Trial Outcomes & Findings for Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan (NCT NCT01410474)
NCT ID: NCT01410474
Last Updated: 2014-09-22
Results Overview
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29). Seroresponse is defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8. 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
341 participants
Primary outcome timeframe
Day 1 and Day 29
Results posted on
2014-09-22
Participant Flow
Subjects were enrolled at three study centres in Taiwan.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
2-10 Years
Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
11-18 Years
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
173
|
168
|
|
Overall Study
COMPLETED
|
173
|
167
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
2-10 Years
Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
11-18 Years
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan
Baseline characteristics by cohort
| Measure |
2-10 Years
n=173 Participants
Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
11-18 Years
n=168 Participants
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
Total
n=341 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.3 Years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
14.0 Years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
10.1 Years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: Analysis was done on modified intention-to-treat (MITT) population i.e subjects in the exposed population who provided evaluable serum samples whose assay results were available for at least one serogroup on day 1 and/or day 29.
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29). Seroresponse is defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8. 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Outcome measures
| Measure |
Overall (2 to 18 Years)
n=336 Participants
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
11-18 Years
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
Overall (2 to 18 Years)
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
|---|---|---|---|
|
Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenA (N=335)
|
83 Percentages of Subjects
Interval 79.0 to 87.0
|
—
|
—
|
|
Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenC (N=333)
|
93 Percentages of Subjects
Interval 90.0 to 96.0
|
—
|
—
|
|
Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenW (N=334)
|
50 Percentages of Subjects
Interval 45.0 to 55.0
|
—
|
—
|
|
Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenY (N=333)
|
65 Percentages of Subjects
Interval 60.0 to 70.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 29Population: Analysis was done on MITT population
Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups. Seroresponse is defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8. 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Outcome measures
| Measure |
Overall (2 to 18 Years)
n=170 Participants
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
11-18 Years
n=166 Participants
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
Overall (2 to 18 Years)
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
|---|---|---|---|
|
Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group
Men A (N=170,165)
|
77 Percentages of Subjects
Interval 70.0 to 83.0
|
89 Percentages of Subjects
Interval 83.0 to 93.0
|
—
|
|
Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group
MenC (N=167,166)
|
92 Percentages of Subjects
Interval 86.0 to 95.0
|
95 Percentages of Subjects
Interval 90.0 to 97.0
|
—
|
|
Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group
MenW (N=168,166)
|
54 Percentages of Subjects
Interval 46.0 to 62.0
|
46 Percentages of Subjects
Interval 38.0 to 54.0
|
—
|
|
Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group
MenY (N=167,166)
|
61 Percentages of Subjects
Interval 53.0 to 69.0
|
69 Percentages of Subjects
Interval 62.0 to 76.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 29Population: Analysis was done on MITT population
Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.
Outcome measures
| Measure |
Overall (2 to 18 Years)
n=170 Participants
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
11-18 Years
n=166 Participants
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
Overall (2 to 18 Years)
n=336 Participants
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenA at Day 1(N=170,165,335)
|
2.05 hSBA Titers
Interval 1.92 to 2.2
|
2.2 hSBA Titers
Interval 2.05 to 2.36
|
2.12 hSBA Titers
Interval 2.02 to 2.24
|
|
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenA at Day 29(N=170,165,335)
|
32 hSBA Titers
Interval 24.0 to 43.0
|
88 hSBA Titers
Interval 66.0 to 117.0
|
53 hSBA Titers
Interval 42.0 to 65.0
|
|
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenC at Day 1 (N=167,166,333)
|
2.66 hSBA Titers
Interval 2.35 to 3.02
|
3.64 hSBA Titers
Interval 3.21 to 4.12
|
3.11 hSBA Titers
Interval 2.83 to 3.42
|
|
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenC at Day 29 (N=167,166,333)
|
117 hSBA Titers
Interval 93.0 to 147.0
|
273 hSBA Titers
Interval 218.0 to 342.0
|
179 hSBA Titers
Interval 151.0 to 211.0
|
|
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenW at Day 1 (N=168,166,334)
|
7.32 hSBA Titers
Interval 5.65 to 9.49
|
15 hSBA Titers
Interval 12.0 to 19.0
|
10 hSBA Titers
Interval 8.62 to 13.0
|
|
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenW at Day 29 (N=168,166,334)
|
49 hSBA Titers
Interval 40.0 to 60.0
|
104 hSBA Titers
Interval 85.0 to 127.0
|
71 hSBA Titers
Interval 61.0 to 82.0
|
|
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenY at Day 1 (N=167,166,333)
|
3.21 hSBA Titers
Interval 2.69 to 3.83
|
3.95 hSBA Titers
Interval 3.31 to 4.71
|
3.56 hSBA Titers
Interval 3.12 to 4.06
|
|
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenY at Day 29 (N=167,166,333)
|
26 hSBA Titers
Interval 20.0 to 33.0
|
56 hSBA Titers
Interval 43.0 to 72.0
|
38 hSBA Titers
Interval 31.0 to 46.0
|
SECONDARY outcome
Timeframe: Day 1 and Day 29Population: Analysis was done on MITT population
Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.
Outcome measures
| Measure |
Overall (2 to 18 Years)
n=170 Participants
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
11-18 Years
n=166 Participants
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
Overall (2 to 18 Years)
n=336 Participants
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
|---|---|---|---|
|
Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenA(N=170,165,335)
|
16 Ratio
Interval 12.0 to 21.0
|
40 Ratio
Interval 30.0 to 53.0
|
25 Ratio
Interval 20.0 to 31.0
|
|
Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenC (N=167,166,333)
|
44 Ratio
Interval 35.0 to 56.0
|
75 Ratio
Interval 59.0 to 95.0
|
57 Ratio
Interval 48.0 to 69.0
|
|
Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenW (N=168,166,334)
|
6.66 Ratio
Interval 5.19 to 8.54
|
6.91 Ratio
Interval 5.39 to 8.85
|
6.78 Ratio
Interval 5.63 to 8.16
|
|
Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenY (N=167,166,333)
|
8.02 Ratio
Interval 6.09 to 11.0
|
14 Ratio
Interval 11.0 to 19.0
|
11 Ratio
Interval 8.67 to 13.0
|
SECONDARY outcome
Timeframe: Day 1 and 29Population: Analysis was done on MITT population
Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall.
Outcome measures
| Measure |
Overall (2 to 18 Years)
n=170 Participants
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
11-18 Years
n=166 Participants
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
Overall (2 to 18 Years)
n=336 Participants
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
|---|---|---|---|
|
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenA at Day 1 (N=170,165,335)
|
1 Percentages of Subjects
Interval 0.0 to 4.0
|
4 Percentages of Subjects
Interval 2.0 to 9.0
|
3 Percentages of Subjects
Interval 1.0 to 5.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenA at Day 29 (N=170,165,335)
|
77 Percentages of Subjects
Interval 70.0 to 83.0
|
90 Percentages of Subjects
Interval 84.0 to 94.0
|
83 Percentages of Subjects
Interval 79.0 to 87.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenC at Day 1 (N=167,166,333)
|
11 Percentages of Subjects
Interval 7.0 to 17.0
|
23 Percentages of Subjects
Interval 17.0 to 31.0
|
17 Percentages of Subjects
Interval 13.0 to 22.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenC at Day 29 (N=167,166,333)
|
95 Percentages of Subjects
Interval 90.0 to 98.0
|
98 Percentages of Subjects
Interval 95.0 to 100.0
|
96 Percentages of Subjects
Interval 94.0 to 98.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenW at Day 1 (N=168,166,334)
|
47 Percentages of Subjects
Interval 39.0 to 55.0
|
70 Percentages of Subjects
Interval 62.0 to 77.0
|
58 Percentages of Subjects
Interval 53.0 to 64.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenW at Day 29 (N=168,166,334)
|
93 Percentages of Subjects
Interval 88.0 to 96.0
|
99 Percentages of Subjects
Interval 96.0 to 100.0
|
96 Percentages of Subjects
Interval 93.0 to 98.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenY at Day 1 (N=167,166,333)
|
22 Percentages of Subjects
Interval 16.0 to 29.0
|
26 Percentages of Subjects
Interval 19.0 to 33.0
|
24 Percentages of Subjects
Interval 19.0 to 29.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
MenY at Day 29 (N=167,166,333)
|
78 Percentages of Subjects
Interval 71.0 to 84.0
|
86 Percentages of Subjects
Interval 79.0 to 91.0
|
82 Percentages of Subjects
Interval 77.0 to 86.0
|
SECONDARY outcome
Timeframe: From day 1 through day 7 postvaccinationPopulation: Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.
Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination.
Outcome measures
| Measure |
Overall (2 to 18 Years)
n=72 Participants
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
11-18 Years
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
Overall (2 to 18 Years)
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
|---|---|---|---|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Diarrhea
|
2 Subjects
|
—
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Rash - Any
|
4 Subjects
|
—
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Injection site tenderness
|
27 Subjects
|
—
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Injection site erythema
|
7 Subjects
|
—
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Injection site induration
|
6 Subjects
|
—
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Change in eating habits
|
2 Subjects
|
—
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Sleepiness
|
3 Subjects
|
—
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Irritability
|
5 Subjects
|
—
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Vomiting
|
7 Subjects
|
—
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Rash - Urticarial
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Fever (≥38°C)
|
4 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: From day 1 through day 7 postvaccinationPopulation: Analysis was done on safety population.
Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination.
Outcome measures
| Measure |
Overall (2 to 18 Years)
n=101 Participants
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
11-18 Years
n=167 Participants
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
Overall (2 to 18 Years)
n=268 Participants
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
|---|---|---|---|
|
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Injection site pain
|
37 Subjects
|
62 Subjects
|
99 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Injection site erythema
|
17 Subjects
|
17 Subjects
|
34 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Injection site induration
|
14 Subjects
|
12 Subjects
|
26 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Chills
|
2 Subjects
|
6 Subjects
|
8 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Nausea
|
10 Subjects
|
10 Subjects
|
20 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Malaise
|
13 Subjects
|
35 Subjects
|
48 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Myalgia
|
20 Subjects
|
49 Subjects
|
69 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Arthralgia
|
3 Subjects
|
13 Subjects
|
16 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Headache
|
11 Subjects
|
29 Subjects
|
40 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Rash - Any
|
7 Subjects
|
4 Subjects
|
11 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Rash - Urticarial
|
3 Subjects
|
3 Subjects
|
6 Subjects
|
|
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Fever (≥38°C)
|
3 Subjects
|
2 Subjects
|
5 Subjects
|
Adverse Events
2-10 Years
Serious events: 1 serious events
Other events: 110 other events
Deaths: 0 deaths
11-18 Years
Serious events: 0 serious events
Other events: 98 other events
Deaths: 0 deaths
Overall (2 to 18 Years)
Serious events: 1 serious events
Other events: 208 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2-10 Years
n=173 participants at risk
Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
11-18 Years
n=167 participants at risk
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
Overall (2 to 18 Years)
n=340 participants at risk
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.58%
1/173 • Number of events 1 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
0.00%
0/167 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
0.29%
1/340 • Number of events 1 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
Other adverse events
| Measure |
2-10 Years
n=173 participants at risk
Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
11-18 Years
n=167 participants at risk
Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
Overall (2 to 18 Years)
n=340 participants at risk
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.8%
10/173 • Number of events 10 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
6.0%
10/167 • Number of events 10 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
5.9%
20/340 • Number of events 20 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
|
General disorders
Injection site erythema
|
33.5%
58/173 • Number of events 58 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
25.7%
43/167 • Number of events 43 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
29.7%
101/340 • Number of events 101 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
|
General disorders
Injection site induration
|
28.3%
49/173 • Number of events 49 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
21.6%
36/167 • Number of events 36 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
25.0%
85/340 • Number of events 85 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
|
General disorders
Injection site pain
|
37.0%
64/173 • Number of events 64 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
37.1%
62/167 • Number of events 62 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
37.1%
126/340 • Number of events 126 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
|
General disorders
Malaise
|
7.5%
13/173 • Number of events 13 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
21.0%
35/167 • Number of events 35 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
14.1%
48/340 • Number of events 48 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
10/173 • Number of events 10 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
1.2%
2/167 • Number of events 2 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
3.5%
12/340 • Number of events 12 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.2%
16/173 • Number of events 16 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
3.6%
6/167 • Number of events 6 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
6.5%
22/340 • Number of events 22 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
3/173 • Number of events 3 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
7.8%
13/167 • Number of events 13 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
4.7%
16/340 • Number of events 16 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.6%
20/173 • Number of events 20 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
29.3%
49/167 • Number of events 49 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
20.3%
69/340 • Number of events 69 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
|
Nervous system disorders
Headache
|
7.5%
13/173 • Number of events 13 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
17.4%
29/167 • Number of events 29 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
12.4%
42/340 • Number of events 42 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.4%
11/173 • Number of events 11 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
2.4%
4/167 • Number of events 4 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
4.4%
15/340 • Number of events 15 • Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place