Trial Outcomes & Findings for Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age (NCT NCT01193920)
NCT ID: NCT01193920
Last Updated: 2014-08-22
Results Overview
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
380 participants
Primary outcome timeframe
Day 61, one month after the second vaccination
Results posted on
2014-08-22
Participant Flow
Participant milestones
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
Non-pregnant women received two injections of saline solution
|
Pregnant 0.5/0.5/0.5 μg
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant 2.5/2.5/2.5 μg
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
Pregnant women who received one injection of saline solution
|
Infants 0.5/0.5/0.5 μg
Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants 2.5/2.5/2.5 μg
Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants 5/5/5 μg
Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants / Placebo
Infants born from women who received saline solution
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
80
|
80
|
80
|
80
|
80
|
80
|
76
|
81
|
|
Overall Study
COMPLETED
|
37
|
20
|
74
|
76
|
74
|
76
|
74
|
76
|
71
|
74
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
6
|
4
|
6
|
4
|
6
|
4
|
5
|
7
|
Reasons for withdrawal
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
Non-pregnant women received two injections of saline solution
|
Pregnant 0.5/0.5/0.5 μg
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant 2.5/2.5/2.5 μg
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
Pregnant women who received one injection of saline solution
|
Infants 0.5/0.5/0.5 μg
Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants 2.5/2.5/2.5 μg
Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants 5/5/5 μg
Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants / Placebo
Infants born from women who received saline solution
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
5
|
1
|
3
|
1
|
3
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
1
|
3
|
3
|
1
|
0
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
3
|
2
|
4
|
|
Overall Study
Unable to classify
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
Baseline characteristics by cohort
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=40 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=20 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 0.5/0.5/0.5 μg
n=80 Participants
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant 2.5/2.5/2.5 μg
n=80 Participants
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant 5/5/5 μg
n=80 Participants
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
n=80 Participants
Pregnant women who received one injection of saline solution
|
Infants 0.5/0.5/0.5 μg
n=80 Participants
Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants 2.5/2.5/2.5 μg
n=80 Participants
Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants 5/5/5 μg
n=76 Participants
Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants / Placebo
n=81 Participants
Infants born from women who received one injection of saline solution
|
Total
n=697 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Non pregnant subjects
|
28.6 years
STANDARD_DEVIATION 5.0 • n=99 Participants
|
29.4 years
STANDARD_DEVIATION 5.1 • n=107 Participants
|
NA years
STANDARD_DEVIATION NA • n=206 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=31 Participants
|
NA years
STANDARD_DEVIATION NA • n=30 Participants
|
NA years
STANDARD_DEVIATION NA • n=3 Participants
|
NA years
STANDARD_DEVIATION NA • n=6 Participants
|
NA years
STANDARD_DEVIATION NA • n=114 Participants
|
NA years
STANDARD_DEVIATION NA
|
28.8 years
STANDARD_DEVIATION 5.0 • n=19 Participants
|
|
Age, Customized
Maternal subjects
|
NA years
STANDARD_DEVIATION NA • n=99 Participants
|
NA years
STANDARD_DEVIATION NA • n=107 Participants
|
25.3 years
STANDARD_DEVIATION 5.2 • n=206 Participants
|
25.3 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
24.2 years
STANDARD_DEVIATION 4.7 • n=31 Participants
|
25.7 years
STANDARD_DEVIATION 5.4 • n=30 Participants
|
NA years
STANDARD_DEVIATION NA • n=3 Participants
|
NA years
STANDARD_DEVIATION NA • n=6 Participants
|
NA years
STANDARD_DEVIATION NA • n=114 Participants
|
NA years
STANDARD_DEVIATION NA
|
25.1 years
STANDARD_DEVIATION 5.1 • n=19 Participants
|
|
Age, Customized
|
NA days
STANDARD_DEVIATION NA • n=99 Participants
|
NA days
STANDARD_DEVIATION NA • n=107 Participants
|
NA days
STANDARD_DEVIATION NA • n=206 Participants
|
NA days
STANDARD_DEVIATION NA • n=7 Participants
|
NA days
STANDARD_DEVIATION NA • n=31 Participants
|
NA days
STANDARD_DEVIATION NA • n=30 Participants
|
3.0 days
STANDARD_DEVIATION 3.3 • n=3 Participants
|
4.0 days
STANDARD_DEVIATION 7.8 • n=6 Participants
|
5.5 days
STANDARD_DEVIATION 16.9 • n=114 Participants
|
3.5 days
STANDARD_DEVIATION 8.8
|
4.0 days
STANDARD_DEVIATION 10.3 • n=19 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
80 Participants
n=7 Participants
|
80 Participants
n=31 Participants
|
80 Participants
n=30 Participants
|
45 Participants
n=3 Participants
|
38 Participants
n=6 Participants
|
33 Participants
n=114 Participants
|
48 Participants
|
544 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
35 Participants
n=3 Participants
|
42 Participants
n=6 Participants
|
43 Participants
n=114 Participants
|
33 Participants
|
153 Participants
n=19 Participants
|
|
Region of Enrollment
South Africa
|
40 participants
n=99 Participants
|
20 participants
n=107 Participants
|
80 participants
n=206 Participants
|
80 participants
n=7 Participants
|
80 participants
n=31 Participants
|
80 participants
n=30 Participants
|
80 participants
n=3 Participants
|
80 participants
n=6 Participants
|
76 participants
n=114 Participants
|
81 participants
|
697 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Day 61, one month after the second vaccinationPopulation: Full Analysis Set (FAS) - primary, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at Day 1 (prior to vaccination) and Day 61
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Outcome measures
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=35 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=19 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
Pregnant women who received one injection of saline solution
|
|---|---|---|---|---|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype Ia >=1 μg/mL (N=34, 19)
|
91 percentage of subjects
Interval 76.0 to 98.0
|
37 percentage of subjects
Interval 16.0 to 62.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype Ia >=2 μg/mL (N=34, 19)
|
91 percentage of subjects
Interval 76.0 to 98.0
|
32 percentage of subjects
Interval 13.0 to 57.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype Ia >=3 μg/mL (N=34, 19)
|
88 percentage of subjects
Interval 73.0 to 97.0
|
26 percentage of subjects
Interval 9.0 to 51.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype Ia >=5 μg/mL (N=34, 19)
|
79 percentage of subjects
Interval 62.0 to 91.0
|
16 percentage of subjects
Interval 3.0 to 40.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype Ia >=8 μg/mL (N=34, 19)
|
76 percentage of subjects
Interval 59.0 to 89.0
|
16 percentage of subjects
Interval 3.0 to 40.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype Ib >=1 μg/mL (N=33, 17)
|
73 percentage of subjects
Interval 54.0 to 87.0
|
24 percentage of subjects
Interval 7.0 to 50.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype Ib >=2 μg/mL (N=33, 17)
|
67 percentage of subjects
Interval 48.0 to 82.0
|
12 percentage of subjects
Interval 1.0 to 36.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype Ib >=3 μg/mL (N=33, 17)
|
64 percentage of subjects
Interval 45.0 to 80.0
|
6 percentage of subjects
Interval 0.0 to 29.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype III >=1 μg/mL
|
89 percentage of subjects
Interval 73.0 to 97.0
|
37 percentage of subjects
Interval 16.0 to 62.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype III >=2 μg/mL
|
69 percentage of subjects
Interval 51.0 to 83.0
|
21 percentage of subjects
Interval 6.0 to 46.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype III >=5 μg/mL
|
51 percentage of subjects
Interval 34.0 to 69.0
|
11 percentage of subjects
Interval 1.0 to 33.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype III >=8 μg/mL
|
49 percentage of subjects
Interval 31.0 to 66.0
|
5 percentage of subjects
Interval 0.0 to 26.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype Ib >=5 μg/mL (N=33, 17)
|
42 percentage of subjects
Interval 25.0 to 61.0
|
6 percentage of subjects
Interval 0.0 to 29.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype Ib >=8 μg/mL (N=33, 17)
|
39 percentage of subjects
Interval 23.0 to 58.0
|
6 percentage of subjects
Interval 0.0 to 29.0
|
—
|
—
|
|
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
Serotype III >=3 μg/mL
|
63 percentage of subjects
Interval 45.0 to 79.0
|
21 percentage of subjects
Interval 6.0 to 46.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 61, one month after the second vaccinationPopulation: FAS - primary, non-pregnant subjects
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
Outcome measures
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=35 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=19 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
Pregnant women who received one injection of saline solution
|
|---|---|---|---|---|
|
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
Serotype Ia (N=34, 19)
|
40 concentrations (μg/mL)
Interval 26.0 to 62.0
|
0.88 concentrations (μg/mL)
Interval 0.49 to 1.59
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
Serotype Ib (N=33, 17)
|
5.3 concentrations (μg/mL)
Interval 2.94 to 9.56
|
0.25 concentrations (μg/mL)
Interval 0.12 to 0.55
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
Serotype III
|
11 concentrations (μg/mL)
Interval 6.43 to 19.0
|
0.61 concentrations (μg/mL)
Interval 0.29 to 1.27
|
—
|
—
|
PRIMARY outcome
Timeframe: Day of deliveryPopulation: FAS primary, maternal subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at delivery
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Outcome measures
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=76 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=77 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 5/5/5 μg
n=73 Participants
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
n=78 Participants
Pregnant women who received one injection of saline solution
|
|---|---|---|---|---|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ia >= 1 μg/mL (N=76,77, 73, 76)
|
86 percentage of subjects
Interval 76.0 to 93.0
|
83 percentage of subjects
Interval 73.0 to 91.0
|
89 percentage of subjects
Interval 80.0 to 95.0
|
38 percentage of subjects
Interval 27.0 to 50.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ia >= 3 μg/mL (N=76, 77, 73, 76)
|
75 percentage of subjects
Interval 64.0 to 84.0
|
71 percentage of subjects
Interval 60.0 to 81.0
|
77 percentage of subjects
Interval 65.0 to 86.0
|
21 percentage of subjects
Interval 13.0 to 32.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ia >= 5 μg/mL (N=76, 77, 73, 76)
|
72 percentage of subjects
Interval 61.0 to 82.0
|
69 percentage of subjects
Interval 57.0 to 79.0
|
75 percentage of subjects
Interval 64.0 to 85.0
|
18 percentage of subjects
Interval 10.0 to 29.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ia >= 8 μg/mL (N=76, 77, 73, 76)
|
64 percentage of subjects
Interval 53.0 to 75.0
|
64 percentage of subjects
Interval 52.0 to 74.0
|
71 percentage of subjects
Interval 59.0 to 81.0
|
9 percentage of subjects
Interval 4.0 to 18.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ib >= 5 μg/mL (N=69, 74, 71, 58)
|
41 percentage of subjects
Interval 29.0 to 53.0
|
41 percentage of subjects
Interval 29.0 to 53.0
|
37 percentage of subjects
Interval 25.0 to 49.0
|
9 percentage of subjects
Interval 3.0 to 19.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ib >= 8 μg/mL (N=69, 74, 71, 58)
|
36 percentage of subjects
Interval 25.0 to 49.0
|
36 percentage of subjects
Interval 26.0 to 48.0
|
32 percentage of subjects
Interval 22.0 to 45.0
|
3 percentage of subjects
Interval 0.0 to 12.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ill >= 3 μg/mL (N=74, 77, 73, 78)
|
49 percentage of subjects
Interval 37.0 to 61.0
|
44 percentage of subjects
Interval 33.0 to 56.0
|
42 percentage of subjects
Interval 31.0 to 55.0
|
4 percentage of subjects
Interval 1.0 to 11.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ia >= 2 μg/mL (N=76, 77, 73, 76)
|
78 percentage of subjects
Interval 67.0 to 86.0
|
74 percentage of subjects
Interval 63.0 to 83.0
|
81 percentage of subjects
Interval 70.0 to 89.0
|
26 percentage of subjects
Interval 17.0 to 38.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ib >= 1 μg/mL (N=69, 74, 71, 58)
|
58 percentage of subjects
Interval 45.0 to 70.0
|
65 percentage of subjects
Interval 53.0 to 76.0
|
65 percentage of subjects
Interval 53.0 to 76.0
|
14 percentage of subjects
Interval 6.0 to 25.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ib >= 2 μg/mL (69, 74, 71, 58)
|
52 percentage of subjects
Interval 40.0 to 64.0
|
51 percentage of subjects
Interval 39.0 to 63.0
|
48 percentage of subjects
Interval 36.0 to 60.0
|
10 percentage of subjects
Interval 4.0 to 21.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ib >= 3 μg/mL (N=69, 74, 71, 58)
|
43 percentage of subjects
Interval 32.0 to 56.0
|
49 percentage of subjects
Interval 37.0 to 61.0
|
42 percentage of subjects
Interval 31.0 to 55.0
|
10 percentage of subjects
Interval 4.0 to 21.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ill >= 1 μg/mL (N=74, 77, 73, 78)
|
69 percentage of subjects
Interval 57.0 to 79.0
|
66 percentage of subjects
Interval 55.0 to 77.0
|
64 percentage of subjects
Interval 52.0 to 75.0
|
14 percentage of subjects
Interval 7.0 to 24.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ill >= 2 μg/mL (N=74, 77, 73, 78)
|
62 percentage of subjects
Interval 50.0 to 73.0
|
53 percentage of subjects
Interval 42.0 to 65.0
|
51 percentage of subjects
Interval 39.0 to 63.0
|
9 percentage of subjects
Interval 4.0 to 18.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ill >= 5 μg/mL (N=74, 77, 73, 78)
|
39 percentage of subjects
Interval 28.0 to 51.0
|
49 percentage of subjects
Interval 29.0 to 52.0
|
36 percentage of subjects
Interval 25.0 to 48.0
|
3 percentage of subjects
Interval 0.0 to 9.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
Serotype Ill >= 8 μg/mL (N=74, 77, 73, 78)
|
34 percentage of subjects
Interval 23.0 to 46.0
|
35 percentage of subjects
Interval 25.0 to 47.0
|
29 percentage of subjects
Interval 19.0 to 41.0
|
3 percentage of subjects
Interval 0.0 to 9.0
|
PRIMARY outcome
Timeframe: Day of deliveryPopulation: FAS primary, maternal subjects
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.
Outcome measures
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=76 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=77 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 5/5/5 μg
n=73 Participants
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
n=78 Participants
Pregnant women who received one injection of saline solution
|
|---|---|---|---|---|
|
Antibody GMC in Maternal Subjects at Day of Delivery
Serotype Ia (N= 76, 77, 73, 76)
|
9.95 Concentration (μg/mL)
Interval 6.6 to 15.0
|
14 Concentration (μg/mL)
Interval 9.19 to 21.0
|
24 Concentration (μg/mL)
Interval 16.0 to 36.0
|
0.67 Concentration (μg/mL)
Interval 0.46 to 0.99
|
|
Antibody GMC in Maternal Subjects at Day of Delivery
Serotype Ib (N=69, 74, 71, 58)
|
2.5 Concentration (μg/mL)
Interval 1.61 to 3.88
|
4.3 Concentration (μg/mL)
Interval 2.74 to 6.76
|
2.93 Concentration (μg/mL)
Interval 1.79 to 4.77
|
0.38 Concentration (μg/mL)
Interval 0.25 to 0.59
|
|
Antibody GMC in Maternal Subjects at Day of Delivery
Serotype III (N=74, 77, 73, 78)
|
2.63 Concentration (μg/mL)
Interval 1.8 to 3.85
|
3.66 Concentration (μg/mL)
Interval 2.52 to 5.31
|
2.83 Concentration (μg/mL)
Interval 1.92 to 4.17
|
0.25 Concentration (μg/mL)
Interval 0.18 to 0.34
|
SECONDARY outcome
Timeframe: Day 31, one month after vaccinationPopulation: FAS, secondary, maternal subjects, day 31, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at day 31
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Outcome measures
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=75 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=74 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 5/5/5 μg
n=69 Participants
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
n=76 Participants
Pregnant women who received one injection of saline solution
|
|---|---|---|---|---|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype Ib>=2μg/mL (N= 65, 69, 66, 61)
|
60 percentage of subjects
Interval 47.0 to 72.0
|
54 percentage of subjects
Interval 41.0 to 66.0
|
50 percentage of subjects
Interval 37.0 to 63.0
|
13 percentage of subjects
Interval 6.0 to 24.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype Ia>=1μg/mL (N=75, 74, 69, 75)
|
85 percentage of subjects
Interval 75.0 to 92.0
|
77 percentage of subjects
Interval 66.0 to 86.0
|
88 percentage of subjects
Interval 78.0 to 95.0
|
33 percentage of subjects
Interval 23.0 to 45.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype Ia>=3μg/mL (N=75, 74, 69, 75)
|
76 percentage of subjects
Interval 65.0 to 85.0
|
73 percentage of subjects
Interval 61.0 to 83.0
|
78 percentage of subjects
Interval 67.0 to 87.0
|
23 percentage of subjects
Interval 14.0 to 34.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype Ia>=5μg/mL (N=75, 74, 69, 75)
|
75 percentage of subjects
Interval 63.0 to 84.0
|
70 percentage of subjects
Interval 59.0 to 80.0
|
71 percentage of subjects
Interval 59.0 to 81.0
|
15 percentage of subjects
Interval 8.0 to 25.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype Ib>=1μg/mL (N= 65, 69, 66, 61)
|
65 percentage of subjects
Interval 52.0 to 76.0
|
68 percentage of subjects
Interval 56.0 to 79.0
|
62 percentage of subjects
Interval 49.0 to 74.0
|
21 percentage of subjects
Interval 12.0 to 34.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype III>=1μg/mL (N= 73, 74, 68, 76)
|
70 percentage of subjects
Interval 58.0 to 80.0
|
65 percentage of subjects
Interval 53.0 to 76.0
|
57 percentage of subjects
Interval 45.0 to 69.0
|
13 percentage of subjects
Interval 6.0 to 23.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype III>=5μg/mL (N=73, 74, 68, 76)
|
41 percentage of subjects
Interval 30.0 to 53.0
|
43 percentage of subjects
Interval 32.0 to 55.0
|
32 percentage of subjects
Interval 22.0 to 45.0
|
3 percentage of subjects
Interval 0.0 to 9.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype III>=8μg/mL (N=73, 74, 68, 76)
|
38 percentage of subjects
Interval 27.0 to 50.0
|
34 percentage of subjects
Interval 23.0 to 46.0
|
29 percentage of subjects
Interval 19.0 to 42.0
|
3 percentage of subjects
Interval 0.0 to 9.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype III>=2μg/mL (N=73, 74, 68, 76)
|
58 percentage of subjects
Interval 45.0 to 69.0
|
54 percentage of subjects
Interval 42.0 to 66.0
|
51 percentage of subjects
Interval 39.0 to 64.0
|
12 percentage of subjects
Interval 6.0 to 21.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype Ia>=2μg/mL (N=75, 74, 69, 75)
|
79 percentage of subjects
Interval 68.0 to 87.0
|
77 percentage of subjects
Interval 66.0 to 86.0
|
81 percentage of subjects
Interval 70.0 to 90.0
|
27 percentage of subjects
Interval 17.0 to 38.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype III>=3μg/mL (N=73, 74, 68, 76)
|
48 percentage of subjects
Interval 36.0 to 60.0
|
50 percentage of subjects
Interval 38.0 to 62.0
|
44 percentage of subjects
Interval 32.0 to 57.0
|
4 percentage of subjects
Interval 1.0 to 11.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype Ia>=8μg/mL (N=75, 74, 69, 75)
|
71 percentage of subjects
Interval 59.0 to 81.0
|
70 percentage of subjects
Interval 59.0 to 80.0
|
71 percentage of subjects
Interval 59.0 to 81.0
|
9 percentage of subjects
Interval 4.0 to 18.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype Ib>=3μg/mL (N= 65, 69, 66, 61)
|
54 percentage of subjects
Interval 41.0 to 66.0
|
48 percentage of subjects
Interval 36.0 to 60.0
|
44 percentage of subjects
Interval 32.0 to 57.0
|
11 percentage of subjects
Interval 5.0 to 22.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype Ib>=5μg/mL (N= 65, 69, 66, 61)
|
48 percentage of subjects
Interval 35.0 to 60.0
|
43 percentage of subjects
Interval 32.0 to 56.0
|
36 percentage of subjects
Interval 25.0 to 49.0
|
10 percentage of subjects
Interval 4.0 to 20.0
|
|
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
serotype Ib>=8μg/mL (N= 65, 69, 66, 61)
|
43 percentage of subjects
Interval 31.0 to 56.0
|
39 percentage of subjects
Interval 28.0 to 52.0
|
30 percentage of subjects
Interval 20.0 to 43.0
|
8 percentage of subjects
Interval 3.0 to 18.0
|
SECONDARY outcome
Timeframe: day 31Population: FAS, secondary, maternal subjects, day 31
Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.
Outcome measures
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=75 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=74 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 5/5/5 μg
n=69 Participants
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
n=76 Participants
Pregnant women who received one injection of saline solution
|
|---|---|---|---|---|
|
Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination
serotype Ia (N=75, 74, 69, 75)
|
13 concentration (μg/mL)
Interval 8.27 to 21.0
|
15 concentration (μg/mL)
Interval 9.54 to 25.0
|
26 concentration (μg/mL)
Interval 16.0 to 43.0
|
0.62 concentration (μg/mL)
Interval 0.41 to 0.93
|
|
Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination
serotype Ib (N=65, 69, 66, 61)
|
2.78 concentration (μg/mL)
Interval 1.68 to 4.59
|
5.42 concentration (μg/mL)
Interval 3.21 to 9.18
|
3.66 concentration (μg/mL)
Interval 2.06 to 6.52
|
0.3 concentration (μg/mL)
Interval 0.19 to 0.49
|
|
Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination
serotype III (N=73, 74, 68, 76)
|
3.01 concentration (μg/mL)
Interval 1.96 to 4.62
|
4.11 concentration (μg/mL)
Interval 2.68 to 6.31
|
2.77 concentration (μg/mL)
Interval 1.75 to 4.37
|
0.19 concentration (μg/mL)
Interval 0.13 to 0.27
|
SECONDARY outcome
Timeframe: Day 361, one year after the first vaccinationPopulation: FAS persistence, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and day 361.
The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.
Outcome measures
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=37 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=20 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
Pregnant women who received one injection of saline solution
|
|---|---|---|---|---|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype Ia >=5μg/mL
|
70 percentage of subjects
Interval 53.0 to 84.0
|
15 percentage of subjects
Interval 3.0 to 38.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype Ia >=8μg/mL
|
62 percentage of subjects
Interval 45.0 to 78.0
|
10 percentage of subjects
Interval 1.0 to 32.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype Ib >=1μg/mL (N=37, 19)
|
81 percentage of subjects
Interval 65.0 to 92.0
|
21 percentage of subjects
Interval 6.0 to 46.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype Ib >=5μg/mL (N=37, 19)
|
38 percentage of subjects
Interval 22.0 to 55.0
|
5 percentage of subjects
Interval 0.0 to 26.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype III >=1μg/mL
|
81 percentage of subjects
Interval 65.0 to 92.0
|
20 percentage of subjects
Interval 6.0 to 44.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype III >=8μg/mL
|
41 percentage of subjects
Interval 25.0 to 58.0
|
5 percentage of subjects
Interval 0.0 to 25.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype Ib >=2μg/mL (N=37, 19)
|
65 percentage of subjects
Interval 47.0 to 80.0
|
16 percentage of subjects
Interval 3.0 to 40.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype Ib >=3μg/mL (37, 19)
|
62 percentage of subjects
Interval 45.0 to 78.0
|
5 percentage of subjects
Interval 0.0 to 26.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype Ib >=8μg/mL (N=37, 19)
|
32 percentage of subjects
Interval 18.0 to 50.0
|
5 percentage of subjects
Interval 0.0 to 26.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype III >=2μg/mL
|
70 percentage of subjects
Interval 53.0 to 84.0
|
15 percentage of subjects
Interval 3.0 to 38.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype III >=3μg/mL
|
65 percentage of subjects
Interval 47.0 to 80.0
|
15 percentage of subjects
Interval 3.0 to 38.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype III >=5μg/mL
|
54 percentage of subjects
Interval 37.0 to 71.0
|
5 percentage of subjects
Interval 0.0 to 25.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype Ia >=1μg/mL
|
86 percentage of subjects
Interval 71.0 to 95.0
|
30 percentage of subjects
Interval 12.0 to 54.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype Ia >=2μg/mL
|
76 percentage of subjects
Interval 59.0 to 88.0
|
30 percentage of subjects
Interval 12.0 to 54.0
|
—
|
—
|
|
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
Serotype Ia >=3μg/mL
|
76 percentage of subjects
Interval 59.0 to 88.0
|
25 percentage of subjects
Interval 9.0 to 49.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 361, one year after the first vaccinationPopulation: FAS persistence, non-pregnant subjects
Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.
Outcome measures
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=37 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=20 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
Pregnant women who received one injection of saline solution
|
|---|---|---|---|---|
|
Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination
serotype Ia
|
15 concentration (μg/mL)
Interval 9.86 to 22.0
|
0.86 concentration (μg/mL)
Interval 0.51 to 1.45
|
—
|
—
|
|
Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination
serotype Ib (N=37, 19)
|
5.28 concentration (μg/mL)
Interval 3.49 to 7.98
|
0.4 concentration (μg/mL)
Interval 0.23 to 0.69
|
—
|
—
|
|
Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination
serotype III
|
7.03 concentration (μg/mL)
Interval 4.5 to 11.0
|
0.3 concentration (μg/mL)
Interval 0.17 to 0.55
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 61Population: Safety set, solicited and unsolicited reactogenicity, non-pregnant subjects
Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.
Outcome measures
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=40 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=20 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 5/5/5 μg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
Pregnant women who received one injection of saline solution
|
|---|---|---|---|---|
|
Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events
Solicited adverse events
|
40 participants
|
19 participants
|
—
|
—
|
|
Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events
Unsolicited adverse events
|
30 participants
|
16 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From day 1 to one year after deliveryPopulation: Safety set, solicited and unsolicited reactogenicity, maternal subjects
Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.
Outcome measures
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=80 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=80 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 5/5/5 μg
n=80 Participants
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
n=80 Participants
Pregnant women who received one injection of saline solution
|
|---|---|---|---|---|
|
Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events
solicited adverse events (N=80, 80, 79, 80)
|
59 participants
|
46 participants
|
59 participants
|
57 participants
|
|
Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events
unsolicited adverse events
|
70 participants
|
59 participants
|
62 participants
|
69 participants
|
SECONDARY outcome
Timeframe: Day 4, day 43 and day 91 after birthPopulation: Per Protocol Set, infants, i.e. all subjects who provided evaluable serum samples at birth, study day 43, study day 91 and within the required time frames
Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.
Outcome measures
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=75 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=77 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 5/5/5 μg
n=69 Participants
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
n=76 Participants
Pregnant women who received one injection of saline solution
|
|---|---|---|---|---|
|
Antibody GMC Per Serotype at Different Time Points in Infants
Serotype Ia (day 4; N=75, 76, 69, 73)
|
6.66 concentration (μg/mL)
Interval 4.03 to 11.0
|
6.52 concentration (μg/mL)
Interval 3.96 to 11.0
|
12 concentration (μg/mL)
Interval 7.21 to 20.0
|
0.49 concentration (μg/mL)
Interval 0.34 to 0.71
|
|
Antibody GMC Per Serotype at Different Time Points in Infants
Serotype Ia (day 43; N= 75, 76, 68, 71)
|
3.21 concentration (μg/mL)
Interval 2.01 to 5.13
|
2.95 concentration (μg/mL)
Interval 1.85 to 4.7
|
5.54 concentration (μg/mL)
Interval 3.38 to 9.06
|
0.31 concentration (μg/mL)
Interval 0.23 to 0.42
|
|
Antibody GMC Per Serotype at Different Time Points in Infants
Serotype Ia (day 91; N=71, 75, 64, 75)
|
1.97 concentration (μg/mL)
Interval 1.31 to 2.95
|
2.22 concentration (μg/mL)
Interval 1.49 to 3.29
|
2.78 concentration (μg/mL)
Interval 1.81 to 4.26
|
0.38 concentration (μg/mL)
Interval 0.29 to 0.49
|
|
Antibody GMC Per Serotype at Different Time Points in Infants
Serotype Ib (day 91; N= 74, 73, 66, 76)
|
0.85 concentration (μg/mL)
Interval 0.61 to 1.18
|
1.08 concentration (μg/mL)
Interval 0.77 to 1.51
|
0.83 concentration (μg/mL)
Interval 0.59 to 1.19
|
0.5 concentration (μg/mL)
Interval 0.39 to 0.63
|
|
Antibody GMC Per Serotype at Different Time Points in Infants
Serotype III (day 4; N= 57, 64, 58, 52)
|
2.11 concentration (μg/mL)
Interval 1.26 to 3.54
|
2.3 concentration (μg/mL)
Interval 1.41 to 3.76
|
1.72 concentration (μg/mL)
Interval 1.03 to 2.87
|
0.29 concentration (μg/mL)
Interval 0.19 to 0.43
|
|
Antibody GMC Per Serotype at Different Time Points in Infants
Serotype III (day 43; N= 64, 75, 61, 63)
|
0.82 concentration (μg/mL)
Interval 0.53 to 1.27
|
0.88 concentration (μg/mL)
Interval 0.59 to 1.31
|
0.68 concentration (μg/mL)
Interval 0.43 to 1.06
|
0.16 concentration (μg/mL)
Interval 0.12 to 0.22
|
|
Antibody GMC Per Serotype at Different Time Points in Infants
Serotype III (day 91; N= 63, 63, 57, 69)
|
0.6 concentration (μg/mL)
Interval 0.42 to 0.85
|
0.69 concentration (μg/mL)
Interval 0.48 to 0.98
|
0.51 concentration (μg/mL)
Interval 0.35 to 0.74
|
0.27 concentration (μg/mL)
Interval 0.21 to 0.34
|
|
Antibody GMC Per Serotype at Different Time Points in Infants
Serotype Ib (day 4; N=71, 71, 66, 62)
|
1.15 concentration (μg/mL)
Interval 0.68 to 1.95
|
1.72 concentration (μg/mL)
Interval 1.02 to 2.92
|
1.39 concentration (μg/mL)
Interval 0.81 to 2.4
|
0.21 concentration (μg/mL)
Interval 0.14 to 0.32
|
|
Antibody GMC Per Serotype at Different Time Points in Infants
Serotype Ib (day 43; N=72, 77, 67, 69)
|
0.73 concentration (μg/mL)
Interval 0.47 to 1.14
|
0.88 concentration (μg/mL)
Interval 0.57 to 1.35
|
0.67 concentration (μg/mL)
Interval 0.42 to 1.07
|
0.15 concentration (μg/mL)
Interval 0.11 to 0.21
|
SECONDARY outcome
Timeframe: one year after birthNumber of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events
Outcome measures
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=79 Participants
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=79 Participants
Non-pregnant women received two injections of saline solution
|
Pregnant 5/5/5 μg
n=74 Participants
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
n=78 Participants
Pregnant women who received one injection of saline solution
|
|---|---|---|---|---|
|
Number of Infants Reporting Serious Adverse Events
Serious AEs
|
19 Number of subjects
|
13 Number of subjects
|
13 Number of subjects
|
18 Number of subjects
|
|
Number of Infants Reporting Serious Adverse Events
At least possibly related SAEs
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Infants Reporting Serious Adverse Events
AEs leading to withdrawal
|
1 Number of subjects
|
2 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
|
Number of Infants Reporting Serious Adverse Events
AEs leading to death
|
1 Number of subjects
|
2 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
Adverse Events
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Non-pregnant/Placebo
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Pregnant 0.5/0.5/0.5 μg
Serious events: 27 serious events
Other events: 72 other events
Deaths: 0 deaths
Pregnant 2.5/2.5/2.5 μg
Serious events: 24 serious events
Other events: 67 other events
Deaths: 0 deaths
Pregnant 5/5/5 μg
Serious events: 25 serious events
Other events: 70 other events
Deaths: 0 deaths
Pregnant/Placebo
Serious events: 30 serious events
Other events: 71 other events
Deaths: 0 deaths
Infants 0.5/0.5/0.5 μg
Serious events: 19 serious events
Other events: 44 other events
Deaths: 0 deaths
Infants 2.5/2.5/2.5 μg
Serious events: 13 serious events
Other events: 49 other events
Deaths: 0 deaths
Infants 5/5/5 μg
Serious events: 13 serious events
Other events: 48 other events
Deaths: 0 deaths
Infants / Placebo
Serious events: 18 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=40 participants at risk
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=20 participants at risk
Non-pregnant women received two injections of saline solution
|
Pregnant 0.5/0.5/0.5 μg
n=80 participants at risk
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant 2.5/2.5/2.5 μg
n=80 participants at risk
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant 5/5/5 μg
n=80 participants at risk
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
n=80 participants at risk
Pregnant women who received one injection of saline solution
|
Infants 0.5/0.5/0.5 μg
n=79 participants at risk
Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants 2.5/2.5/2.5 μg
n=79 participants at risk
Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants 5/5/5 μg
n=74 participants at risk
Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants / Placebo
n=78 participants at risk
Infants born from women who received one injection of saline solution
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
urinary tract infection
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.7%
2/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
urinary tract infection bacteria
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
wound sepsis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Injury, poisoning and procedural complications
burns second degree
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Injury, poisoning and procedural complications
perineal laceration
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Injury, poisoning and procedural complications
post procedural haemorrhage
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Reproductive system and breast disorders
vaginal haemorrage
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Injury, poisoning and procedural complications
seroma
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Injury, poisoning and procedural complications
thermal burn
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Injury, poisoning and procedural complications
vulvovaginal injury
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Injury, poisoning and procedural complications
wound secretion
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Metabolism and nutrition disorders
failure to thrive
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.4%
1/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Metabolism and nutrition disorders
hypernatraemia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.7%
2/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
gestational hypertension
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
15.0%
12/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.4%
1/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Investigations
coagulation factor IX level decreased
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
1/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Nervous system disorders
dizziness
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
1/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Nervous system disorders
convulsion
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Nervous system disorders
convulsion neonatal
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Nervous system disorders
hypoxic-ischaemic encephalopathy
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
abortion spontaneous
|
2.5%
1/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
jaundice neonatal
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.7%
2/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
low birth weight baby
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
premature baby
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
breech presentation
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
cephalo-pelvic disproportion
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.2%
5/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
eclampsia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
failed induction of labour
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
false labour
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
foetal death
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
oligohydramnios
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
foetal distress syndrome
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
12.5%
10/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
11.2%
9/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
13.8%
11/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
foetal hypokinesia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
haemorrage in pregnancy
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
hyperemesis gravidarum
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
labour complication
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
postpartum haemorrage
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
pre-eclampsia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
premature labour
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
premature rupture of membranes
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
premature separation of placenta
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
prolonged labour
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
7.5%
6/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.2%
5/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
prolonged pregnancy
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
retained product of conception
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
stillbirth
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Pregnancy, puerperium and perinatal conditions
umbilical cord prolapse
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Renal and urinary disorders
hydronephrosis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Renal and urinary disorders
renal impairment
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.7%
2/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Cardiac disorders
Tachycardia foetal
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Cardiac disorders
cardiac disorder
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Congenital, familial and genetic disorders
congenital pneumonia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Eye disorders
strabism
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
pyrexia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Hepatobiliary disorders
jaundice
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.4%
1/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Immune system disorders
hypersensitivity
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
abscess limb
|
2.5%
1/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
acute tonsillitis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
bronchiolitis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.4%
1/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
bronchopneumonia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.6%
2/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
bullous impetigo
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
cellulitis
|
2.5%
1/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
chorioamnionitis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
meningitis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
dysentery
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
eczema herpeticum
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.1%
4/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
4.1%
3/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
HIV infection
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.4%
1/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
klebsiella sepsis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
lower respiratory tract infection
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
otitis media
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
pneumonia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
postoperative wound infection
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
postpartum sepsis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
pyelonephritis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
respiratory syncytial virus bronchiolitis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
sepsis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
sepsis neonatal
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
4.1%
3/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
streptococcal sepsis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
umbilical sepsis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory distress syndrome
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Respiratory, thoracic and mediastinal disorders
neonathal asphyxia
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Respiratory, thoracic and mediastinal disorders
transient tachypnoea of the newborn
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.4%
4/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.1%
4/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Skin and subcutaneous tissue disorders
erythema toxicum neonatorum
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Surgical and medical procedures
labour induction
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Vascular disorders
hypertension
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Vascular disorders
subgaleal haematoma
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.4%
1/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
Other adverse events
| Measure |
Non-pregnant 20/20/20 μg +Aluminum Hydroxide
n=40 participants at risk
Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
|
Non-pregnant/Placebo
n=20 participants at risk
Non-pregnant women received two injections of saline solution
|
Pregnant 0.5/0.5/0.5 μg
n=80 participants at risk
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant 2.5/2.5/2.5 μg
n=80 participants at risk
Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant 5/5/5 μg
n=80 participants at risk
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Pregnant/Placebo
n=80 participants at risk
Pregnant women who received one injection of saline solution
|
Infants 0.5/0.5/0.5 μg
n=79 participants at risk
Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants 2.5/2.5/2.5 μg
n=79 participants at risk
Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants 5/5/5 μg
n=74 participants at risk
Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
|
Infants / Placebo
n=78 participants at risk
Infants born from women who received one injection of saline solution
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
anaemia
|
10.0%
4/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
1/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Gastrointestinal disorders
nausea
|
42.5%
17/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
30.0%
6/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
20.0%
16/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
8.8%
7/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
21.2%
17/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
10.0%
8/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
chills
|
37.5%
15/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
30.0%
6/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
20.0%
16/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
8.8%
7/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
10.0%
8/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
11.2%
9/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
fatigue
|
72.5%
29/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
60.0%
12/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
48.8%
39/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
42.5%
34/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
53.8%
43/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
46.2%
37/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
feeling hot
|
7.5%
3/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
1/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
injection site induration
|
47.5%
19/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
20.0%
4/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
8.8%
7/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
11.2%
9/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
11.2%
9/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
injection site erythema
|
30.0%
12/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
15.0%
3/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
12.5%
10/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
10.0%
8/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
8.8%
7/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
injection site haemorrhage
|
17.5%
7/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
15.0%
3/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
injection site pain
|
97.5%
39/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
75.0%
15/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
35.0%
28/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
31.2%
25/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
32.5%
26/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
30.0%
24/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
injection site swelling
|
35.0%
14/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
10.0%
2/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.2%
5/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.2%
5/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
injection site warmth
|
60.0%
24/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
45.0%
9/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
26.2%
21/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
15.0%
12/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
18.8%
15/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
18.8%
15/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
malaise
|
35.0%
14/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
35.0%
7/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
17.5%
14/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
16.2%
13/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
21.2%
17/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
20.0%
16/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
pain
|
25.0%
10/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
15.0%
3/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
pyrexia
|
15.0%
6/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.2%
5/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
influenza
|
2.5%
1/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
1/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
10.0%
8/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
18.8%
15/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.2%
5/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.4%
1/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
tonsillitis
|
7.5%
3/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
upper respiratory tract infection
|
7.5%
3/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
1/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
32.5%
26/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
32.5%
26/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
42.5%
34/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
40.0%
32/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
26.6%
21/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
32.9%
26/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
24.3%
18/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
30.8%
24/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
urinary tract infection
|
2.5%
1/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
1/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
8.8%
7/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
10.0%
8/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Investigations
aspartate aminotransferase increased
|
2.5%
1/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
10.0%
2/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
57.5%
23/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
30.0%
6/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
25.0%
20/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
17.5%
14/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
18.8%
15/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
25.0%
20/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
72.5%
29/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
55.0%
11/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
25.0%
20/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
28.7%
23/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
32.5%
26/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
23.8%
19/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
10.0%
2/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Nervous system disorders
dizziness
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.2%
5/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.2%
5/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Nervous system disorders
headache
|
70.0%
28/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
75.0%
15/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
58.8%
47/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
31.2%
25/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
55.0%
44/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
42.5%
34/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Reproductive system and breast disorders
vaginal discharge
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
7.5%
6/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
11.2%
9/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
8.8%
7/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
7.5%
3/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
8.8%
7/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
7.5%
6/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.4%
1/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
5.0%
2/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
7.5%
6/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
11.4%
9/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
21.5%
17/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
27.0%
20/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
19.2%
15/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Skin and subcutaneous tissue disorders
rash
|
10.0%
4/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.2%
5/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.7%
2/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Vascular disorders
hypertension
|
7.5%
3/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
4/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
7.5%
6/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
7.5%
6/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
induration
|
10.0%
4/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Eye disorders
conjunctivitis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.1%
4/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
7.6%
6/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
9.5%
7/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.1%
4/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
4.1%
3/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Hepatobiliary disorders
jaundice
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.3%
5/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.8%
5/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.6%
2/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
bronchiolitis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.3%
5/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
4.1%
3/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
fungal skin infection
|
2.5%
1/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.0%
1/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
11.4%
9/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
12.7%
10/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
13.5%
10/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
7.7%
6/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
gastroenteritis
|
5.0%
2/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
7.6%
6/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
8.9%
7/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.4%
1/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Infections and infestations
oral candidiasis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.4%
4/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.1%
4/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
13.9%
11/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
7.6%
6/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.4%
4/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
7.7%
6/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Skin and subcutaneous tissue disorders
dermatitis diaper
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.3%
1/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
10.8%
8/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
7.7%
6/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
Skin and subcutaneous tissue disorders
eczema
|
0.00%
0/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
5.1%
4/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
10.1%
8/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
6.8%
5/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
15.4%
12/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
|
General disorders
Influenza like illness
|
2.5%
1/40 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/20 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
2.5%
2/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
1.2%
1/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
10.0%
8/80 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
3.8%
3/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/79 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/74 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
0.00%
0/78 • Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Other disclosure agreement: 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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER