Trial Outcomes & Findings for Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings (NCT NCT01412801)
NCT ID: NCT01412801
Last Updated: 2014-09-12
Results Overview
GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
270 participants
Primary outcome timeframe
Day of delivery/birth
Results posted on
2014-09-12
Participant Flow
Subjects were enrolled at Malawi and South Africa
All the enrolled subjects are included in the trial. Also,only the mothers who received the glycoconjugates were considered enrolled.
Participant milestones
| Measure |
HIVposCD4LOW_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4HIGH_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVneg_Maternal
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4LOW(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but \> 50 cells/µL .
|
HIVposCD4HIGH(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/µL
|
HIVneg(Infants)
Infants born to HIV-antibody negative maternal subjects
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
91
|
89
|
90
|
91
|
88
|
87
|
|
Overall Study
COMPLETED
|
87
|
84
|
83
|
87
|
85
|
84
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
7
|
4
|
3
|
3
|
Reasons for withdrawal
| Measure |
HIVposCD4LOW_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4HIGH_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVneg_Maternal
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4LOW(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but \> 50 cells/µL .
|
HIVposCD4HIGH(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/µL
|
HIVneg(Infants)
Infants born to HIV-antibody negative maternal subjects
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
4
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
4
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
1
|
0
|
0
|
0
|
|
Overall Study
Relocated to another area
|
0
|
0
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
Baseline characteristics by cohort
| Measure |
HIVposCD4LOW_Maternal
n=91 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4HIGH_Maternal
n=89 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVneg_Maternal
n=90 Participants
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4LOW (Infants)
n=91 Participants
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but \> 50 cells/µL
|
HIVposCD4HIGH (Infants)
n=88 Participants
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/µL
|
HIVneg (Infants)
n=87 Participants
Infants born to HIV-antibody negative maternal subjects
|
Total
n=536 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Maternal Subjects
|
28.3 years
STANDARD_DEVIATION 4.8 • n=99 Participants
|
28.1 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
24.7 years
STANDARD_DEVIATION 4.4 • 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
|
27.1 years
STANDARD_DEVIATION 5.0 • n=3 Participants
|
|
Age, Customized
Infants
|
NA days
STANDARD_DEVIATION NA • n=99 Participants
|
NA days
STANDARD_DEVIATION NA • n=107 Participants
|
NA days
STANDARD_DEVIATION NA • n=206 Participants
|
4.1 days
STANDARD_DEVIATION 1.6 • n=7 Participants
|
6.7 days
STANDARD_DEVIATION 2.5 • n=31 Participants
|
1.3 days
STANDARD_DEVIATION 1.1 • n=30 Participants
|
1.6 days
STANDARD_DEVIATION 1.0 • n=3 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
41 Participants
n=30 Participants
|
393 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
46 Participants
n=30 Participants
|
143 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Day of delivery/birthPopulation: Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable).
GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
Outcome measures
| Measure |
HIVposCD4LOW_Maternal
n=83 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4HIGH_Maternal
n=81 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVneg_Maternal
n=83 Participants
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4LOW(Infants)
n=83 Participants
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but \> 50 cells/µL .
|
HIVposCD4HIGH(Infants)
n=81 Participants
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/µL
|
HIVneg(Infants)
n=83 Participants
Infants born to HIV-antibody negative maternal subjects
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth
GBS serotypes Ib(74, 80, 82, 44, 56, 57)
|
1.84 μg/mL
Interval 1.22 to 2.77
|
2.4 μg/mL
Interval 1.64 to 3.52
|
4.08 μg/mL
Interval 2.85 to 5.83
|
1.31 μg/mL
Interval 0.78 to 2.19
|
1.62 μg/mL
Interval 1.03 to 2.56
|
2.67 μg/mL
Interval 1.7 to 4.2
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth
GBS serotypes Ia (83, 81, 83, 79, 81, 83)
|
2.07 μg/mL
Interval 1.44 to 2.98
|
2.31 μg/mL
Interval 1.6 to 3.34
|
3.98 μg/mL
Interval 2.75 to 5.74
|
1.01 μg/mL
Interval 0.66 to 1.56
|
1.22 μg/mL
Interval 0.8 to 1.87
|
3.91 μg/mL
Interval 2.56 to 5.96
|
|
Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth
GBS serotypes III (83, 72, 82, 54, 51, 66)
|
1.07 μg/mL
Interval 0.71 to 1.6
|
1.03 μg/mL
Interval 0.69 to 1.53
|
3.61 μg/mL
Interval 2.51 to 5.18
|
0.6 μg/mL
Interval 0.36 to 0.99
|
0.52 μg/mL
Interval 0.31 to 0.88
|
3.88 μg/mL
Interval 2.47 to 6.1
|
PRIMARY outcome
Timeframe: Day of delivery/birthPopulation: Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable).
The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.
Outcome measures
| Measure |
HIVposCD4LOW_Maternal
n=79 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4HIGH_Maternal
n=79 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVneg_Maternal
n=83 Participants
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4LOW(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but \> 50 cells/µL .
|
HIVposCD4HIGH(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/µL
|
HIVneg(Infants)
Infants born to HIV-antibody negative maternal subjects
|
|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth.
Serotype III (53,44,66)
|
0.6 Ratios
Interval 0.44 to 0.82
|
0.51 Ratios
Interval 0.36 to 0.72
|
0.56 Ratios
Interval 0.43 to 0.75
|
—
|
—
|
—
|
|
Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth.
Serotype Ia
|
0.58 Ratios
Interval 0.49 to 0.69
|
0.6 Ratios
Interval 0.51 to 0.72
|
0.72 Ratios
Interval 0.61 to 0.85
|
—
|
—
|
—
|
|
Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth.
Serotype Ib (41,54,57)
|
0.51 Ratios
Interval 0.38 to 0.69
|
0.64 Ratios
Interval 0.5 to 0.83
|
0.49 Ratios
Interval 0.38 to 0.63
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, 15, 31 and at DeliveryPopulation: FAS (Maternal Subjects in the Exposed Population) who -Secondary objective serum GMC: provided at least one evaluable sample result at day 1 (prior to vaccination), day 15, day 31, or at delivery;- Secondary objective kinetics: provided at least one evaluable serum sample at day 1 (prior to vaccination), day 15, day 31, and at delivery.
Immunogenicity was measured as Geometric Mean Concentration of Antibody levels for GBS Serotypes Ia, Ib and III after receiving one dose of GBS Trivalent Vaccine.
Outcome measures
| Measure |
HIVposCD4LOW_Maternal
n=74 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4HIGH_Maternal
n=75 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVneg_Maternal
n=77 Participants
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4LOW(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but \> 50 cells/µL .
|
HIVposCD4HIGH(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/µL
|
HIVneg(Infants)
Infants born to HIV-antibody negative maternal subjects
|
|---|---|---|---|---|---|---|
|
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Serotype Ib Day 15
|
2.93 µg/mL
Interval 1.73 to 4.95
|
3.5 µg/mL
Interval 2.17 to 5.65
|
6.07 µg/mL
Interval 3.98 to 9.26
|
—
|
—
|
—
|
|
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Serotype Ia Day 1
|
0.24 µg/mL
Interval 0.19 to 0.3
|
0.25 µg/mL
Interval 0.2 to 0.32
|
0.38 µg/mL
Interval 0.3 to 0.48
|
—
|
—
|
—
|
|
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Serotype Ia Day 15
|
2.62 µg/mL
Interval 1.64 to 4.17
|
2.95 µg/mL
Interval 1.86 to 4.69
|
5.61 µg/mL
Interval 3.56 to 8.84
|
—
|
—
|
—
|
|
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Serotype Ia Day 31
|
2.68 µg/mL
Interval 1.75 to 4.1
|
3.26 µg/mL
Interval 2.14 to 4.98
|
6.63 µg/mL
Interval 4.37 to 10.0
|
—
|
—
|
—
|
|
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Serotype Ia At delivery
|
2.22 µg/mL
Interval 1.5 to 3.29
|
2.69 µg/mL
Interval 1.82 to 3.98
|
4.49 µg/mL
Interval 3.06 to 6.6
|
—
|
—
|
—
|
|
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Serotype Ib Day 1
|
0.51 µg/mL
Interval 0.38 to 0.7
|
0.36 µg/mL
Interval 0.27 to 0.48
|
0.4 µg/mL
Interval 0.31 to 0.51
|
—
|
—
|
—
|
|
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Serotype Ib Day 31
|
2.62 µg/mL
Interval 1.62 to 4.24
|
3.68 µg/mL
Interval 2.38 to 5.7
|
5.35 µg/mL
Interval 3.63 to 7.87
|
—
|
—
|
—
|
|
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Serotype Ib At delivery
|
2.12 µg/mL
Interval 1.36 to 3.31
|
3.04 µg/mL
Interval 2.03 to 4.56
|
3.84 µg/mL
Interval 2.69 to 5.5
|
—
|
—
|
—
|
|
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Serotype III Day 1
|
0.12 µg/mL
Interval 0.086 to 0.17
|
0.099 µg/mL
Interval 0.072 to 0.14
|
0.14 µg/mL
Interval 0.1 to 0.18
|
—
|
—
|
—
|
|
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Serotype III Day 15
|
1.24 µg/mL
Interval 0.79 to 1.95
|
1.52 µg/mL
Interval 0.97 to 2.36
|
5.9 µg/mL
Interval 3.99 to 8.72
|
—
|
—
|
—
|
|
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Serotype III Day 31
|
1.51 µg/mL
Interval 0.97 to 2.35
|
1.31 µg/mL
Interval 0.85 to 2.02
|
5.35 µg/mL
Interval 3.66 to 7.83
|
—
|
—
|
—
|
|
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Serotype III At delivery
|
1.25 µg/mL
Interval 0.81 to 1.94
|
1.07 µg/mL
Interval 0.7 to 1.65
|
3.8 µg/mL
Interval 2.61 to 5.55
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day of DeliveryPopulation: FAS (Maternal Subjects)
Immunogenicity was measured in terms of the percentages of maternal subjects with ELISA Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold after receiving one dose of GBS Trivalent Vaccine.Threshold values of 0.1, 0.2, 0.5, 1, 2, 3, 5, and 8 μg/mL were used for serum concentrations for maternal subjects.
Outcome measures
| Measure |
HIVposCD4LOW_Maternal
n=83 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4HIGH_Maternal
n=82 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVneg_Maternal
n=83 Participants
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4LOW(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but \> 50 cells/µL .
|
HIVposCD4HIGH(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/µL
|
HIVneg(Infants)
Infants born to HIV-antibody negative maternal subjects
|
|---|---|---|---|---|---|---|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 3 µg/mL(Serotype Ia)
|
40 Percentage of maternal subjects
|
46 Percentage of maternal subjects
|
54 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 1 µg/mL(Serotype Ib)
|
65 Percentage of maternal subjects
|
63 Percentage of maternal subjects
|
69 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 1 µg/mL(Serotype III)
|
47 Percentage of maternal subjects
|
41 Percentage of maternal subjects
|
73 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 2 µg/mL(Serotype III)
|
36 Percentage of maternal subjects
|
24 Percentage of maternal subjects
|
64 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 0.2 µg/mL(Serotype Ia)
|
100 Percentage of maternal subjects
|
99 Percentage of maternal subjects
|
100 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 0.5 µg/mL(Serotype Ia)
|
67 Percentage of maternal subjects
|
71 Percentage of maternal subjects
|
82 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 1 µg/mL(Serotype Ia)
|
55 Percentage of maternal subjects
|
59 Percentage of maternal subjects
|
71 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 2 µg/mL(Serotype Ia)
|
51 Percentage of maternal subjects
|
49 Percentage of maternal subjects
|
60 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 5 µg/mL(Serotype Ia)
|
30 Percentage of maternal subjects
|
41 Percentage of maternal subjects
|
53 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 8 µg/mL(Serotype Ia)
|
22 Percentage of maternal subjects
|
30 Percentage of maternal subjects
|
47 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 0.1 µg/mL(Serotype Ib)
|
89 Percentage of maternal subjects
|
98 Percentage of maternal subjects
|
98 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 0.2 µg/mL(Serotype Ib)
|
88 Percentage of maternal subjects
|
98 Percentage of maternal subjects
|
98 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 0.5 µg/mL(Serotype Ib)
|
83 Percentage of maternal subjects
|
84 Percentage of maternal subjects
|
90 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 2 µg/mL(Serotype Ib)
|
40 Percentage of maternal subjects
|
41 Percentage of maternal subjects
|
47 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 3 µg/mL(Serotype Ib)
|
28 Percentage of maternal subjects
|
35 Percentage of maternal subjects
|
40 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 5 µg/mL(Serotype Ib)
|
20 Percentage of maternal subjects
|
26 Percentage of maternal subjects
|
28 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 8 µg/mL(Serotype Ib)
|
13 Percentage of maternal subjects
|
17 Percentage of maternal subjects
|
24 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 0.1 µg/mL(Serotype III)
|
96 Percentage of maternal subjects
|
80 Percentage of maternal subjects
|
95 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 0.2 µg/mL(Serotype III)
|
82 Percentage of maternal subjects
|
76 Percentage of maternal subjects
|
89 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 0.5 µg/mL(Serotype III)
|
63 Percentage of maternal subjects
|
51 Percentage of maternal subjects
|
86 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 3 µg/mL(Serotype III)
|
29 Percentage of maternal subjects
|
18 Percentage of maternal subjects
|
54 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 5 µg/mL(Serotype III)
|
18 Percentage of maternal subjects
|
13 Percentage of maternal subjects
|
49 Percentage of maternal subjects
|
—
|
—
|
—
|
|
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
≥ 8 µg/mL(Serotype III)
|
17 Percentage of maternal subjects
|
12 Percentage of maternal subjects
|
40 Percentage of maternal subjects
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeksPopulation: Safety Set (Solicited AEs, Maternal Subjects)
Safety was assessed in terms of the number of subjects with solicited local AEs after receiving one dose of the GBS Trivalent Vaccine
Outcome measures
| Measure |
HIVposCD4LOW_Maternal
n=88 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4HIGH_Maternal
n=88 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVneg_Maternal
n=90 Participants
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4LOW(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but \> 50 cells/µL .
|
HIVposCD4HIGH(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/µL
|
HIVneg(Infants)
Infants born to HIV-antibody negative maternal subjects
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With Solicited Local Adverse Events (AEs)
Ecchymosis(87, 88, 90)
|
0 percentage of Subjects
|
0 percentage of Subjects
|
1 percentage of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Local Adverse Events (AEs)
Erythema(87, 88, 89)
|
0 percentage of Subjects
|
1 percentage of Subjects
|
1 percentage of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Local Adverse Events (AEs)
Induration(87, 88, 90)
|
0 percentage of Subjects
|
1 percentage of Subjects
|
0 percentage of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Local Adverse Events (AEs)
Swelling(87, 88, 90)
|
0 percentage of Subjects
|
0 percentage of Subjects
|
2 percentage of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Local Adverse Events (AEs)
Pain(87, 88, 90)
|
18 percentage of Subjects
|
30 percentage of Subjects
|
39 percentage of Subjects
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeksPopulation: Safety Set (Solicited AEs, Maternal Subjects)
Safety was assessed in terms of the number of subjects with solicited systemic AEs after receiving one dose of the GBS Trivalent Vaccine
Outcome measures
| Measure |
HIVposCD4LOW_Maternal
n=88 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4HIGH_Maternal
n=88 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVneg_Maternal
n=90 Participants
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4LOW(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but \> 50 cells/µL .
|
HIVposCD4HIGH(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/µL
|
HIVneg(Infants)
Infants born to HIV-antibody negative maternal subjects
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With Solicited Systemic AEs
Stayed home(Other indicators)
|
3 percentages of Subjects
|
5 percentages of Subjects
|
9 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Chills(87,88,90)
|
9 percentages of Subjects
|
14 percentages of Subjects
|
22 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Nausea(87,88,89)
|
13 percentages of Subjects
|
17 percentages of Subjects
|
22 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Malaise(87,88,90)
|
10 percentages of Subjects
|
19 percentages of Subjects
|
23 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Myalgia(87,88,90)
|
8 percentages of Subjects
|
17 percentages of Subjects
|
23 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Arthralgia(87,88,90)
|
13 percentages of Subjects
|
23 percentages of Subjects
|
29 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Headache(87,88,90)
|
24 percentages of Subjects
|
32 percentages of Subjects
|
43 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Fatigue(87,88,90)
|
24 percentages of Subjects
|
31 percentages of Subjects
|
47 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Rash(87,88,90)
|
3 percentages of Subjects
|
1 percentages of Subjects
|
1 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Fever ( ≥ 38°C)(87, 88, 90)
|
3 percentages of Subjects
|
0 percentages of Subjects
|
0 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Temperature(<38°C)(87, 88,90)
|
97 percentages of Subjects
|
100 percentages of Subjects
|
100 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Temperature(38-38.4°C)(87, 88,90)
|
1 percentages of Subjects
|
0 percentages of Subjects
|
0 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Temperature(38.5-38.9°C)(87, 88,90)
|
1 percentages of Subjects
|
0 percentages of Subjects
|
0 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Temperature(39-39.4°C)(87, 88,90)
|
0 percentages of Subjects
|
0 percentages of Subjects
|
0 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Temperature(39.5-39.9°C)(87, 88,90)
|
1 percentages of Subjects
|
0 percentages of Subjects
|
0 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Temperature(≥ 40°C)(87, 88,90)
|
0 percentages of Subjects
|
0 percentages of Subjects
|
0 percentages of Subjects
|
—
|
—
|
—
|
|
Percentages of Subjects With Solicited Systemic AEs
Analgesic antipyr. meds(Other indicators)
|
7 percentages of Subjects
|
10 percentages of Subjects
|
9 percentages of Subjects
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Study Termination, for up to 24 weeksPopulation: Safety Set (Unsolicited AEs, Maternal Subjects)
Safety was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events after receiving one dose of the GBS Trivalent Vaccine
Outcome measures
| Measure |
HIVposCD4LOW_Maternal
n=90 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4HIGH_Maternal
n=89 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVneg_Maternal
n=90 Participants
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4LOW(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but \> 50 cells/µL .
|
HIVposCD4HIGH(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/µL
|
HIVneg(Infants)
Infants born to HIV-antibody negative maternal subjects
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects Who Experienced Unsolicited Adverse Events
Any AE
|
74 percentages of subjects
|
76 percentages of subjects
|
78 percentages of subjects
|
—
|
—
|
—
|
|
Percentages of Subjects Who Experienced Unsolicited Adverse Events
Possibly related AE
|
7 percentages of subjects
|
13 percentages of subjects
|
23 percentages of subjects
|
—
|
—
|
—
|
|
Percentages of Subjects Who Experienced Unsolicited Adverse Events
SAE
|
28 percentages of subjects
|
31 percentages of subjects
|
32 percentages of subjects
|
—
|
—
|
—
|
|
Percentages of Subjects Who Experienced Unsolicited Adverse Events
Possibly related SAE
|
0 percentages of subjects
|
0 percentages of subjects
|
0 percentages of subjects
|
—
|
—
|
—
|
|
Percentages of Subjects Who Experienced Unsolicited Adverse Events
AE leading to withdrawal from study
|
0 percentages of subjects
|
1 percentages of subjects
|
0 percentages of subjects
|
—
|
—
|
—
|
|
Percentages of Subjects Who Experienced Unsolicited Adverse Events
Medically attended AEs
|
47 percentages of subjects
|
49 percentages of subjects
|
54 percentages of subjects
|
—
|
—
|
—
|
|
Percentages of Subjects Who Experienced Unsolicited Adverse Events
Death
|
0 percentages of subjects
|
1 percentages of subjects
|
0 percentages of subjects
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Birth to Study Termination, for up to 24 weeksPopulation: Safety Set (Unsolicited AEs, Infants)
Safety in Infants was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events since birth to study termination
Outcome measures
| Measure |
HIVposCD4LOW_Maternal
n=91 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but \> 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4HIGH_Maternal
n=88 Participants
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVneg_Maternal
n=87 Participants
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
|
HIVposCD4LOW(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but \> 50 cells/µL .
|
HIVposCD4HIGH(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/µL
|
HIVneg(Infants)
Infants born to HIV-antibody negative maternal subjects
|
|---|---|---|---|---|---|---|
|
Percentages of Infants Who Experienced Unsolicited Adverse Events
AE leading to withdrawal from study
|
4 percentages of Infant subjects
|
2 percentages of Infant subjects
|
2 percentages of Infant subjects
|
—
|
—
|
—
|
|
Percentages of Infants Who Experienced Unsolicited Adverse Events
Medically attended AEs
|
23 percentages of Infant subjects
|
33 percentages of Infant subjects
|
24 percentages of Infant subjects
|
—
|
—
|
—
|
|
Percentages of Infants Who Experienced Unsolicited Adverse Events
Any AE
|
41 percentages of Infant subjects
|
49 percentages of Infant subjects
|
43 percentages of Infant subjects
|
—
|
—
|
—
|
|
Percentages of Infants Who Experienced Unsolicited Adverse Events
Possibly related AE
|
0 percentages of Infant subjects
|
2 percentages of Infant subjects
|
1 percentages of Infant subjects
|
—
|
—
|
—
|
|
Percentages of Infants Who Experienced Unsolicited Adverse Events
SAE
|
19 percentages of Infant subjects
|
18 percentages of Infant subjects
|
18 percentages of Infant subjects
|
—
|
—
|
—
|
|
Percentages of Infants Who Experienced Unsolicited Adverse Events
Possibly related SAE
|
0 percentages of Infant subjects
|
0 percentages of Infant subjects
|
0 percentages of Infant subjects
|
—
|
—
|
—
|
|
Percentages of Infants Who Experienced Unsolicited Adverse Events
Death
|
4 percentages of Infant subjects
|
2 percentages of Infant subjects
|
2 percentages of Infant subjects
|
—
|
—
|
—
|
Adverse Events
HIVposCD4LOW (Infants)
Serious events: 17 serious events
Other events: 13 other events
Deaths: 0 deaths
HIVposCD4HIGH (Infants)
Serious events: 16 serious events
Other events: 11 other events
Deaths: 0 deaths
HIVneg (Infants)
Serious events: 16 serious events
Other events: 7 other events
Deaths: 0 deaths
Total (Infants)
Serious events: 49 serious events
Other events: 31 other events
Deaths: 0 deaths
HIVposCD4LOW_Maternal Subjects
Serious events: 25 serious events
Other events: 55 other events
Deaths: 0 deaths
HIVposCD4HIGH_Maternal Subjects
Serious events: 28 serious events
Other events: 68 other events
Deaths: 0 deaths
HIVneg_Maternal Subjects
Serious events: 29 serious events
Other events: 71 other events
Deaths: 0 deaths
Total Maternal Subjects
Serious events: 82 serious events
Other events: 194 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIVposCD4LOW (Infants)
n=91 participants at risk
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/μL but \> 50 cells/μL
|
HIVposCD4HIGH (Infants)
n=88 participants at risk
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/μL .
|
HIVneg (Infants)
n=87 participants at risk
Infants born to HIV-antibody negative maternal subjects
|
Total (Infants)
n=266 participants at risk
Total number of Infants participated in the study
|
HIVposCD4LOW_Maternal Subjects
n=90 participants at risk
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/μL but \> 50 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
|
HIVposCD4HIGH_Maternal Subjects
n=89 participants at risk
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
|
HIVneg_Maternal Subjects
n=90 participants at risk
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
|
Total Maternal Subjects
n=269 participants at risk
Total number of Maternal subjects participated in the study
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.3%
2/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.75%
2/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC DISEASE OF NEWBORN
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Cardiac disorders
CARDIAC DISORDER
|
1.1%
1/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Congenital, familial and genetic disorders
CHROMOSOMAL DELETION
|
1.1%
1/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Congenital, familial and genetic disorders
CONGENITAL PNEUMONIA
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Congenital, familial and genetic disorders
PATENT DUCTUS ARTERIOSUS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Congenital, familial and genetic disorders
TALIPES
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Congenital, familial and genetic disorders
TRISOMY 21
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Gastrointestinal disorders
INGUINAL HERNIA, OBSTRUCTIVE
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
1.1%
1/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.75%
2/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
General disorders
FEELING JITTERY
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
AMNIOTIC CAVITY INFECTION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.74%
2/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
BREAST ABSCESS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
ENDOMETRITIS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
MALARIA
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.74%
2/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
MENINGITIS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
PNEUMONIA
|
2.2%
2/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
3/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
POST PROCEDURAL SEPSIS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
SEPSIS
|
1.1%
1/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
SEPSIS NEONATAL
|
3.3%
3/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
5.7%
5/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.4%
3/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
4.1%
11/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
SYPHILIS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.74%
2/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Injury, poisoning and procedural complications
PERINEAL INJURY
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.74%
2/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Injury, poisoning and procedural complications
UTERINE RUPTURE
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.3%
2/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.75%
2/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.75%
2/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Nervous system disorders
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY
|
1.1%
1/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.4%
3/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.5%
4/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Nervous system disorders
PARTIAL SEIZURES
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Nervous system disorders
VIITH NERVE PARALYSIS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
BREECH PRESENTATION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.74%
2/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
CAPUT SUCCEDANEUM
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
CEPHALO-PELVIC DISPROPORTION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.3%
3/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
10.0%
9/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
4.5%
12/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
CERVIX DYSTOCIA
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
ECLAMPSIA
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
FAILED INDUCTION OF LABOUR
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.74%
2/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
FALSE LABOUR
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.74%
2/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL DISTRESS SYNDROME
|
1.1%
1/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.75%
2/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
6.7%
6/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.3%
9/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
GESTATIONAL DIABETES
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
GESTATIONAL HYPERTENSION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.4%
3/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.5%
4/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
HAEMORRHAGE IN PREGNANCY
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
4.5%
4/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
6/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
HYPEREMESIS GRAVIDARUM
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
JAUNDICE NEONATAL
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.3%
2/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.3%
2/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.5%
4/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
LOW BIRTH WEIGHT BABY
|
2.2%
2/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.3%
2/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.9%
5/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
POSTPARTUM HAEMORRHAGE
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
3/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
PRE-ECLAMPSIA
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
3/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE BABY
|
5.5%
5/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.4%
3/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.4%
3/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
4.1%
11/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE DELIVERY
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.4%
3/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
6/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE LABOUR
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.4%
3/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.6%
7/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
PRETERM PREMATURE RUPTURE OF MEMBRANES
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.3%
3/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
7.9%
7/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
4.5%
12/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
PROLONGED LABOUR
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.3%
3/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
5.6%
5/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
5.6%
5/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
4.8%
13/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
PROLONGED PREGNANCY
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.74%
2/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
PROLONGED RUPTURE OF MEMBRANES
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.4%
3/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.5%
4/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
RETAINED PLACENTA OR MEMBRANES
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.74%
2/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
RETAINED PRODUCTS OF CONCEPTION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
STILLBIRTH
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
THREATENED LABOUR
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
3/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Pregnancy, puerperium and perinatal conditions
TRANSVERSE PRESENTATION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Reproductive system and breast disorders
UTERINE CERVIX STENOSIS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
NEONATAL ASPHYXIA
|
1.1%
1/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.3%
2/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.3%
2/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.9%
5/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
NEONATAL ASPIRATION
|
2.2%
2/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.5%
4/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
NEONATAL RESPIRATORY DISTRESS SYNDROME
|
5.5%
5/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.3%
2/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.6%
7/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
TRANSIENT TACHYPNOEA OF THE NEWBORN
|
2.2%
2/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
3/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Skin and subcutaneous tissue disorders
MELANOSIS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
1.1%
1/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Surgical and medical procedures
CAESAREAN SECTION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
6/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Vascular disorders
HAEMATOMA
|
1.1%
1/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.75%
2/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Vascular disorders
SHOCK
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.37%
1/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Vascular disorders
SUBGALEAL HAEMATOMA
|
1.1%
1/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
Other adverse events
| Measure |
HIVposCD4LOW (Infants)
n=91 participants at risk
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/μL but \> 50 cells/μL
|
HIVposCD4HIGH (Infants)
n=88 participants at risk
Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/μL .
|
HIVneg (Infants)
n=87 participants at risk
Infants born to HIV-antibody negative maternal subjects
|
Total (Infants)
n=266 participants at risk
Total number of Infants participated in the study
|
HIVposCD4LOW_Maternal Subjects
n=90 participants at risk
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/μL but \> 50 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
|
HIVposCD4HIGH_Maternal Subjects
n=89 participants at risk
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count \>350 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
|
HIVneg_Maternal Subjects
n=90 participants at risk
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
|
Total Maternal Subjects
n=269 participants at risk
Total number of Maternal subjects participated in the study
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.4%
3/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
5.6%
5/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.7%
10/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.38%
1/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
7.8%
7/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.0%
8/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
13.3%
12/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
18.0%
16/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
24.4%
22/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
18.6%
50/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
General disorders
CHILLS
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
8.9%
8/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
13.5%
12/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
22.2%
20/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
14.9%
40/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
General disorders
FATIGUE
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
23.3%
21/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
30.3%
27/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
46.7%
42/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
33.5%
90/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
General disorders
INJECTION SITE PAIN
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
17.8%
16/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
30.3%
27/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
40.0%
36/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
29.4%
79/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
General disorders
MALAISE
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
10.0%
9/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
20.2%
18/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
23.3%
21/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
17.8%
48/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
General disorders
PAIN
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.3%
3/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.4%
3/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
5.6%
5/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
4.1%
11/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
CONJUNCTIVITIS
|
7.7%
7/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.4%
3/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.3%
2/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
4.5%
12/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
11.0%
10/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
6.8%
6/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.4%
3/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
7.1%
19/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
10.0%
9/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
10.1%
9/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
7.1%
19/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
6.7%
6/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
5.6%
5/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
4.5%
12/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Injury, poisoning and procedural complications
PERINEAL INJURY
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
18.9%
17/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
27.0%
24/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
23.3%
21/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
23.0%
62/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
12.2%
11/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
22.5%
20/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
28.9%
26/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
21.2%
57/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
7.8%
7/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
16.9%
15/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
23.3%
21/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
16.0%
43/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
0.00%
0/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
25.6%
23/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
36.0%
32/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
45.6%
41/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
35.7%
96/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.1%
1/91 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.3%
2/88 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.1%
1/87 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
1.5%
4/266 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.3%
3/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
2.2%
2/89 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
5.6%
5/90 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
3.7%
10/269 • Throughout the study period, for up to 24 weeks
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER