Trial Outcomes & Findings for Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children (NCT NCT00262028)
NCT ID: NCT00262028
Last Updated: 2016-02-11
Results Overview
Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
910 participants
Primary outcome timeframe
1 month post vaccination (Day 29)
Results posted on
2016-02-11
Participant Flow
Subjects were recruited from a single center.
All enrolled subjects participated in this study.
Participant milestones
| Measure |
MenACWY (2-5 Years Old)
Subjects received one dose of the investigational MenACWY-cross-reactive material (CRM) conjugate vaccine.
|
MenACWY-PS (2-5 Years Old)
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
|
MenACWY (6-10 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY-PS (6-10 Years Old)
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
|
MenACWY (12-15 Months Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY+PnC (12-15 Months)
Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine (PnC).
|
MenACWY (16-23 Months)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY+DTaP (16-23 Months)
Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with diphtheria-tetanus-acellular pertussis (DTaP) vaccine.
|
MenACWY-PS (3-5 Years Old)
Children aged 3 to 5 years receiving MenACWY- polysaccharide (PS) vaccine from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
152
|
153
|
157
|
157
|
74
|
73
|
71
|
73
|
100
|
|
Overall Study
COMPLETED
|
128
|
126
|
137
|
134
|
62
|
60
|
59
|
55
|
81
|
|
Overall Study
NOT COMPLETED
|
24
|
27
|
20
|
23
|
12
|
13
|
12
|
18
|
19
|
Reasons for withdrawal
| Measure |
MenACWY (2-5 Years Old)
Subjects received one dose of the investigational MenACWY-cross-reactive material (CRM) conjugate vaccine.
|
MenACWY-PS (2-5 Years Old)
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
|
MenACWY (6-10 Years Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY-PS (6-10 Years Old)
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
|
MenACWY (12-15 Months Old)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY+PnC (12-15 Months)
Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine (PnC).
|
MenACWY (16-23 Months)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY+DTaP (16-23 Months)
Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with diphtheria-tetanus-acellular pertussis (DTaP) vaccine.
|
MenACWY-PS (3-5 Years Old)
Children aged 3 to 5 years receiving MenACWY- polysaccharide (PS) vaccine from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
6
|
5
|
2
|
3
|
5
|
7
|
2
|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
5
|
5
|
4
|
3
|
3
|
5
|
6
|
|
Overall Study
Administrative Reason
|
11
|
14
|
9
|
12
|
6
|
7
|
4
|
6
|
10
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Unable to classify
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
Baseline characteristics by cohort
| Measure |
MenACWY (2-5 Years Old)
n=152 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY-PS (2-5 Years Old)
n=153 Participants
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
|
MenACWY (6-10 Years Old)
n=157 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years Old)
n=157 Participants
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
|
MenACWY (12-15 Months Old)
n=74 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY-PnC (12-15 Months Old)
n=73 Participants
Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
|
MenACWY (16-23 Months Old)
n=71 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY+DTaP (16-23 Months Old)
n=73 Participants
Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
|
MenACWY+PS (3-5 YearsOld)
n=100 Participants
Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
|
Total
n=1010 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
NA months
STANDARD_DEVIATION NA • n=5 Participants
|
NA months
STANDARD_DEVIATION NA • n=7 Participants
|
NA months
STANDARD_DEVIATION NA • n=5 Participants
|
NA months
STANDARD_DEVIATION NA • n=4 Participants
|
12.2 months
STANDARD_DEVIATION 0.5 • n=21 Participants
|
12.2 months
STANDARD_DEVIATION 0.5 • n=10 Participants
|
18.2 months
STANDARD_DEVIATION 1.3 • n=115 Participants
|
18.2 months
STANDARD_DEVIATION 1.4 • n=24 Participants
|
52.6 months
STANDARD_DEVIATION 11.4 • n=42 Participants
|
24.7 months
STANDARD_DEVIATION 17.5 • n=42 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
29 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
36 Participants
n=24 Participants
|
51 Participants
n=42 Participants
|
NA Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
44 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
37 Participants
n=24 Participants
|
49 Participants
n=42 Participants
|
NA Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 1 month post vaccination (Day 29)Population: Analysis was done on per protocol population i.e. all subjects who received one dose of vaccine and provided serum samples at the relevant time points (day 1, day 29 and day 360) and had no major protocol deviation.
Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Outcome measures
| Measure |
MenACWY-CRM (2-10 Years Old)
n=284 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (2-10 Years)
n=285 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years Old)
Subjects received one dose of investigational MenACWY-CRM vaccine
|
MenACWY-PS (6-10 Years Old)
Subjects received one dose of licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
|
|---|---|---|---|---|---|---|
|
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup A (Day 1), N=280, 281
|
6 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup A (Day 29), N=280, 281
|
228 Subjects
|
125 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup C (Day 1)
|
80 Subjects
|
81 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup C (Day 29)
|
232 Subjects
|
181 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup W (Day 1), N=279, 282
|
111 Subjects
|
108 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup W (Day 29), N=279, 282
|
263 Subjects
|
202 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup Y (Day 1), N=280, 282
|
61 Subjects
|
68 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup Y (Day 29), N=280, 282
|
254 Subjects
|
167 Subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month post vaccination (Day 29)Population: Analysis was done on per protocol population. The total number of participants analyzed in the MenACWY-CRM (2-10 Years Old) group (282), is different respect with that reported in the Outcome Measure 1 (281). There, the largest number for each group across the 4 strains was reported (not all strains had a result from the lab-i.e. C strain).
Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Outcome measures
| Measure |
MenACWY-CRM (2-10 Years Old)
n=135 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (2-10 Years)
n=138 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years Old)
n=147 Participants
Subjects received one dose of investigational MenACWY-CRM vaccine
|
MenACWY-PS (6-10 Years Old)
n=145 Participants
Subjects received one dose of licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup A (Day 1), N=133,138,147,143
|
2 Percentages of subjects
Interval 0.0 to 5.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
3 Percentages of subjects
Interval 1.0 to 7.0
|
1 Percentages of subjects
Interval 0.018 to 4.0
|
—
|
—
|
|
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup A (Day 29), N=133,138,147,143
|
80 Percentages of subjects
Interval 72.0 to 86.0
|
43 Percentages of subjects
Interval 34.0 to 51.0
|
83 Percentages of subjects
Interval 76.0 to 89.0
|
46 Percentages of subjects
Interval 38.0 to 55.0
|
—
|
—
|
|
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup C (Day 1), N=135,138,146,145
|
23 Percentages of subjects
Interval 16.0 to 31.0
|
11 Percentages of subjects
Interval 6.0 to 17.0
|
34 Percentages of subjects
Interval 26.0 to 42.0
|
46 Percentages of subjects
Interval 37.0 to 54.0
|
—
|
—
|
|
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup C (Day 29), N=135,138,146,145
|
76 Percentages of subjects
Interval 68.0 to 83.0
|
45 Percentages of subjects
Interval 36.0 to 54.0
|
88 Percentages of subjects
Interval 82.0 to 93.0
|
82 Percentages of subjects
Interval 75.0 to 88.0
|
—
|
—
|
|
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup W (Day 1), N=135,138,144,144
|
32 Percentages of subjects
Interval 24.0 to 40.0
|
22 Percentages of subjects
Interval 16.0 to 30.0
|
47 Percentages of subjects
Interval 39.0 to 56.0
|
53 Percentages of subjects
Interval 45.0 to 62.0
|
—
|
—
|
|
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup W (Day 29), N=135,138,144,144
|
90 Percentages of subjects
Interval 84.0 to 95.0
|
55 Percentages of subjects
Interval 46.0 to 64.0
|
98 Percentages of subjects
Interval 94.0 to 100.0
|
88 Percentages of subjects
Interval 81.0 to 92.0
|
—
|
—
|
|
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup Y (Day 1), N=134,138,146,144
|
18 Percentages of subjects
Interval 12.0 to 25.0
|
13 Percentages of subjects
Interval 8.0 to 20.0
|
25 Percentages of subjects
Interval 19.0 to 33.0
|
35 Percentages of subjects
Interval 27.0 to 43.0
|
—
|
—
|
|
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Serogroup Y (Day 29), N=134,138,146,144
|
87 Percentages of subjects
Interval 80.0 to 92.0
|
49 Percentages of subjects
Interval 40.0 to 57.0
|
95 Percentages of subjects
Interval 89.0 to 98.0
|
69 Percentages of subjects
Interval 61.0 to 77.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month post vaccination (Day 29)Population: Analysis was done on per protocol population.
Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.
Outcome measures
| Measure |
MenACWY-CRM (2-10 Years Old)
n=241 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (2-10 Years)
n=91 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years Old)
Subjects received one dose of investigational MenACWY-CRM vaccine
|
MenACWY-PS (6-10 Years Old)
Subjects received one dose of licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Serogroup A (Day 1), N=240,91
|
0 Percentages of subjects
Interval 0.0 to 2.0
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Serogroup A (Day 29), N=240,91
|
81 Percentages of subjects
Interval 76.0 to 86.0
|
51 Percentages of subjects
Interval 40.0 to 61.0
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Serogroup C (Day 1), N=241,91
|
3 Percentages of subjects
Interval 1.0 to 6.0
|
12 Percentages of subjects
Interval 6.0 to 21.0
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Serogroup C (Day 29), N=241,91
|
90 Percentages of subjects
Interval 86.0 to 94.0
|
42 Percentages of subjects
Interval 32.0 to 53.0
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Serogroup W (Day 1), N=240,91
|
3 Percentages of subjects
Interval 1.0 to 6.0
|
24 Percentages of subjects
Interval 16.0 to 34.0
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Serogroup W (Day 29), N=240,91
|
86 Percentages of subjects
Interval 81.0 to 90.0
|
63 Percentages of subjects
Interval 52.0 to 73.0
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Serogroup Y (Day 1), N=238,91
|
2 Percentages of subjects
Interval 1.0 to 5.0
|
15 Percentages of subjects
Interval 9.0 to 24.0
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Serogroup Y (Day 29), N=238,91
|
64 Percentages of subjects
Interval 58.0 to 70.0
|
51 Percentages of subjects
Interval 40.0 to 61.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month post vaccination (Day 29)Population: Analysis was done on per protocol population.
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.
Outcome measures
| Measure |
MenACWY-CRM (2-10 Years Old)
n=281 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (2-10 Years)
n=283 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years Old)
Subjects received one dose of investigational MenACWY-CRM vaccine
|
MenACWY-PS (6-10 Years Old)
Subjects received one dose of licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
|
|---|---|---|---|---|---|---|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup A (Day 1), N=280, 281
|
2.06 Titers
Interval 2.02 to 2.1
|
2.02 Titers
Interval 1.98 to 2.06
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup A (Day 29), N=280, 281
|
36 Titers
Interval 30.0 to 44.0
|
6.31 Titers
Interval 5.21 to 7.64
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup C (Day 1)
|
3.07 Titers
Interval 2.77 to 3.4
|
3.33 Titers
Interval 3.01 to 3.68
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup C (Day 29)
|
26 Titers
Interval 21.0 to 34.0
|
15 Titers
Interval 12.0 to 20.0
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup W (Day 1), N=279, 282
|
5.74 Titers
Interval 4.86 to 6.78
|
5.63 Titers
Interval 4.77 to 6.65
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup W (Day 29), N=279, 282
|
60 Titers
Interval 50.0 to 71.0
|
14 Titers
Interval 12.0 to 17.0
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup Y (Day 1), N=280, 282
|
3.32 Titers
Interval 2.95 to 3.73
|
3.34 Titers
Interval 2.97 to 3.76
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup Y (Day 29), N=280, 282
|
54 Titers
Interval 44.0 to 66.0
|
11 Titers
Interval 9.29 to 14.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month post vaccination (Day 29)Population: Analysis was done on per protocol population.
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.
Outcome measures
| Measure |
MenACWY-CRM (2-10 Years Old)
n=135 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (2-10 Years)
n=138 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years Old)
n=147 Participants
Subjects received one dose of investigational MenACWY-CRM vaccine
|
MenACWY-PS (6-10 Years Old)
n=145 Participants
Subjects received one dose of licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
|
|---|---|---|---|---|---|---|
|
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup A (Day 1), N=133,138,147,143
|
2.04 Titer
Interval 2.0 to 2.07
|
2 Titer
Interval 1.97 to 2.03
|
2.08 Titer
Interval 2.01 to 2.15
|
2.03 Titer
Interval 1.96 to 2.11
|
—
|
—
|
|
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup A (Day 29), N=133,138,147,143
|
28 Titer
Interval 22.0 to 37.0
|
5.8 Titer
Interval 4.49 to 7.5
|
45 Titer
Interval 34.0 to 60.0
|
6.84 Titer
Interval 5.17 to 9.06
|
—
|
—
|
|
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup C (Day 1), N=135,138,146,145
|
2.81 Titer
Interval 2.52 to 3.13
|
2.38 Titer
Interval 2.14 to 2.65
|
3.33 Titer
Interval 2.84 to 3.9
|
4.58 Titer
Interval 3.91 to 5.38
|
—
|
—
|
|
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup C (Day 29), N=135,138,146,145
|
14 Titer
Interval 11.0 to 19.0
|
6.93 Titer
Interval 5.22 to 9.18
|
47 Titer
Interval 34.0 to 67.0
|
33 Titer
Interval 23.0 to 47.0
|
—
|
—
|
|
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup W (Day 1), N=135,138,144,144
|
4.68 Titer
Interval 3.78 to 5.8
|
3.64 Titer
Interval 2.95 to 4.5
|
6.94 Titer
Interval 5.45 to 8.84
|
8.55 Titer
Interval 6.71 to 11.0
|
—
|
—
|
|
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup W (Day 29), N=135,138,144,144
|
43 Titer
Interval 34.0 to 56.0
|
7.84 Titer
Interval 6.12 to 10.0
|
80 Titer
Interval 65.0 to 99.0
|
24 Titer
Interval 20.0 to 30.0
|
—
|
—
|
|
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup Y (Day 1), N=134,138,146,144
|
3 Titer
Interval 2.61 to 3.44
|
2.57 Titer
Interval 2.24 to 2.95
|
3.65 Titer
Interval 3.03 to 4.38
|
4.3 Titer
Interval 3.58 to 5.18
|
—
|
—
|
|
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup Y (Day 29), N=134,138,146,144
|
42 Titer
Interval 31.0 to 56.0
|
7.17 Titer
Interval 5.37 to 9.58
|
68 Titer
Interval 51.0 to 90.0
|
18 Titer
Interval 13.0 to 24.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month post vaccination (Day 29)Population: Analysis was done on per protocol population.
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.
Outcome measures
| Measure |
MenACWY-CRM (2-10 Years Old)
n=241 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (2-10 Years)
n=91 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years Old)
Subjects received one dose of investigational MenACWY-CRM vaccine
|
MenACWY-PS (6-10 Years Old)
Subjects received one dose of licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
|
|---|---|---|---|---|---|---|
|
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
Serogroup A (Day 1), N=240,91
|
2 Titer
Interval 2.0 to 2.0
|
2 Titer
Interval 2.0 to 2.0
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
Serogroup A (Day 29), N=240,91
|
18 Titer
Interval 15.0 to 21.0
|
7.18 Titer
Interval 5.34 to 9.64
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
Serogroup C (Day 1), N=241,91
|
2.13 Titer
Interval 2.02 to 2.25
|
2.44 Titer
Interval 2.23 to 2.68
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
Serogroup C (Day 29), N=241,91
|
22 Titer
Interval 18.0 to 26.0
|
7.09 Titer
Interval 5.29 to 9.5
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
Serogroup W (Day 1), N=240,91
|
2.13 Titer
Interval 1.94 to 2.33
|
3.91 Titer
Interval 3.36 to 4.55
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
Serogroup W (Day 29), N=240,91
|
18 Titer
Interval 15.0 to 21.0
|
9.52 Titer
Interval 7.21 to 13.0
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
Serogroup Y (Day 1), N=238,91
|
2.11 Titer
Interval 1.97 to 2.25
|
2.69 Titer
Interval 2.42 to 3.0
|
—
|
—
|
—
|
—
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
Serogroup Y (Day 29), N=238,91
|
11 Titer
Interval 8.91 to 14.0
|
8.48 Titer
Interval 6.01 to 12.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months post vaccination (Day 360)Population: Analysis was done on per protocol population.
Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Outcome measures
| Measure |
MenACWY-CRM (2-10 Years Old)
n=253 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (2-10 Years)
n=240 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years Old)
n=119 Participants
Subjects received one dose of investigational MenACWY-CRM vaccine
|
MenACWY-PS (6-10 Years Old)
n=114 Participants
Subjects received one dose of licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years)
n=134 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years)
n=126 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
|---|---|---|---|---|---|---|
|
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup A (Day 1), N=253,238,119,114,134,124
|
6 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
4 Subjects
|
1 Subjects
|
|
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup A (Day 360), N=253,238,119,114,134,124
|
71 Subjects
|
44 Subjects
|
27 Subjects
|
15 Subjects
|
44 Subjects
|
29 Subjects
|
|
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup C (Day 1), N=252,240,119,114,133,126
|
70 Subjects
|
72 Subjects
|
26 Subjects
|
12 Subjects
|
44 Subjects
|
60 Subjects
|
|
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup C (Day 360), N=252,240,119,114,133,126
|
172 Subjects
|
126 Subjects
|
77 Subjects
|
41 Subjects
|
95 Subjects
|
85 Subjects
|
|
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup W (Day 1), N=249,237,119,113,130,124
|
96 Subjects
|
85 Subjects
|
35 Subjects
|
21 Subjects
|
61 Subjects
|
64 Subjects
|
|
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup W (Day 360), N=249,237,119,113,130,124
|
234 Subjects
|
119 Subjects
|
108 Subjects
|
41 Subjects
|
126 Subjects
|
78 Subjects
|
|
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup Y (Day 1), N=250,239,118,113,132,126
|
53 Subjects
|
59 Subjects
|
22 Subjects
|
14 Subjects
|
31 Subjects
|
45 Subjects
|
|
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup Y (Day 360), N=250,239,118,113,132,126
|
215 Subjects
|
90 Subjects
|
101 Subjects
|
26 Subjects
|
114 Subjects
|
64 Subjects
|
SECONDARY outcome
Timeframe: 12 months post vaccination (Day 360)Population: Analysis was done on per protocol population.
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Outcome measures
| Measure |
MenACWY-CRM (2-10 Years Old)
n=253 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (2-10 Years)
n=240 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years Old)
n=119 Participants
Subjects received one dose of investigational MenACWY-CRM vaccine
|
MenACWY-PS (6-10 Years Old)
n=114 Participants
Subjects received one dose of licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years)
n=134 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years)
n=126 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
|---|---|---|---|---|---|---|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup A (Day 1), N=253,238,119,114,134,124
|
2.06 Titer
Interval 2.02 to 2.11
|
2.02 Titer
Interval 1.97 to 2.07
|
2.04 Titer
Interval 2.0 to 2.08
|
2 Titer
Interval 1.96 to 2.04
|
2.09 Titer
Interval 2.0 to 2.17
|
2.04 Titer
Interval 1.95 to 2.12
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup A (Day 360), N=253,238,119114,134,124
|
3.88 Titer
Interval 3.39 to 4.44
|
3 Titer
Interval 2.61 to 3.44
|
3.15 Titer
Interval 2.73 to 3.64
|
2.49 Titer
Interval 2.15 to 2.89
|
4.66 Titer
Interval 3.75 to 5.8
|
3.55 Titer
Interval 2.83 to 4.45
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup C (Day 1), N=252,240,119,114,133,126
|
3.04 Titer
Interval 2.73 to 3.39
|
3.43 Titer
Interval 3.07 to 3.84
|
2.77 Titer
Interval 2.47 to 3.12
|
2.38 Titer
Interval 2.11 to 2.69
|
3.3 Titer
Interval 2.79 to 3.9
|
4.77 Titer
Interval 4.01 to 5.67
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup C (Day 360), N=252,240,119,114,133,126
|
11 Titer
Interval 8.64 to 13.0
|
9.02 Titer
Interval 7.23 to 11.0
|
7.53 Titer
Interval 5.93 to 9.55
|
4.71 Titer
Interval 3.69 to 6.01
|
15 Titer
Interval 11.0 to 21.0
|
16 Titer
Interval 12.0 to 23.0
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup W (Day 1), N=249,237,119,113,130,124
|
5.5 Titer
Interval 4.62 to 6.55
|
5.38 Titer
Interval 4.5 to 6.44
|
4.4 Titer
Interval 3.52 to 5.51
|
3.43 Titer
Interval 2.73 to 4.32
|
6.75 Titer
Interval 5.23 to 8.7
|
8.1 Titer
Interval 6.25 to 11.0
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup W (Day 360), N=249,237,119,113,130,124
|
42 Titer
Interval 35.0 to 50.0
|
7.57 Titer
Interval 6.33 to 9.07
|
36 Titer
Interval 28.0 to 46.0
|
4.95 Titer
Interval 3.83 to 6.4
|
49 Titer
Interval 38.0 to 62.0
|
11 Titer
Interval 8.75 to 14.0
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup Y (Day 1), N=250,239,118,113,132,126
|
3.29 Titer
Interval 2.9 to 3.73
|
3.4 Titer
Interval 2.99 to 3.87
|
3.04 Titer
Interval 2.62 to 3.53
|
2.56 Titer
Interval 2.2 to 2.98
|
3.53 Titer
Interval 2.91 to 4.27
|
4.39 Titer
Interval 3.61 to 5.35
|
|
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Serogroup Y (Day 360), N=250,239,118,113,132,126
|
27 Titer
Interval 22.0 to 33.0
|
5.29 Titer
Interval 4.34 to 6.45
|
24 Titer
Interval 19.0 to 31.0
|
3.42 Titer
Interval 2.65 to 4.43
|
30 Titer
Interval 23.0 to 40.0
|
7.82 Titer
Interval 5.86 to 10.0
|
SECONDARY outcome
Timeframe: Day 1 to 7 post vaccinationPopulation: Analysis was done on safety population i.e. all randomized subjects who received a vaccination and who had follow up safety data.
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Outcome measures
| Measure |
MenACWY-CRM (2-10 Years Old)
n=151 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (2-10 Years)
n=153 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years Old)
n=157 Participants
Subjects received one dose of investigational MenACWY-CRM vaccine
|
MenACWY-PS (6-10 Years Old)
n=157 Participants
Subjects received one dose of licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Sleepiness
|
25 Subjects
|
24 Subjects
|
NA Subjects
|
NA Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Irritability
|
29 Subjects
|
26 Subjects
|
NA Subjects
|
NA Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Vomiting
|
12 Subjects
|
6 Subjects
|
NA Subjects
|
NA Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Diarrhea
|
11 Subjects
|
6 Subjects
|
NA Subjects
|
NA Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Chills, N=156, 157
|
NA Subjects
|
NA Subjects
|
13 Subjects
|
5 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Nausea, N=156, 157
|
NA Subjects
|
NA Subjects
|
6 Subjects
|
6 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Malaise, N=156, 157
|
NA Subjects
|
NA Subjects
|
12 Subjects
|
9 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Myalgia, N=156, 157
|
NA Subjects
|
NA Subjects
|
12 Subjects
|
4 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Arthralgia, N=151,153,156,157
|
3 Subjects
|
7 Subjects
|
5 Subjects
|
3 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Headache, N=151,153,156,157
|
6 Subjects
|
3 Subjects
|
29 Subjects
|
17 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Other
|
40 Subjects
|
31 Subjects
|
37 Subjects
|
23 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Stayed at home due to reactions, N=146,151,154,156
|
6 Subjects
|
5 Subjects
|
6 Subjects
|
3 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Analg./antipyr. med. used, N=150,152,157,157
|
38 Subjects
|
28 Subjects
|
36 Subjects
|
23 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Local reactions
|
56 Subjects
|
37 Subjects
|
70 Subjects
|
50 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Injection site pain
|
43 Subjects
|
30 Subjects
|
57 Subjects
|
43 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Injection site erythema
|
23 Subjects
|
11 Subjects
|
26 Subjects
|
9 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Injection site induration
|
17 Subjects
|
5 Subjects
|
26 Subjects
|
6 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Systemic reactions
|
55 Subjects
|
45 Subjects
|
39 Subjects
|
28 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Change in eating habits, N=145,150
|
18 Subjects
|
16 Subjects
|
NA Subjects
|
NA Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 7 post vaccinationPopulation: Analysis was done on safety population.
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Outcome measures
| Measure |
MenACWY-CRM (2-10 Years Old)
n=74 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (2-10 Years)
n=71 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years Old)
n=71 Participants
Subjects received one dose of investigational MenACWY-CRM vaccine
|
MenACWY-PS (6-10 Years Old)
n=73 Participants
Subjects received one dose of licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Local reactions
|
37 Subjects
|
29 Subjects
|
40 Subjects
|
35 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Injection site reaction tenderness
|
15 Subjects
|
17 Subjects
|
19 Subjects
|
18 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Injection site reaction erythema
|
29 Subjects
|
17 Subjects
|
30 Subjects
|
25 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Injection site reaction induration
|
16 Subjects
|
13 Subjects
|
16 Subjects
|
10 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Systemic reactions
|
47 Subjects
|
50 Subjects
|
51 Subjects
|
50 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Change in eating habits, N=74,70,71,72
|
11 Subjects
|
20 Subjects
|
13 Subjects
|
18 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Sleepiness
|
22 Subjects
|
32 Subjects
|
21 Subjects
|
25 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Persistent crying, N=74,70,71,72
|
1 Subjects
|
3 Subjects
|
4 Subjects
|
4 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Irritability
|
36 Subjects
|
40 Subjects
|
33 Subjects
|
32 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Vomiting
|
1 Subjects
|
2 Subjects
|
4 Subjects
|
5 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Diarrhea
|
10 Subjects
|
11 Subjects
|
20 Subjects
|
16 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Other
|
35 Subjects
|
44 Subjects
|
25 Subjects
|
41 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Analgesic/antipyretic medicine used
|
35 Subjects
|
44 Subjects
|
25 Subjects
|
41 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1- Day 360 (throughout the study)Population: Analysis was done on safety population.
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Outcome measures
| Measure |
MenACWY-CRM (2-10 Years Old)
n=151 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (2-10 Years)
n=153 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years Old)
n=157 Participants
Subjects received one dose of investigational MenACWY-CRM vaccine
|
MenACWY-PS (6-10 Years Old)
n=157 Participants
Subjects received one dose of licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years
Any AE
|
56 Subjects
|
43 Subjects
|
45 Subjects
|
33 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years
Possibly or probably related AEs
|
6 Subjects
|
7 Subjects
|
15 Subjects
|
9 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years
SAEs
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years
AEs leading to premature withdrawal
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1- Day 360 (Throughout the study)Population: Analysis was done on safety population.
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Outcome measures
| Measure |
MenACWY-CRM (2-10 Years Old)
n=74 Participants
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (2-10 Years)
n=71 Participants
Subjects received one dose of the licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years Old)
n=71 Participants
Subjects received one dose of investigational MenACWY-CRM vaccine
|
MenACWY-PS (6-10 Years Old)
n=73 Participants
Subjects received one dose of licensed MenACWY-PS vaccine
|
MenACWY-CRM (6-10 Years)
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
|
MenACWY-PS (6-10 Years)
Subjects received one dose of the licensed MenACWY-PS vaccine
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Any AE
|
35 Subjects
|
33 Subjects
|
25 Subjects
|
30 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Possibly or probably related AEs
|
6 Subjects
|
1 Subjects
|
1 Subjects
|
4 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
AEs leading to premature withdrawal
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
SAEs
|
2 Subjects
|
3 Subjects
|
3 Subjects
|
2 Subjects
|
—
|
—
|
Adverse Events
MenACWY (2-5 Years Old)
Serious events: 2 serious events
Other events: 82 other events
Deaths: 0 deaths
MenACWY-PS (2-5 Years Old)
Serious events: 1 serious events
Other events: 69 other events
Deaths: 0 deaths
MenACWY (6-10 Years Old)
Serious events: 0 serious events
Other events: 81 other events
Deaths: 0 deaths
MenACWY-PS (6-10 Years Old)
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
MenACWY (12-15 Months Old)
Serious events: 2 serious events
Other events: 64 other events
Deaths: 0 deaths
MenACWY-PnC (12-15 Months Old)
Serious events: 3 serious events
Other events: 61 other events
Deaths: 0 deaths
MenACWY (16-23 Months Old)
Serious events: 3 serious events
Other events: 62 other events
Deaths: 0 deaths
MenACWY+DTaP (16-23 Months Old)
Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths
MenACWY-PS (3-5 Years Old)
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenACWY (2-5 Years Old)
n=151 participants at risk
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY-PS (2-5 Years Old)
n=153 participants at risk
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
|
MenACWY (6-10 Years Old)
n=157 participants at risk
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY-PS (6-10 Years Old)
n=157 participants at risk
Subjects received one dose of the licensed MenACWY-CRM polysaccharide vaccine.
|
MenACWY (12-15 Months Old)
n=74 participants at risk
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY-PnC (12-15 Months Old)
n=71 participants at risk
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
|
MenACWY (16-23 Months Old)
n=71 participants at risk
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY+DTaP (16-23 Months Old)
n=73 participants at risk
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
|
MenACWY-PS (3-5 Years Old)
n=100 participants at risk
Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune not licensed in US in children under 2 years of ages) served as controls for the 12-23-months-old part two toddlers.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.65%
1/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.0%
1/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Infections and infestations
APPENDICITIS
|
0.66%
1/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.65%
1/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.0%
1/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Infections and infestations
EMPYEMA
|
0.66%
1/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.66%
1/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Infections and infestations
PERITONITIS
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.65%
1/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.0%
1/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Nervous system disorders
FEBRILE CONVULSION
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL HYPERREACTIVITY
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.66%
1/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.66%
1/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
Other adverse events
| Measure |
MenACWY (2-5 Years Old)
n=151 participants at risk
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY-PS (2-5 Years Old)
n=153 participants at risk
Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
|
MenACWY (6-10 Years Old)
n=157 participants at risk
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY-PS (6-10 Years Old)
n=157 participants at risk
Subjects received one dose of the licensed MenACWY-CRM polysaccharide vaccine.
|
MenACWY (12-15 Months Old)
n=74 participants at risk
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY-PnC (12-15 Months Old)
n=71 participants at risk
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
|
MenACWY (16-23 Months Old)
n=71 participants at risk
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
|
MenACWY+DTaP (16-23 Months Old)
n=73 participants at risk
Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
|
MenACWY-PS (3-5 Years Old)
n=100 participants at risk
Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune not licensed in US in children under 2 years of ages) served as controls for the 12-23-months-old part two toddlers.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
7.9%
12/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
3.9%
6/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
13.5%
10/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
16.9%
12/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
28.2%
20/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
23.3%
17/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
4.0%
4/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Gastrointestinal disorders
TEETHING
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
9.5%
7/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.8%
2/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
4.1%
3/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Gastrointestinal disorders
VOMITING
|
8.6%
13/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
3.9%
6/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.64%
1/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
5.6%
4/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
7.0%
5/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
8.2%
6/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.0%
2/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
General disorders
CHILLS
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
8.3%
13/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
3.2%
5/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
General disorders
CRYING
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
4.2%
3/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
5.6%
4/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
5.5%
4/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
General disorders
INJECTION SITE ERYTHEMA
|
15.2%
23/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
7.2%
11/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
16.6%
26/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
5.7%
9/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
39.2%
29/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
23.9%
17/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
42.3%
30/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
34.2%
25/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
5.0%
5/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
General disorders
INJECTION SITE INDURATION
|
11.3%
17/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
3.3%
5/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
16.6%
26/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
3.8%
6/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
21.6%
16/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
18.3%
13/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
22.5%
16/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
13.7%
10/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.0%
2/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
General disorders
INJECTION SITE PAIN
|
28.5%
43/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
19.6%
30/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
36.3%
57/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
27.4%
43/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
20.3%
15/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
25.4%
18/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
26.8%
19/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
24.7%
18/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
22.0%
22/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
General disorders
MALAISE
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
7.6%
12/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
5.7%
9/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
General disorders
PYREXIA
|
7.9%
12/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
6.5%
10/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.9%
3/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.5%
4/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
9.5%
7/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
5.6%
4/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
5.6%
4/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
8.2%
6/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
7.0%
7/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Infections and infestations
CROUP INFECTIOUS
|
1.3%
2/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.65%
1/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.7%
2/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
7.0%
5/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.7%
2/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Infections and infestations
OTITIS MEDIA
|
2.6%
4/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.0%
3/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
10.8%
8/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
7.0%
5/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.0%
2/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.6%
10/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
3.9%
6/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.5%
4/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.5%
4/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
13.5%
10/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
8.5%
6/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
6.8%
5/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.0%
2/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
7.6%
12/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.5%
4/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Nervous system disorders
HEADACHE
|
4.6%
7/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.0%
3/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
18.5%
29/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
11.5%
18/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
3.0%
3/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Nervous system disorders
SOMNOLENCE
|
16.6%
25/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
15.7%
24/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
29.7%
22/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
45.1%
32/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
29.6%
21/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
34.2%
25/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
13.0%
13/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Psychiatric disorders
EATING DISORDER
|
11.9%
18/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
10.5%
16/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
14.9%
11/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
28.2%
20/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
18.3%
13/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
24.7%
18/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
9.0%
9/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Psychiatric disorders
IRRITABILITY
|
19.2%
29/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
17.0%
26/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.00%
0/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
48.6%
36/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
56.3%
40/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
46.5%
33/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
43.8%
32/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
14.0%
14/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
1.3%
2/151 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.3%
2/153 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.64%
1/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
0.64%
1/157 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
2.7%
2/74 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
5.6%
4/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/71 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.4%
1/73 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
1.0%
1/100 • Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60