Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12 (NCT NCT00944034)
NCT ID: NCT00944034
Last Updated: 2017-08-14
Results Overview
Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1588 participants
Primary outcome timeframe
1 month after booster
Results posted on
2017-08-14
Participant Flow
Subjects were enrolled from 6 centres in Belgium, 4 in Czech, 24 in Germany, 5 in Italy, 16 in Spain and 4 in UK who had previously participated in and completed the study V72P12.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
B+R246_18
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B12 14
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
|
B18 20
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
|
B24 26
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
|
B+R246_12
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.age
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
157
|
152
|
174
|
164
|
143
|
106
|
78
|
73
|
246
|
51
|
56
|
188
|
|
Overall Study
COMPLETED
|
150
|
143
|
170
|
150
|
123
|
102
|
73
|
63
|
236
|
50
|
52
|
183
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
4
|
14
|
20
|
4
|
5
|
10
|
10
|
1
|
4
|
5
|
Reasons for withdrawal
| Measure |
B+R246_18
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B12 14
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
|
B18 20
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
|
B24 26
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
|
B+R246_12
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.age
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Inappropriate enrollment
|
1
|
0
|
1
|
2
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
2
|
5
|
8
|
2
|
2
|
3
|
4
|
0
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
0
|
5
|
7
|
0
|
1
|
5
|
1
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
2
|
3
|
0
|
1
|
1
|
4
|
0
|
0
|
2
|
|
Overall Study
Unable to classify
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Administrative reason
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12
Baseline characteristics by cohort
| Measure |
B+R246_12
n=188 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=157 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=152 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
n=174 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
n=164 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
n=143 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
n=106 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
n=78 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
n=73 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B12 14
n=246 Participants
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
|
B18 20
n=51 Participants
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
|
B24 26
n=56 Participants
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
|
Total
n=1588 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
188 Participants
n=93 Participants
|
157 Participants
n=4 Participants
|
152 Participants
n=27 Participants
|
174 Participants
n=483 Participants
|
164 Participants
n=36 Participants
|
143 Participants
n=10 Participants
|
106 Participants
n=115 Participants
|
78 Participants
n=40 Participants
|
73 Participants
n=8 Participants
|
246 Participants
n=62 Participants
|
51 Participants
n=95 Participants
|
56 Participants
n=129 Participants
|
1588 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
12.6 months
STANDARD_DEVIATION 1.2 • n=93 Participants
|
18.1 months
STANDARD_DEVIATION 0.6 • n=4 Participants
|
24 months
STANDARD_DEVIATION 0.4 • n=27 Participants
|
12.7 months
STANDARD_DEVIATION 0.9 • n=483 Participants
|
18.1 months
STANDARD_DEVIATION 0.5 • n=36 Participants
|
24 months
STANDARD_DEVIATION 0.3 • n=10 Participants
|
12.8 months
STANDARD_DEVIATION 1.4 • n=115 Participants
|
18 months
STANDARD_DEVIATION 0.4 • n=40 Participants
|
24 months
STANDARD_DEVIATION 0.5 • n=8 Participants
|
12.6 months
STANDARD_DEVIATION 1.3 • n=62 Participants
|
18 months
STANDARD_DEVIATION 0.2 • n=95 Participants
|
24 months
STANDARD_DEVIATION 0.2 • n=129 Participants
|
17.1 months
STANDARD_DEVIATION 4.7 • n=36 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
81 Participants
n=483 Participants
|
80 Participants
n=36 Participants
|
75 Participants
n=10 Participants
|
62 Participants
n=115 Participants
|
41 Participants
n=40 Participants
|
34 Participants
n=8 Participants
|
115 Participants
n=62 Participants
|
23 Participants
n=95 Participants
|
23 Participants
n=129 Participants
|
762 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
93 Participants
n=483 Participants
|
84 Participants
n=36 Participants
|
68 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
37 Participants
n=40 Participants
|
39 Participants
n=8 Participants
|
131 Participants
n=62 Participants
|
28 Participants
n=95 Participants
|
33 Participants
n=129 Participants
|
826 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 1 month after boosterPopulation: The analysis was performed on the per-protocol population. This outcome measure was assessed only for the strains H44/76, NZ98/254 and 5/99. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.
Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.
Outcome measures
| Measure |
B+R246_12
n=162 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=120 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=108 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.
hSBA≥ 1: 5 (H44/76 strain)(N = 158,116,101)
|
97 percentage of subjects
Interval 93.0 to 99.0
|
100 percentage of subjects
Interval 96.0 to 100.0
|
100 percentage of subjects
Interval 95.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.
hSBA≥ 1: 5 (M10713 strain)
|
NA percentage of subjects
In this group exploratory analyses was not performed
|
NA percentage of subjects
In this group exploratory analyses was not performed
|
NA percentage of subjects
In this group exploratory analyses was not performed
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.
hSBA≥ 1: 5 (5/99 strain)(N= 156,118,100)
|
100 percentage of subjects
Interval 97.0 to 100.0
|
100 percentage of subjects
Interval 96.0 to 100.0
|
100 percentage of subjects
Interval 95.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.
hSBA≥ 1: 5 (NZ 98/254 strain)(N= 159,118,103)
|
95 percentage of subjects
Interval 89.0 to 98.0
|
77 percentage of subjects
Interval 67.0 to 86.0
|
84 percentage of subjects
Interval 74.0 to 92.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after boosterPopulation: The analysis was performed on per-protocol population. This outcome measure was assessed only against H44/76, NZ98/254 and 5/99 strains. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.
Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.
Outcome measures
| Measure |
B+R246_12
n=145 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=114 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=98 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.
hSBA≥ 1: 5 (H44/76 strain)(N= 138,111,93)
|
100 percentage of subjects
Interval 97.0 to 100.0
|
99 percentage of subjects
Interval 94.0 to 100.0
|
100 percentage of subjects
Interval 95.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.
hSBA≥ 1: 5 (NZ 98/254 strain)(N= 142,111,95)
|
96 percentage of subjects
Interval 90.0 to 99.0
|
86 percentage of subjects
Interval 76.0 to 93.0
|
89 percentage of subjects
Interval 80.0 to 96.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.
hSBA≥ 1: 5 (M10713 strain)
|
NA percentage of subjects
In this group exploratory analyses was not performed
|
NA percentage of subjects
In this group exploratory analyses was not performed
|
NA percentage of subjects
In this group exploratory analyses was not performed
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.
hSBA≥ 1: 5 (5/99 strain)(N= 142,110,92)
|
100 percentage of subjects
Interval 97.0 to 100.0
|
100 percentage of subjects
Interval 96.0 to 100.0
|
100 percentage of subjects
Interval 95.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after boosterPopulation: The analysis was performed on the per-protocol population
Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.
Outcome measures
| Measure |
B+R246_12
n=86 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=58 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=48 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.
hSBA≥ 1: 5 (H44/76 strain)(N= 83,56,48 )
|
100 percentage of subjects
Interval 94.0 to 100.0
|
98 percentage of subjects
Interval 88.0 to 100.0
|
100 percentage of subjects
Interval 91.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.
hSBA≥ 1: 5 (5/99 strain)(N= 84,56,46)
|
100 percentage of subjects
Interval 94.0 to 100.0
|
100 percentage of subjects
Interval 92.0 to 100.0
|
100 percentage of subjects
Interval 90.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.
hSBA≥ 1: 5 (NZ 98/254 strain)(N= 83,56,48)
|
97 percentage of subjects
Interval 89.0 to 100.0
|
80 percentage of subjects
Interval 65.0 to 91.0
|
96 percentage of subjects
Interval 83.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.
hSBA≥ 1: 5 (M10713 strain)(N= 67,50,41)
|
76 percentage of subjects
Interval 62.0 to 87.0
|
74 percentage of subjects
Interval 57.0 to 87.0
|
95 percentage of subjects
Interval 81.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after boosterPopulation: The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain) (N=158 116 101 138 111 93 83 56 48) For hSBA≥ 1: 5 (5/99 strain) (N=156 118 100 142 110 92 84 56 46) For hSBA≥ 1: 5 (NZ 98/254 strain) (N=159 118 103 142 111 95 86 56 48) For hSBA≥ 1: 5 (M10713 strain) (N=0 0 0 0 0 0 67 50 41)
The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
Outcome measures
| Measure |
B+R246_12
n=162 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=120 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=108 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
n=145 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
n=114 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
n=98 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
n=86 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
n=58 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
n=48 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.
hSBA≥ 1: 5 (5/99 strain)
|
1276 Titers
Interval 1092.0 to 1491.0
|
2183 Titers
Interval 1824.0 to 2611.0
|
1820 Titers
Interval 1497.0 to 2212.0
|
1713 Titers
Interval 1454.0 to 2020.0
|
2058 Titers
Interval 1710.0 to 2476.0
|
2739 Titers
Interval 2233.0 to 3361.0
|
1558 Titers
Interval 1262.0 to 1923.0
|
1486 Titers
Interval 1148.0 to 1924.0
|
2081 Titers
Interval 1564.0 to 2771.0
|
|
Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.
hSBA≥ 1: 5 (NZ 98/254 strain)
|
36 Titers
Interval 29.0 to 44.0
|
15 Titers
Interval 12.0 to 19.0
|
17 Titers
Interval 14.0 to 22.0
|
34 Titers
Interval 27.0 to 42.0
|
17 Titers
Interval 14.0 to 22.0
|
19 Titers
Interval 15.0 to 25.0
|
47 Titers
Interval 36.0 to 62.0
|
17 Titers
Interval 12.0 to 24.0
|
33 Titers
Interval 23.0 to 47.0
|
|
Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.
hSBA≥ 1: 5 (M10713 strain)
|
NA Titers
In this group exploratory analyses was not performed.
|
NA Titers
In this group exploratory analyses was not performed.
|
NA Titers
In this group exploratory analyses was not performed.
|
NA Titers
In this group exploratory analyses was not performed.
|
NA Titers
In this group exploratory analyses was not performed.
|
NA Titers
In this group exploratory analyses was not performed.
|
12 Titers
Interval 8.52 to 17.0
|
15 Titers
Interval 10.0 to 23.0
|
26 Titers
Interval 17.0 to 41.0
|
|
Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.
hSBA≥ 1: 5 (H44/76 strain)
|
125 Titers
Interval 106.0 to 148.0
|
123 Titers
Interval 101.0 to 149.0
|
108 Titers
Interval 88.0 to 133.0
|
178 Titers
Interval 149.0 to 213.0
|
164 Titers
Interval 135.0 to 200.0
|
152 Titers
Interval 122.0 to 188.0
|
135 Titers
Interval 108.0 to 170.0
|
92 Titers
Interval 70.0 to 121.0
|
128 Titers
Interval 95.0 to 172.0
|
SECONDARY outcome
Timeframe: 1 month after boosterPopulation: The analysis was performed on the per-protocol population
Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
Outcome measures
| Measure |
B+R246_12
n=162 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=145 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=86 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
n=239 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age
hSBA≥ 1: 5 (5/99 strain)(N= 156,142,84,216)
|
1301 Titers
Interval 1076.0 to 1573.0
|
1763 Titers
Interval 1441.0 to 2157.0
|
1607 Titers
Interval 1243.0 to 2077.0
|
49 Titers
Interval 42.0 to 58.0
|
—
|
—
|
—
|
—
|
—
|
|
GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age
hSBA≥ 1: 5 (NZ 98/254 strain)(N= 159,142,86,220)
|
37 Titers
Interval 29.0 to 46.0
|
35 Titers
Interval 27.0 to 44.0
|
48 Titers
Interval 36.0 to 65.0
|
3.71 Titers
Interval 3.06 to 4.5
|
—
|
—
|
—
|
—
|
—
|
|
GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age
hSBA≥ 1: 5 (H44/76 strain)(N= 158,138,83,217)
|
125 Titers
Interval 102.0 to 154.0
|
179 Titers
Interval 144.0 to 223.0
|
137 Titers
Interval 104.0 to 181.0
|
18 Titers
Interval 15.0 to 21.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after boosterPopulation: The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain)(N=116 101 111 93 56 48 46 52), hSBA≥ 1: 5 (5/99 strain) (N=118 100 110 92 56 46 48 50), hSBA≥ 1: 5 (NZ 98/254 strain) (N=118 103 111 95 56 48 47 50)
Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
Outcome measures
| Measure |
B+R246_12
n=120 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=108 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=114 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
n=98 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
n=58 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
n=48 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
n=47 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
n=53 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age
hSBA≥ 1: 5 (H44/76 strain)
|
126 Titers
Interval 104.0 to 154.0
|
110 Titers
Interval 89.0 to 136.0
|
162 Titers
Interval 132.0 to 198.0
|
155 Titers
Interval 124.0 to 193.0
|
93 Titers
Interval 70.0 to 123.0
|
132 Titers
Interval 97.0 to 180.0
|
18 Titers
Interval 13.0 to 25.0
|
14 Titers
Interval 10.0 to 19.0
|
—
|
|
GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age
hSBA≥ 1: 5 (5/99 strain)
|
2195 Titers
Interval 1790.0 to 2691.0
|
1811 Titers
Interval 1449.0 to 2262.0
|
2034 Titers
Interval 1648.0 to 2511.0
|
2735 Titers
Interval 2166.0 to 3455.0
|
1483 Titers
Interval 1107.0 to 1986.0
|
2087 Titers
Interval 1508.0 to 2889.0
|
41 Titers
Interval 30.0 to 56.0
|
30 Titers
Interval 22.0 to 41.0
|
—
|
|
GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age
hSBA≥ 1: 5 (NZ 98/254 strain)
|
16 Titers
Interval 12.0 to 20.0
|
18 Titers
Interval 14.0 to 23.0
|
17 Titers
Interval 14.0 to 22.0
|
20 Titers
Interval 15.0 to 26.0
|
17 Titers
Interval 12.0 to 25.0
|
34 Titers
Interval 23.0 to 49.0
|
2.76 Titers
Interval 1.87 to 4.08
|
2.1 Titers
Interval 1.44 to 3.07
|
—
|
SECONDARY outcome
Timeframe: 1 month after second vaccinationPopulation: The analysis was performed on the per-protocol population
Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
Outcome measures
| Measure |
B+R246_12
n=189 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=44 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=49 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months
hSBA≥ 1: 5 (NZ 98/254 strain)(N = 179,44,45)
|
40 Titers
Interval 35.0 to 47.0
|
23 Titers
Interval 17.0 to 30.0
|
24 Titers
Interval 18.0 to 32.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months
hSBA≥ 1: 5 (M10713 strain)(N= 0,34,37)
|
NA Titers
In this group exploratory analyses was not performed.
|
14 Titers
Interval 8.02 to 23.0
|
18 Titers
Interval 11.0 to 29.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months
hSBA≥ 1: 5 (H44/76 strain)(N= 156,42,45)
|
188 Titers
Interval 164.0 to 216.0
|
171 Titers
Interval 130.0 to 224.0
|
177 Titers
Interval 136.0 to 231.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months
hSBA≥ 1: 5 (5/99 strain)(N= 177, 40,46)
|
635 Titers
Interval 548.0 to 735.0
|
491 Titers
Interval 359.0 to 672.0
|
559 Titers
Interval 417.0 to 749.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after booster vaccinationPopulation: The analysis was performed on the per-protocol population
Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.
Outcome measures
| Measure |
B+R246_12
n=162 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=119 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=108 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
n=145 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
n=114 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
n=98 Participants
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
n=86 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
n=58 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
n=48 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.
|
5334 IU/mL
Interval 4670.0 to 6093.0
|
6395 IU/mL
Interval 5474.0 to 7470.0
|
6864 IU/mL
Interval 5826.0 to 8087.0
|
6605 IU/mL
Interval 5733.0 to 7609.0
|
6418 IU/mL
Interval 5477.0 to 7520.0
|
8120 IU/mL
Interval 6833.0 to 9649.0
|
6125 IU/mL
Interval 5110.0 to 7342.0
|
5952 IU/mL
Interval 4771.0 to 7426.0
|
6774 IU/mL
Interval 5305.0 to 8649.0
|
SECONDARY outcome
Timeframe: 1 month after booster vaccinationPopulation: The analysis was performed on the per-protocol population
Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA
Outcome measures
| Measure |
B+R246_12
n=177 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=44 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=47 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.
|
122 IU/mL
Interval 101.0 to 147.0
|
121 IU/mL
Interval 84.0 to 176.0
|
100 IU/mL
Interval 69.0 to 144.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From day 1 to day 7 after vaccinationPopulation: Analysis was done on the Safety Population.
The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.
Outcome measures
| Measure |
B+R246_12
n=170 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=153 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=126 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Antipyretic therapeutic
|
37 participants
|
39 participants
|
21 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Injection site Erythema
|
117 participants
|
94 participants
|
94 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Injection site Induration
|
93 participants
|
62 participants
|
73 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Diarrhea
|
37 participants
|
23 participants
|
27 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Unusual Crying
|
52 participants
|
51 participants
|
40 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Rash
|
7 participants
|
3 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Fever ( >= 38C )
|
52 participants
|
55 participants
|
28 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Any Ohter
|
59 participants
|
59 participants
|
40 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Antipyretic prophylactic
|
32 participants
|
28 participants
|
25 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Any
|
156 participants
|
135 participants
|
116 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Any Local
|
137 participants
|
119 participants
|
113 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Injection site Tenderness
|
104 participants
|
104 participants
|
105 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Injection site Swelling
|
57 participants
|
52 participants
|
50 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Any Systemic
|
134 participants
|
118 participants
|
101 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
ChangeEat.Habits
|
66 participants
|
59 participants
|
51 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Sleepiness
|
63 participants
|
56 participants
|
52 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Vomiting
|
8 participants
|
9 participants
|
8 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Irritbility
|
104 participants
|
91 participants
|
83 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Body Temp. <38 C
|
118 participants
|
98 participants
|
98 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Medical Attend. Fever
|
5 participants
|
5 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: day 1 to day 7 after vaccinationPopulation: The analysis was done on safety population
The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.
Outcome measures
| Measure |
B+R246_12
n=239 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=51 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=55 Participants
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Injection site Tenderness (vaccination 1)
|
151 participants
|
35 participants
|
47 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Injection site Tenderness (vaccination 2)
|
143 participants
|
32 participants
|
42 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Injection site Erythema (vaccination 1)
|
151 participants
|
32 participants
|
39 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Injection site Erythema (vaccination 2)
|
148 participants
|
33 participants
|
31 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Injection site Induration (vaccination 1)
|
112 participants
|
20 participants
|
27 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Injection site Induration (vaccination 2)
|
101 participants
|
24 participants
|
22 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Injection site Swelling (vaccination 1)
|
81 participants
|
15 participants
|
19 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Injection site Swelling (vaccination 2)
|
72 participants
|
18 participants
|
19 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Change in Eating habits (vaccination 1)
|
95 participants
|
13 participants
|
25 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Change in Eating habits (vaccination 2)
|
83 participants
|
19 participants
|
21 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Sleepiness (vaccination 1)
|
106 participants
|
21 participants
|
18 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Sleepiness (vaccination 2)
|
78 participants
|
16 participants
|
18 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Vomiting (vaccination 1)
|
19 participants
|
5 participants
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Vomiting (vaccination 2)
|
18 participants
|
1 participants
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Diarrhea (vaccination 1)
|
43 participants
|
13 participants
|
20 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Diarrhea (vaccination 2)
|
35 participants
|
5 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Irritability (vaccination 1)
|
156 participants
|
23 participants
|
28 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Irritability (vaccination 2)
|
126 participants
|
27 participants
|
23 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Unusual Crying (vaccination 1)
|
81 participants
|
13 participants
|
15 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Unusual Crying (vaccination 2)
|
67 participants
|
14 participants
|
15 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Rash (vaccination 1)
|
13 participants
|
5 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Rash (vaccination 2)
|
10 participants
|
4 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Fever ( >= 38C ) (vaccination 1)
|
83 participants
|
14 participants
|
15 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Body Temp.<38 C (vaccination 1)
|
156 participants
|
37 participants
|
39 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Body Temp.<38 C (vaccination 2)
|
163 participants
|
36 participants
|
39 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Medical Attend. Fever (vaccination 1)
|
9 participants
|
2 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Medical Attend. Fever (vaccination 2)
|
5 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Antipyretic prophylactic (vaccination 1)
|
49 participants
|
8 participants
|
8 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Antipyretic prophylactic (vaccination 2)
|
45 participants
|
9 participants
|
11 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Antipyretic therapeutic (vaccination 1)
|
66 participants
|
9 participants
|
11 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Antipyretic therapeutic (vaccination 2)
|
54 participants
|
11 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Fever ( >= 38C ) (vaccination 2)
|
74 participants
|
15 participants
|
13 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
B+R246_12
Serious events: 5 serious events
Other events: 180 other events
Deaths: 0 deaths
B+R246_18
Serious events: 3 serious events
Other events: 147 other events
Deaths: 0 deaths
B+R246_24
Serious events: 6 serious events
Other events: 140 other events
Deaths: 0 deaths
B246_12
Serious events: 6 serious events
Other events: 163 other events
Deaths: 0 deaths
B246_18
Serious events: 7 serious events
Other events: 139 other events
Deaths: 0 deaths
B246_24
Serious events: 1 serious events
Other events: 116 other events
Deaths: 0 deaths
B+R234_12
Serious events: 5 serious events
Other events: 102 other events
Deaths: 0 deaths
B+R234_18
Serious events: 5 serious events
Other events: 73 other events
Deaths: 0 deaths
B+R234_24
Serious events: 3 serious events
Other events: 62 other events
Deaths: 0 deaths
B12 14
Serious events: 16 serious events
Other events: 230 other events
Deaths: 0 deaths
B18 20
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
B24 26
Serious events: 1 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
B+R246_12
n=185 participants at risk
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=152 participants at risk
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=144 participants at risk
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
n=170 participants at risk
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
n=153 participants at risk
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
n=126 participants at risk
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
n=104 participants at risk
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
n=74 participants at risk
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
n=66 participants at risk
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B12 14
n=239 participants at risk
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
|
B18 20
n=51 participants at risk
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
|
B24 26
n=55 participants at risk
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.59%
1/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.65%
1/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.8%
1/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.69%
1/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.5%
1/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Autism
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Petit mal Epilepsy
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.96%
1/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Congenital, familial and genetic disorders
Congenital aural fistula
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.69%
1/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.65%
1/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.59%
1/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Social circumstances
Walking disability
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.69%
1/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
2/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.96%
1/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.5%
1/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.3%
3/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
General disorders
Pyrexia
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.96%
1/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Gastrointestinal disorders
Coeliac Disease
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.66%
1/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Gastrointestinal disorders
Acetonaemic vomiting
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
1/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.59%
1/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
1/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.59%
1/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.66%
1/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.59%
1/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Abscess
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.65%
1/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.79%
1/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.5%
1/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.59%
1/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Bronchopneumonia
|
0.54%
1/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Ear Infection
|
0.54%
1/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.65%
1/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.66%
1/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.3%
2/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.7%
2/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.84%
2/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.54%
1/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.66%
1/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.65%
1/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.59%
1/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Pneumonia
|
1.1%
2/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.69%
1/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.96%
1/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Respiratory syncytial virus
|
0.54%
1/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Tonsillitis
|
0.54%
1/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.5%
1/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Eczema herpeticum
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.96%
1/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Influenza
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.65%
1/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Viral infection
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.59%
1/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
1/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
Other adverse events
| Measure |
B+R246_12
n=185 participants at risk
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B+R246_18
n=152 participants at risk
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R246_24
n=144 participants at risk
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B246_12
n=170 participants at risk
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
|
B246_18
n=153 participants at risk
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
|
B246_24
n=126 participants at risk
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
|
B+R234_12
n=104 participants at risk
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
|
B+R234_18
n=74 participants at risk
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
|
B+R234_24
n=66 participants at risk
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
|
B12 14
n=239 participants at risk
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
|
B18 20
n=51 participants at risk
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
|
B24 26
n=55 participants at risk
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Infection
|
0.54%
1/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
2/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
3/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.6%
2/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.9%
2/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
1/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.5%
1/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.84%
2/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.9%
3/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.5%
3/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.6%
14/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.9%
12/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.5%
5/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.6%
13/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.2%
8/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.6%
7/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.9%
3/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.4%
4/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.0%
2/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
10.0%
24/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
11.8%
6/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
14.5%
8/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Nervous system disorders
Somnolence
|
38.9%
72/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
40.1%
61/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
50.0%
72/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
37.1%
63/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
36.6%
56/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
41.3%
52/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
48.1%
50/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
44.6%
33/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
40.9%
27/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
54.0%
129/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
49.0%
25/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
50.9%
28/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
General disorders
Crying
|
30.3%
56/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
28.3%
43/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
31.9%
46/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
30.6%
52/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
33.3%
51/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
31.7%
40/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
39.4%
41/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
24.3%
18/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
33.3%
22/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
43.9%
105/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
33.3%
17/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
45.5%
25/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
General disorders
Induration
|
1.1%
2/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
2/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.8%
3/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
3/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.2%
4/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.9%
2/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.84%
2/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
1/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.3%
4/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
General disorders
Injection site erythema
|
68.6%
127/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
65.8%
100/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
75.7%
109/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
68.8%
117/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
61.4%
94/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
74.6%
94/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
73.1%
76/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
70.3%
52/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
74.2%
49/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
74.9%
179/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
74.5%
38/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
74.5%
41/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
General disorders
Injection site induration
|
54.6%
101/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
48.7%
74/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
52.8%
76/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
54.7%
93/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
40.5%
62/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
57.9%
73/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
50.0%
52/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
55.4%
41/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
53.0%
35/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
61.9%
148/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
52.9%
27/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
60.0%
33/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
General disorders
Injection site pain
|
57.8%
107/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
75.0%
114/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
81.9%
118/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
61.2%
104/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
68.0%
104/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
83.3%
105/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
67.3%
70/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
75.7%
56/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
77.3%
51/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
78.2%
187/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
80.4%
41/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
92.7%
51/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
General disorders
Injection site swelling
|
39.5%
73/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
34.9%
53/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
43.8%
63/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
33.5%
57/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
34.0%
52/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
39.7%
50/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
30.8%
32/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
48.6%
36/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
37.9%
25/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
44.8%
107/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
41.2%
21/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
43.6%
24/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
General disorders
Pyrexia
|
42.2%
78/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
37.5%
57/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
34.7%
50/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
35.3%
60/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
38.6%
59/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
25.4%
32/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
51.0%
53/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
37.8%
28/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
40.9%
27/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
55.6%
133/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
47.1%
24/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
40.0%
22/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
General disorders
Swelling
|
0.54%
1/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.66%
1/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
2/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.59%
1/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.3%
2/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.6%
2/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
1/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.5%
3/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Psychiatric disorders
Eating disorder
|
34.6%
64/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
46.1%
70/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
47.2%
68/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
38.8%
66/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
38.6%
59/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
40.5%
51/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
39.4%
41/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
39.2%
29/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
42.4%
28/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
52.7%
126/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
41.2%
21/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
61.8%
34/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Psychiatric disorders
Irritability
|
59.5%
110/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
65.8%
100/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
63.9%
92/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
61.2%
104/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
59.5%
91/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
65.9%
83/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
69.2%
72/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
71.6%
53/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
66.7%
44/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
74.1%
177/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
62.7%
32/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
63.6%
35/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
2/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.3%
2/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.69%
1/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.2%
2/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.65%
1/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.79%
1/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.96%
1/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.84%
2/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.9%
3/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.6%
2/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.1%
39/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
17.1%
26/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
22.2%
32/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
23.5%
40/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
17.6%
27/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
21.4%
27/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
20.2%
21/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
24.3%
18/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
19.7%
13/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
30.1%
72/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
31.4%
16/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
38.2%
21/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Gastrointestinal disorders
Enteritis
|
2.7%
5/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.69%
1/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.2%
2/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
3/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.4%
3/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.9%
2/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
1/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.0%
2/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.7%
4/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.9%
3/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.8%
1/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Gastrointestinal disorders
Teething
|
4.3%
8/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
3/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.69%
1/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.2%
2/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.9%
3/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.7%
2/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
6.3%
15/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
1/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
15/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
10.5%
16/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.6%
11/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.6%
13/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.8%
12/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.9%
10/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
14.4%
15/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
10.8%
8/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.0%
2/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
17.2%
41/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
13.7%
7/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
14.5%
8/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
4.9%
9/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.3%
2/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
2/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.5%
6/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.3%
5/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.9%
2/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.4%
4/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.4%
13/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
1/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.6%
2/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.3%
2/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.69%
1/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.59%
1/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.3%
2/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.6%
2/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.96%
1/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.5%
1/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.3%
3/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
1/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.5%
3/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
9/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.9%
9/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
13.9%
20/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.7%
8/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.3%
5/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.1%
9/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
9.6%
10/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
9.5%
7/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.6%
5/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
10.9%
26/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
15.7%
8/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.3%
4/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Bronchitis
|
3.8%
7/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.2%
11/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.5%
5/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
11.2%
19/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.6%
7/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.0%
5/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
8.7%
9/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
8.1%
6/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
6.1%
4/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.9%
19/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.9%
3/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
16.4%
9/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.79%
1/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.96%
1/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
1/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.84%
2/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.9%
3/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.8%
1/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Conjunctivitis
|
5.9%
11/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.2%
11/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.1%
3/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.9%
10/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
6.5%
10/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.6%
7/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.8%
5/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
1/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.5%
3/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
6.3%
15/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.8%
4/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.3%
4/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Ear infection
|
6.5%
12/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.3%
8/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.2%
6/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.6%
13/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.3%
5/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.8%
6/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
13.5%
14/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
6.8%
5/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.5%
3/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
12.1%
29/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
11.8%
6/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.3%
4/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Fungal infection
|
1.1%
2/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.59%
1/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.96%
1/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
1/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.5%
3/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
9.2%
17/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.9%
6/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.8%
4/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.3%
9/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.3%
5/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.6%
7/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.8%
4/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.7%
2/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.2%
10/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.8%
4/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.6%
2/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Influenza
|
1.6%
3/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.6%
4/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.69%
1/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.8%
3/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.3%
2/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.79%
1/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.7%
2/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
1/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
9.1%
5/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Lice infestation
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.59%
1/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.3%
4/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
10.8%
20/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.9%
6/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
8.3%
12/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.6%
13/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.8%
12/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.2%
4/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
6.7%
7/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
6.8%
5/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.0%
2/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
8.8%
21/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
15.7%
8/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
12.7%
7/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Otitis media
|
1.6%
3/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.9%
6/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
2/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.5%
6/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.6%
4/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.6%
2/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.9%
3/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.7%
2/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
6.1%
4/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.6%
11/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.9%
2/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.3%
4/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Pharyngitis
|
3.8%
7/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.3%
8/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.1%
3/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.9%
5/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
9.2%
14/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.8%
6/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.8%
5/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.1%
3/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.5%
3/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
6.7%
16/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.9%
3/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.8%
1/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Respiratory tract infection
|
4.9%
9/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
3/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
2/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.5%
6/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.0%
3/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.4%
3/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.8%
5/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.7%
2/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.0%
2/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.3%
8/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
9.8%
5/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
10.9%
6/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Rhinitis
|
5.4%
10/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.3%
5/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.8%
4/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.1%
12/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.6%
4/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.6%
7/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.8%
4/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.1%
3/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.5%
1/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.1%
17/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.9%
2/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
9.1%
5/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.66%
1/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
2/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.3%
2/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.79%
1/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.42%
1/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.9%
3/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Tonsillitis
|
3.2%
6/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.9%
9/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.9%
7/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.3%
9/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.9%
6/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.4%
3/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.8%
5/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.1%
3/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.5%
3/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.9%
14/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.9%
2/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.5%
3/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
10/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.3%
8/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.5%
6/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
9.8%
15/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.0%
5/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
9.6%
10/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
2.7%
2/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.5%
18/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.9%
2/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
9.1%
5/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Varicella
|
2.2%
4/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.66%
1/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.4%
2/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.2%
2/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.3%
2/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.6%
7/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.9%
2/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
0.00%
0/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
7.6%
5/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.8%
9/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
9.8%
5/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
1.8%
1/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
|
Infections and infestations
Viral infection
|
6.5%
12/185 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
3.9%
6/152 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.2%
6/144 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.1%
7/170 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
6.5%
10/153 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.0%
5/126 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
4.8%
5/104 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
6.8%
5/74 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
9.1%
6/66 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
8.8%
21/239 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
15.7%
8/51 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
5.5%
3/55 • From day 1 to day 7 after vaccination
Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER