Trial Outcomes & Findings for Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia (NCT NCT01725217)
NCT ID: NCT01725217
Last Updated: 2023-04-28
Results Overview
Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29). The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA \<1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
198 participants
Primary outcome timeframe
Day 29
Results posted on
2023-04-28
Participant Flow
Subjects were enrolled at 5 centers in Russia
All enrolled subjects were included in the study
Participant milestones
| Measure |
≥2 to ≤10 Years
Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
|
≥11 to ≤17 Years
Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
66
|
|
Overall Study
COMPLETED
|
65
|
66
|
66
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
≥2 to ≤10 Years
Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
|
≥11 to ≤17 Years
Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia
Baseline characteristics by cohort
| Measure |
≥2 to ≤10 Years
n=66 Participants
Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
|
≥11 to ≤17 Years
n=66 Participants
Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
n=66 Participants
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
6.0 year
STANDARD_DEVIATION 2.7 • n=5 Participants
|
13.8 year
STANDARD_DEVIATION 2.1 • n=7 Participants
|
38.8 year
STANDARD_DEVIATION 12.5 • n=5 Participants
|
19.6 year
STANDARD_DEVIATION 15.9 • n=4 Participants
|
|
Sex: Female, Male
FEMALE
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Sex: Female, Male
MALE
|
31 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Analysis was done on Full Analysis Set (FAS), i.e., all subjects in the exposed population who provided one evaluable serum sample whose assay result is available for at least one serogroup at baseline and at day 29
Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29). The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA \<1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4
Outcome measures
| Measure |
Overall (≥2 Years)
n=193 Participants
All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
|
≥11 to ≤17 Years
Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
|---|---|---|---|---|
|
Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination
MenA
|
85 Percentage of subjects
Interval 79.0 to 90.0
|
—
|
—
|
—
|
|
Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination
MenC
|
74 Percentage of subjects
Interval 67.0 to 80.0
|
—
|
—
|
—
|
|
Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination
MenW
|
60 Percentage of subjects
Interval 53.0 to 67.0
|
—
|
—
|
—
|
|
Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination
MenY
|
83 Percentage of subjects
Interval 77.0 to 88.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Analysis was done on FAS dataset
Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM
Outcome measures
| Measure |
Overall (≥2 Years)
n=63 Participants
All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
|
≥11 to ≤17 Years
n=65 Participants
Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
n=65 Participants
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
|---|---|---|---|---|
|
Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group
MenA
|
89 Percentage of subjects
Interval 78.0 to 95.0
|
89 Percentage of subjects
Interval 79.0 to 96.0
|
77 Percentage of subjects
Interval 65.0 to 86.0
|
—
|
|
Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group
MenC
|
69 Percentage of subjects
Interval 56.0 to 80.0
|
82 Percentage of subjects
Interval 70.0 to 90.0
|
71 Percentage of subjects
Interval 58.0 to 81.0
|
—
|
|
Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group
MenW
|
73 Percentage of subjects
Interval 60.0 to 83.0
|
51 Percentage of subjects
Interval 38.0 to 63.0
|
57 Percentage of subjects
Interval 44.0 to 69.0
|
—
|
|
Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group
MenY
|
77 Percentage of subjects
Interval 65.0 to 87.0
|
88 Percentage of subjects
Interval 77.0 to 95.0
|
85 Percentage of subjects
Interval 74.0 to 92.0
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: Analysis was done on FAS dataset
Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group
Outcome measures
| Measure |
Overall (≥2 Years)
n=193 Participants
All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
|
≥11 to ≤17 Years
n=63 Participants
Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
n=65 Participants
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
n=65 Participants
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination
MenA (Day 1)
|
2.35 human serum bactericidal assay titer
Interval 2.17 to 2.55
|
2.17 human serum bactericidal assay titer
Interval 1.79 to 2.62
|
2.43 human serum bactericidal assay titer
Interval 2.01 to 2.93
|
2.61 human serum bactericidal assay titer
Interval 2.11 to 3.23
|
|
Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination
MenA (Day 29)
|
93 human serum bactericidal assay titer
Interval 73.0 to 119.0
|
67 human serum bactericidal assay titer
Interval 38.0 to 119.0
|
134 human serum bactericidal assay titer
Interval 77.0 to 233.0
|
76 human serum bactericidal assay titer
Interval 41.0 to 143.0
|
|
Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination
MenC (Day 1)
|
4.07 human serum bactericidal assay titer
Interval 3.45 to 4.8
|
3.16 human serum bactericidal assay titer
Interval 2.18 to 4.57
|
3.59 human serum bactericidal assay titer
Interval 2.5 to 5.15
|
6.68 human serum bactericidal assay titer
Interval 4.43 to 10.0
|
|
Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination
MenC (Day 29)
|
59 human serum bactericidal assay titer
Interval 43.0 to 81.0
|
28 human serum bactericidal assay titer
Interval 14.0 to 56.0
|
47 human serum bactericidal assay titer
Interval 24.0 to 92.0
|
112 human serum bactericidal assay titer
Interval 52.0 to 243.0
|
|
Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination
MenW (Day 1)
|
12 human serum bactericidal assay titer
Interval 9.42 to 15.0
|
7.93 human serum bactericidal assay titer
Interval 4.69 to 13.0
|
21 human serum bactericidal assay titer
Interval 13.0 to 36.0
|
13 human serum bactericidal assay titer
Interval 7.16 to 23.0
|
|
Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination
MenW (Day 29)
|
111 human serum bactericidal assay titer
Interval 89.0 to 139.0
|
94 human serum bactericidal assay titer
Interval 56.0 to 155.0
|
117 human serum bactericidal assay titer
Interval 72.0 to 191.0
|
143 human serum bactericidal assay titer
Interval 83.0 to 248.0
|
|
Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination
MenY (Day 1)
|
2.93 human serum bactericidal assay titer
Interval 2.61 to 3.28
|
3.02 human serum bactericidal assay titer
Interval 2.33 to 3.92
|
3.73 human serum bactericidal assay titer
Interval 2.89 to 4.82
|
2.74 human serum bactericidal assay titer
Interval 2.05 to 3.66
|
|
Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination
MenY (Day 29)
|
58 human serum bactericidal assay titer
Interval 46.0 to 74.0
|
32 human serum bactericidal assay titer
Interval 18.0 to 56.0
|
67 human serum bactericidal assay titer
Interval 39.0 to 115.0
|
80 human serum bactericidal assay titer
Interval 43.0 to 147.0
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: Analysis was done on FAS dataset
Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group
Outcome measures
| Measure |
Overall (≥2 Years)
n=193 Participants
All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
|
≥11 to ≤17 Years
n=63 Participants
Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
n=65 Participants
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
n=65 Participants
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
|---|---|---|---|---|
|
Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination
MenA (Day 1)
|
6 Percentage of Subjects
Interval 3.0 to 10.0
|
2 Percentage of Subjects
Interval 0.04 to 9.0
|
5 Percentage of Subjects
Interval 1.0 to 13.0
|
11 Percentage of Subjects
Interval 4.0 to 21.0
|
|
Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination
MenA (Day 29)
|
89 Percentage of Subjects
Interval 83.0 to 93.0
|
89 Percentage of Subjects
Interval 78.0 to 95.0
|
92 Percentage of Subjects
Interval 83.0 to 97.0
|
85 Percentage of Subjects
Interval 74.0 to 92.0
|
|
Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination
MenC (Day 1)
|
26 Percentage of Subjects
Interval 20.0 to 33.0
|
13 Percentage of Subjects
Interval 6.0 to 23.0
|
17 Percentage of Subjects
Interval 9.0 to 28.0
|
49 Percentage of Subjects
Interval 37.0 to 62.0
|
|
Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination
MenC (Day 29)
|
84 Percentage of Subjects
Interval 78.0 to 89.0
|
76 Percentage of Subjects
Interval 63.0 to 86.0
|
86 Percentage of Subjects
Interval 75.0 to 93.0
|
89 Percentage of Subjects
Interval 79.0 to 96.0
|
|
Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination
MenW (Day 1)
|
57 Percentage of Subjects
Interval 50.0 to 64.0
|
30 Percentage of Subjects
Interval 19.0 to 43.0
|
71 Percentage of Subjects
Interval 58.0 to 81.0
|
69 Percentage of Subjects
Interval 57.0 to 80.0
|
|
Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination
MenW (Day 29)
|
97 Percentage of Subjects
Interval 93.0 to 99.0
|
95 Percentage of Subjects
Interval 87.0 to 99.0
|
98 Percentage of Subjects
Interval 92.0 to 100.0
|
97 Percentage of Subjects
Interval 89.0 to 100.0
|
|
Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination
MenY (Day 1)
|
16 Percentage of Subjects
Interval 11.0 to 22.0
|
10 Percentage of Subjects
Interval 4.0 to 20.0
|
15 Percentage of Subjects
Interval 8.0 to 26.0
|
22 Percentage of Subjects
Interval 12.0 to 33.0
|
|
Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination
MenY (Day 29)
|
88 Percentage of Subjects
Interval 82.0 to 92.0
|
79 Percentage of Subjects
Interval 67.0 to 88.0
|
94 Percentage of Subjects
Interval 85.0 to 98.0
|
89 Percentage of Subjects
Interval 79.0 to 96.0
|
SECONDARY outcome
Timeframe: Within days 1 through 7 postvaccinationPopulation: Analysis was done on safety dataset, i.e. all subjects in the exposed population who provided any post-baseline safety data
Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination
Outcome measures
| Measure |
Overall (≥2 Years)
n=27 Participants
All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
|
≥11 to ≤17 Years
n=18 Participants
Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
|---|---|---|---|---|
|
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Tenderness
|
41 Percentage of subjects
|
39 Percentage of subjects
|
—
|
—
|
|
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Erythema
|
26 Percentage of subjects
|
28 Percentage of subjects
|
—
|
—
|
|
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Induration
|
19 Percentage of subjects
|
17 Percentage of subjects
|
—
|
—
|
|
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Change in Eating Habits
|
4 Percentage of subjects
|
6 Percentage of subjects
|
—
|
—
|
|
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Sleepiness
|
33 Percentage of subjects
|
28 Percentage of subjects
|
—
|
—
|
|
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Irritability
|
26 Percentage of subjects
|
17 Percentage of subjects
|
—
|
—
|
|
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Vomiting
|
4 Percentage of subjects
|
0 Percentage of subjects
|
—
|
—
|
|
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Diarrhea
|
11 Percentage of subjects
|
11 Percentage of subjects
|
—
|
—
|
|
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Rash
|
4 Percentage of subjects
|
6 Percentage of subjects
|
—
|
—
|
|
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Fever (≥38 °C)
|
4 Percentage of subjects
|
6 Percentage of subjects
|
—
|
—
|
|
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Use of analgesics/antipyretics
|
7 Percentage of subjects
|
0 Percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Within days 1 through 7 postvaccinationPopulation: Analysis was done on safety dataset
Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group
Outcome measures
| Measure |
Overall (≥2 Years)
n=170 Participants
All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
|
≥11 to ≤17 Years
n=38 Participants
Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
n=66 Participants
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
n=66 Participants
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
|---|---|---|---|---|
|
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Pain
|
48 Percentage of Subjects
|
42 Percentage of Subjects
|
50 Percentage of Subjects
|
50 Percentage of Subjects
|
|
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Erythema
|
18 Percentage of Subjects
|
18 Percentage of Subjects
|
18 Percentage of Subjects
|
17 Percentage of Subjects
|
|
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Induration
|
14 Percentage of Subjects
|
11 Percentage of Subjects
|
17 Percentage of Subjects
|
12 Percentage of Subjects
|
|
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Chills
|
9 Percentage of Subjects
|
8 Percentage of Subjects
|
8 Percentage of Subjects
|
12 Percentage of Subjects
|
|
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Nausea
|
8 Percentage of Subjects
|
3 Percentage of Subjects
|
11 Percentage of Subjects
|
8 Percentage of Subjects
|
|
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Malaise
|
20 Percentage of Subjects
|
16 Percentage of Subjects
|
23 Percentage of Subjects
|
20 Percentage of Subjects
|
|
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Myalgia
|
19 Percentage of Subjects
|
13 Percentage of Subjects
|
29 Percentage of Subjects
|
14 Percentage of Subjects
|
|
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Arthralgia
|
9 Percentage of Subjects
|
3 Percentage of Subjects
|
11 Percentage of Subjects
|
11 Percentage of Subjects
|
|
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Headache
|
25 Percentage of Subjects
|
18 Percentage of Subjects
|
27 Percentage of Subjects
|
27 Percentage of Subjects
|
|
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Rash
|
2 Percentage of Subjects
|
3 Percentage of Subjects
|
0 Percentage of Subjects
|
5 Percentage of Subjects
|
|
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Fever (≥38 °C)
|
3 Percentage of Subjects
|
5 Percentage of Subjects
|
3 Percentage of Subjects
|
2 Percentage of Subjects
|
|
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Use of analgesic/antipyretics
|
11 Percentage of Subjects
|
18 Percentage of Subjects
|
9 Percentage of Subjects
|
9 Percentage of Subjects
|
SECONDARY outcome
Timeframe: AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29Population: Analysis was done on safety dataset
Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group
Outcome measures
| Measure |
Overall (≥2 Years)
n=197 Participants
All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
|
≥11 to ≤17 Years
n=65 Participants
Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
n=66 Participants
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
n=66 Participants
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
|---|---|---|---|---|
|
Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination
Any AEs(days 1 through 7)
|
17 percentage of subjects
|
20 percentage of subjects
|
12 percentage of subjects
|
18 percentage of subjects
|
|
Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination
At least possibly related AEs (days 1 through 7)
|
10 percentage of subjects
|
3 percentage of subjects
|
9 percentage of subjects
|
18 percentage of subjects
|
|
Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination
SAE(days 1 through 29)
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination
At least possibly related SAE(days 1 through 29)
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination
Medically attended AE(days 1 through 29)
|
4 percentage of subjects
|
8 percentage of subjects
|
2 percentage of subjects
|
3 percentage of subjects
|
|
Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination
Premature withdrawal due to AE(days 1 through 29)
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
Adverse Events
≥2 to ≤10 Years
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
≥11 to ≤17 Years
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
≥18 Years
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Overall (≥2 Years)
Serious events: 0 serious events
Other events: 128 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
≥2 to ≤10 Years
n=65 participants at risk
Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
|
≥11 to ≤17 Years
n=66 participants at risk
Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
|
≥18 Years
n=66 participants at risk
Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
|
Overall (≥2 Years)
n=197 participants at risk
All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/65 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
10.6%
7/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
7.6%
5/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
6.6%
13/197 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
|
General disorders
Chills
|
4.6%
3/65 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
7.6%
5/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
12.1%
8/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
8.1%
16/197 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
|
General disorders
Injection site erythema
|
18.5%
12/65 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
19.7%
13/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
15.2%
10/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
17.8%
35/197 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
|
General disorders
Injection site induration
|
12.3%
8/65 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
16.7%
11/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
12.1%
8/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
13.7%
27/197 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
|
General disorders
Injection site pain
|
41.5%
27/65 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
50.0%
33/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
50.0%
33/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
47.2%
93/197 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
|
General disorders
Irritability
|
10.8%
7/65 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
0.00%
0/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
0.00%
0/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
3.6%
7/197 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
|
General disorders
Malaise
|
9.2%
6/65 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
22.7%
15/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
19.7%
13/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
17.3%
34/197 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
|
Infections and infestations
Rhinitis
|
9.2%
6/65 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
0.00%
0/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
1.5%
1/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
3.6%
7/197 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/65 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
10.6%
7/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
10.6%
7/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
7.6%
15/197 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
5/65 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
28.8%
19/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
13.6%
9/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
16.8%
33/197 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
|
Nervous system disorders
Headache
|
12.3%
8/65 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
27.3%
18/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
27.3%
18/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
22.3%
44/197 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
|
Nervous system disorders
Somnolence
|
13.8%
9/65 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
1.5%
1/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
0.00%
0/66 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
5.1%
10/197 • From day 1 through day 29
Serious adverse events (SAEs) were collected from day 1 through day 29
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60