C
|
445 titers (1/dilution)
Interval 255.0 to 776.0
|
1559 titers (1/dilution)
Interval 1140.0 to 2131.0
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup Y
|
260 titers (1/dilution)
Interval 177.0 to 382.0
|
591 titers (1/dilution)
Interval 464.0 to 753.0
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Serogroup W 135
|
493 titers (1/dilution)
Interval 316.0 to 772.0
|
910 titers (1/dilution)
Interval 728.0 to 1136.0
|
PRIMARY outcome
Timeframe: Within 30 minutes after vaccinationPopulation: Analysis was performed on SafAS population which included participants who received at least one dose of the study or control vaccine and had safety data available.
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (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. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=100 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=199 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccinationPopulation: Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.
A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=100 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=199 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
Pain
|
32 Participants
|
61 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
Erythema
|
5 Participants
|
23 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
Swelling
|
2 Participants
|
15 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
Fever
|
1 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
Headache
|
28 Participants
|
47 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
Malaise
|
15 Participants
|
44 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
Myalgia
|
26 Participants
|
70 Participants
|
PRIMARY outcome
Timeframe: Within 30 days after vaccinationPopulation: Analysis was performed on the SafAS population.
An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. 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. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE.
Outcome measures
| Measure |
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=100 Participants
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
Group 1: MenACYW Conjugate Vaccine
n=199 Participants
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
|---|---|---|
|
Number of Participants With Unsolicited Adverse Events After Vaccination
Unsolicited AE
|
17 Participants
|
41 Participants
|
|
Number of Participants With Unsolicited Adverse Events After Vaccination
Unsolicited non-serious AE
|
17 Participants
|
41 Participants
|
|
Number of Participants With Unsolicited Adverse Events After Vaccination
Grade 3 unsolicited non-serious AE
|
3 Participants
|
2 Participants
|
Adverse Events
Group 1: MenACYW Conjugate Vaccine
Serious events: 0 serious events
Other events: 114 other events
Deaths: 0 deaths
Group 2: Menomune® A/C/Y/W 135 Vaccine
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=199 participants at risk
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Menomune® A/C/Y/W 135 Vaccine
n=100 participants at risk
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
|
|---|---|---|
|
General disorders
Injection Site Erythema
|
11.6%
23/199 • Number of events 23 • Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
|
5.0%
5/100 • Number of events 5 • Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
|
|
General disorders
Injection Site Pain
|
30.7%
61/199 • Number of events 61 • Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
|
32.0%
32/100 • Number of events 32 • Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
|
|
General disorders
Injection Site Swelling
|
7.5%
15/199 • Number of events 15 • Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
|
2.0%
2/100 • Number of events 2 • Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
|
|
General disorders
Malaise
|
22.1%
44/199 • Number of events 44 • Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
|
15.0%
15/100 • Number of events 15 • Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
35.2%
70/199 • Number of events 70 • Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
|
26.0%
26/100 • Number of events 26 • Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
|
|
Nervous system disorders
Headache
|
23.6%
47/199 • Number of events 48 • Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
|
29.0%
29/100 • Number of events 30 • Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).
A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
|
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