Trial Outcomes & Findings for Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1 (NCT NCT01717638)
NCT ID: NCT01717638
Last Updated: 2015-01-13
Results Overview
The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8. The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
805 participants
Primary outcome timeframe
Day 1 (24-36 months post booster; baseline for naive)
Results posted on
2015-01-13
Participant Flow
Subjects were enrolled from 4 centers from the UK, 4 centers from Italy, 4 centers from Spain, 19 centers from Czech Republic.
All subjects were included in the trial.
Participant milestones
| Measure |
B+R246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B12 14_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 \&14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 \& 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 \& 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48_50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
67
|
61
|
60
|
66
|
64
|
55
|
43
|
29
|
28
|
100
|
11
|
12
|
209
|
|
Overall Study
COMPLETED
|
67
|
60
|
59
|
66
|
63
|
54
|
41
|
28
|
26
|
99
|
11
|
12
|
190
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
1
|
1
|
2
|
1
|
2
|
1
|
0
|
0
|
19
|
Reasons for withdrawal
| Measure |
B+R246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B12 14_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 \&14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 \& 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 \& 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48_50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Father in hospital
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
1
|
0
|
2
|
1
|
2
|
1
|
0
|
0
|
18
|
Baseline Characteristics
Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1
Baseline characteristics by cohort
| Measure |
B+R246_12_48
n=67 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=61 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=60 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=66 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
n=64 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
n=55 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
n=43 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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
n=29 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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
n=28 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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B12 14_48
n=100 Participants
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 \&14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B18 20_48
n=11 Participants
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 \& 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B24 26_48
n=12 Participants
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 \& 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
n=209 Participants
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
Total
n=805 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.8 Months
STANDARD_DEVIATION 3.4 • n=93 Participants
|
52.1 Months
STANDARD_DEVIATION 3.4 • n=4 Participants
|
51.7 Months
STANDARD_DEVIATION 3.5 • n=27 Participants
|
51.7 Months
STANDARD_DEVIATION 3.5 • n=483 Participants
|
51.3 Months
STANDARD_DEVIATION 3.7 • n=36 Participants
|
52.3 Months
STANDARD_DEVIATION 3.7 • n=10 Participants
|
51.8 Months
STANDARD_DEVIATION 3.4 • n=115 Participants
|
51.4 Months
STANDARD_DEVIATION 3.4 • n=40 Participants
|
53.1 Months
STANDARD_DEVIATION 3.5 • n=8 Participants
|
51.7 Months
STANDARD_DEVIATION 3.3 • n=62 Participants
|
53.4 Months
STANDARD_DEVIATION 4.3 • n=95 Participants
|
56.8 Months
STANDARD_DEVIATION 1.5 • n=129 Participants
|
53.7 Months
STANDARD_DEVIATION 3.6 • n=36 Participants
|
52.4 Months
STANDARD_DEVIATION 3.6 • n=36 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
32 Participants
n=36 Participants
|
30 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
17 Participants
n=40 Participants
|
13 Participants
n=8 Participants
|
50 Participants
n=62 Participants
|
6 Participants
n=95 Participants
|
4 Participants
n=129 Participants
|
99 Participants
n=36 Participants
|
387 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
32 Participants
n=36 Participants
|
25 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
12 Participants
n=40 Participants
|
15 Participants
n=8 Participants
|
50 Participants
n=62 Participants
|
5 Participants
n=95 Participants
|
8 Participants
n=129 Participants
|
110 Participants
n=36 Participants
|
418 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 1 (24-36 months post booster; baseline for naive)Population: Full Analysis Set (Fas), Persistency: All subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1). Persistence data sets include nonvaccination and vaccination subsets of subjects from different groups with different primary vaccination schedules of MenB+Routine vaccines and routine vaccines.
The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8. The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).
Outcome measures
| Measure |
B+R246_12_48
n=67 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=60 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=60 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=66 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
n=63 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
n=54 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
n=42 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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
n=28 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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
n=28 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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
n=206 Participants
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206
|
12 Percentages of subjects
Interval 5.0 to 22.0
|
18 Percentages of subjects
Interval 10.0 to 30.0
|
24 Percentages of subjects
Interval 14.0 to 37.0
|
20 Percentages of subjects
Interval 11.0 to 32.0
|
27 Percentages of subjects
Interval 17.0 to 40.0
|
35 Percentages of subjects
Interval 23.0 to 49.0
|
12 Percentages of subjects
Interval 4.0 to 26.0
|
25 Percentages of subjects
Interval 11.0 to 45.0
|
21 Percentages of subjects
Interval 8.0 to 41.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
NZ 98/254 - ≥ 1:5
|
9 Percentages of subjects
Interval 3.0 to 18.0
|
8 Percentages of subjects
Interval 3.0 to 18.0
|
12 Percentages of subjects
Interval 5.0 to 23.0
|
9 Percentages of subjects
Interval 3.0 to 19.0
|
11 Percentages of subjects
Interval 5.0 to 22.0
|
9 Percentages of subjects
Interval 3.0 to 20.0
|
10 Percentages of subjects
Interval 3.0 to 23.0
|
11 Percentages of subjects
Interval 2.0 to 28.0
|
11 Percentages of subjects
Interval 2.0 to 28.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192
|
54 Percentages of subjects
Interval 41.0 to 66.0
|
68 Percentages of subjects
Interval 54.0 to 79.0
|
74 Percentages of subjects
Interval 61.0 to 85.0
|
55 Percentages of subjects
Interval 42.0 to 68.0
|
53 Percentages of subjects
Interval 40.0 to 66.0
|
80 Percentages of subjects
Interval 66.0 to 89.0
|
68 Percentages of subjects
Interval 51.0 to 81.0
|
75 Percentages of subjects
Interval 55.0 to 89.0
|
75 Percentages of subjects
Interval 55.0 to 89.0
|
60 Percentages of subjects
Interval 53.0 to 67.0
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200
|
91 Percentages of subjects
Interval 82.0 to 97.0
|
97 Percentages of subjects
Interval 88.0 to 100.0
|
93 Percentages of subjects
Interval 83.0 to 98.0
|
94 Percentages of subjects
Interval 85.0 to 98.0
|
94 Percentages of subjects
Interval 84.0 to 98.0
|
100 Percentages of subjects
Interval 93.0 to 100.0
|
90 Percentages of subjects
Interval 77.0 to 97.0
|
86 Percentages of subjects
Interval 67.0 to 96.0
|
96 Percentages of subjects
Interval 82.0 to 100.0
|
3 Percentages of subjects
Interval 1.0 to 6.0
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
NZ 98/254 - ≥ 1:8
|
4 Percentages of subjects
Interval 1.0 to 13.0
|
5 Percentages of subjects
Interval 1.0 to 14.0
|
8 Percentages of subjects
Interval 3.0 to 18.0
|
8 Percentages of subjects
Interval 3.0 to 17.0
|
3 Percentages of subjects
Interval 0.0 to 11.0
|
4 Percentages of subjects
Interval 0.0 to 13.0
|
2 Percentages of subjects
Interval 0.06 to 13.0
|
7 Percentages of subjects
Interval 1.0 to 24.0
|
11 Percentages of subjects
Interval 2.0 to 28.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192
|
49 Percentages of subjects
Interval 37.0 to 62.0
|
53 Percentages of subjects
Interval 39.0 to 66.0
|
60 Percentages of subjects
Interval 47.0 to 73.0
|
48 Percentages of subjects
Interval 35.0 to 61.0
|
45 Percentages of subjects
Interval 32.0 to 58.0
|
65 Percentages of subjects
Interval 51.0 to 77.0
|
60 Percentages of subjects
Interval 43.0 to 75.0
|
61 Percentages of subjects
Interval 41.0 to 78.0
|
61 Percentages of subjects
Interval 41.0 to 78.0
|
56 Percentages of subjects
Interval 48.0 to 63.0
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200
|
93 Percentages of subjects
Interval 83.0 to 98.0
|
98 Percentages of subjects
Interval 91.0 to 100.0
|
97 Percentages of subjects
Interval 88.0 to 100.0
|
97 Percentages of subjects
Interval 89.0 to 100.0
|
100 Percentages of subjects
Interval 94.0 to 100.0
|
100 Percentages of subjects
Interval 93.0 to 100.0
|
90 Percentages of subjects
Interval 77.0 to 97.0
|
89 Percentages of subjects
Interval 72.0 to 98.0
|
96 Percentages of subjects
Interval 82.0 to 100.0
|
5 Percentages of subjects
Interval 2.0 to 8.0
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206
|
7 Percentages of subjects
Interval 2.0 to 17.0
|
10 Percentages of subjects
Interval 4.0 to 21.0
|
17 Percentages of subjects
Interval 8.0 to 29.0
|
11 Percentages of subjects
Interval 4.0 to 21.0
|
24 Percentages of subjects
Interval 14.0 to 36.0
|
28 Percentages of subjects
Interval 16.0 to 42.0
|
7 Percentages of subjects
Interval 1.0 to 19.0
|
21 Percentages of subjects
Interval 8.0 to 41.0
|
21 Percentages of subjects
Interval 8.0 to 41.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: Day 1 (24-36 months post booster; baseline for naive)Population: FAS, Persistency.
The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).
Outcome measures
| Measure |
B+R246_12_48
n=67 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=60 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=60 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=66 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
n=63 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
n=54 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
n=42 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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
n=28 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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
n=28 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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
n=206 Participants
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
H44/76; N=67,60,59,65,63,54,42,28,28,206
|
1.75 Titers
Interval 1.36 to 2.25
|
1.68 Titers
Interval 1.29 to 2.19
|
2.41 Titers
Interval 1.83 to 3.19
|
1.72 Titers
Interval 1.29 to 2.29
|
1.99 Titers
Interval 1.49 to 2.65
|
2.69 Titers
Interval 1.96 to 3.7
|
1.51 Titers
Interval 1.04 to 2.18
|
2.2 Titers
Interval 1.38 to 3.49
|
2.2 Titers
Interval 1.37 to 3.53
|
1.04 Titers
Interval 1.01 to 1.07
|
|
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
5/99; N=67,60,58,64,62,54,42,28,28,200
|
36 Titers
Interval 27.0 to 48.0
|
69 Titers
Interval 50.0 to 94.0
|
69 Titers
Interval 50.0 to 96.0
|
59 Titers
Interval 45.0 to 78.0
|
57 Titers
Interval 43.0 to 75.0
|
111 Titers
Interval 82.0 to 151.0
|
52 Titers
Interval 34.0 to 81.0
|
62 Titers
Interval 36.0 to 108.0
|
101 Titers
Interval 57.0 to 177.0
|
1.15 Titers
Interval 1.05 to 1.27
|
|
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
M10713; N=65,59,58,62,60,54,40,28,28,192
|
6.14 Titers
Interval 4.19 to 8.99
|
7.36 Titers
Interval 4.94 to 11.0
|
9.08 Titers
Interval 5.97 to 14.0
|
7.86 Titers
Interval 5.17 to 12.0
|
7.77 Titers
Interval 5.07 to 12.0
|
15 Titers
Interval 9.49 to 24.0
|
9.61 Titers
Interval 5.81 to 16.0
|
11 Titers
Interval 5.92 to 20.0
|
11 Titers
Interval 5.9 to 21.0
|
8.75 Titers
Interval 6.74 to 11.0
|
|
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
NZ 98/254
|
1.25 Titers
Interval 1.03 to 1.52
|
1.29 Titers
Interval 1.05 to 1.59
|
1.38 Titers
Interval 1.11 to 1.72
|
1.48 Titers
Interval 1.2 to 1.83
|
1.34 Titers
Interval 1.08 to 1.66
|
1.52 Titers
Interval 1.2 to 1.92
|
1.32 Titers
Interval 1.05 to 1.65
|
1.25 Titers
Interval 0.94 to 1.66
|
1.62 Titers
Interval 1.21 to 2.16
|
1.01 Titers
Interval 0.99 to 1.03
|
PRIMARY outcome
Timeframe: Day 1 (24-36 months post booster dose; baseline for naive)Population: FAS, Persistency.
The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.
Outcome measures
| Measure |
B+R246_12_48
n=63 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=57 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=54 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=59 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
n=56 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
n=47 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
n=39 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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
n=28 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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
n=25 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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
H44/76; N=62,56,52,57,55,46,38,27,25,206
|
0.012 Ratio
Interval 0.0091 to 0.017
|
0.013 Ratio
Interval 0.0096 to 0.018
|
0.023 Ratio
Interval 0.016 to 0.033
|
0.0092 Ratio
Interval 0.0066 to 0.013
|
0.013 Ratio
Interval 0.0097 to 0.018
|
0.023 Ratio
Interval 0.016 to 0.033
|
0.0091 Ratio
Interval 0.0064 to 0.013
|
0.023 Ratio
Interval 0.015 to 0.036
|
0.023 Ratio
Interval 0.014 to 0.036
|
—
|
|
Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
5/99; N=61,57,50,57,55,44,37,27,25,200
|
0.029 Ratio
Interval 0.023 to 0.037
|
0.032 Ratio
Interval 0.026 to 0.041
|
0.043 Ratio
Interval 0.033 to 0.056
|
0.031 Ratio
Interval 0.024 to 0.041
|
0.034 Ratio
Interval 0.026 to 0.045
|
0.054 Ratio
Interval 0.04 to 0.074
|
0.035 Ratio
Interval 0.026 to 0.048
|
0.037 Ratio
Interval 0.025 to 0.054
|
0.055 Ratio
Interval 0.037 to 0.081
|
—
|
|
Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
NZ 98/254
|
0.028 Ratio
Interval 0.021 to 0.039
|
0.094 Ratio
Interval 0.067 to 0.13
|
0.071 Ratio
Interval 0.05 to 0.1
|
0.043 Ratio
Interval 0.031 to 0.06
|
0.081 Ratio
Interval 0.058 to 0.11
|
0.11 Ratio
Interval 0.075 to 0.16
|
0.03 Ratio
Interval 0.02 to 0.044
|
0.082 Ratio
Interval 0.05 to 0.14
|
0.066 Ratio
Interval 0.038 to 0.11
|
—
|
|
Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
M10713; N=26,24,25
|
NA Ratio
GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.
|
NA Ratio
GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.
|
NA Ratio
GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.
|
NA Ratio
GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.
|
NA Ratio
GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.
|
NA Ratio
GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.
|
0.67 Ratio
Interval 0.32 to 1.4
|
0.91 Ratio
Interval 0.4 to 2.05
|
0.47 Ratio
Interval 0.21 to 1.07
|
—
|
SECONDARY outcome
Timeframe: Day 1 (22-34 months post last MenB vaccine)Population: FAS, Persistency. Note: Reporting groups in this endpoint and in endpoints 5 and 6 received vaccination according to different schedules with respect to the groups reported in endpoints 1, 2 and 3.
The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.
Outcome measures
| Measure |
B+R246_12_48
n=96 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=11 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=11 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=206 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
hSBA≥ 1:8 (M10713 strain; N=96,10,10,192)
|
49 Percentages of subjects
Interval 39.0 to 59.0
|
40 Percentages of subjects
Interval 12.0 to 74.0
|
60 Percentages of subjects
Interval 26.0 to 88.0
|
56 Percentages of subjects
Interval 48.0 to 63.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
hSBA≥ 1:5 (H44/76 strain)
|
11 Percentages of subjects
Interval 6.0 to 20.0
|
9 Percentages of subjects
Interval 0.0 to 41.0
|
9 Percentages of subjects
Interval 0.0 to 41.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
hSBA≥ 1:5 (5/99 strain; N=96,11,11,200)
|
84 Percentages of subjects
Interval 76.0 to 91.0
|
100 Percentages of subjects
Interval 72.0 to 100.0
|
100 Percentages of subjects
Interval 72.0 to 100.0
|
5 Percentages of subjects
Interval 2.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
hSBA≥ 1:5 (NZ 98/254 strain)
|
3 Percentages of subjects
Interval 1.0 to 9.0
|
18 Percentages of subjects
Interval 2.0 to 52.0
|
0 Percentages of subjects
Interval 0.0 to 28.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
hSBA≥ 1:5 (M10713 strain; N=96,10,10,192)
|
59 Percentages of subjects
Interval 49.0 to 69.0
|
60 Percentages of subjects
Interval 26.0 to 88.0
|
60 Percentages of subjects
Interval 26.0 to 88.0
|
60 Percentages of subjects
Interval 53.0 to 67.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
hSBA≥ 1:8 (H44/76 strain)
|
8 Percentages of subjects
Interval 4.0 to 16.0
|
9 Percentages of subjects
Interval 0.0 to 41.0
|
0 Percentages of subjects
Interval 0.0 to 28.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
hSBA≥ 1:8 (5/99 strain; N=96,11,11,200)
|
81 Percentages of subjects
Interval 72.0 to 88.0
|
100 Percentages of subjects
Interval 72.0 to 100.0
|
100 Percentages of subjects
Interval 72.0 to 100.0
|
3 Percentages of subjects
Interval 1.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
hSBA≥ 1:8 (NZ 98/254 strain)
|
2 Percentages of subjects
Interval 0.0 to 7.0
|
18 Percentages of subjects
Interval 2.0 to 52.0
|
0 Percentages of subjects
Interval 0.0 to 28.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (22-36 months post last MenB vaccine; baseline for naive)Population: FAS, Persistency.
The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.
Outcome measures
| Measure |
B+R246_12_48
n=96 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=11 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=11 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=206 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
H44/76 strain
|
1.61 Titers
Interval 1.3 to 2.0
|
2.03 Titers
Interval 1.11 to 3.72
|
1.69 Titers
Interval 0.91 to 3.12
|
1.04 Titers
Interval 1.01 to 1.07
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
5/99 strain; N=96, 11, 11, 200
|
23 Titers
Interval 17.0 to 32.0
|
47 Titers
Interval 20.0 to 112.0
|
69 Titers
Interval 29.0 to 165.0
|
1.15 Titers
Interval 1.05 to 1.27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
NZ 98/254 strain
|
1.15 Titers
Interval 0.96 to 1.37
|
2.68 Titers
Interval 1.65 to 4.36
|
1.06 Titers
Interval 0.65 to 1.75
|
1.01 Titers
Interval 0.99 to 1.03
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
M10713 strain; N=96, 10, 10, 192
|
7.83 Titers
Interval 5.54 to 11.0
|
9.67 Titers
Interval 3.54 to 26.0
|
8.4 Titers
Interval 3.03 to 23.0
|
8.75 Titers
Interval 6.74 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (22-34 months post last MenB vaccine)Population: FAS, Persistency.
The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.
Outcome measures
| Measure |
B+R246_12_48
n=88 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=9 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=10 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
5/99 strain
|
0.45 Ratio
Interval 0.34 to 0.59
|
1.9 Ratio
Interval 0.84 to 4.29
|
1.36 Ratio
Interval 0.62 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
NZ 98/254 strain; N=88, 9, 8
|
0.28 Ratio
Interval 0.21 to 0.37
|
0.73 Ratio
Interval 0.32 to 1.68
|
0.42 Ratio
Interval 0.17 to 1.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
H44/76 strain
|
0.092 Ratio
Interval 0.069 to 0.12
|
0.18 Ratio
Interval 0.078 to 0.43
|
0.2 Ratio
Interval 0.086 to 0.45
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
M10713 strain; N=7, 7, 8
|
11 Ratio
Interval 3.34 to 38.0
|
6.05 Ratio
Interval 1.45 to 25.0
|
6.88 Ratio
Interval 1.68 to 28.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 31 (1 month post vaccination)Population: Analysis was done on FAS, Immunogenicity, ie, all subjects in the enrolled population who actually received a study vaccination, and provided at least one evaluable serum sample at post baseline.
The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.
Outcome measures
| Measure |
B+R246_12_48
n=26 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=18 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=16 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=16 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
n=26 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
n=15 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
n=40 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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
n=26 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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
n=26 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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
n=175 Participants
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
100 Percentages of subjects
Interval 81.0 to 100.0
|
100 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
100 Percentages of subjects
Interval 78.0 to 100.0
|
97 Percentages of subjects
Interval 87.0 to 100.0
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
71 Percentages of subjects
Interval 64.0 to 78.0
|
|
Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
100 Percentages of subjects
Interval 81.0 to 100.0
|
100 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
100 Percentages of subjects
Interval 78.0 to 100.0
|
100 Percentages of subjects
Interval 91.0 to 100.0
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
90 Percentages of subjects
Interval 85.0 to 94.0
|
|
Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,167
|
84 Percentages of subjects
Interval 64.0 to 95.0
|
89 Percentages of subjects
Interval 65.0 to 99.0
|
88 Percentages of subjects
Interval 62.0 to 98.0
|
93 Percentages of subjects
Interval 66.0 to 100.0
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
93 Percentages of subjects
Interval 68.0 to 100.0
|
97 Percentages of subjects
Interval 85.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
77 Percentages of subjects
Interval 70.0 to 83.0
|
|
Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,173
|
92 Percentages of subjects
Interval 75.0 to 99.0
|
83 Percentages of subjects
Interval 59.0 to 96.0
|
94 Percentages of subjects
Interval 70.0 to 100.0
|
81 Percentages of subjects
Interval 54.0 to 96.0
|
88 Percentages of subjects
Interval 70.0 to 98.0
|
80 Percentages of subjects
Interval 52.0 to 96.0
|
95 Percentages of subjects
Interval 83.0 to 99.0
|
92 Percentages of subjects
Interval 75.0 to 99.0
|
92 Percentages of subjects
Interval 75.0 to 99.0
|
24 Percentages of subjects
Interval 18.0 to 31.0
|
|
Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,175
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
100 Percentages of subjects
Interval 81.0 to 100.0
|
100 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 79.0 to 100.0
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
100 Percentages of subjects
Interval 78.0 to 100.0
|
97 Percentages of subjects
Interval 87.0 to 100.0
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
63 Percentages of subjects
Interval 55.0 to 70.0
|
|
Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
100 Percentages of subjects
Interval 81.0 to 100.0
|
100 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
100 Percentages of subjects
Interval 78.0 to 100.0
|
100 Percentages of subjects
Interval 91.0 to 100.0
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
100 Percentages of subjects
Interval 87.0 to 100.0
|
87 Percentages of subjects
Interval 81.0 to 92.0
|
|
Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,173
|
85 Percentages of subjects
Interval 65.0 to 96.0
|
61 Percentages of subjects
Interval 36.0 to 83.0
|
81 Percentages of subjects
Interval 54.0 to 96.0
|
75 Percentages of subjects
Interval 48.0 to 93.0
|
88 Percentages of subjects
Interval 70.0 to 98.0
|
80 Percentages of subjects
Interval 52.0 to 96.0
|
88 Percentages of subjects
Interval 73.0 to 96.0
|
81 Percentages of subjects
Interval 61.0 to 93.0
|
88 Percentages of subjects
Interval 70.0 to 98.0
|
17 Percentages of subjects
Interval 12.0 to 24.0
|
|
Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,167
|
76 Percentages of subjects
Interval 55.0 to 91.0
|
89 Percentages of subjects
Interval 65.0 to 99.0
|
88 Percentages of subjects
Interval 62.0 to 98.0
|
93 Percentages of subjects
Interval 66.0 to 100.0
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
93 Percentages of subjects
Interval 68.0 to 100.0
|
97 Percentages of subjects
Interval 85.0 to 100.0
|
100 Percentages of subjects
Interval 86.0 to 100.0
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
74 Percentages of subjects
Interval 67.0 to 81.0
|
SECONDARY outcome
Timeframe: Day 31 (1 month post vaccination)Population: Analysis was done on FAS (Immunogenicity).
The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.
Outcome measures
| Measure |
B+R246_12_48
n=26 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=18 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=16 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=16 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
n=26 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
n=15 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
n=40 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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
n=26 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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
n=26 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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
n=175 Participants
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
M10713 strain; N=25,18,16,14,25,15,36,25,25,167
|
22 Titers
Interval 13.0 to 37.0
|
19 Titers
Interval 10.0 to 36.0
|
28 Titers
Interval 14.0 to 54.0
|
32 Titers
Interval 16.0 to 65.0
|
37 Titers
Interval 22.0 to 63.0
|
33 Titers
Interval 17.0 to 64.0
|
53 Titers
Interval 40.0 to 71.0
|
58 Titers
Interval 40.0 to 84.0
|
51 Titers
Interval 35.0 to 73.0
|
20 Titers
Interval 15.0 to 25.0
|
|
GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
5/99 strain; N=26,18,16,16,26,15,38,26,26,171
|
754 Titers
Interval 478.0 to 1190.0
|
1719 Titers
Interval 993.0 to 2976.0
|
933 Titers
Interval 518.0 to 1682.0
|
1959 Titers
Interval 1091.0 to 3517.0
|
1387 Titers
Interval 878.0 to 2191.0
|
1954 Titers
Interval 1068.0 to 3575.0
|
1711 Titers
Interval 1186.0 to 2470.0
|
1239 Titers
Interval 787.0 to 1953.0
|
1280 Titers
Interval 803.0 to 2041.0
|
34 Titers
Interval 27.0 to 42.0
|
|
GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
H44/76 strain; N=26,18,16,16,26,15,39,26,26,175
|
108 Titers
Interval 70.0 to 168.0
|
115 Titers
Interval 68.0 to 195.0
|
107 Titers
Interval 61.0 to 188.0
|
173 Titers
Interval 98.0 to 303.0
|
191 Titers
Interval 123.0 to 297.0
|
212 Titers
Interval 119.0 to 379.0
|
167 Titers
Interval 109.0 to 258.0
|
146 Titers
Interval 85.0 to 251.0
|
135 Titers
Interval 78.0 to 235.0
|
11 Titers
Interval 8.51 to 14.0
|
|
GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,173
|
22 Titers
Interval 13.0 to 36.0
|
11 Titers
Interval 5.66 to 20.0
|
28 Titers
Interval 14.0 to 55.0
|
16 Titers
Interval 8.2 to 31.0
|
21 Titers
Interval 13.0 to 36.0
|
15 Titers
Interval 7.66 to 31.0
|
26 Titers
Interval 18.0 to 36.0
|
18 Titers
Interval 12.0 to 28.0
|
27 Titers
Interval 18.0 to 42.0
|
2.25 Titers
Interval 1.84 to 2.75
|
SECONDARY outcome
Timeframe: Day 31 (1 month post vaccination)Population: Analysis was done on FAS (Immunogenicity).
The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.
Outcome measures
| Measure |
B+R246_12_48
n=26 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=18 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=16 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=16 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
n=26 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
n=15 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
n=40 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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
n=25 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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
n=26 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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
n=175 Participants
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
5/99 strain; N=26,18,16,15,25,15,38,25,26,168
|
32 Ratio
Interval 22.0 to 47.0
|
23 Ratio
Interval 15.0 to 36.0
|
15 Ratio
Interval 9.45 to 25.0
|
30 Ratio
Interval 18.0 to 49.0
|
20 Ratio
Interval 13.0 to 29.0
|
18 Ratio
Interval 11.0 to 29.0
|
33 Ratio
Interval 23.0 to 49.0
|
20 Ratio
Interval 12.0 to 32.0
|
12 Ratio
Interval 7.16 to 19.0
|
29 Ratio
Interval 23.0 to 37.0
|
|
Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173
|
17 Ratio
Interval 10.0 to 29.0
|
10 Ratio
Interval 5.43 to 19.0
|
19 Ratio
Interval 9.54 to 37.0
|
8.93 Ratio
Interval 4.57 to 17.0
|
17 Ratio
Interval 10.0 to 29.0
|
13 Ratio
Interval 6.48 to 26.0
|
19 Ratio
Interval 14.0 to 27.0
|
14 Ratio
Interval 9.35 to 22.0
|
17 Ratio
Interval 11.0 to 26.0
|
2.25 Ratio
Interval 1.84 to 2.75
|
|
Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
M10713 strain; N=24,17,16,12,23,15,35,24,25,158
|
3.15 Ratio
Interval 1.81 to 5.48
|
4.46 Ratio
Interval 2.31 to 8.6
|
3.36 Ratio
Interval 1.69 to 6.7
|
3.49 Ratio
Interval 1.58 to 7.7
|
3.74 Ratio
Interval 2.12 to 6.59
|
4.21 Ratio
Interval 2.08 to 8.51
|
5.35 Ratio
Interval 3.48 to 8.21
|
3.86 Ratio
Interval 2.23 to 6.66
|
4.04 Ratio
Interval 2.35 to 6.94
|
2 Ratio
Interval 1.62 to 2.46
|
|
Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
H44/76 strain; N=26,18,16,16,26,15,39,25,26,175
|
60 Ratio
Interval 40.0 to 92.0
|
72 Ratio
Interval 44.0 to 120.0
|
41 Ratio
Interval 24.0 to 71.0
|
77 Ratio
Interval 45.0 to 132.0
|
88 Ratio
Interval 58.0 to 134.0
|
46 Ratio
Interval 26.0 to 80.0
|
109 Ratio
Interval 71.0 to 167.0
|
63 Ratio
Interval 37.0 to 108.0
|
64 Ratio
Interval 37.0 to 110.0
|
10 Ratio
Interval 8.2 to 13.0
|
SECONDARY outcome
Timeframe: Day 31 (1 month post vaccination)Population: Analysis was done on FAS, Immunogenicity.
The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.
Outcome measures
| Measure |
B+R246_12_48
n=26 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=18 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=16 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=16 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
n=26 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
n=15 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
n=40 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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
n=25 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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
n=26 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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
n=175 Participants
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
5/99 strain; N=26,18,16,15,25,15,38,25,26,168
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
94 Percentages of subjects
Interval 73.0 to 100.0
|
94 Percentages of subjects
Interval 70.0 to 100.0
|
100 Percentages of subjects
Interval 78.0 to 100.0
|
92 Percentages of subjects
Interval 74.0 to 99.0
|
100 Percentages of subjects
Interval 78.0 to 100.0
|
97 Percentages of subjects
Interval 86.0 to 100.0
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
85 Percentages of subjects
Interval 65.0 to 96.0
|
86 Percentages of subjects
Interval 80.0 to 91.0
|
|
Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173
|
81 Percentages of subjects
Interval 61.0 to 93.0
|
61 Percentages of subjects
Interval 36.0 to 83.0
|
81 Percentages of subjects
Interval 54.0 to 96.0
|
69 Percentages of subjects
Interval 41.0 to 89.0
|
88 Percentages of subjects
Interval 70.0 to 98.0
|
73 Percentages of subjects
Interval 45.0 to 92.0
|
88 Percentages of subjects
Interval 73.0 to 96.0
|
72 Percentages of subjects
Interval 51.0 to 88.0
|
85 Percentages of subjects
Interval 65.0 to 96.0
|
17 Percentages of subjects
Interval 12.0 to 24.0
|
|
Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
M10713 strain; N=24,17,16,12,23,15,35,24,25,158
|
38 Percentages of subjects
Interval 19.0 to 59.0
|
47 Percentages of subjects
Interval 23.0 to 72.0
|
31 Percentages of subjects
Interval 11.0 to 59.0
|
33 Percentages of subjects
Interval 10.0 to 65.0
|
39 Percentages of subjects
Interval 20.0 to 61.0
|
40 Percentages of subjects
Interval 16.0 to 68.0
|
49 Percentages of subjects
Interval 31.0 to 66.0
|
46 Percentages of subjects
Interval 26.0 to 67.0
|
32 Percentages of subjects
Interval 15.0 to 54.0
|
21 Percentages of subjects
Interval 15.0 to 28.0
|
|
Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
H44/76 strain; N=26,18,16,16,26,15,39,25,26,175
|
92 Percentages of subjects
Interval 75.0 to 99.0
|
100 Percentages of subjects
Interval 81.0 to 100.0
|
100 Percentages of subjects
Interval 79.0 to 100.0
|
100 Percentages of subjects
Interval 79.0 to 100.0
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
93 Percentages of subjects
Interval 68.0 to 100.0
|
97 Percentages of subjects
Interval 87.0 to 100.0
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
96 Percentages of subjects
Interval 80.0 to 100.0
|
63 Percentages of subjects
Interval 55.0 to 70.0
|
SECONDARY outcome
Timeframe: Day 31 (1 month post vaccination)Population: Analysis was done on FAS (Immunogenicity).
The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.
Outcome measures
| Measure |
B+R246_12_48
n=97 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=10 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=12 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=175 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
hSBA≥ 1:5 (5/99 strain; N=95,10,12,171)
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 69.0 to 100.0
|
100 Percentages of subjects
Interval 74.0 to 100.0
|
90 Percentages of subjects
Interval 85.0 to 94.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
hSBA≥ 1:5 (H44/76 strain)
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 69.0 to 100.0
|
100 Percentages of subjects
Interval 74.0 to 100.0
|
71 Percentages of subjects
Interval 64.0 to 78.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
hSBA≥ 1:5 (NZ 98/254 strain; N=95,10,12,173)
|
96 Percentages of subjects
Interval 90.0 to 99.0
|
70 Percentages of subjects
Interval 35.0 to 93.0
|
100 Percentages of subjects
Interval 74.0 to 100.0
|
24 Percentages of subjects
Interval 18.0 to 31.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
hSBA≥ 1:5 (M10713 strain; N=90,9,10,167)
|
93 Percentages of subjects
Interval 86.0 to 98.0
|
100 Percentages of subjects
Interval 66.0 to 100.0
|
90 Percentages of subjects
Interval 55.0 to 100.0
|
77 Percentages of subjects
Interval 70.0 to 83.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
hSBA≥ 1:8 (H44/76 strain)
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 69.0 to 100.0
|
100 Percentages of subjects
Interval 74.0 to 100.0
|
63 Percentages of subjects
Interval 55.0 to 70.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
hSBA≥ 1:8 (5/99 strain; N=94,10,12,171)
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 69.0 to 100.0
|
100 Percentages of subjects
Interval 74.0 to 100.0
|
87 Percentages of subjects
Interval 81.0 to 92.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
hSBA≥ 1:8 (NZ 98/254 strain; N=95,10,12,173)
|
95 Percentages of subjects
Interval 88.0 to 98.0
|
60 Percentages of subjects
Interval 26.0 to 88.0
|
100 Percentages of subjects
Interval 74.0 to 100.0
|
17 Percentages of subjects
Interval 12.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
hSBA≥ 1:8 (M10713 strain; N=90,9,10,167)
|
92 Percentages of subjects
Interval 85.0 to 97.0
|
100 Percentages of subjects
Interval 66.0 to 100.0
|
90 Percentages of subjects
Interval 55.0 to 100.0
|
74 Percentages of subjects
Interval 67.0 to 81.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 31 (1 month post vaccination)Population: Analysis was done on FAS (Immunogenicity).
The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.
Outcome measures
| Measure |
B+R246_12_48
n=97 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=10 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=12 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=183 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
NZ 98/254 strain; N=95,10,12,173
|
31 Titers
Interval 25.0 to 39.0
|
18 Titers
Interval 8.87 to 35.0
|
47 Titers
Interval 25.0 to 88.0
|
2.25 Titers
Interval 1.84 to 2.75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
M10713 strain; N=90,9,10,167
|
38 Titers
Interval 29.0 to 49.0
|
74 Titers
Interval 34.0 to 164.0
|
84 Titers
Interval 39.0 to 180.0
|
20 Titers
Interval 15.0 to 25.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
H44/76 strain
|
154 Titers
Interval 124.0 to 191.0
|
145 Titers
Interval 76.0 to 277.0
|
211 Titers
Interval 116.0 to 383.0
|
11 Titers
Interval 8.51 to 14.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
5/99 strain; N= 94,10,12,171
|
1575 Titers
Interval 1219.0 to 2034.0
|
2381 Titers
Interval 1112.0 to 5095.0
|
3604 Titers
Interval 1785.0 to 7278.0
|
34 Titers
Interval 27.0 to 42.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 31 (1 month post vaccination)Population: Analysis was done on FAS (Immunogenicity).
The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.
Outcome measures
| Measure |
B+R246_12_48
n=97 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=10 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=11 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=175 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.
H44/76 strain
|
99 Ratio
Interval 79.0 to 125.0
|
67 Ratio
Interval 34.0 to 135.0
|
133 Ratio
Interval 68.0 to 258.0
|
10 Ratio
Interval 8.2 to 13.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.
5/99 strain; N=92,10,11,168
|
70 Ratio
Interval 57.0 to 86.0
|
51 Ratio
Interval 27.0 to 95.0
|
55 Ratio
Interval 30.0 to 99.0
|
29 Ratio
Interval 23.0 to 37.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.
NZ 98/254 strain; N=93,10,11,173
|
27 Ratio
Interval 21.0 to 36.0
|
5.96 Ratio
Interval 2.7 to 13.0
|
38 Ratio
Interval 18.0 to 81.0
|
2.25 Ratio
Interval 1.84 to 2.75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.
M10713 strain; N=88,9,9,158
|
5.24 Ratio
Interval 3.91 to 7.02
|
7.06 Ratio
Interval 2.92 to 17.0
|
7.35 Ratio
Interval 3.03 to 18.0
|
2 Ratio
Interval 1.62 to 2.46
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 31 (1 month post vaccination)Population: Analysis was done on FAS (Immunogenicity).
The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported. Fourfold increase is defined as- for subjects with a pre-vaccination titer \<1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer.
Outcome measures
| Measure |
B+R246_12_48
n=95 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=10 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=11 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=175 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine
M10713 strain; N=88,9,9,158
|
58 Percentages of subjects
Interval 47.0 to 68.0
|
67 Percentages of subjects
Interval 30.0 to 93.0
|
56 Percentages of subjects
Interval 21.0 to 86.0
|
21 Percentages of subjects
Interval 15.0 to 28.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine
H44/76 strain
|
99 Percentages of subjects
Interval 94.0 to 100.0
|
90 Percentages of subjects
Interval 55.0 to 100.0
|
100 Percentages of subjects
Interval 72.0 to 100.0
|
63 Percentages of subjects
Interval 55.0 to 70.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine
5/99 strain; N=92,10,11,168
|
100 Percentages of subjects
Interval 96.0 to 100.0
|
90 Percentages of subjects
Interval 55.0 to 100.0
|
100 Percentages of subjects
Interval 72.0 to 100.0
|
86 Percentages of subjects
Interval 80.0 to 91.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine
NZ 98/254 strain; N=93,10,11,173
|
94 Percentages of subjects
Interval 86.0 to 98.0
|
50 Percentages of subjects
Interval 19.0 to 81.0
|
100 Percentages of subjects
Interval 72.0 to 100.0
|
17 Percentages of subjects
Interval 12.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 91 (1 month post second vaccination)Population: Analysis was done on FAS (Immunogenicity).
The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age. Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains. Immune sufficiency was not applicable for M10713 strain.
Outcome measures
| Measure |
B+R246_12_48
n=175 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.
hSBA≥ 1:8 (H44/76 strain)
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.
hSBA≥ 1:5 (H44/76 strain)
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.
hSBA≥ 1:5 (5/99 strain)
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.
hSBA≥ 1:5 (NZ 98/254 strain; N=174)
|
91 Percentages of subjects
Interval 85.0 to 95.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.
hSBA≥ 1:8 (5/99 strain)
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.
hSBA≥ 1:8 (NZ 98/254 strain; N=174)
|
80 Percentages of subjects
Interval 73.0 to 86.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 91 (1 month post second vaccination)Population: Analysis was done on FAS (Immunogenicity).
The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.
Outcome measures
| Measure |
B+R246_12_48
n=175 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
H44/76 strain
|
109 Titers
Interval 98.0 to 120.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
5/99 strain
|
343 Titers
Interval 302.0 to 389.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
NZ 98/254 strain; N=174
|
17 Titers
Interval 14.0 to 19.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
M10713 strain; N=171
|
47 Titers
Interval 40.0 to 56.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 91 (1 month post second vaccination)Population: Analysis was done on FAS (Immunogenicity).
The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.
Outcome measures
| Measure |
B+R246_12_48
n=175 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
H44/76 strain
|
105 Ratio
Interval 94.0 to 116.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
5/99 strain; N=172
|
299 Ratio
Interval 256.0 to 350.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
NZ 98/254 strain; N=174
|
17 Ratio
Interval 14.0 to 19.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
M10713 strain; N=171
|
5.12 Ratio
Interval 3.95 to 6.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 91 (1 month post second vaccination)Population: Analysis was done on FAS (Immunogenicity).
The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.
Outcome measures
| Measure |
B+R246_12_48
n=175 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
H44/76 strain
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
5/99 strain; N=172
|
99 Percentages of subjects
Interval 97.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
NZ 98/254 strain; N=174
|
80 Percentages of subjects
Interval 73.0 to 86.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
M10713 strain; N=161
|
51 Percentages of subjects
Interval 43.0 to 59.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From day 1 to day 7 after vaccinationPopulation: Analysis was done on the safety population, ie, all subjects in the Exposed population who provided post vaccination and post-baseline safety data.
The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.
Outcome measures
| Measure |
B+R246_12_48
n=29 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=20 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=17 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=19 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
n=27 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
n=17 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
n=43 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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
n=29 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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
n=27 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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Rash
|
2 Number of subjects
|
1 Number of subjects
|
0 Number of subjects
|
5 Number of subjects
|
2 Number of subjects
|
4 Number of subjects
|
7 Number of subjects
|
5 Number of subjects
|
2 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Any local
|
27 Number of subjects
|
18 Number of subjects
|
17 Number of subjects
|
16 Number of subjects
|
24 Number of subjects
|
17 Number of subjects
|
38 Number of subjects
|
28 Number of subjects
|
27 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Pain (mild)
|
4 Number of subjects
|
5 Number of subjects
|
1 Number of subjects
|
6 Number of subjects
|
5 Number of subjects
|
2 Number of subjects
|
4 Number of subjects
|
6 Number of subjects
|
7 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Pain (moderate)
|
18 Number of subjects
|
9 Number of subjects
|
13 Number of subjects
|
4 Number of subjects
|
14 Number of subjects
|
9 Number of subjects
|
24 Number of subjects
|
14 Number of subjects
|
17 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Pain (severe)
|
5 Number of subjects
|
4 Number of subjects
|
3 Number of subjects
|
6 Number of subjects
|
4 Number of subjects
|
5 Number of subjects
|
10 Number of subjects
|
8 Number of subjects
|
3 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Erythema (25 - 50 mm)
|
2 Number of subjects
|
3 Number of subjects
|
3 Number of subjects
|
5 Number of subjects
|
6 Number of subjects
|
3 Number of subjects
|
5 Number of subjects
|
6 Number of subjects
|
5 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Erythema (51 - 100 mm)
|
5 Number of subjects
|
2 Number of subjects
|
1 Number of subjects
|
2 Number of subjects
|
7 Number of subjects
|
3 Number of subjects
|
10 Number of subjects
|
6 Number of subjects
|
3 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Erythema (>100 mm)
|
1 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
2 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Induration (51 - 100 mm)
|
1 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
2 Number of subjects
|
1 Number of subjects
|
2 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Induration (>100 mm)
|
1 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Swelling (25 - 50 mm)
|
1 Number of subjects
|
3 Number of subjects
|
3 Number of subjects
|
4 Number of subjects
|
5 Number of subjects
|
3 Number of subjects
|
7 Number of subjects
|
7 Number of subjects
|
4 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Swelling (51 - 100 mm)
|
1 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
2 Number of subjects
|
3 Number of subjects
|
2 Number of subjects
|
7 Number of subjects
|
5 Number of subjects
|
1 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Swelling (>100 mm)
|
1 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Any Systemic
|
26 Number of subjects
|
15 Number of subjects
|
14 Number of subjects
|
18 Number of subjects
|
19 Number of subjects
|
13 Number of subjects
|
36 Number of subjects
|
27 Number of subjects
|
23 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Change in eating habits
|
12 Number of subjects
|
6 Number of subjects
|
6 Number of subjects
|
12 Number of subjects
|
7 Number of subjects
|
8 Number of subjects
|
20 Number of subjects
|
11 Number of subjects
|
13 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Headache
|
5 Number of subjects
|
1 Number of subjects
|
6 Number of subjects
|
3 Number of subjects
|
2 Number of subjects
|
3 Number of subjects
|
7 Number of subjects
|
5 Number of subjects
|
8 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Irritability
|
18 Number of subjects
|
9 Number of subjects
|
11 Number of subjects
|
14 Number of subjects
|
13 Number of subjects
|
8 Number of subjects
|
23 Number of subjects
|
20 Number of subjects
|
16 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Diarrhea
|
4 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
2 Number of subjects
|
4 Number of subjects
|
2 Number of subjects
|
6 Number of subjects
|
4 Number of subjects
|
3 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Vomiting
|
0 Number of subjects
|
1 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
0 Number of subjects
|
5 Number of subjects
|
3 Number of subjects
|
2 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Fever (≥ 38.0 °C)
|
6 Number of subjects
|
3 Number of subjects
|
3 Number of subjects
|
2 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
5 Number of subjects
|
4 Number of subjects
|
2 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Antipyretic used (prophylactically)
|
1 Number of subjects
|
2 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
2 Number of subjects
|
1 Number of subjects
|
7 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Induration (25 - 50 mm)
|
2 Number of subjects
|
2 Number of subjects
|
1 Number of subjects
|
2 Number of subjects
|
5 Number of subjects
|
2 Number of subjects
|
6 Number of subjects
|
7 Number of subjects
|
6 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Arthralagia
|
12 Number of subjects
|
4 Number of subjects
|
6 Number of subjects
|
9 Number of subjects
|
8 Number of subjects
|
5 Number of subjects
|
11 Number of subjects
|
8 Number of subjects
|
12 Number of subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Antipyretic used (therapeutically)
|
5 Number of subjects
|
5 Number of subjects
|
4 Number of subjects
|
3 Number of subjects
|
3 Number of subjects
|
1 Number of subjects
|
10 Number of subjects
|
4 Number of subjects
|
3 Number of subjects
|
—
|
SECONDARY outcome
Timeframe: From day 1 to day 7 after vaccinationPopulation: Analysis was done on the safety population.
The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.
Outcome measures
| Measure |
B+R246_12_48
n=99 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=10 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=12 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Any local
|
94 Number of subjects
|
9 Number of subjects
|
11 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Erythema (51 - 100 mm)
|
7 Number of subjects
|
1 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Erythema (>100 mm)
|
2 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Induration (25 - 50 mm)
|
8 Number of subjects
|
1 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Induration (51 - 100 mm)
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Rash
|
13 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Vomiting
|
6 Number of subjects
|
2 Number of subjects
|
1 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Pain (mild)
|
33 Number of subjects
|
2 Number of subjects
|
2 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Pain (moderate)
|
42 Number of subjects
|
6 Number of subjects
|
8 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Pain (severe)
|
19 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Erythema (25 - 50 mm)
|
12 Number of subjects
|
2 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Induration (>100 mm)
|
1 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Swelling (25 - 50 mm)
|
18 Number of subjects
|
2 Number of subjects
|
3 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Swelling (51 - 100 mm)
|
2 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Injection site Swelling (>100 mm)
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Any Systemic
|
78 Number of subjects
|
6 Number of subjects
|
9 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Change in eating habits
|
42 Number of subjects
|
0 Number of subjects
|
3 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Arthralagia
|
28 Number of subjects
|
1 Number of subjects
|
6 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Headache
|
20 Number of subjects
|
2 Number of subjects
|
4 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Irritability
|
53 Number of subjects
|
4 Number of subjects
|
5 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Diarrhea
|
5 Number of subjects
|
0 Number of subjects
|
2 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Fever (≥ 38.0 °C)
|
16 Number of subjects
|
4 Number of subjects
|
5 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Antipyretic used (prophylactically)
|
5 Number of subjects
|
2 Number of subjects
|
2 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Antipyretic used (therapeutically)
|
18 Number of subjects
|
4 Number of subjects
|
5 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From day 1 to day 7 after any vaccinationPopulation: Analysis was done on the safety population.
The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local\* and systemic adverse events.
Outcome measures
| Measure |
B+R246_12_48
n=205 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=194 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Injection site Induration (51-100 mm; N= 204, 194)
|
3 Number of subjects
|
4 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Injection site Induration(>100 mm; N= 204, 194
|
0 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Irritability; N= 204, 193
|
67 Number of subjects
|
58 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Any local
|
186 Number of subjects
|
161 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Injection site Pain (mild)
|
81 Number of subjects
|
70 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Injection site Pain (moderate)
|
77 Number of subjects
|
66 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Injection site Pain (severe)
|
27 Number of subjects
|
21 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Injection site Erythema (25 - 50 mm; N= 204, 194)
|
34 Number of subjects
|
15 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Injection site Erythema (51 - 100 mm; N= 204, 194)
|
8 Number of subjects
|
19 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Injection site Erythema (>100 mm; N= 204, 194)
|
1 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Injection site Induration (25 - 50 mm; N= 204, 194
|
23 Number of subjects
|
16 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Injection site Swelling (25 - 50 mm; N= 204, 194
|
26 Number of subjects
|
20 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Injection site Swelling (51 - 100 mm; N= 204, 194)
|
3 Number of subjects
|
4 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Injection site Swelling (>100 mm; N= 204, 194)
|
1 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Any Systemic
|
137 Number of subjects
|
108 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Rash; N=201, 192
|
15 Number of subjects
|
10 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Change in eating habits; N= 203, 194
|
49 Number of subjects
|
43 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Headache; N= 204, 194
|
25 Number of subjects
|
24 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Arthralagia; N= 203, 192
|
45 Number of subjects
|
40 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Vomiting
|
8 Number of subjects
|
6 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Diarrhea; N= 204, 193
|
11 Number of subjects
|
8 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Fever (≥ 38.0 °C; N= 204, 189)
|
20 Number of subjects
|
16 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Antipyretic used (prophylactically; N= 204, 193)
|
17 Number of subjects
|
23 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
Antipyretic used (therapeutically; N= 204, 193)
|
22 Number of subjects
|
24 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From day 1 to study terminationPopulation: Analysis was done on the safety population.
The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.
Outcome measures
| Measure |
B+R246_12_48
n=30 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=20 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=17 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=19 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
n=27 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
n=17 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
n=43 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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
n=29 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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
n=28 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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Any AEs
|
8 Number of subjects
|
4 Number of subjects
|
4 Number of subjects
|
7 Number of subjects
|
7 Number of subjects
|
3 Number of subjects
|
11 Number of subjects
|
11 Number of subjects
|
6 Number of subjects
|
—
|
|
Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
SAEs
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
—
|
|
Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
AEs leading to withdrawal
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
—
|
SECONDARY outcome
Timeframe: From day 1 to study terminationPopulation: Analysis was done on the safety population.
The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.
Outcome measures
| Measure |
B+R246_12_48
n=100 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=11 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=12 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Any AE
|
25 Number of subjects
|
2 Number of subjects
|
4 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
SAEs
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
AEs leading to withdrawal
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From day 1 to study terminationPopulation: Analysis was done on the safety population.
The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.
Outcome measures
| Measure |
B+R246_12_48
n=206 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited AEs After Any Vaccination.
Any AEs
|
105 Number of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Unsolicited AEs After Any Vaccination.
SAEs
|
3 Number of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Unsolicited AEs After Any Vaccination.
AEs leading to premature withdrawal
|
1 Number of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
B+R246_12_48
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
B+R246_18_48
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
B+R246_24_48
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
B246_12_48
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
B246_18_48
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
B246_24_48
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
B+R234_12_48
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
B+R234_18_48
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
B+R234_24_48
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
B12 14_48
Serious events: 0 serious events
Other events: 97 other events
Deaths: 0 deaths
B18 20_48
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
B24 26_48
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
B48 50
Serious events: 3 serious events
Other events: 200 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
B+R246_12_48
n=30 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=20 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=17 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=19 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
n=27 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
n=17 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
n=43 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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
n=29 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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
n=28 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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B12 14_48
n=100 participants at risk
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 \&14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B18 20_48
n=11 participants at risk
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 \& 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B24 26_48
n=12 participants at risk
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 \& 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
n=206 participants at risk
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
CROUP INFECTIOUS
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.49%
1/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.49%
1/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.49%
1/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.49%
1/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Injury, poisoning and procedural complications
PERIORBITAL HAEMATOMA
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.49%
1/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.49%
1/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
Other adverse events
| Measure |
B+R246_12_48
n=30 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_18_48
n=20 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R246_24_48
n=17 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_12_48
n=19 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_18_48
n=27 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B246_24_48
n=17 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. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_12_48
n=43 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 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_18_48
n=29 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 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B+R234_24_48
n=28 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. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B12 14_48
n=100 participants at risk
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 \&14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B18 20_48
n=11 participants at risk
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 \& 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B24 26_48
n=12 participants at risk
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 \& 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
|
B48 50
n=206 participants at risk
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.3%
1/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.9%
1/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
1.0%
1/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.49%
1/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
76.7%
23/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
65.0%
13/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
76.5%
13/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
84.2%
16/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
77.8%
21/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
82.4%
14/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
88.4%
38/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
82.8%
24/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
82.1%
23/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
73.0%
73/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
72.7%
8/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
58.3%
7/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
80.6%
166/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
General disorders
INJECTION SITE INDURATION
|
70.0%
21/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
40.0%
8/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
64.7%
11/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
73.7%
14/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
40.7%
11/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
70.6%
12/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
55.8%
24/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
72.4%
21/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
67.9%
19/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
46.0%
46/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
54.5%
6/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
33.3%
4/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
56.8%
117/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
General disorders
INJECTION SITE PAIN
|
90.0%
27/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
95.0%
19/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
100.0%
17/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
84.2%
16/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
85.2%
23/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
94.1%
16/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
88.4%
38/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
96.6%
28/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
96.4%
27/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
94.0%
94/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
81.8%
9/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
91.7%
11/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
93.2%
192/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
General disorders
INJECTION SITE SWELLING
|
40.0%
12/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
35.0%
7/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
58.8%
10/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
68.4%
13/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
37.0%
10/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
64.7%
11/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
58.1%
25/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
58.6%
17/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
50.0%
14/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
46.0%
46/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
54.5%
6/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
58.3%
7/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
46.6%
96/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
General disorders
PYREXIA
|
23.3%
7/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
15.0%
3/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
17.6%
3/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
10.5%
2/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
3.7%
1/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.9%
1/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
16.3%
7/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
13.8%
4/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
7.1%
2/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
19.0%
19/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
45.5%
5/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
41.7%
5/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
17.5%
36/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Infections and infestations
ACUTE TONSILLITIS
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
6.9%
2/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.49%
1/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.9%
1/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
3.6%
1/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
3.0%
3/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
2.9%
6/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Infections and infestations
ERYTHEMA INFECTIOSUM
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.9%
1/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.49%
1/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Infections and infestations
GASTROENTERITIS
|
3.3%
1/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
3.6%
1/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
9.1%
1/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.97%
2/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.9%
1/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.49%
1/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.3%
1/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
9.1%
1/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
8.3%
1/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
1.5%
3/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
3.6%
1/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
1.0%
1/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
8.3%
1/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
1.5%
3/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Nervous system disorders
SOMNOLENCE
|
60.0%
18/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
35.0%
7/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
47.1%
8/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
47.4%
9/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
44.4%
12/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
35.3%
6/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
51.2%
22/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
72.4%
21/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
50.0%
14/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
52.0%
52/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
27.3%
3/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
25.0%
3/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
51.0%
105/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
10.5%
2/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
2.3%
1/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
1.0%
1/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.3%
11/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.3%
1/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
2.3%
1/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.9%
1/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.3%
1/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.49%
1/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.3%
1/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Skin and subcutaneous tissue disorders
RASH
|
6.7%
2/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.0%
1/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
26.3%
5/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
7.4%
2/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
23.5%
4/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
16.3%
7/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
17.2%
5/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
7.1%
2/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
13.0%
13/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
11.7%
24/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
40.0%
12/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
20.0%
4/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
35.3%
6/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
47.4%
9/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
29.6%
8/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
29.4%
5/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
25.6%
11/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
27.6%
8/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
42.9%
12/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
28.0%
28/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
9.1%
1/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
50.0%
6/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
32.5%
67/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Nervous system disorders
HEADACHE
|
16.7%
5/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
5.0%
1/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
35.3%
6/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
15.8%
3/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
7.4%
2/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
17.6%
3/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
16.3%
7/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
17.2%
5/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
28.6%
8/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
20.0%
20/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
18.2%
2/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
33.3%
4/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
19.4%
40/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Psychiatric disorders
EATING DISORDER
|
40.0%
12/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
30.0%
6/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
35.3%
6/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
63.2%
12/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
25.9%
7/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
47.1%
8/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
46.5%
20/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
37.9%
11/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
46.4%
13/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
42.0%
42/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
25.0%
3/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
36.4%
75/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Psychiatric disorders
IRRITABILITY
|
60.0%
18/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
45.0%
9/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
64.7%
11/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
73.7%
14/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
48.1%
13/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
47.1%
8/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
53.5%
23/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
69.0%
20/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
57.1%
16/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
53.0%
53/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
36.4%
4/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
41.7%
5/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
44.2%
91/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
|
Respiratory, thoracic and mediastinal disorders
CATARRH
|
0.00%
0/30 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/20 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/19 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/27 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/17 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/43 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/29 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/28 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/100 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
9.1%
1/11 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/12 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
0.00%
0/206 • Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.
Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246\_12\_48, B+R246\_18\_48, B+R246\_24\_48, B246\_12\_48, B246\_18\_48, B246\_24\_48 si referred to the subsect of subjects who actually received vaccination in the present study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER