Trial Outcomes & Findings for Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants (NCT NCT00657709)
NCT ID: NCT00657709
Last Updated: 2017-10-10
Results Overview
The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3630 participants
Primary outcome timeframe
one month after the third vaccination
Results posted on
2017-10-10
Participant Flow
16 sites in Finland, 28 sites in the Czech Republic, 13 sites in Germany, 6 sites in Austria, 7 sites in Italy.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
rMenB Lot1
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
MenC+ Routine
Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
833
|
828
|
820
|
659
|
490
|
|
Overall Study
COMPLETED
|
810
|
795
|
792
|
645
|
457
|
|
Overall Study
NOT COMPLETED
|
23
|
33
|
28
|
14
|
33
|
Reasons for withdrawal
| Measure |
rMenB Lot1
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
MenC+ Routine
Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
|
|---|---|---|---|---|---|
|
Overall Study
AE or Death
|
7
|
7
|
6
|
7
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
15
|
15
|
5
|
9
|
|
Overall Study
Lost to Follow-up
|
9
|
9
|
7
|
1
|
21
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
1
|
2
|
Baseline Characteristics
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Baseline characteristics by cohort
| Measure |
rMenB Lot1
n=833 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=828 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
n=820 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
n=659 Participants
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
MenC+ Routine
n=490 Participants
Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
|
Total
n=3630 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
73.8 Days
STANDARD_DEVIATION 9.5 • n=5 Participants
|
74.1 Days
STANDARD_DEVIATION 9.6 • n=7 Participants
|
73.3 Days
STANDARD_DEVIATION 9.4 • n=5 Participants
|
74.7 Days
STANDARD_DEVIATION 9.3 • n=4 Participants
|
70.6 Days
STANDARD_DEVIATION 9.7 • n=21 Participants
|
73.5 Days
STANDARD_DEVIATION 9.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
403 Participants
n=5 Participants
|
400 Participants
n=7 Participants
|
416 Participants
n=5 Participants
|
318 Participants
n=4 Participants
|
234 Participants
n=21 Participants
|
1771 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
430 Participants
n=5 Participants
|
428 Participants
n=7 Participants
|
404 Participants
n=5 Participants
|
341 Participants
n=4 Participants
|
256 Participants
n=21 Participants
|
1859 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: one month after the third vaccinationPopulation: Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.
The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
Outcome measures
| Measure |
rMenB Lot1
n=386 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=380 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
n=394 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
|---|---|---|---|---|---|
|
The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
44/76-SL strain (Baseline)
|
1.21 Titers
Interval 1.14 to 1.29
|
1.19 Titers
Interval 1.12 to 1.27
|
1.19 Titers
Interval 1.12 to 1.27
|
—
|
—
|
|
The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
44/76-SL strain one month after 3rd vaccination
|
87 Titers
Interval 80.0 to 95.0
|
98 Titers
Interval 90.0 to 106.0
|
85 Titers
Interval 78.0 to 93.0
|
—
|
—
|
|
The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
5/99 strain (Baseline)
|
1.21 Titers
Interval 1.14 to 1.3
|
1.2 Titers
Interval 1.12 to 1.28
|
1.21 Titers
Interval 1.13 to 1.29
|
—
|
—
|
|
The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
5/99 strain one month after 3rd vaccination
|
598 Titers
Interval 550.0 to 651.0
|
681 Titers
Interval 626.0 to 741.0
|
607 Titers
Interval 558.0 to 661.0
|
—
|
—
|
|
The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
NZ98/254 strain (Baseline)
|
1.03 Titers
Interval 1.0 to 1.06
|
1.06 Titers
Interval 1.03 to 1.1
|
1.04 Titers
Interval 1.0 to 1.07
|
—
|
—
|
|
The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
one month after 3rd vaccination
|
15 Titers
Interval 13.0 to 17.0
|
14 Titers
Interval 12.0 to 16.0
|
15 Titers
Interval 14.0 to 17.0
|
—
|
—
|
PRIMARY outcome
Timeframe: one month after the third vaccinationPopulation: Analysis was done on PP population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.
The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.
Outcome measures
| Measure |
rMenB Lot1
n=1160 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=121 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
|---|---|---|---|---|---|
|
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
44/76-SL strain-1 Month after 3rd vaccination
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
3 Percentages of subjects
Interval 1.0 to 7.0
|
—
|
—
|
—
|
|
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
5/99 strain (Baseline)
|
4 Percentages of subjects
Interval 3.0 to 5.0
|
7 Percentages of subjects
Interval 3.0 to 13.0
|
—
|
—
|
—
|
|
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
5/99 strain-1 Month after 3rd vaccination
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
2 Percentages of subjects
Interval 0.0 to 6.0
|
—
|
—
|
—
|
|
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
44/76-SL strain (Baseline)
|
3 Percentages of subjects
Interval 2.0 to 4.0
|
3 Percentages of subjects
Interval 1.0 to 8.0
|
—
|
—
|
—
|
|
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
NZ98/254 strain (Baseline)
|
1 Percentages of subjects
Interval 1.0 to 2.0
|
1 Percentages of subjects
Interval 0.021 to 5.0
|
—
|
—
|
—
|
|
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
1 Month after 3rd vaccination
|
84 Percentages of subjects
Interval 82.0 to 86.0
|
2 Percentages of subjects
Interval 0.0 to 6.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after the third vaccinationPopulation: Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.
The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination.
Outcome measures
| Measure |
rMenB Lot1
n=386 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=380 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
n=394 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
n=121 Participants
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
|---|---|---|---|---|---|
|
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)
44/76-SL Baseline
|
4 Percentages of subjects
Interval 2.0 to 6.0
|
2 Percentages of subjects
Interval 1.0 to 4.0
|
3 Percentages of subjects
Interval 2.0 to 6.0
|
3 Percentages of subjects
Interval 1.0 to 8.0
|
—
|
|
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)
44/76-SL-1 Month after 3rd vaccination
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
3 Percentages of subjects
Interval 1.0 to 7.0
|
—
|
|
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)
5/99 Baseline
|
3 Percentages of subjects
Interval 2.0 to 5.0
|
4 Percentages of subjects
Interval 3.0 to 7.0
|
4 Percentages of subjects
Interval 2.0 to 7.0
|
7 Percentages of subjects
Interval 3.0 to 13.0
|
—
|
|
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)
5/99-1 Month after 3rd vaccination
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
2 Percentages of subjects
Interval 0.0 to 6.0
|
—
|
|
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)
NZ 98/254 Baseline
|
1 Percentages of subjects
Interval 0.0 to 2.0
|
2 Percentages of subjects
Interval 1.0 to 4.0
|
1 Percentages of subjects
Interval 0.0 to 2.0
|
1 Percentages of subjects
Interval 0.021 to 5.0
|
—
|
|
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)
1 Month after 3rd vaccination
|
84 Percentages of subjects
Interval 80.0 to 88.0
|
81 Percentages of subjects
Interval 77.0 to 85.0
|
85 Percentages of subjects
Interval 81.0 to 89.0
|
2 Percentages of subjects
Interval 0.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: 1 Month after the third vaccinationPopulation: Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.
The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ.
Outcome measures
| Measure |
rMenB Lot1
n=1160 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=121 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ
44/76 Strain (Baseline)
|
1.15 Titers
Interval 1.12 to 1.19
|
1.12 Titers
Interval 1.04 to 1.22
|
—
|
—
|
—
|
|
Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ
44/76 Strain-1 Month after third vaccination
|
91 Titers
Interval 87.0 to 95.0
|
1.2 Titers
Interval 1.1 to 1.31
|
—
|
—
|
—
|
|
Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ
5/99 Strain (Baseline)
|
1.18 Titers
Interval 1.14 to 1.22
|
1.21 Titers
Interval 1.1 to 1.33
|
—
|
—
|
—
|
|
Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ
5/99 Strain-1 Month after third vaccination
|
635 Titers
Interval 606.0 to 665.0
|
1.06 Titers
Interval 0.97 to 1.17
|
—
|
—
|
—
|
|
Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ
NZ98/254 (Baseline)
|
1.05 Titers
Interval 1.03 to 1.07
|
1.01 Titers
Interval 0.99 to 1.04
|
—
|
—
|
—
|
|
Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ
1 Month after third vaccination
|
14 Titers
Interval 13.0 to 15.0
|
1.04 Titers
Interval 0.98 to 1.11
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after third vaccinationPopulation: Analysis was done on PP dataset.
The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination.
Outcome measures
| Measure |
rMenB Lot1
n=615 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=600 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
n=611 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
n=1823 Participants
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
Routine
n=113 Participants
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)
Baseline
|
22 IU/mL
Interval 21.0 to 23.0
|
22 IU/mL
Interval 21.0 to 22.0
|
22 IU/mL
Interval 21.0 to 23.0
|
22 IU/mL
Interval 21.0 to 22.0
|
21 IU/mL
Interval 20.0 to 21.0
|
|
Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)
1 Month after 3rd vaccination
|
3149 IU/mL
Interval 2960.0 to 3352.0
|
3484 IU/mL
Interval 3270.0 to 3712.0
|
3103 IU/mL
Interval 2915.0 to 3304.0
|
3370 IU/mL
Interval 3270.0 to 3472.0
|
22 IU/mL
Interval 21.0 to 23.0
|
SECONDARY outcome
Timeframe: 1 month after third vaccinationPopulation: Analysis was done on Immunogenicity Routine PP (Pertussis Antigens)
Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination.
Outcome measures
| Measure |
rMenB Lot1
n=241 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=246 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations
FHA (Baseline)
|
9.98 IU/mL
Interval 8.78 to 11.0
|
9.28 IU/mL
Interval 8.17 to 11.0
|
—
|
—
|
—
|
|
Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations
1 Month post 3rd vaccination; FHA
|
123 IU/mL
Interval 114.0 to 133.0
|
147 IU/mL
Interval 136.0 to 158.0
|
—
|
—
|
—
|
|
Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations
Pertactin (Baseline)
|
6.3 IU/mL
Interval 5.52 to 7.17
|
5.36 IU/mL
Interval 4.71 to 6.11
|
—
|
—
|
—
|
|
Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations
1 Month post 3rd vaccination; Pertactin
|
107 IU/mL
Interval 97.0 to 119.0
|
139 IU/mL
Interval 126.0 to 155.0
|
—
|
—
|
—
|
|
Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations
PT (Baseline)
|
2.82 IU/mL
Interval 2.68 to 2.96
|
2.82 IU/mL
Interval 2.68 to 2.96
|
—
|
—
|
—
|
|
Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations
1 Month post 3rd vaccination; PT
|
41 IU/mL
Interval 37.0 to 44.0
|
51 IU/mL
Interval 46.0 to 55.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 Month after third vaccinationPopulation: Analysis was done on PP population.
The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(\>=1:8). Diptheria and Tetanus: primary endpoint ELISA \>=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA\>=1.0 IU/mL. HepB (HBV):primary endpoint ELISA \>=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC \>=0.35 mcg/ml
Outcome measures
| Measure |
rMenB Lot1
n=245 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=252 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
|---|---|---|---|---|---|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
Anti-DiphtheriaToxin ≥0.1IU/mL(Baseline)
|
38 Percentages Of Subjects
Interval 32.0 to 44.0
|
38 Percentages Of Subjects
Interval 32.0 to 45.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;anti-D
|
100 Percentages Of Subjects
Interval 98.0 to 100.0
|
100 Percentages Of Subjects
Interval 98.0 to 100.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
Anti-DiphtheriaToxin ≥1.0 IU/mL(Baseline)
|
2 Percentages Of Subjects
Interval 1.0 to 5.0
|
2 Percentages Of Subjects
Interval 1.0 to 5.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination, anti-D≥1.0 IU/mL
|
80 Percentages Of Subjects
Interval 75.0 to 85.0
|
86 Percentages Of Subjects
Interval 81.0 to 90.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
Anti-TetanusToxin ≥0.1 IU/mL(Baseline)
|
93 Percentages Of Subjects
Interval 88.0 to 96.0
|
95 Percentages Of Subjects
Interval 91.0 to 97.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;anti-T
|
100 Percentages Of Subjects
Interval 98.0 to 100.0
|
100 Percentages Of Subjects
Interval 98.0 to 100.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
Anti-Tetanus Toxin ≥1.0 IU/mL(Baseline)
|
24 Percentages Of Subjects
Interval 18.0 to 30.0
|
27 Percentages Of Subjects
Interval 22.0 to 33.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month after third vaccination,anti-T≥1.0 IU/mL
|
91 Percentages Of Subjects
Interval 86.0 to 94.0
|
95 Percentages Of Subjects
Interval 91.0 to 97.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
Polio 1 ≥1:8 (Baseline)
|
75 Percentages Of Subjects
Interval 69.0 to 80.0
|
72 Percentages Of Subjects
Interval 66.0 to 77.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;Polio 1
|
95 Percentages Of Subjects
Interval 92.0 to 98.0
|
97 Percentages Of Subjects
Interval 94.0 to 99.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
Polio 2 (Baseline)
|
68 Percentages Of Subjects
Interval 62.0 to 74.0
|
69 Percentages Of Subjects
Interval 63.0 to 74.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;Polio 2
|
88 Percentages Of Subjects
Interval 84.0 to 92.0
|
94 Percentages Of Subjects
Interval 90.0 to 97.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
Polio 3 (Baseline)
|
48 Percentages Of Subjects
Interval 41.0 to 54.0
|
49 Percentages Of Subjects
Interval 42.0 to 55.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;Polio 3
|
97 Percentages Of Subjects
Interval 94.0 to 99.0
|
98 Percentages Of Subjects
Interval 95.0 to 99.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
HBV ≥10 mIU/mL (Baseline)
|
22 Percentages Of Subjects
Interval 17.0 to 28.0
|
15 Percentages Of Subjects
Interval 10.0 to 20.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;HBV
|
98 Percentages Of Subjects
Interval 95.0 to 99.0
|
100 Percentages Of Subjects
Interval 99.0 to 100.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
Anti-PRP (HIB) ≥ 0.15 μg/mL(Baseline)
|
54 Percentages Of Subjects
Interval 47.0 to 60.0
|
55 Percentages Of Subjects
Interval 49.0 to 62.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post 3rd vaccination;anti-PRP ≥ 0.15
|
99 Percentages Of Subjects
Interval 97.0 to 100.0
|
100 Percentages Of Subjects
Interval 98.0 to 100.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
Anti-PRP (HIB) ≥ 1.0 μg/mL (Baseline)
|
12 Percentages Of Subjects
Interval 9.0 to 17.0
|
10 Percentages Of Subjects
Interval 7.0 to 15.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;anti-PRP ≥ 1.0
|
79 Percentages Of Subjects
Interval 73.0 to 84.0
|
79 Percentages Of Subjects
Interval 73.0 to 84.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
PnC4 ≥0.35μg/mL (Baseline)
|
2 Percentages Of Subjects
Interval 0.0 to 4.0
|
2 Percentages Of Subjects
Interval 1.0 to 5.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;PnC4
|
98 Percentages Of Subjects
Interval 95.0 to 99.0
|
100 Percentages Of Subjects
Interval 98.0 to 100.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
PnC 6B ≥0.35μg/mL (Baseline)
|
14 Percentages Of Subjects
Interval 10.0 to 19.0
|
16 Percentages Of Subjects
Interval 12.0 to 22.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;PnC 6B
|
90 Percentages Of Subjects
Interval 85.0 to 93.0
|
88 Percentages Of Subjects
Interval 83.0 to 92.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
PnC 9V ≥0.35μg/mL (Baseline)
|
4 Percentages Of Subjects
Interval 2.0 to 7.0
|
3 Percentages Of Subjects
Interval 1.0 to 6.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;PnC 9V
|
100 Percentages Of Subjects
Interval 98.0 to 100.0
|
100 Percentages Of Subjects
Interval 98.0 to 100.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
PnC 14 ≥0.35μg/mL (Baseline)
|
33 Percentages Of Subjects
Interval 27.0 to 39.0
|
38 Percentages Of Subjects
Interval 31.0 to 44.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;PnC 14
|
96 Percentages Of Subjects
Interval 93.0 to 98.0
|
97 Percentages Of Subjects
Interval 94.0 to 99.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
PnC 18C ≥0.35μg/mL (Baseline)
|
10 Percentages Of Subjects
Interval 7.0 to 15.0
|
17 Percentages Of Subjects
Interval 12.0 to 22.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;PnC 18
|
98 Percentages Of Subjects
Interval 96.0 to 100.0
|
99 Percentages Of Subjects
Interval 97.0 to 100.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
PnC 19F ≥0.35μg/mL (Baseline)
|
20 Percentages Of Subjects
Interval 15.0 to 26.0
|
21 Percentages Of Subjects
Interval 16.0 to 27.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post third vaccination;PnC 19
|
96 Percentages Of Subjects
Interval 93.0 to 98.0
|
96 Percentages Of Subjects
Interval 93.0 to 98.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
PnC 23F ≥0.35μg/mL (Baseline)
|
16 Percentages Of Subjects
Interval 12.0 to 21.0
|
22 Percentages Of Subjects
Interval 17.0 to 28.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Antibody Response Against the Routine Antigens
1 Month post 3rd vaccination;PnC 23F
|
92 Percentages Of Subjects
Interval 88.0 to 95.0
|
95 Percentages Of Subjects
Interval 92.0 to 97.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: Analysis was done on PP dataset.
Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid).
Outcome measures
| Measure |
rMenB Lot1
n=238 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=243 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
|---|---|---|---|---|---|
|
Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens
FHA
|
84 Percentages of Subjects
Interval 79.0 to 88.0
|
87 Percentages of Subjects
Interval 82.0 to 91.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens
Pertactin
|
79 Percentages of Subjects
Interval 73.0 to 84.0
|
88 Percentages of Subjects
Interval 84.0 to 92.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens
PT
|
92 Percentages of Subjects
Interval 88.0 to 95.0
|
95 Percentages of Subjects
Interval 91.0 to 97.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 Month after third vaccinationPopulation: Analysis was done on PP dataset.
Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age.
Outcome measures
| Measure |
rMenB Lot1
n=370 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=359 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
n=376 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
n=1102 Participants
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
Routine
n=114 Participants
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
|---|---|---|---|---|---|
|
Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination
44/76-SL
|
99 Percentages of Subjects
Interval 97.0 to 100.0
|
100 Percentages of Subjects
Interval 99.0 to 100.0
|
98 Percentages of Subjects
Interval 97.0 to 99.0
|
99 Percentages of Subjects
Interval 98.0 to 100.0
|
1 Percentages of Subjects
Interval 0.023 to 5.0
|
|
Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination
5/99
|
100 Percentages of Subjects
Interval 99.0 to 100.0
|
100 Percentages of Subjects
Interval 99.0 to 100.0
|
99 Percentages of Subjects
Interval 98.0 to 100.0
|
100 Percentages of Subjects
Interval 99.0 to 100.0
|
2 Percentages of Subjects
Interval 0.0 to 6.0
|
|
Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination
NZ98/254
|
70 Percentages of Subjects
Interval 66.0 to 75.0
|
69 Percentages of Subjects
Interval 64.0 to 74.0
|
75 Percentages of Subjects
Interval 70.0 to 79.0
|
71 Percentages of Subjects
Interval 69.0 to 74.0
|
1 Percentages of Subjects
Interval 0.022 to 5.0
|
SECONDARY outcome
Timeframe: 1 month after third vaccinationPopulation: Analysis was done on PP population
Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains.
Outcome measures
| Measure |
rMenB Lot1
n=386 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=379 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
n=394 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
n=1156 Participants
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
Routine
n=119 Participants
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
|---|---|---|---|---|---|
|
Percentage of Subjects With hSBA Titers ≥1:8
44/76-SL (Baseline)
|
2 Percentages of subjects
Interval 1.0 to 4.0
|
2 Percentages of subjects
Interval 1.0 to 3.0
|
2 Percentages of subjects
Interval 1.0 to 4.0
|
2 Percentages of subjects
Interval 1.0 to 3.0
|
2 Percentages of subjects
Interval 0.0 to 6.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8
1 Month after 3rd vaccination-44/76-SL
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
1 Percentages of subjects
Interval 0.022 to 5.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8
5/99 (Baseline)
|
3 Percentages of subjects
Interval 1.0 to 5.0
|
3 Percentages of subjects
Interval 1.0 to 5.0
|
2 Percentages of subjects
Interval 1.0 to 4.0
|
3 Percentages of subjects
Interval 2.0 to 4.0
|
2 Percentages of subjects
Interval 0.0 to 6.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8
1 Month after 3rd vaccination-5/99
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
2 Percentages of subjects
Interval 0.0 to 6.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8
NZ98/254 (Baseline)
|
1 Percentages of subjects
Interval 0.063 to 2.0
|
1 Percentages of subjects
Interval 0.0 to 3.0
|
0 Percentages of subjects
Interval 0.0 to 1.0
|
1 Percentages of subjects
Interval 0.0 to 1.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8
1 Month after 3rd vaccination
|
70 Percentages of subjects
Interval 66.0 to 75.0
|
70 Percentages of subjects
Interval 65.0 to 74.0
|
75 Percentages of subjects
Interval 70.0 to 79.0
|
72 Percentages of subjects
Interval 69.0 to 74.0
|
1 Percentages of subjects
Interval 0.021 to 5.0
|
SECONDARY outcome
Timeframe: upto 7 days after any vaccinationPopulation: The analysis was done on safety subset population - all subjects enrolled who received study vaccination and provided post-baseline safety data.
The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events.
Outcome measures
| Measure |
rMenB Lot1
n=2479 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=490 Participants
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Any Local
|
2388 Participants
|
443 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Injection site tenderness
|
2147 Participants
|
266 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Injection site erythema
|
2049 Participants
|
261 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Injection site induration
|
1908 Participants
|
227 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Injection site swelling
|
1174 Participants
|
84 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Any Systemic
|
2450 Participants
|
459 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Change in Eating Habits
|
1787 Participants
|
257 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Sleepiness
|
2159 Participants
|
353 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Vomiting
|
662 Participants
|
116 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Diarrhea
|
1086 Participants
|
164 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Irritability
|
2296 Participants
|
370 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Unusual Crying
|
2109 Participants
|
352 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Rash
|
318 Participants
|
43 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Fever >= 38.5C
|
1912 Participants
|
228 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Others
|
2302 Participants
|
325 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Medical Attend. Fever
|
57 Participants
|
16 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Analg. Antipyretic Med.Used
|
2302 Participants
|
325 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Antipyretic Med.Used
|
2240 Participants
|
314 Participants
|
—
|
—
|
—
|
Adverse Events
rMenB Lot1
Serious events: 70 serious events
Other events: 827 other events
Deaths: 0 deaths
rMenB Lot2
Serious events: 80 serious events
Other events: 825 other events
Deaths: 0 deaths
rMenB Lot3
Serious events: 60 serious events
Other events: 817 other events
Deaths: 0 deaths
Routine
Serious events: 51 serious events
Other events: 652 other events
Deaths: 0 deaths
MenC+Routine
Serious events: 28 serious events
Other events: 482 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rMenB Lot1
n=832 participants at risk
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=828 participants at risk
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
n=820 participants at risk
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
n=659 participants at risk
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
MenC+Routine
n=490 participants at risk
Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Aplasia pure red cell
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Congenital, familial and genetic disorders
Cerebral Palsy
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Congenital, familial and genetic disorders
Congenital Coronary Artery Malformation
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Congenital, familial and genetic disorders
Faciodigitogenital Dysplasia
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Congenital, familial and genetic disorders
Gnathoschisis
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Congenital, familial and genetic disorders
Microcephaly
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Congenital, familial and genetic disorders
Thalassaemia Beta
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Eye disorders
Blindness
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.46%
3/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Gastrointestinal disorders
Enteritis
|
0.24%
2/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.24%
2/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.30%
2/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Gastrointestinal disorders
Infantile Colic
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Gastrointestinal disorders
Intusscusception
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Gastrointestinal disorders
Stomatitis
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
General disorders
Irritability
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
General disorders
Pyrexia
|
0.36%
3/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.37%
3/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Immune system disorders
Milk allergy
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Bronchiolitis
|
0.48%
4/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.24%
2/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.61%
5/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.41%
2/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Bronchitis
|
0.72%
6/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
1.4%
12/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.85%
7/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
1.7%
11/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Bronchopneumonia
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.48%
4/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Exanthema Subitum
|
0.24%
2/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Febrile Infection
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
12/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.85%
7/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
1.5%
12/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
1.1%
7/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.41%
2/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Gastroenteritis Adenovirus
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.36%
3/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.48%
4/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.41%
2/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Gastroenteritis Salmonella
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Infection
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Laryngitis
|
0.84%
7/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.48%
4/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.37%
3/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.46%
3/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Mastitis
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.30%
2/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Otitis media
|
0.36%
3/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.24%
2/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.73%
6/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.46%
3/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Otitis media acute
|
0.24%
2/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Pertussis
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.24%
2/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.36%
3/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.48%
4/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.37%
3/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.30%
2/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Pseudocroup
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Pyelonephritis
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.36%
3/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.73%
6/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.30%
2/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Pyelonephritis acute
|
0.24%
2/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.36%
3/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.37%
3/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.30%
2/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Respiratory syncytial virus
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.30%
2/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.24%
2/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
H1N1 Influenza
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Tonsilitis
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.24%
2/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.24%
2/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.61%
3/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Varicella
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Viral infection
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.36%
3/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.30%
2/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Foregin body trauma
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.24%
2/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
vaccination complication
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Feeding disorder or infancy or early childhood
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.30%
2/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Premature closure of cranial sutures
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Nervous system disorders
Convulsion
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.24%
2/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • Number of events 1 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Nervous system disorders
Febrile Convulsion
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.37%
3/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Nervous system disorders
Generalised Tonic-Clonic Seizure
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Nervous system disorders
Infantile spasms
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Psychiatric disorders
Breath Holding
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Psychiatric disorders
Decreased activity
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.24%
2/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.30%
2/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Eczema Nummular
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Surgical and medical procedures
Labial frenectomy
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Surgical and medical procedures
Tendon operation
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Vascular disorders
Kawasaki's disease
|
0.12%
1/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.20%
1/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/828 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.12%
1/820 • Number of events 1 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/659 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Influenza
|
0.00%
0/832 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.24%
2/828 • Number of events 2 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/820 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.15%
1/659 • Number of events 1 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.00%
0/490 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
Other adverse events
| Measure |
rMenB Lot1
n=832 participants at risk
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot2
n=828 participants at risk
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
rMenB Lot3
n=820 participants at risk
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
|
Routine
n=659 participants at risk
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
|
MenC+Routine
n=490 participants at risk
Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
59/832 • Number of events 66 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
7.0%
58/828 • Number of events 66 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
7.3%
60/820 • Number of events 69 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
6.5%
43/659 • Number of events 48 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
8.2%
40/490 • Number of events 51 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Nervous system disorders
Somnolence
|
85.8%
714/832 • Number of events 1657 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
88.0%
729/828 • Number of events 1684 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
87.3%
716/820 • Number of events 1624 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
72.2%
476/659 • Number of events 914 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
72.0%
353/490 • Number of events 711 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
General disorders
Crying
|
85.8%
714/832 • Number of events 1740 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
85.9%
711/828 • Number of events 1750 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
83.5%
685/820 • Number of events 1693 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
64.3%
424/659 • Number of events 822 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
71.8%
352/490 • Number of events 752 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
General disorders
Injection site erythema
|
87.6%
729/832 • Number of events 4171 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
88.5%
733/828 • Number of events 4135 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
85.9%
704/820 • Number of events 4034 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
75.4%
497/659 • Number of events 1792 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
78.6%
385/490 • Number of events 1788 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
General disorders
Injection site induration
|
83.2%
692/832 • Number of events 4024 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
82.1%
680/828 • Number of events 3915 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
81.0%
664/820 • Number of events 3926 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
68.6%
452/659 • Number of events 1741 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
79.6%
390/490 • Number of events 1761 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
General disorders
Injection site pain
|
88.5%
736/832 • Number of events 4472 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
88.9%
736/828 • Number of events 4497 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
88.8%
728/820 • Number of events 4541 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
63.0%
415/659 • Number of events 1364 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
73.1%
358/490 • Number of events 1615 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
General disorders
Injection site swelling
|
52.9%
440/832 • Number of events 1683 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
56.3%
466/828 • Number of events 1688 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
53.2%
436/820 • Number of events 1743 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
38.5%
254/659 • Number of events 653 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
37.6%
184/490 • Number of events 519 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
General disorders
Pyrexia
|
78.8%
656/832 • Number of events 1344 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
78.0%
646/828 • Number of events 1338 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
78.4%
643/820 • Number of events 1332 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
48.4%
319/659 • Number of events 493 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
50.6%
248/490 • Number of events 425 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
General disorders
Vaccination site induration
|
5.0%
42/832 • Number of events 76 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
3.6%
30/828 • Number of events 60 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
4.6%
38/820 • Number of events 74 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
0.61%
4/659 • Number of events 5 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
10.4%
51/490 • Number of events 105 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Psychiatric disorders
Eating disorder
|
70.7%
588/832 • Number of events 1152 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
72.8%
603/828 • Number of events 1223 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
72.7%
596/820 • Number of events 1211 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
49.9%
329/659 • Number of events 580 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
52.4%
257/490 • Number of events 492 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Psychiatric disorders
Irritability
|
92.4%
769/832 • Number of events 2181 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
91.9%
761/828 • Number of events 2168 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
93.4%
766/820 • Number of events 2183 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
82.5%
544/659 • Number of events 1339 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
75.5%
370/490 • Number of events 877 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
44.5%
370/832 • Number of events 607 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
45.9%
380/828 • Number of events 632 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
44.9%
368/820 • Number of events 624 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
34.1%
225/659 • Number of events 358 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
34.3%
168/490 • Number of events 286 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
26.1%
217/832 • Number of events 315 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
28.3%
234/828 • Number of events 329 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
26.3%
216/820 • Number of events 317 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
16.4%
108/659 • Number of events 149 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
24.5%
120/490 • Number of events 178 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.5%
121/832 • Number of events 180 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
14.4%
119/828 • Number of events 168 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
13.4%
110/820 • Number of events 147 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
13.4%
88/659 • Number of events 116 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
10.2%
50/490 • Number of events 79 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Bronchitis
|
12.3%
102/832 • Number of events 129 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
11.8%
98/828 • Number of events 132 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
11.5%
94/820 • Number of events 123 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
14.7%
97/659 • Number of events 125 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
12.0%
59/490 • Number of events 80 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Conjunctivitis
|
8.9%
74/832 • Number of events 91 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
9.7%
80/828 • Number of events 100 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
9.4%
77/820 • Number of events 91 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
9.1%
60/659 • Number of events 66 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
3.3%
16/490 • Number of events 19 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Ear infection
|
10.3%
86/832 • Number of events 119 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
8.5%
70/828 • Number of events 106 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
7.0%
57/820 • Number of events 85 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
9.0%
59/659 • Number of events 91 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
5.3%
26/490 • Number of events 38 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Exanthema subitum
|
5.5%
46/832 • Number of events 46 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
5.7%
47/828 • Number of events 47 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
5.6%
46/820 • Number of events 46 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
5.8%
38/659 • Number of events 38 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
4.3%
21/490 • Number of events 21 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
4.1%
34/832 • Number of events 34 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
5.7%
47/828 • Number of events 51 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
4.6%
38/820 • Number of events 41 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
3.8%
25/659 • Number of events 25 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
2.9%
14/490 • Number of events 15 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
9.4%
78/832 • Number of events 97 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
9.5%
79/828 • Number of events 108 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
9.9%
81/820 • Number of events 106 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
11.1%
73/659 • Number of events 107 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
2.4%
12/490 • Number of events 12 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Otitis media
|
18.3%
152/832 • Number of events 256 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
17.5%
145/828 • Number of events 267 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
19.0%
156/820 • Number of events 284 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
18.8%
124/659 • Number of events 229 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
5.7%
28/490 • Number of events 38 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Rhinitis
|
9.4%
78/832 • Number of events 90 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
12.0%
99/828 • Number of events 120 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
7.1%
58/820 • Number of events 66 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
9.6%
63/659 • Number of events 84 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
6.1%
30/490 • Number of events 33 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.1%
142/832 • Number of events 190 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
15.2%
126/828 • Number of events 172 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
16.2%
133/820 • Number of events 175 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
14.3%
94/659 • Number of events 124 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
9.6%
47/490 • Number of events 59 • All serious adverse events and medically attended adverse events are collected from Day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Of a total of 3630 enrolled subjects, 3629 received at least one vaccination and were included in the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60