Trial Outcomes & Findings for Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children (NCT NCT00616421)
NCT ID: NCT00616421
Last Updated: 2016-02-15
Results Overview
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2907 participants
Primary outcome timeframe
1 month postvaccination
Results posted on
2016-02-15
Participant Flow
Participants were enrolled at 67 centers in the USA and Canada.
All subjects enrolled were included in the trial.
Participant milestones
| Measure |
MenACWY-CRM (2 Doses)
2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study days 1 and 61 in children 2 to 5 years of age
|
MenACWY-CRM (1 Dose)
1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day 1
|
Licensed Polysaccharide Vaccine
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
|---|---|---|---|
|
Overall Study
STARTED
|
359
|
1278
|
1270
|
|
Overall Study
COMPLETED
|
333
|
1240
|
1229
|
|
Overall Study
NOT COMPLETED
|
26
|
38
|
41
|
Reasons for withdrawal
| Measure |
MenACWY-CRM (2 Doses)
2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study days 1 and 61 in children 2 to 5 years of age
|
MenACWY-CRM (1 Dose)
1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day 1
|
Licensed Polysaccharide Vaccine
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
11
|
8
|
|
Overall Study
Lost to Follow-up
|
12
|
26
|
30
|
|
Overall Study
Inappropriate enrollment
|
3
|
0
|
1
|
|
Overall Study
Administrative reason
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
2
|
|
Overall Study
Unable to classify
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
Baseline characteristics by cohort
| Measure |
MenACWY-CRM (2 Doses)
n=359 Participants
2 injections of the Novartis MenACWY-CRM vaccine administered on study days 1 and 61 in children 2 to 5 years of age.
|
MenACWY-CRM (1 Dose)
n=1278 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day1.
|
Licensed Polysaccharide Vaccine
n=1270 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1.
|
Total
n=2907 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
3.5 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
5.5 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
5.6 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
5.3 years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=5 Participants
|
622 Participants
n=7 Participants
|
580 Participants
n=5 Participants
|
1373 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
188 Participants
n=5 Participants
|
656 Participants
n=7 Participants
|
690 Participants
n=5 Participants
|
1534 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 month postvaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=607 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=615 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
Serogroup A (N=606, 611)
|
72 Percentages of subjects
Interval 68.0 to 75.0
|
77 Percentages of subjects
Interval 73.0 to 80.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
Serogroup C (N=607, 615)
|
60 Percentages of subjects
Interval 56.0 to 64.0
|
56 Percentages of subjects
Interval 52.0 to 60.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
Serogroup W (N=594, 605)
|
72 Percentages of subjects
Interval 68.0 to 75.0
|
58 Percentages of subjects
Interval 54.0 to 62.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
Serogroup Y (N=593, 600)
|
66 Percentages of subjects
Interval 62.0 to 70.0
|
45 Percentages of subjects
Interval 41.0 to 49.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month postvaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=554 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=541 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
Serogroup A (N=551, 541)
|
77 Percentages of subjects
Interval 73.0 to 80.0
|
83 Percentages of subjects
Interval 79.0 to 86.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
Serogroup C (N=554, 539)
|
63 Percentages of subjects
Interval 59.0 to 67.0
|
57 Percentages of subjects
Interval 53.0 to 62.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
Serogroup W (N=542, 533)
|
57 Percentages of subjects
Interval 53.0 to 61.0
|
44 Percentages of subjects
Interval 40.0 to 49.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
Serogroup Y (N=545, 539)
|
58 Percentages of subjects
Interval 54.0 to 62.0
|
39 Percentages of subjects
Interval 35.0 to 44.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month postvaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=1161 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=1154 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.
Serogroup A (N=1157, 1152)
|
74 Percenatage of subjects
Interval 71.0 to 76.0
|
80 Percenatage of subjects
Interval 77.0 to 82.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.
Serogroup C (N=1161, 1154)
|
61 Percenatage of subjects
Interval 58.0 to 64.0
|
57 Percenatage of subjects
Interval 54.0 to 60.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.
Serogroup W (N=1136, 1138)
|
65 Percenatage of subjects
Interval 62.0 to 67.0
|
51 Percenatage of subjects
Interval 48.0 to 54.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.
Serogroup Y (N=1138, 1139)
|
62 Percenatage of subjects
Interval 60.0 to 65.0
|
42 Percenatage of subjects
Interval 40.0 to 45.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month postvaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=1161 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=1154 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age
Serogroup A (N=1157, 1152)
|
75 Percentage of subjects
Interval 72.0 to 77.0
|
80 Percentage of subjects
Interval 78.0 to 83.0
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age
Serogroup C (N=1161, 1154)
|
72 Percentage of subjects
Interval 70.0 to 75.0
|
68 Percentage of subjects
Interval 66.0 to 71.0
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age
Serogroup W (N=1136, 1138)
|
90 Percentage of subjects
Interval 88.0 to 92.0
|
60 Percentage of subjects
Interval 57.0 to 63.0
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age
Serogroup Y (N=1138, 1139)
|
77 Percentage of subjects
Interval 75.0 to 80.0
|
79 Percentage of subjects
Interval 77.0 to 81.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month postvaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=1161 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=1154 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.
Serogroup A (N=1157, 1152)
|
30 Titers
Interval 27.0 to 31.0
|
29 Titers
Interval 26.0 to 33.0
|
—
|
—
|
|
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.
Serogroup C (N=1161, 1154)
|
23 Titers
Interval 21.0 to 27.0
|
17 Titers
Interval 15.0 to 20.0
|
—
|
—
|
|
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.
Serogroup W (N=1136, 1138)
|
49 Titers
Interval 44.0 to 54.0
|
26 Titers
Interval 23.0 to 29.0
|
—
|
—
|
|
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.
Serogroup Y (N=1138, 1139)
|
29 Titers
Interval 25.0 to 32.0
|
12 Titers
Interval 11.0 to 14.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month postvaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=607 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=554 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
n=615 Participants
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
n=541 Participants
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Serogroup A (N=606, 611, 551, 541)
|
72 Percentages of subjects
Interval 68.0 to 75.0
|
78 Percentages of subjects
Interval 74.0 to 81.0
|
77 Percentages of subjects
Interval 74.0 to 81.0
|
83 Percentages of subjects
Interval 80.0 to 86.0
|
|
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Serogroup C (N=607, 615, 554, 539)
|
68 Percentages of subjects
Interval 64.0 to 72.0
|
64 Percentages of subjects
Interval 60.0 to 68.0
|
77 Percentages of subjects
Interval 73.0 to 89.0
|
74 Percentages of subjects
Interval 70.0 to 77.0
|
|
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Serogroup W (N=594, 605, 542, 533)
|
90 Percentages of subjects
Interval 87.0 to 92.0
|
75 Percentages of subjects
Interval 71.0 to 78.0
|
91 Percentages of subjects
Interval 88.0 to 93.0
|
84 Percentages of subjects
Interval 81.0 to 87.0
|
|
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Serogroup Y (N=593, 600, 545, 539)
|
76 Percentages of subjects
Interval 72.0 to 79.0
|
57 Percentages of subjects
Interval 53.0 to 61.0
|
79 Percentages of subjects
Interval 76.0 to 83.0
|
63 Percentages of subjects
Interval 59.0 to 67.0
|
SECONDARY outcome
Timeframe: 1 month postvaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=607 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=615 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
n=551 Participants
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
n=541 Participants
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Serogroup A (N=606, 611, 551, 541)
|
26 Titers
Interval 22.0 to 30.0
|
25 Titers
Interval 21.0 to 29.0
|
35 Titers
Interval 29.0 to 42.0
|
35 Titers
Interval 29.0 to 41.0
|
|
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Serogroup C (N=607, 615, 554, 539)
|
18 Titers
Interval 15.0 to 20.0
|
13 Titers
Interval 11.0 to 15.0
|
36 Titers
Interval 29.0 to 42.0
|
27 Titers
Interval 21.0 to 33.0
|
|
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Serogroup W (N=594, 605, 542, 533)
|
43 Titers
Interval 38.0 to 50.0
|
21 Titers
Interval 19.0 to 25.0
|
61 Titers
Interval 52.0 to 72.0
|
35 Titers
Interval 30.0 to 42.0
|
|
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Serogroup Y (N=593, 600, 545, 539)
|
24 Titers
Interval 20.0 to 28.0
|
10 Titers
Interval 8.68 to 12.0
|
34 Titers
Interval 28.0 to 41.0
|
14 Titers
Interval 12.0 to 17.0
|
SECONDARY outcome
Timeframe: 1 month postvaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=293 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=607 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)
Serogroup A (N=291, 606)
|
91 Percentages of subjects
Interval 87.0 to 94.0
|
72 Percentages of subjects
Interval 68.0 to 75.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)
Serogroup C (N=293, 607)
|
98 Percentages of subjects
Interval 95.0 to 99.0
|
60 Percentages of subjects
Interval 56.0 to 64.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)
Serogroup W (N=288, 594)
|
89 Percentages of subjects
Interval 85.0 to 92.0
|
72 Percentages of subjects
Interval 68.0 to 75.0
|
—
|
—
|
|
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)
Serogroup Y (N=286, 593)
|
95 Percentages of subjects
Interval 91.0 to 97.0
|
66 Percentages of subjects
Interval 62.0 to 70.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month postvaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=293 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=607 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Serogroup A (N=291, 606)
|
91 Percentages of subjects
Interval 88.0 to 94.0
|
72 Percentages of subjects
Interval 68.0 to 75.0
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Serogroup C (N=293, 607)
|
99 Percentages of subjects
Interval 97.0 to 100.0
|
68 Percentages of subjects
Interval 64.0 to 72.0
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Serogroup W (N=288, 594)
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
90 Percentages of subjects
Interval 87.0 to 92.0
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Serogroup Y (N=286, 593)
|
98 Percentages of subjects
Interval 95.0 to 99.0
|
76 Percentages of subjects
Interval 72.0 to 79.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month postvaccinationPopulation: The analysis was performed on the per-protocol (PP) population.
The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y. ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=293 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=607 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Serogroup A (N=291, 606)
|
64 Titers
Interval 51.0 to 81.0
|
27 Titers
Interval 23.0 to 82.0
|
—
|
—
|
|
GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Serogroup C (N=293, 607)
|
144 Titers
Interval 118.0 to 177.0
|
18 Titers
Interval 15.0 to 21.0
|
—
|
—
|
|
GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Serogroup W (N=288, 594)
|
132 Titers
Interval 111.0 to 157.0
|
41 Titers
Interval 36.0 to 47.0
|
—
|
—
|
|
GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Serogroup Y (N=286, 593)
|
102 Titers
Interval 82.0 to 126.0
|
23 Titers
Interval 20.0 to 27.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Study days 1 to 7Population: The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported.
Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=693 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=684 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Injection site pain
|
33 Percentages of subjects
|
35 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Injection site erythema
|
27 Percentages of subjects
|
18 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Injection site induration
|
18 Percentages of subjects
|
18 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Change in Eating Habits (N=683, 671)
|
9 Percentages of subjects
|
10 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Sleepiness (N=692, 684)
|
16 Percentages of subjects
|
18 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Irritability (N=692, 684)
|
21 Percentages of subjects
|
22 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Vomiting (N=692, 684)
|
3 Percentages of subjects
|
3 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Diarrhea (N=692, 684)
|
7 Percentages of subjects
|
8 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Arthralgia
|
3 Percentages of subjects
|
4 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Headache
|
5 Percentages of subjects
|
6 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Rash
|
4 Percentages of subjects
|
5 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Fever ( ≥ 38C ; N=692, 684)
|
2 Percentages of subjects
|
2 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Fever ( ≥ 40.0C )
|
0 Percentages of subjects
|
0 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Stayed home (N=682, 670)
|
3 Percentages of subjects
|
2 Percentages of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Analgesic/Antipyretic medication used
|
11 Percentages of subjects
|
13 Percentages of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Study days 1 to 7Population: The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported.
Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=582 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=571 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Injection site pain
|
39 Percenatage of subjects
|
45 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Injection site erythema
|
28 Percenatage of subjects
|
22 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Injection site induration
|
17 Percenatage of subjects
|
13 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Chills
|
5 Percenatage of subjects
|
5 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Nausea
|
8 Percenatage of subjects
|
6 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Malaise
|
14 Percenatage of subjects
|
11 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Myalgia
|
10 Percenatage of subjects
|
10 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Arthralgia
|
6 Percenatage of subjects
|
4 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Headache
|
18 Percenatage of subjects
|
13 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Rash
|
5 Percenatage of subjects
|
3 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Fever ( ≥ 38C ; N=582, 570)
|
2 Percenatage of subjects
|
2 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Fever ( ≥ 40.0C ; N=582, 570)
|
0 Percenatage of subjects
|
1 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Stayed home (N=575, 566)
|
3 Percenatage of subjects
|
2 Percenatage of subjects
|
—
|
—
|
|
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Analgesic/Antipyretic medication used
|
9 Percenatage of subjects
|
10 Percenatage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: day 1 to study termination (day 240)Population: The analysis was performed on safety population. Only groups receiving 1 dose vaccine are reported.
Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.
Outcome measures
| Measure |
MenACWY-CRM (1 Dose)
n=1275 Participants
1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
|
Licensed Polysaccharide Vaccine
n=1255 Participants
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
|
MenACWY-CRM (6 to 10 Yoa)
1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine (6 to 10 Yoa)
1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
Any AEs
|
26 Percentage of Subjects
|
24 Percentage of Subjects
|
—
|
—
|
|
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
Possibly probably related AEs
|
5 Percentage of Subjects
|
5 Percentage of Subjects
|
—
|
—
|
|
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
SAEs
|
1 Percentage of Subjects
|
1 Percentage of Subjects
|
—
|
—
|
|
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
AEs leading to discontinuation
|
0 Percentage of Subjects
|
0 Percentage of Subjects
|
—
|
—
|
|
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
Possibly probably related SAEs
|
0 Percentage of Subjects
|
0 Percentage of Subjects
|
—
|
—
|
|
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
Death
|
0 Percentage of Subjects
|
0 Percentage of Subjects
|
—
|
—
|
Adverse Events
MenACWY-CRM (2 Doses)
Serious events: 2 serious events
Other events: 253 other events
Deaths: 0 deaths
MenACWY-CRM (1 Dose)_2 to 5 Years
Serious events: 5 serious events
Other events: 424 other events
Deaths: 0 deaths
MenACWY-CRM (1 Dose)_6 to 10 Years
Serious events: 3 serious events
Other events: 340 other events
Deaths: 0 deaths
Licensed Polysaccharide Vaccine_2 to 5 Years
Serious events: 5 serious events
Other events: 419 other events
Deaths: 0 deaths
Licensed Polysaccharide Vaccine_6 to 10 Years
Serious events: 2 serious events
Other events: 342 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenACWY-CRM (2 Doses)
n=351 participants at risk
2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
|
MenACWY-CRM (1 Dose)_2 to 5 Years
n=693 participants at risk
1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 5 years of age.
|
MenACWY-CRM (1 Dose)_6 to 10 Years
n=582 participants at risk
1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine_2 to 5 Years
n=684 participants at risk
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 5 years of age.
|
Licensed Polysaccharide Vaccine_6 to 10 Years
n=571 participants at risk
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.15%
1/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.28%
1/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Gastrointestinal disorders
Mouth Cyst
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.18%
1/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
General disorders
Pyrexia
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.15%
1/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.15%
1/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Infections and infestations
Bronchopneumonia
|
0.28%
1/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Infections and infestations
Parvovirus infection
|
0.28%
1/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Infections and infestations
Peritonsillar Abscess
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.14%
1/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.29%
2/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.15%
1/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Infections and infestations
Shigella infection
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.17%
1/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Infections and infestations
Cellulitis Staphylococcal
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.17%
1/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.15%
1/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Adrenal Haematoma
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.17%
1/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.17%
1/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.17%
1/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.15%
1/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Pulmonary Contusion
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.17%
1/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Traumatic Lung Injury
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.17%
1/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.29%
2/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.17%
1/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Psychiatric disorders
Psychiatric Symptom
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.18%
1/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Spasm
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.14%
1/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.17%
1/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
Other adverse events
| Measure |
MenACWY-CRM (2 Doses)
n=351 participants at risk
2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
|
MenACWY-CRM (1 Dose)_2 to 5 Years
n=693 participants at risk
1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 5 years of age.
|
MenACWY-CRM (1 Dose)_6 to 10 Years
n=582 participants at risk
1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 6 to 10 years of age.
|
Licensed Polysaccharide Vaccine_2 to 5 Years
n=684 participants at risk
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 5 years of age.
|
Licensed Polysaccharide Vaccine_6 to 10 Years
n=571 participants at risk
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 6 to 10 years of age.
|
|---|---|---|---|---|---|
|
Infections and infestations
upper respiratory tract infection
|
5.7%
20/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
1.9%
13/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.69%
4/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
1.3%
9/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.18%
1/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
General disorders
injection site pain
|
43.0%
151/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
32.6%
226/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
38.8%
226/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
35.2%
241/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
44.8%
256/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
General disorders
injection site erythema
|
37.3%
131/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
26.8%
186/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
28.2%
164/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
24.9%
170/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
22.1%
126/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
General disorders
irritablility
|
27.9%
98/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
21.2%
147/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
22.2%
152/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
General disorders
injection site induration
|
23.4%
82/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
18.2%
126/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
16.7%
97/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
18.4%
126/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
12.8%
73/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Nervous system disorders
somnolence
|
23.1%
81/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
15.7%
109/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
18.4%
126/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Nervous system disorders
headache
|
7.7%
27/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
5.3%
37/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
18.0%
105/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
5.7%
39/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
13.8%
79/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
General disorders
mailaise
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
14.1%
82/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
10.9%
62/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Psychiatric disorders
eating disorder
|
16.0%
56/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
9.2%
64/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
10.1%
69/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Gastrointestinal disorders
diarrhoea
|
10.0%
35/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
7.5%
52/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.69%
4/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
8.0%
55/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.35%
2/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
General disorders
rash
|
8.8%
31/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
4.8%
33/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
4.8%
28/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
5.1%
35/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
3.7%
21/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
5.7%
20/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
3.6%
25/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
6.5%
38/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
3.5%
24/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
4.4%
25/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
General disorders
pyrexia
|
5.7%
20/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
3.6%
25/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
2.6%
15/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
2.9%
20/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
2.3%
13/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Gastrointestinal disorders
NAUSEA
|
0.85%
3/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.29%
2/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
8.6%
50/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
6.5%
37/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Gastrointestinal disorders
VOMITING
|
5.4%
19/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
3.6%
25/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.34%
2/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
3.2%
22/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.88%
5/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
General disorders
CHILLS
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
5.2%
30/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
4.6%
26/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/351 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/693 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
10.7%
62/582 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
0.00%
0/684 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
10.3%
59/571 • All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place